Deals Shaping The Medical Industry, October 2012

The Dealmaking column is a survey of recent transactions, including strategic alliances, mergers & acquisitions, and financings, in the life sciences industries. Deals are listed by the following industry sectors: in vitro diagnostics, medical devices, pharmaceuticals, and research/analytical instrumentation and reagents. All transactions are excerpted from Elsevier's Strategic Transactions database, providing comprehensive transaction coverage from 1991 to the present.

IN VITRO DIAGNOSTICS

Mergers & Acquisitions

Danaher Corp.

Beckman Coulter Inc.

IRIS International Inc.

Medical and industrial products manufacturer Danaher Corp. is acquiring publicly traded IRIS International Inc. (body fluid analysis, sample processing, and early disease detection) for $352mm, or $19.50 per share (a 51% premium). (Sep.)

IRIS, which was founded in 1979, operates in three units. Its primary business is in vitro diagnostics that analyze the chemistry and morphology of cells and sediments in urine and other body fluids. Via its flagship iQ series, IRIS is the top global company in the automated urine microscopy systems market. These products use real-time video flow imaging to display microscopic images of samples. Some of IRIS’s most recently launched offerings include iRICELL, which combines urine microscopy and urine chemistry to provide fully automated complete urinalysis testing, and iChemVELOCITY, an automated urine chemistry analyzer. The company’s second segment sells sample processing equipment and accessories, such as small centrifuges (under the StatSpin brand), blood separators, and semi-automated DNA processing stations. And finally, IRIS has developed the molecular diagnostics platform Nucleic Acid Detection Immuno-Assay (NADiA) as part of its personalized medicine business. Last year regulators in the US and EU approved IRIS’s first NADiA assay, the NADiA ProsVue, a prognostic that identifies post-radical prostatectomy patients at reduced risk for recurrence of prostate cancer. The company is also investigating applications for NADiA in HIV, including monitoring HIV viral load during anti-retroviral therapy. In 2011, IRIS recorded a $1.2mm net loss on $118.3mm in revenues, and at the end of Q2 2012 had $27.2mm cash on hand. Post-acquisition, IRIS will become a division of Beckman Coulter Inc., which Danaher acquired in February 2011 for $6.8bn. Beckman believes the current deal brings additional offerings that will aid in automation in central labs. In addition, Beckman may potentially integrate IRIS’s cell imaging technology and hematology pipeline (including the 3GEMS platform to automate blood cell identification and characterization) into Beckman’s hematology portfolio. Investment Banks/Advisors: Citigroup Inc. (IRIS International Inc.)

Illumina Inc.

BlueGnome Ltd.

Illumina Inc. has acquired BlueGnome Ltd., a privately held company focused on diagnostics for genetic abnormalities associated with developmental delay, cancer, and infertility. (Sep.)

Formed in 2002, BlueGnome has created the 24sure preimplantation genetic screening test, which counts the chromosomes in a single human cell in order to increase the success of in vitro fertilization rates and reduce miscarriages. BlueGnome also sells CytoChip, a test to detect genetic abnormalities that accompany developmental delay or complex leukemias. The product is used by over 200 labs in more than 40 countries and has replaced the traditional G-band karyotyping as a first-line cytogenetic test. BlueGnome--which has offices in the UK, the US, and Singapore--will continue to be led by its founders, Nick Haan and Graham Snudden, and will become part of Illumina’s diagnostics business. Illumina was the target of a hostile takeover earlier this year; Roche had offered to pay up to $51/share, but Illumina’s shareholders rebuffed the attempt.

Alliances

Axial Biotech Inc.

Transgenomic Inc.

Transgenomic Inc. (laboratory services, molecular tools, and diagnostics) has acquired spinal disorder-focused Axial Biotech Inc.’s ScoliScore test for adolescent idiopathic scoliosis (AIS). (Aug.)

The purchase price for ScoliScore and related intellectual property is $4.4mm in cash. Transgenomic also benefits from Axial’s established revenue and customer base, and access to a US market estimated at 400,000 patients. With a 99% accuracy rate, ScoliScore is the first saliva-based multi-gene test that assesses spinal curve progression for adolescent children with AIS. The diagnostic determines which patients are unlikely to require surgical intervention. (Just 2-4% of children diagnosed with AIS progress to severe spinal curvature.) By using ScoliScore to understand the likelihood for the disease’s progression, physicians can reduce the need for x-rays and resulting harmful exposure to radiation.

Biogen Idec Inc.

Regulus Therapeutics Inc.

Regulus Therapeutics Inc. (a 2007 joint venture between Alnylam and Isis) will help Biogen Inc. identify blood-borne microRNA biomarkers for multiple sclerosis. (Aug.)

Biogen Idec will make an equity investment in Regulus and pay $750k up front plus up to $1.3mm in research milestones. Regulus also received $5mm from the issuance of a convertible note to Biogen. Information and discoveries regarding microRNA biomarkers in MS patients can be used in the development of companion diagnostics and to monitor disease progression. Ultimately this will enable better decision-making in the clinical development process--by selecting optimal patients for trials--and assist in early-stage drug discovery. Biogen already markets the MS drugs Tysabri, Avonex, and Fampyra. This deal was penned one day after Regulus granted AstraZeneca PLC exclusive rights to develop and sell microRNA therapeutics for three preclinical targets focused on cardiovascular and metabolic diseases and oncology.

Quidel Corp.

Diagnostic Hybrids Inc.

InGen BioSciences

InGen BioSciences has signed an exclusive distribution agreement with Quidel Corp.’s Diagnostic Hybrids Inc. to sell 14 bacterial and viral diagnostics and pregnancy tests in France. (Aug.)

InGen has licensed rights to Diagnostic Hybrids’ QuickVue culture and direct fluorescent antibody diagnostics for influenza, H1N1 influenza A, metapneumovirus, and herpes infections (herpes simplex virus, cytomegalovirus, and varicella zoster virus). The newly licensed products--which only require 3-15 minutes for results--complement InGen’s portfolio, which includes tests for respiratory infections (Bordetella pertussis, pneumonia, influenza, and Streptococcus), sexually transmitted infections (hepatitis, herpes I and II, and HIV), and an hCG pregnancy test. The transaction is in line with InGen’s recent deal with Cylex under which InGen got exclusive rights to sell the ImmuKnow assay in France; the test monitors immune system function in transplant patients.

Financings

Response Genetics Inc.

Response Genetics Inc. (molecular diagnostics for cancer) completed a $3.3mm placement to a single unnamed investor, which bought 3mm shares at $1.10, a 39% premium. Separately, the company’s partner GlaxoSmithKline PLC purchased 5mm shares at the same price (for a 15.2% equity stake) as part of their 2010 collaboration. (Sep.)

Sequenom Inc.

Sequenom Inc. (genetic analysis) has privately sold $110mm of its five-year convertible senior notes. They have a fixed-rate interest of 5%--payable semiannually on April 1 and October 1 of each year starting next April--and convert into 216.1 common shares per $1k principal amount (an initial conversion rate of $4.63; the stock is currently averaging $3.76). Sequenom will use the money to market its MaterniT21 Plus diagnostic, which analyzes circulating cell-free DNA present in a maternal blood sample. It tests for increases in chromosomal material associated with Trisomy 21, 18, and 13. (Sep.)

MEDICAL DEVICES

Mergers & Acquisitions

Boston Scientific Corp.

BridgePoint Medical Inc.

Boston Scientific Corp. has acquired closely held cardiovascular device firm BridgePoint Medical Inc. (Sep.)

Formed in 2005 as Prospex Medical, BridgePoint raised over $25mm through several venture rounds from investors that include New Enterprise Associates, Polaris Venture Partners, and Foundation Medical Partners. BridgePoint has developed a catheter-based system for coronary total occlusions (CTOs), which uses the CrossBoss CTO crossing catheter and Stingray CTO re-entry system. The FDA-cleared and CE-Marked devices enable surgeons to navigate highly diseased arteries in order to restore blood flow. It is the only system in the US that has been okayed for crossing and re-entry as a means to treat coronary CTOs. An alternative to bypass surgery requiring weeks of recovery, patients on which the BridgePoint system is used are released from the hospital after just one day. BSC will add BridgePoint to its Interventional Cardiology business; its Peripheral Intervention unit already offers TruePath and OffRoad CTO devices. Earlier this year BSC added to its cardiovascular devices through the acquisition of implantable defibrillator company Cameron Health.

CardioNet Inc.

CardioCore Lab Inc.

BioTelemetry Inc. (wireless devices to diagnose and monitor cardiac arrhythmias) has acquired closely held centralized cardiac testing lab CardioCore Lab Inc. for $23.5mm, of which $3.5mm may be paid in common stock at CardioNet's option. (Aug.)

CardioCore Lab was formed in 1992 as Central Cardiac Testing (it changed its name in 2003) and has two locations in the US and one in London. The company offers ECG testing services, Holter services (data transfer, analysis, ECG extraction), ambulatory blood pressure monitoring and analysis, and echocardiography scan and analysis services. CardioCore should generate up to $20mm in revenue with the potential for $4mm in earnings for FYE 2012. The transaction is designed to move CardioNet’s Mobile Cardiac Outpatient Telemetry--the next-generation ambulatory cardiac monitoring service that provides beat-to-beat, real-time analysis--into the growing cardiac testing laboratory services market, and help CardioNet become a full-service cardiac monitoring firm. CardioNet’s last acquisition was finalized in 2010, when it purchased Biotel for $11.3mm in order to enter the cardiac clinical research services market.

Conmed Corp.

Viking Systems Inc.

ConMed Corp. (minimally invasive surgical devices) has agreed to pay $0.27 in cash per share (a 42% premium), or $22.5mm including stock options and warrants, to acquire publicly traded Viking Systems Inc. (surgical visualization systems). (Aug.)

Viking’s business is focused on the sale of three-dimensional high-definition (3DHD) surgical video solutions for use during complex minimally invasive procedures. The company’s lead product--the Viking 3D-HD Vision System--is made up of a flat screen monitor, 3D-HD camera heads, endoscopes, and laparoscopes, and is used by surgeons in urological, gynecological, bariatric, cardiac, neurological, and general surgeries. Viking states that its system is the only stand-alone 3D laparoscopic vision system that is both FDA approved and CE-Marked. The company also manufactures 2D digital cameras, which it sells to customers such as Boston Scientific and Medtronic for OEM programs. The 3D-HD capability is a new area for ConMed, which offers a wide variety of surgical device options including arthroscopy instruments, electrosurgery tools, patient monitoring systems, and endoscopy solutions. One area where the businesses of ConMed and Viking will overlap is in the 2D camera space, through ConMed’s ConMed Linvatec unit. As a result, ConMed has decided to fold Linvatec’s Santa Barbara, CA, design center into Viking’s Westborough, MA-based operations (eliminating some ConMed employees in the process) and create a new strategic business headed by Viking’s president and CEO Jed Kennedy. Viking Systems was formed in 1998 and reported revenues of $10.8mm for 2011, with a $3mm loss. Investment Banks/Advisors: Cantor Fitzgerald & Co. (Viking Systems Inc.)

ConvaTec Inc.

180 Medical Holdings Inc.

ConvaTec Inc. (wound care and ostomy products) has acquired closely held urological device company 180 Medical Holdings Inc. for $321mm. (Aug.)

The newly acquired firm offers sterile catheter and other disposable medical supplies to patients with urinary incontinence, spinal cord injuries, multiple sclerosis, transverse myelitis, spina bifida, and other conditions requiring catheterization. 180 Medical was established in 2001 by Todd Brown--who was paralyzed from the chest down in a motocross accident--and employs workers with spinal cord injuries. It sells various Bard, Coloplast, Mentor, Rusch, and Rochester hydrophilic, closed system, or intermittent catheters for adults and children. ConvaTec last expanded its product portfolio in June when it purchased Trio Healthcare International Ltd.

Getinge AB

Kinetic Concepts Inc.

Health care equipment company Getinge AB has agreed to pay $275mm to buy the Therapeutic Support Systems (TSS) business of Kinetic Concepts Inc. (therapeutic devices for wound care). Getinge will integrate TSS into its Extended Care division under the ArjoHuntleigh brand. (Aug.)

TSS was one of the first businesses that helped KCI make a name for itself when the company was born in 1976. TSS products--mainly beds and mattress replacement systems--are aimed at helping caretakers manage chronic and traumatic cases of patient immobility to prevent serious complications. Brands include the TheraPulse ATP and KinAir MedSurg pulsating air suspension therapy systems, which help prevent and treat pressure ulcers; RotoProne and RotoRest kinetic systems which, in their 40° side-to-side rotation of patients, help manage and prevent acute respiratory distress syndrome and ventilator assisted pneumonia; and the BariAir, BariMaxx, and MaxxAir ETS therapeutic bed systems used in bariatric patient care. KCI is divesting the business to focus further on its more profitable negative-pressure wound healing products. The company was taken private by Apax Partners and affiliates in late 2011 and at the start of this year, announced that it was pursuing alternative options for TSS as it tried cut costs and climb out from a large amount of debt. TSS brought in $247mm in 2011 revenues. Getinge looks forward to both the synergies of the acquired business’ products with its own (the Extended Care division offers various patient handling and medical bed systems, as well as similar pressure ulcer prevent products), and it will also benefit from the new markets it gains access to through TSS, including critical care and bariatrics. Additionally, the acquisition expands Getinge’s presence in the US: 60% of TSS sales came from the US in 2011, while Getinge’s activities in that country only accounted for about a third of the company’s revenues. Investment Banks/Advisors: Credit Suisse Group; UBS Investment Bank (Kinetic Concepts Inc.)

Masimo Corp.

Phasein AB

Masimo Corp. (noninvasive monitoring technologies) has paid $30.4mm in cash for Phasein AB, a private Swedish specialist of multi-gas measurement. Phasein’s current CEO Robert Zyzanski will stay on in his role post acquisition. (Aug.)

Using its Sigma Multigas Technology, which detects changes in infrared radiation to determine gas concentrations in a mixture, Phasein has created multi-gas analyzers that noninvasively measure and monitor respiratory gases including carbon dioxide (CO2), oxygen, and anesthetics such as nitrous oxide (laughing gas). The company develops and distributes ultra-compact capnographs, which monitor CO2 in exhaled air, and sells both the mainstream and sidestream versions of the product. (The difference is in the placement of the CO2 sensor--in mainstream, it’s located in the airway between the endotracheal tube and breathing circuit, and in sidestream, the sensor is in the main unit, away from the airway, and the gas samples are pumped in through a separate tube.) Just last year, the FDA granted 510(k) clearance to Phasein’s ISA sidestream analyzer, while the mainstream IRMA device has been on the US market since 2005. The company also sells the Emma/Capnocheck capnometer, used in emergency room or acute care settings for real-time monitoring; the device is partnered in the US with Smiths Medical. Phasein raised SEK25mm ($40mm) from Karolinska Investment Fund and SEB Företagsinvest in 2003. The current deal marks Masimo’s first foray into multi-gas measurement, which the company believes is worth $500mm worldwide. Masimo already specializes in another type of patient monitoring called pulse oximetry (via the SET line), which measures the pulse rate and oxygen saturation level of arterial blood. In addition, four years ago Masimo launched the rainbow Acoustic Monitoring product for monitoring of acoustic respiration rate. And more recently, through its takeover of SEDLine, Masimo acquired analyzers of brain electrical activity for purposes of anesthesia or sedation.

Siemens AG

Siemens Healthcare Diagnostics Inc.

Penrith Corp.

Siemens Healthcare Diagnostics Inc. (a division of Siemens AG’s Siemens Healthcare GMBH) has acquired closely held ultrasound equipment maker Penrith Corp. (Aug.)

Penrith’s president Michael Cannon will stay on as the VP and general manager of point-of-care solutions at Siemens’ ultrasound unit. Penrith focuses on miniaturized and portable ultrasound systems that are used in emergency departments, mobile hospitals, and triage centers. The company’s only approved product is Elettra, which received 510(k) clearance in November 2010. The compact system is used for diagnostic imaging or fluid flow analysis in fetal, abdominal, intra-operative, cardiac, and musculoskeletal settings. Penrith was founded in 2005, and based on Form D filings has raised approximately $16.1mm since inception. Under its Acuson brand, Siemens already sells dozens of ultrasound devices used in cardiology, obstetrics/gynecology, and radiology, as well as ultrasound transducers. (Penrith’s Elettra was deemed substantially equivalent to Siemens’ Acuson products.) Siemens says the current transaction is part of its Agenda 2013 plan--launched in November 2011--to strengthen its health care segment’s innovativeness and competitiveness.

Teleflex Inc.

LMA International NV

Intavent Direct Ltd.

In its fifth acquisition so far this year, Teleflex Inc. (critical care and surgical devices) has acquired publicly traded and leading laryngeal mask maker LMA International NV for SGD343.5mm ($277mm; $0.50 per share, a 67% premium). The deal includes all of LMA’s assets, but excludes approximately $13.7mm in cash, which will be distributed to LMA’s former stockholders. (Aug.)

LMA is a Curacao-based firm that was founded in 1998 and completed an IPO on the SGX Singapore exchange seven years later. With offices around the world, the company manufactures the LMA brand of laryngeal masks, a type of supraglottic airway device that’s used by anesthesiologists and emergency room health care providers for respiration and ventilation during surgical and life-saving procedures. Intavent Direct Ltd., a leading UK laryngeal mask airway company, has been supplying these LMA products in the UK, Ireland, and Channel Islands since March 2003. In 2011, the portfolio realized $8.2mm in sales. In a separate transaction concurrent to the LMA acquisition, Teleflex’s European subsidiary Teleflex Medical Europe Ltd. has purchased this business--including IP, trademarks, and distribution rights--plus some other equipment from Intavent. Besides the laryngeal masks, LMA also sells LMA Atomization devices for nasal drug delivery of very fine particles. In 2011 LMA achieved net income of $16.1mm on $123.9mm in revenues. The deal provides Teleflex with LMA’s current 85% share of the worldwide laryngeal masks market. (Teleflex previously held less than 1% share.) In addition, LMA’s products are expected to boost Teleflex’s anesthesia and respiratory unit sales past $530mm. Thus far in 2012, Teleflex has also bought surgical catheter maker Hotspur Technologies for $15mm; polymer coatings company Semprus BioSciences for $30mm plus earn-outs; Axiom Technology Partners (laparoscopic fascial closure systems) for $7.5mm; and the EZ-Blocker line of disposable catheters used for lung isolation or one-lung ventilation (this device was acquired from an anesthesiologist). Teleflex has decided to focus on branded products and innovative late-stage technologies; as a result, the company is in the process of divesting its OEM orthopedics business to Tecomet for $45.2mm. Investment Banks/Advisors: Brown Brothers Harriman & Co. (Teleflex Inc.)

Tornier NV

OrthoHelix Surgical Designs Inc.

Orthopedic device firm Tornier NV is acquiring closely held OrthoHelix Surgical Designs Inc., which is developing implants and tools for small bone reconstructive surgery, for $100mm in cash and $35mm in Tornier ordinary shares, plus up to $20mm in earn-outs based on consolidated revenues of lower extremity joints and trauma products in 2013 and 2014. (Aug.)

Post-acquisition, OrthoHelix will operate as a Tornier subsidiary, retain all brand names, continue selling to current customers, and keep its Ohio facilities and 80 employees. OrthoHelix’s portfolio consists of implantable screw and plate systems for repairing small bone fractures and deformities of the foot and ankle. Leading the way is the MaxLock Extreme small bone screw and plate systems with anatomic contouring, low profile, and multiplanar fixation. Another product, the DRLock Extreme volar plate and screw system, is used for fractures and osteotomies of the distal radius. The company’s plates incorporate Tribrid technology allowing them to accommodate non-locking, fixed angle locking, and variable angle locking screws. In lower extremities, Tornier currently sells ankle arthroplasty and biologic products however the company says there is very little overlap between its portfolio and that of OrthoHelix. OrthoHelix’s products are currently sold only in the US, where 2012 revenues are expected to reach about $29mm, up 30% from the previous year; Tornier plans to expand its reach internationally. The transaction will significantly expand Tornier’s sales to foot and ankle surgeons and its lower extremity revenue is expected to at least double.

Alliances

Aerocrine AB

Stallergenes SA

Stallergenes SA (immunotherapies) will exclusively market and distribute Aerocrine AB’s (nitric oxide monitoring devices) NIOX MINO airway inflammation kit to diagnose and monitor asthma. The multi-year agreement will first cover France, Italy, Poland, Turkey, and the Middle East, but could be expanded. (Aug.)

Aerocrine’s alliance with ThermoFisher for NIOX MINO, which included France and Italy, will be terminated. The handheld FDA-cleared and CE-Marked device is designed to not only determine airway inflammation, but help identify the likelihood of a patient responding to a corticosteroid, to monitor inflammation to determine if a corticosteroid is needed, and determine patient compliance. Stallergenes will use its local sales teams to market NIOX MINO to specialists, including allergologists and pulmonologists. The French biopharma already sells Oralair 300 IR sublingual immunotherapy tablets, Staloral allergen extract solution, Phostal and Alustal suspensions used in the injection of allergen extracts, and Alyostal diagnostics for intra-dermal reaction, nasal provocation testing, conjunctival provocation, and a transdermal skin patch for contact dermatitis testing.

BO-Pharma BV

Verisante Technology Inc.

Verisante Technology Inc. (early cancer detection devices) has granted device distributor BO-Pharma BV exclusive rights to sell its Verisante Aura skin lesion imaging device in Belgium, the Netherlands, and Luxemburg. (Sep.)

Verisante Aura is a non-invasive optical imaging system that uses Raman spectroscopy to analyze skin lesions. Physicians use the device when they are suspicious of areas on the skin and want confirmation before doing a biopsy. Aura can rapidly scan the chemical composition of multiple skin spots for 21 different cancer biomarkers and provide immediate feedback on the detection of melanoma, squamous cell carcinoma, or basal cell carcinoma. The device received the CE Mark last year, and has also been approved for sale in Canada and Australia. Bo-Pharma looks forward to adding Aura to its product offerings, including the Ambulight system, a photodynamic therapy that allows for the home treatment of non-melanoma skin cancers. Through its Bo-Esthetics division, the company also distributes injectables, light therapies, and laser systems for skin aging, acne, and body contouring.

Concessus SA

ThermoGenesis Corp.

Over the next four years, Concessus SA (diagnostic lab and research equipment) has rights to distribute cell processing company Cesca Therapeutics Inc.’s AXP AutoXpress and BioArchive devices in France, Spain, Switzerland, Benelux, Liechtenstein, and the Nordic countries (excluding Iceland). (Sep.)

Concessus takes over the licenses for AXP from GE Healthcare, which previous had rights in these territories under a 2005 deal (GE will continue to supply AXP in the US and Canada). Concessus had already been distributing BioArchive in certain regions since 2010. AXP and BioArchive make up ThermoGenesis’ portfolio of products that extract adult stem cells from cord blood for laboratories and point-of-care markets. AXP is an automated device that isolates and retrieves stem cells from umbilical cord blood. With a 97% mononuclear cell (MNC) recovery rate, AXP separates the plasma, red blood cells, and MNCs each into separate disposable bags. The product was first launched in 2006 and last year had sales of $8mm, representing 34% of ThermoGenesis’ total revenue. Less than a month ago, ThermoGenesis partnered AXP with Golden Meditech Holdings in some Asian countries. BioArchive is a robotic storage system that cryopreserves and archives up to 3.6k stem cell samples in liquid nitrogen for future transplants or treatments. Introduced in 1998, BioArchive achieved $8.7mm in 2011 sales, 37% of ThermoGenesis’ revenues. Concessus has been supplying blood banking equipment for over twenty years, and also has its own stem cell separation technologies.

Corindus Vascular Robotics Inc.

Royal Philips Electronics NV

Expanding upon their prior deal, Royal Philips Electronics NV will exclusively distribute in the US Corindus Vascular Robotics Inc.’s (robotic-assisted heart devices) CorPath 200 system for percutaneous coronary intervention. (Aug.)

Last year the companies signed an agreement enabling Philips to use CorPath 200 specifically with its interventional cardiology technologies. Under the new deal both Corindus and Philips will be able to sell CorPath 200 in the US. Corindus says CorPath 200 is the first robotic-assisted system available across the globe--it was recently cleared by the FDA--for the minimally invasive treatment of obstructed arteries in coronary artery disease patients. CorPath 200 can be integrated into all of the main x-ray fluoroscopy systems, including Philips’ Allura x-ray equipment, and can be used with traditional stents, catheters, and guide wires.

DARA BioSciences Inc.

Helsinn Group

For a ten-year period, Midatech Pharma US Inc. (mainly cancer products) has received exclusive rights to sell Swiss spec pharma Helsinn Group’s Gelclair topical treatment in the US for oral mucositis, a painful tissue swelling in the mouth caused by radiation or chemotherapy. DARA also has the right to sublicense. (Sep.)

Helsinn will get an up-front payment, milestones, plus commercialization performance fees and royalties. DARA must meet certain minimum sales requirements, and may have the right to market Gelclair in an additional indication should Helsinn pursue approval. Gelclair, which received 510(k) clearance in 2001, is a bioadherent topical polyvinylpyrrolidone and sodium hyalonurate gel that forms a protective film adhering to the oral mucosa. In 2003, Helsinn acquired exclusive global rights to the product from Sinclair Pharmaceuticals (now Sinclair IS Pharma). Helsinn has sublicensed US rights, which have changed hands a couple times. OSI Pharmaceuticals (a division of Astellas) initially sold Gelclair in North America (via OSI’s acquisition of Cell Pathways), but ended the alliance in 2004. Two years later, EKR Therapeutics (bought by Cornerstone Therapeutics) received the US license (and co-promoted with ProStrakan (now part of Kyowa Hakko Kirin)), but EKR switched focus to cardiovascular drugs and terminated its agreement with Helsinn in 2009. Since then, Gelclair has been off the US market. Under the current transaction with Helsinn, DARA is required to launch the gel in the US before March 12, 2013. DARA already has several oncology supportive care products that came into the company’s portfolio in 2012. Innocutis Holdings granted DARA US co-promotion rights to Bionect, for burns and skin irritation following radiation and chemotherapy. DARA is prepping to introduce Soltamox, a liquid form of tamoxifen for breast cancer gained through the acquisition of Oncogenerix. (This deal signaled DARA’s shift to cancer products; previously the biotech had been developing drug candidates for multiple indications including pain, diabetes, cardiovascular disease, inflammation, and psoriasis.) DARA also expects to file later this year an ANDA to sell generic gemcitabine, in-licensed from Uman Pharma.

Golden Meditech Holdings Ltd.

ThermoGenesis Corp.

In a five-year deal that may be renewed in one-year increments, Cesca Therapeutics Inc. (automated blood processing systems for regenerative medicine) has licensed Chinese device and health care services firm Golden Meditech Holdings Ltd. exclusive rights to distribute its cord blood processor AXP AutoXpress in the People’s Republic of China, Singapore, Indonesia, India, and the Philippines. The agreement excludes Hong Kong and Taiwan. (Aug.)

Meditech will be required to purchase a certain amount of the product each year. AXP AutoXpress is a line of automated devices that isolate and capture stem cells from umbilical cord blood in closed systems. AXP has a 97%-plus retain rate for mononuclear cells, which include infection-fighting blood cells as well as stem cells that can replicate and regenerate. The cord blood is placed into a sterile blood processing disposable bag set that is put into the AXP device and centrifuged, where components are separated. ThermoGenesis also sells other stem cell processing accessories. AXP was launched in March 2006 in the US (where GE Healthcare has rights), and has received approval in India. It is awaiting regulatory clearance in China, Singapore, Indonesia, and the Philippines. In 2011, AXP accounted for 34% of ThermoGenesis’ $23.4mm in total net revenues. In an effort to streamline operations and concentrate on regenerative medicine offerings, ThermoGenesis last month divested its fibrin sealant CryoSeal to Japanese partner Asahi Kasei Medical. Next on ThermoGenesis’ list to sell is the ThermoLine group of blood plasma freezers and thawers. AXP is a nice fit for Meditech, which holds the majority stake in China’s largest umbilical cord bank, China Cord Blood Corp. Meditech is also the top Chinese provider of autologous blood recovery systems and has a Chinese JV with Fenwal (recently acquired by Fresenius) focused on blood collection and transfusion products. (In March 2010, ThermoGenesis licensed Fenwal exclusive distribution rights to AXP AutoXpress in China, India, and Japan. It’s not clear whether this agreement has terminated as a result of the current alliance, or if the deal will go on via Meditech’s relationship with Fenwal.)

Johnson & Johnson

Janssen Biotech Inc.

West Pharmaceutical Services Inc.

West Pharmaceutical Services Inc. (injectable drugs) will work with Johnson & Johnson’s Janssen Biotech Inc. on the development of a self-injection product. (Sep.)

Janssen created the technology to ease injection of drugs or biologics into the patient while also enabling the safe and reliable delivery of medication. The companies will jointly complete development, but West alone will be in charge of commercial scale-up, manufacturing, and marketing of the resulting product under the name SelfDose. The new device will complement West’s existing offerings, including ConfiDose auto-injector technology and SmartDose electronic patch injector system. West last united with a Big Pharma in June, when it signed an evaluation agreement with Amgen for Daikyo Crystal Zenith drug containment technologies.

Life-Tech Inc.

SRS Medical Systems Inc.

SRS Medical Corp.

Life-Tech Inc. (diagnostic and therapeutic devices) will sell urinary incontinence device firm SRS Medical Corp.’s CT3000 UroCuff system in North America. (Aug.)

The CT3000 UroCuff enables noninvasive analysis of male voiding pressure. It differentiates between bladder outlet obstruction and low bladder pressure. Similar to a blood pressure cuff, the penile cuff is attached and the patient urinates into a flow meter. The CT3000 UroCuff provides reliable results, on par with those of catheter-based procedures. Life-Tech’s urology division has developed instrumentation to quantify and determine the cause of incontinence and obstruction, including Microflo II and NovaFlo uroflow meters, and the VesiScan portable bladder volume measurement system.

Medline Industries Inc.

Teleflex Inc.

Medline Industries Inc. will market fellow medical and surgical supplies firm Teleflex Inc.’s Rusch urological devices throughout the US. (Aug.)

The Rusch bladder management products include Foley and intermittent catheters for drainage and operative urology, as well as endo-urology devices for diagnostic testing and surgical procedures. Medline already offers 11 Rusch products, mainly feeding tubes and oxygen masks. Teleflex has been quite busy in the last few months; not only has the company divested its OEM orthopedics unit, but it also acquired LMA International (laryngeal masks), Hotspur Technologies (critical care and surgical catheters), Semprus (polymer to cover implants), and the EZ-Blocker anesthesiology product line.

Neuralstem Inc.

Q Therapeutics Inc.

Neural stem cell producer Neuralstem Inc. has licensed Q Therapeutics Inc. (CNS diseases) rights to its spinal cord delivery platform and floating cannula. (Sep.)

The minimally invasive cannula injects stem cells directly into the gray matter of the spinal cord where the cells will protect and integrate with spinal cord neurons. In October 2008, Neuralstem exclusively licensed the technology from the Cleveland Clinic Foundation, where it was created by Nicholas M. Boulis, MD. The device is protected by the US patent 7,833,217, “Floating spinal cannula and method of use,” and the US patent application 12/913,527 under the same name. While this is the first time it has partnered the product, Neuralstem says it does plan to sign other licensing agreements with industry and academia in the future. Last month, the company completed a Phase I study of this system for intraspinal delivery of its neural stem cell therapeutic NSI566 for ALS. The trial demonstrated that the procedure was safe and halted disease progression in some of the 18 patients tested. Q Therapeutics is working on its own neural glial cell treatment called Q-Cells, which replaces oligodendrocytes in the protective myelin sheath on damaged neurons, and also promotes generation of astrocytes for neuroprotection. The company is targeting demyelinating conditions, with an initial indication in ALS (in collaboration with the University of Utah).

Pfizer Inc.

Stellar Pharmaceuticals Inc.

Pfizer Inc. has licensed Tribute Pharmaceuticals Canada Inc. exclusive rights to commercialize the Gelfoam surgical hemostasis kit in Canada. (Aug.)

Stellar will promote, market, and sell Gelfoam to surgeons and other health care professionals, while Pfizer continues distribution, regulatory, and medical-related activities. Approved in Canada and the US, Gelfoam is used as a hemostatic agent during surgical procedures to control capillary, venous, and arteriolar bleeding when conventional methods such as pressure and ligature are ineffective or impractical. A couple months ago, Stellar received exclusive Canadian rights to Theramed Corp.’s Collatamp G gentamicin impregnated sponge, which is designed for the local hemostasis of capillary, parenchymatous, and seeping hemorrhages in areas where there is a high risk for surgical site infections. Stellar plans to sell both of these complementary products side by side.

St. Jude Medical Inc.

Vascular Solutions Inc.

Vascular Solutions Inc. has acquired fellow cardiovascular device company St. Jude Medical Inc.’s Venture wire control catheter, a deflectable-tip catheter used during coronary and peripheral interventional procedures for guidewire directional control. (Aug.)

Vascular Solutions will pay $3mm in cash for the device, of which $2.25mm will be paid up front and the remainder upon the successful transition of manufacturing processes. The company bought the remaining inventory and manufacturing equipment as well as pertinent IP from St. Jude Medical; production is expected to restart in Q2 2013, followed by a global re-launch of the device. Venture can be angled up to 90 degrees, which lends support to surgeons when crossing tight lesions. Three versions of the product are sold worldwide: over-the-wire, rapid-exchange, and coronary sinus, all of which are 6 French-compatible and control a standard 0.014 inch guidewire. Venture fits in nicely with Vascular Solutions' GuideLiner and SuperCross catheters. Vascular Solutions completed a similar agreement about two years ago when it purchased Escalon Vascular Access’ Smart Needle and pdAccess Doppler-guided needle access devices used during catheterization for $5mm up front and $750k upon transfer of the manufacturing process.

Financings

Bacterin International Holdings Inc.

Biomaterials company Xtant Medical Holdings Inc. (primarily anti-infective device coatings and bone graft materials) has received a $25mm term loan from OrbiMed Advisors affiliate ROS Acquisition Offshore LP. Under the arrangement, Bacterin will receive $20mm up front, with the option to draw down the remaining $5mm based upon the achievement of certain revenue goals by December 31, 2013. (Aug.)

The loan carries interest of LIBOR plus 12.13%. Bacterin has also agreed to pay ROS a 1.75% royalty on its first $45mm in net sales, plus 1% of revenues exceeding $45mm. After repaying existing debt to MidCap Financial, Bacterin will net $10mm and use the proceeds to expand its sales force. The arrangement enables the company, which will now have $11mm in cash on hand, to attain profitability without requiring additional capital. Bacterin went public in 2010 as the result of a reverse merger with K-Kitz, a publicly traded shell that ceased operations and took over both Bacterin’s business and name. The company now has three main operating areas. Its coatings segment develops antimicrobial bioactive implantable device coatings intended to prevent biofilm formation, a natural bacteria that can contaminate the surface of an implant, reducing its functionality and potentially causing an infection in the patient. The biologics business (started in 2005) offers a portfolio of biologic scaffolds designed to optimize the growth factors in human allografts and promote bone repair and growth. Its demineralized bone matrix (DBM) allografts include OsteoSponge (made from cancellous bone), for cranial and foot/ankle surgeries; OsteoWrap (made of cortical bone), used in spinal, neurological, cranio-maxillofacial, reconstructive, and various other orthopedic procedures; and OsteoSelect, a sterile DBM putty and bone void filler. Finally, the company’s device division makes surgical instrument kits for use with the biologic unit’s allografts. The Bacterin transaction was announced the same day as OmniGuide (minimally invasive surgical instruments), another OrbiMed-backed medical device company, brought in $35mm through a non-dilutive financing. The investment firm also counts several orthopedic players--including Cerapedics (bone substitutes), Bonovo (implants and surgical and fixation devices), and DFINE (radiofrequency devices for vertebral compression fractures)--in its portfolio.

Solta Medical Inc.

Solta Medical Inc. (devices used during aesthetic procedures) has netted $14.2mm through the follow-on public offering of 5.7mm common shares at $2.65. (Aug.)

Investment Banks/Advisors: Canaccord Genuity Corp.; Roth Capital Partners

Sunshine Heart Inc.

Cardiovascular device maker Sunshine Heart Inc. has netted $18.7mm through the follow-on public offering of 2.9mm common shares at $7. (Aug.)

Investment Banks/Advisors: Canaccord Genuity Corp.; Cowen & Co. LLC; Craig-Hallum Inc.; Lazard LLC

Wright Medical Group Inc.

Device firm Wright Medical Group NV has received net proceeds of $251.2mm through the sale of 2% five-year senior notes that convert into cash. Interest is payable on February 15 and August 15 each year. The notes convert at $25.44 per common share. About half of the money will pay the outstanding term loan under its senior credit facility. (Aug.)

Investment Banks/Advisors: JP Morgan & Co.

PHARMACEUTICALS

Mergers & Acquisitions

bionomics Ltd.

Eclipse Therapeutics Inc.

Australian cancer, immune, and CNS drug developer Bionomics Ltd. has acquired privately held US-based Bionomics Inc. (developing drugs that target cancer stem cells). Bionomics issued 23.9mm of its shares, valued at $7.9mm, giving Eclipse shareholders a 6.5% stake in Bionomics. (Sep.)

Eclipse is also entitled to cash earn-outs based on late-stage development or partnering achievements. Eclipse was spun out of Biogen Idec in 2011 after Biogen deprioritized its cancer stem cell (CSC) business. Former Biogen employees Drs. Peter Chu and Christopher Reyes, together with Dr. Jonathan Lim of City Hill Ventures (Eclipse’s seed investor), founded Eclipse to discover new therapeutic antibodies that target CSCs. The company has used its CSC Rx Discovery platform and IP exclusively licensed from Biogen to develop its first compound, ET101. The project is aimed at undisclosed solid tumors, and is set to begin clinical trials in 2014. Eclipse’s pipeline also holds a multispecific mAb and antibody drug conjugates, both also for solid tumors. The acquisition provides Bionomics with a strong foothold in the US cancer market. The company also looks forward to the addition of Eclipse’s compounds to its own cancer candidates. Leading Bionomics’ oncology pipeline is BNC105, a vascular disrupting agent in Phase II trials for renal cancer. Following the acquisition, Drs. Chu and Reyes will assume the positions of VP, US operations and cancer biology, and VP, R&D biologics, respectively, at the new Bionomics Inc., and Dr. Lim will become a nonexecutive director. Investment Banks/Advisors: Aquilo Partners Inc. (Eclipse Therapeutics Inc.)

Charles River Laboratories International Inc.

Accugenix Inc.

CRO Charles River Laboratories International Inc. (CRL) is acquiring privately held Accugenix Inc. (contract microbial detection and characterization services) for $17mm in cash. (Aug.)

CRL expects Accugenix’s sales to account for 1% of its total revenues in 2013. Accugenix was established in 1990 as Acculab and initially used the traditional fatty acid analysis method for identifying microbes. In 2005, the company switched to DNA sequencing, a more accurate and faster way for in vitro microbial detection. Today Accugenix performs cGMP-compliant microbial identification testing required by the FDA in manufacturing plants for quality control monitoring. The company claims its in-house libraries have sequenced over 5k species of micro-organisms, including bacteria and fungi. These detection solutions are used during production of drugs, devices, nutraceuticals, and personal care and cosmetic products. Accugenix offers genetic microbial identification services (under the AccuGENX-ID brand), as well as proteotypic identification, DNA sequence analysis, and strain typing of environmental isolates. The transaction complements CRL’s endotoxin and microbial detection kits and reagents business, which tests devices and injectable drugs for contamination using a processed extract from horseshoe crab blood. The company says it plans to acquire more firms like Accugenix, plus expand existing products. Before year-end, CRL would like to launch a fully automated version of its Endosafe-MCS (multi-cartridge system) for high-volume central testing labs, and anticipates extending this technology into other areas such as renal dialysis and cellular therapy. CRL’s last acquisition attempt was two years ago, when it tried to buy Chinese CRO WuXi for $1.5bn. The companies ended up mutually terminating the agreement.

Church & Dwight Co. Inc.

Avid Health Inc.

Personal care and household products company Church & Dwight Co. Inc. has acquired closely held gummy vitamins and supplements maker Avid Health Inc. for $650mm in cash. (Aug.)

The transaction marks Church & Dwight’s entrance into the dietary supplement market. A portfolio company of Bear Growth Capital Partners, Avid was formed in 2005 and reported revenues of $230mm with an EBITDA of $58mm for the twelve months ending June 30, 2012. The company’s most popular vitamin brands are Vitafusion and L’il Critters, both the number one brands of gummy vitamins for adults and children, respectively. Church & Dwight’s past acquisitions, focused on its traditional household and consumer markets, have included Simply Saline for $70mm from Blairex two years ago, and Del Laboratories, the maker of Orajel numbing gel, for $380mm in 2008. Church & Dwight’s consumer health care portfolio also includes First Response and Answer pregnancy tests, the Nair hair remover, and Aim toothpaste.

Colby Pharmaceutical Co.

Othera Pharmaceuticals Inc.

Cancer-focused Colby Pharmaceutical Co. has acquired Othera Pharmaceuticals Inc., a closely held company mostly focused on drug candidates for ophthalmic diseases, but it is also working on cancer and inflammatory disease therapeutics. (Sep.)

Formed in 2002, Othera has raised about $40mm through venture rounds and counts Ben Franklin Technology Partners, Commerce Health Ventures, Fletcher Spaght, Johnson & Johnson Development Corp., Liberty Venture Partners, NewSpring Capital, NJTC Venture Fund, and Wynnefield Capital Advisors as its investors. Othera has been developing drugs to treat age-related eye diseases, including preclinical OT551 (for geographic atrophy and dry age-related macular degeneration) and OT440 (as a neuroprotectant for glaucoma) as well as other small-molecule drug candidates for Nrf-2 regulated diseases caused by oxidative stress injury. Othera will merge into Colby, which is focused on the development of cancer treatments, including CP200 (for solid tumors), CP300 (for therapy-resistant and hypoxic metastatic solid tumors), and CPD410 (for advanced radio and chemotherapy-resistant and hypoxic tumors).

Cortex Pharmaceuticals Inc.

Pier Pharmaceuticals Inc.

Neuroscience drug developer RespireRx Pharmaceuticals Inc. has acquired closely held respiratory therapeutics firm Pier Pharmaceuticals Inc. in a stock swap. Cortex issued 58mm common shares valued at $3.48mm. (Aug.)

Pier Pharmaceuticals was formed in 2007 as SteadySleep Rx Co. and has been developing dronabinol, a derivative of the cannabis plant, for obstructive sleep apnea. It is about to begin Phase II trials (fully funded by a $5mm National Institutes of Health grant). The drug has already been approved by the FDA for refractory chemotherapy-induced nausea and vomiting and anorexia in AIDS patients. Cortex had been working on Ampakine drug candidates, which increase glutamate activity to AMPA receptors for neurological conditions, including neurodegeneration, stroke, psychoses, and trauma; the company will now solely focus on brain-controlled breathing disorders. Cortex’s efforts will go towards the continued development of both dronabinol and CX1739, a Phase II compound for opiate-induced respiratory depression and central sleep apnea. Cortex will continue to be led by Mark Varney, PhD, and its board will consist of eight members, three of which are former Pier directors. Investment Banks/Advisors: LifeTech Capital (Pier Pharmaceuticals Inc.)

Covidien PLC

Mallinckrodt LLC

CNS Therapeutics Inc.

Mallinckrodt PLC (major US opioid supplier; subsidiary of Medtronic Minimally Invasive Therapies’s Covidien Ltd.) has paid $100mm to acquire CNS Therapeutics Inc., a private company focused on intrathecal drug delivery. (Sep.)

CNS was founded in 2007 to treat neurological conditions by delivering compounds directly to the central nervous system, and bypassing the blood-brain barrier for increased efficacy at lower doses and reduced side effects compared with oral formulations. To do this, the company is using intrathecal drug delivery, or administration directly under the arachnoid membrane of the brain or spinal cord. In 2010, CNS launched its first (and only, to date) product, Gablofen, which is a generic version (AP-rated and bioequivalent) of Medtronic’s Lioresal (baclofen), originally introduced in 1992 by Novartis as an orphan drug. Available in four different concentrations, Gablofen is indicated for severe muscle spasticity and delivered to the spinal fluid via Medtronic’s implantable SynchroMed II programmable pump. CNS has earlier-stage projects in development for Parkinson’s disease (in collaboration with the University of Helsinki and with funding from the Michael J. Fox Foundation; the program involves a therapeutic protein injected into the brain) and intractable chronic pain. CNS has raised a total of $16.1mm in equity from investors, including Thomas, McNerney & Partners and InterWest Partners. The acquisition is the latest in a string of deals by Mallinckrodt to add to its portfolio, as the company plans to spin off from Covidien in the middle of next year. Just last month Mallinckrodt bought the pain medicine Roxicodone (oxycodone) from Xanodyne Pharmaceuticals, and earlier this year it licensed US co-promotion rights to Horizon’s Duexis (ibuprofen and famotidine) for arthritis and GI ulcers, and to Zogenix’s migraine drug-device Sumavel DosePro.

Meda AB

Jazz Pharmaceuticals PLC

Meda AB has acquired fellow specialty pharmaco Jazz Pharmaceuticals PLC’s women’s health business for $95mm in cash. (Sep.)

Included in the transaction are Elestrin (estradiol gel) for moderate-to-severe vasomotor symptoms that can accompany menopause; Gastrocrom (cromolyn sodium) for chronic inflammatory conditions, including mastocytosis; AVC cream (sulfanilamide) for vulvovaginitis; the urinary antiseptic Urelle to relieve symptoms associated with urinary tract infections; and the prenatal vitamins Natelle and Gesticare. Jazz reported 2011 combined net sales of $30.4mm for the drugs, almost half of which came from sales of Elestrin. About 60 of Jazz sales reps will be offered employment at Meda. The divesture will allow Jazz to focus on its core therapeutics--for cancer and neurological conditions--while enabling Meda to build up its product offerings in the US, where it already sells Aldara (actinic keratoses), Onsolis (breakthrough pain in patients with cancer), Soma (acute painful muscloskeletal conditions), Tambacor (arrhythmia), and Proctofoam (inflammation and itching near the anal area). Meda will add women’s health to its key therapy areas, which prior to the acquisition were respiratory, cardiology, neurology, and dermatology markets.

Mercury Pharma Group Ltd.

Cinven has acquired closely held specialty drug company Mercury Pharma Group Ltd. from fellow PE firm HgCapital for £465mm ($729.9mm). (Aug.)

Formed in 1989 as Goldshield Group PLC, Mercury Pharma was listed on the London Stock Exchange from 1991 until late 2009, when it was bought by HgCapital in a £178mm public-to-private management buy-out. (HgCapital says it received a 4.1x return on the deal.) Mercury, which sells its products to retail pharmacies and hospitals in the UK as well as over 50 countries across the globe, reported over £100mm in 2011 sales. The company offers both branded and generic products, including Codipar for pain; Stelazine for anxiety, depression, or nausea; Eltroxin for hypothyroidism; Bufyl epidural injection for labor pain; as well as other anti-psychotic, anti-inflammatory, hypertension, and critical and emergency care products. Cinven has quite some experience in the health care sector; after buying one of the biggest private hospital operations in the UK, Spire Healthcare, for £1.7bn in 2007, it sold off Swedish diagnostics firm Phadia AB to Thermo Fisher Scientific last year, gaining about $3.5bn from the transaction. Investment Banks/Advisors: Deloitte & Touche

Physicians Formula Holdings Inc.

PE firm Swander Pace has agreed to acquire skin care and cosmetics company Physicians Formula Holdings Inc. for $4.25 per share in cash (a 22% premium), for a total of $58.3mm. (Aug.)

Post-merger Physicians Formula will be a privately held company that will continue to operate under the current management with the same employees. Formed in 1937 by Dr. Frank Crandall to develop cosmetics for his wife who had sensitive skin, Physicians Formula went public in 2006 via its $49.4mm IPO. It reported 2011 sales of $80.9mm with a net loss of $1.2mm. The company says it is one of the ten largest cosmetics companies in the US mass market channel, selling its products--for skin aging, dry skin, cleansing, and sun exposure care--in over 25k retail stores across the country. Swander Pace will add Physicians Formula to its other consumer health products portfolio companies, including Gilchrist & Soames and Insight Pharmaceuticals. Investment Banks/Advisors: Blackstone Group

Pristine Solutions Inc.

Eaton Scientific Systems Ltd.

Public non-medical firm Pristine Solutions Inc. has acquired all of the outstanding shares of closely held women’s health company Eaton Scientific Systems Ltd. in exchange for 25mm common shares, valued at $4.75mm. (Aug.)

Formed in 2006, Eaton has been working on a new indication for homatropine, an existing FDA-approved drug that is used in eye drops to dilate the pupil and given to reverse the muscarinic and CNS effects that can accompany indirect cholinomimetic administration. Eaton is developing homatropine as Tropine 3, a Phase I non-hormonal treatment for hot flashes in pre-menopausal, peri-menopausal, and post-menopausal women. Protected by US Patent No. 60/719,756, it is designed to reduce the intensity, duration, and number of hot flashes. Pristine is assembling a senior management team and group of scientific advisors to monitor clinical testing of Tropine 3. Eaton will become a wholly owned subsidiary of Pristine, which prior to the acquisition considered itself a start-up development-stage company that only sold tankless water heaters in Jamaica, where the company is headquartered.

Riemser Arzneimittel AG

AXA Private Equity has acquired closely held German spec pharma Riemser Arzneimittel AG. Other private equity firms that were rumored to have been interested in Riemser included Warburg Pincus, Montagu, and Triton Advisers. (Aug.)

Riemser was founded in 1990 as an affiliate (then called Riemser Tierarzneimittel GMBH) of the Friedrich-Loffler Research Institute for Animal Diseases. The Braun family bought out Riemser two years later and is still the majority owner. TVM Capital and GE Healthcare Financial Services are minority shareholders. In March 2011, Riemser sold its animal health operations to Ecuphar NV so that it could focus on in-licensed niche human prescription drugs, which the company markets in 95 countries, in the areas of cancer, infectious disease, dermatology, pain, and cardiology, as well as dentistry preparations, including implants, tissue regeneration systems, and endodontic/periodontic products. In the last few years, Riemser has completed several acquisitions. It bought Grunenthal’s tuberculosis and antibiotics portfolio in 2010; curasan’s dental business in 2008; and acquired Rentschler Pharma GMBH in 2008. Riemser also has a relationship with Helsinn Healthcare; Riemser holds German rights to cancer supportive care products Aloxi (chemotherapy-induced nausea and vomiting (CINV)) and Gelclair (oral gel for oral mucositis), and a Phase III fixed-dose combination of netupitant/palonosetron for CINV. Riemser’s 2011 sales totaled €100mm ($129mm), and the company says over the next few years it plans to invest 10-15% of its revenues into its pipeline as well as life cycle management for existing drugs, including pursuing additional indications.

Sumitomo Chemical Co.

Sunovion Pharmaceuticals Inc.

Elevation Pharmaceuticals Inc.

Sumitomo Dainippon Pharma Co. Ltd.’s Sunovion Pharmaceuticals Inc. (mainly CNS and respiratory treatments) has agreed to acquire closely held respiratory therapeutics developer Elevation Pharmaceuticals Inc. for $100mm, plus up to $330 in earn-outs: $90mm based on the successful development of EP101, another $210mm for reaching commercialization goals pertaining to the drug candidate, and $30mm for the development of additional programs. EP101 is in Phase II for moderate-to-severe chronic obstructive pulmonary disease and should begin Phase III during 2H 2013. The company claims it is the only long-acting, nebulized bronchodilator in development. (Aug.)

EP101 is a solution formulation of glycopyrrolate--a long-acting muscarinic antagonist--which is delivered using a customized eFlow nebulizer. (Pari Pharma licensed the device to Elevation and that agreement will transfer to Sunovion.) Elevation is also developing Phase I EP102 for COPD and preclinical EP103 for COPD and asthma. Formed in 2008 to create aerosolized treatments for respiratory conditions--primarily for patients that cannot use dry powder or metered-dose inhalers--Elevation has raised $44mm; its most recent financing, a Series B, brought in $12.4mm at the end of last year. The company counts Nov Ventures, Canaan Partners, TPG Biotech, Care Capital, and Mesa Verde Venture Partners as its investors. Elevation will become a wholly owned subsidiary of Sunovion and its seven employees will remain as consultants on EP101 for at least a year. The transaction complements Sunovion’s respiratory treatments, including the marketed asthma therapies Xopenex and Alvesco; allergy drugs Omnaris and Zetonna; and COPD pharmaceutical Brovana. Investment Banks/Advisors: Jefferies & Co. Inc. (Elevation Pharmaceuticals Inc.); Barclays Bank PLC (Sunovion Pharmaceuticals Inc.)

Valeant Pharmaceuticals International Inc.

Medicis Pharmaceutical Corp.

In support of its pursuit to become a leader in the dermatology field, Valeant Pharmaceuticals International Inc. is scooping up fellow public pharmaco Medicis Pharmaceutical Corp. for $2.6bn in cash. Valeant is paying $44 per share, a 36% premium. (Sep.)

Medicis becomes a Valeant subsidiary and maintains its headquarters in Arizona, which will also be the location for the combined company's commercial dermatology operations. The acquired firm’s strong dermatology portfolio includes Solodyn and Ziana for acne, Restylane and Perlane for wrinkles and folds, Dysport for glabellar lines, and Zyclara for actinic keratosis. For 2011, Medicis reported $721.1mm in revenues and income of $126.5mm. As of the end of June 2012, the company had $830mm in cash on hand. The Valeant/Medicis combination could bring in 2012 revenues of $1.7bn and is expected to rival worldwide dermatology leader Allergan and second-largest Galderma. Valeant has been actively seeking out companies both to acquire and from which to in-license, particularly in the areas of dermatology, ophthalmology, and podiatry. In its last dermatology deal (in May 2012), Valeant paid $64mm to gain AcneFree and other assets from skin care firm University Medical Pharmaceuticals Corp. Over the last couple of years, Valeant has purchased dermatology-focused VitalScience, J&J’s Ortho Dermatologics, and Sanofi’s Dermik Laboratories. The Medicis deal is Valeant’s largest since its $3.3bn reverse merger with Biovail in mid-2010. Investment Banks/Advisors: Deutsche Bank AG; Roberts Mitani LLC (Medicis Pharmaceutical Corp.); JP Morgan & Co. (Valeant Pharmaceuticals International Inc.)

Alliances

Allergan Inc.

Molecular Partners AG

Allergan Inc. (ophthalmic, GI, and dermatology therapeutics) has signed two simultaneous agreements with Molecular Partners AG (MP; protein therapeutics) involving the development of Designed Ankyrin Repeat Proteins (DARPins) for ophthalmic conditions. (Aug.)

MP will receive combined up-front payments of $62.5mm under the two arrangements; with up to $1.4bn in development, regulatory, and sales milestones; plus tiered royalties up into the low double-digits on resulting products. In the first deal, Allergan has licensed exclusive design, development, and marketing rights to MP's MP0260, a preclinical dual anti-VEGF-A/PDGF-B DARPin and related back-up compounds for exudative age-related macular degeneration (AMD). The companies will work together to get MP0260 through human proof-of-concept, at which time MP has the option to co-fund Allergan’s development expenses in exchange for a “significant” increase in royalties. In the second agreement, the companies will design and develop DARPins for targets that have been identified as the cause of serious eye diseases. During the research phase, Allergan may exercise options to exclusively license three ophthalmology drug candidates. For each one exercised, Allergan will pay an option fee and will be in charge of all development, manufacturing, and marketing. The new deals build upon the companies’ previous work together; about a year ago Allergan licensed exclusive global rights to MP0112, a Phase IIb DARPin VEGF inhibitor for diabetic macular edema and wet AMD. MP's other recent collaborator is J&J’s Janssen, for which MP is identifying DARPins for immunology diseases.

Apricus Biosciences Inc.

NexMed (USA) Inc.

Takeda Pharmaceutical Co. Ltd.

Takeda Pharmaceuticals International GMBH

Specialty pharmaceuticals company Apricus Biosciences Inc. and its NexMed (USA) Inc. unit have chosen , the Swiss division of Takeda Pharmaceutical Co. Ltd., to exclusively sell the erectile dysfunction treatment Vitaros (alprostadil) in the UK. (Sep.)

Takeda pays a combined up-front fee and regulatory and commercialization milestones of up to €34.65mm ($44.6mm). The EMA accepted the drug’s marketing authorization application for review in June 2011, and the partners are planning for approval during 2013. Vitaros is a topical vasodilator supplied in the AccuDose single-dose applicator. Created with Apricus’s NexACT delivery technology, the unique formulation helps overcome the skin’s natural barrier properties, and allows for more rapid uptake of the active ingredient. Vitaros takes effect in about 15 minutes, as opposed to the 30 minutes or longer for some oral ED medications. Apricus' partners in other territories around the world include Sandoz International GMBH (Germany), Warner Chilcott (US), Abbott (Canada), Bracco (Italy), Neopharm (Israel), and Elis Pharmaceuticals (Middle East and Gulf countries).

Ascendis Pharma AS

United Therapeutics Corp.

United Therapeutics Corp. (hypertension, cancer, and infectious disease treatments) has licensed exclusive rights to use Ascendis Pharma AS’s (improves existing drugs with its linker platform) TransCon technology to deliver Remodulin (treprostinil) for pulmonary arterial hypertension (PAH). (Sep.)

United Therapeutics also gets the exclusive worldwide rights to use TransCon to develop prostacyclin, prostacyclin analog, and prostacyclin-related products for PAH. TransCon--which conjugates peptides, proteins, and small molecules to different carriers--provides for controlled, long-acting release of a drug. It will enable treprostinil to be self-injected instead of using the current method of delivery: continuous infusion pump. The companies have already conducted a successful preclinical study using the technology to deliver treprostinil. In addition to ease of use, the new injectable may minimize injection site pain and reactions that have been linked to subcutaneous infusion of treprostinil. Originally discovered by Pfizer, Remodulin came into the hands of United Therapeutics in the 1990s.

Aspen Pharmacare Holdings Ltd.

Aspen Global Inc.

GlaxoSmithKline PLC

GlaxoSmithKline PLC has divested what it calls its “classic brands” available in Australia to Aspen Global Inc. (the holding company for South African-based Aspen Pharmacare Holdings Ltd.’s international businesses) for £172mm ($270mm) in cash. There will be a £31mm profit deferral pre-tax since GSK holds an 18.6% stake in Aspen Pharmacare. (Aug.)

Aspen takes on existing manufacturing agreements and will task its Aspen Australia division with distributing the drugs. The transaction involves 25 products that have gone generic and are no longer being actively promoted. In the first six months of 2012, the portfolio has achieved £31mm in sales, not even close to half of the £83mm generated for the entirety of 2011. The Big Pharma says the decline is due to the Australian government’s required annual price reductions for competitive discounting to pharmacies, as well as increased generic competition. Aspen is acquiring multiple medicines in infectious disease, neurology, and gastroenterology, areas where the company currently has little or no presence. The products include antiviral Valtrex (valacyclovir) for cold sores, genital herpes, herpes zoster, and cytomegalovirus (the patent on this drug expired in Australia in 2011); and antibacterials Amoxil (amoxicillin), Augmentin (amoxicillin and clavulanate), and Timentin (ticarcillin and clavulanate). In the CNS space, Aspen is gaining the anti-epileptic Lamictal (lamotrigine); antidepressant Aropax (paroxetine); Imigran (sumatriptan) for migraine; and pain reliever Kapanol (morphine). Other purchased therapeutics include Mesasal (mesalazine) for acute inflammatory large bowel disease including Crohn’s and ulcerative colitis; Zantac (ranitidine) for peptic ulcers, reflux, Zollinger-Ellison disease, and scleroderma oesophagitis; Zofran (ondansetron) for post-operative- and chemotherapy-induced nausea and vomiting; plus undisclosed muscle relaxers. The current deal marks GSK’s fourth divestment of de-prioritized assets in less than a year, and its second sale to Aspen Pharmacare. In April 2012, Aspen bought 19 noncore OTC products distributed in international markets for £164mm. The transaction followed previous sales to Omega Pharma NV and Prestige Brands for other OTC products marketed in the US, Canada, and Europe, as GSK attempts to increase returns to shareholders and focus on higher-growth businesses. Investment Banks/Advisors: Investec Bank PLC (Aspen Global Inc.)

AstraZeneca PLC

MedImmune LLC

MedImmune-WuXi joint venture

WuXi PharmaTech Inc.

WuXi AppTec Inc.

AstraZeneca PLC’s MedImmune LLC is taking advantage of an opportunity to develop and sell one of its compounds in China by creating a 50/50 joint venture with WuXi AppTec Inc. (biopharma and device R&D outsourcing). The JV will be tasked with turning out MEDI5117, an autoimmune and inflammatory disease candidate that is currently in Phase I trials in the US and Europe. (Sep.)

The JV will take over all development, gleaning expertise from MedImmune for technical and development know-how, and from WuXi for local regulatory, manufacturing, and preclinical/clinical trial support. MedImmune retains an option to acquire full commercialization rights, but if it chooses not to exercise the option, the JV will hold rights to sell in China. MedImmune is eligible for milestones, and WuXi will realize revenues based on the services it provides to the JV. MEDI5117 is a fully human monoclonal antibody that inhibits interleukin-6 and is long-acting thanks to its design by MedImmune’s half-life extending mutation platform YTE. While the project is being eyed in the US and Europe for other indications, the partners will develop it in China solely for rheumatoid arthritis. An IND application will be filed shortly so trials can begin in China as soon as possible. MedImmune looks forward to the fast-track regulatory pathway it now has access to through its relationship with WuXi. Since MEDI5117 will be developed and sold by a Chinese company (the JV), the compound will be viewed as a domestic drug and will have better opportunity for faster development times, as opposed to hurdles MedImmune would have had to overcome if the drug were to be seen as imported.

AstraZeneca PLC

Regulus Therapeutics Inc.

Regulus Therapeutics Inc. (oligonucleotides) has granted AstraZeneca PLC exclusive rights to develop and sell microRNA therapeutics for three preclinical targets focused on cardiovascular and metabolic diseases and oncology. (Aug.)

AZ paid $3mm in cash up front, and committed to a $25mm equity investment that will occur if Regulus successfully completes an IPO of greater than $50mm. (If the IPO does not happen, the companies will discuss an alternative arrangement for AZ to invest the $25mm; if they cannot agree on terms of the investment at that point, both the stock agreement and the collaboration will be terminated.) In addition, AZ could also hand over preclinical, clinical, and sales milestones of up to $509mm, and sales royalties ranging from the mid-single digits to the low end of a 10-20% range. Regulus will lead preclinical studies, and then hand over the reins to AZ, which will carry out and fund all activities through commercialization. The first defined compound in the deal is Regulus’ lead miRNA program for atherosclerosis, targetomg microRNA-33. (Regulus holds exclusive rights to microRNA-33 IP from NYU.) The candidate has been shown to reduce arterial plaque and increase blood levels of HDL (“good cholesterol”). Details on the cancer and metabolic projects were not released. The agreement is not the first in the antisense space for AZ. Most recently, it has signed alliances with Silence Therapeutics in 2007 and 2008 (both of which have since been extended) to develop siRNAs for cancer, respiratory disease, and other conditions. Regulus adds AZ to its growing list of Big Pharma partners. While the company has yet to see a project to market, it has miRNAs in the works for inflammatory diseases and HCV through its relationship with GlaxoSmithKline, and for fibrosis and other indications in a tie-up with Sanofi.

Baxter International Inc.

Onconova Therapeutics Inc.

Baxter International Inc. has paid $50mm up front for European rights to Estybon (rigosertib), a Phase III compound for myelodysplastic syndromes (MDS) that is being developed by Onconova Therapeutics Inc. (small-molecule drug discovery for cancer). The deal covers 32 European countries, including the EU, Switzerland, Norway, and Turkey. (Sep.)

In addition to the up-front, Baxter has also committed to pay up to $515mm in development and regulatory milestones, plus sales milestones and royalties. (This is all in addition to and separate from a $50mm equity investment in Onconova that Baxter made in July.) In addition to MDS, rigosertib is also in a Phase II/III trial for pancreatic cancer. Baxter retains an option to take part in development and commercialization of the project in additional indications that Onconova may choose to pursue. Rigosertib inhibits both the PI3K and PLK (polo-like kinase) pathways, which have been shown as key mechanisms in the growth of solid tumors and blood cancers. The compound was designated as an orphan drug in both the US and Europe for MDS; SymBio Pharmaceuticals is developing it in Phase I trials in Japan and South Korea under a 2011 deal. Onconova will continue to seek partners for remaining territories, but for now looks forward to using the funds it gained from Baxter to finance remaining rigosertib trials, as well as studies of its refractory lymphoma candidate ON013105 (Phase I) and Ex-RAD, a therapy to protect cells from the harmful effects of radiation (Phase I). Baxter adds rigosertib to its growing hematology and oncology business, which includes chemotherapeutics for various blood cancers, and anti-emetics to help with chemo side effects.

Beijing Tide Pharmaceutical Co. Ltd.

NeuroDiscovery Ltd.

Sosei Group Corp.

Sosei Co. Ltd.

Sosei Co. Ltd. (also does business as Sosei KK), the pharmaceutical and sales division of Sosei Group Corp. (repurposes existing drugs), has licensed Chinese biotech Beijing Tide Pharmaceutical Co. Ltd. (BT) worldwide IP rights to its Phase I neuropathic pain candidate SD118 (NSL043). (Aug.)

Sosei will receive sales milestones. BT is responsible for designing and funding an upcoming Phase II proof-of-principle trial in China. The company will also maintain SD118’s global patent portfolio. Based on how SD118 performs in China in the clinic and on the market, Sosei may decide to take back rights in certain ex-Chinese territories. Sosei says the class of compounds to which SD118 belongs avoids efficacy problems and undesirable side effects associated with certain analgesics. The Japanese pharma discovered SD118 using its Drug Reprofiling Platform and had been co-developing the candidate with NeuroDiscovery since 2006. However in March 2010, NeuroDiscovery terminated their deal and returned all rights to Sosei. NeuroDiscovery, though, will receive 32% of the future revenue generated by the product (including fees part of the current licensing). Sosei is now assigning SD118’s IP to BT so that it can prioritize development resources. The company’s pipeline contains two compounds for COPD (one of which, NVA237, is awaiting approval in Europe and Japan), and a medicine for oropharyngeal candidiasis. BT, which specializes in injectable lipid microsphere drugs for targeted drug delivery, already markets two pain-relieving flurbiprofen products: the Kaifen injection, and Debaian hydrophilic polymer plaster.

Biokine Therapeutics Ltd.

BioLineRx Ltd.

Specialty pharmaceuticals company BioLineRx Ltd. has licensed exclusive global rights to Phase II-ready blood cancer candidate BKT140 from Biokine Therapeutics Ltd. (cancer and inflammation treatments). (Sep.)

There is no up-front payment associated with the deal, but BioLineRx will pay $50k-100k per month for development services provided by Biokine. The companies have devised a clinical development plan for the candidate (which BioLineRx has renamed BL8040): if timelines of the plan are met, BioLineRx is responsible for a payment of $250k, the only milestone payment applicable under the alliance. Should BioLineRx sublicense the project to a third party, it will hand over 40-60% of the amounts it receives in connection with the sublicensing, on a sliding scale based on its investment in the compound at the time. BL8040 is a CXCR4 chemokine receptor antagonist. CXCR4 is over-expressed in more than 70% of cancers, and has been shown to be involved in tumor growth, angiogenesis, metastasis, and cell survival. BioLineRx will seek orphan drug status for the candidate, and plans to have it in Phase II trials for acute myeloid leukemia during the first half of next year, with the intention of expanding development for additional hematological cancers in the future. Despite multiple in-licensing transactions over the years, BioLineRx only has one active cancer project in its pipeline right now. BL5040 is a preclinical cachexia candidate that has implications in cancer-related disease. Other compounds the company is focusing on include clinical ones for schizophrenia, acute myocardial infarction, skin lesions, IBD, and neuropathic pain, and preclinical studies ongoing for a variety of infectious, inflammatory, and dermatology conditions.

Bristol-Myers Squibb Co.

Summit PLC

Summit Therapeutics PLC (therapeutics for muscular, neurological, and infectious diseases) has licensed Bristol-Myers Squibb Co. exclusive rights to use its Seglin platform to discover and develop candidates against up to ten targets in multiple indications. (Sep.)

BMS pays a $100k technology access fee; up to $30mm in research, development, and regulatory milestones for each resulting product; and sales royalties. The Big Pharma is solely responsible for discovery research plus clinical trials and marketing. The Seglin platform centers on the role that carbohydrates play in the function of physiological systems. It creates small-molecule carbohydrate mimics known as Seglins, or second-generation iminosugars, which can recognize and interact with carbohydrate receptor drug targets. Summit gained its carbohydrate chemistry technologies through acquisitions of MNL Pharma and Dextra Laboratories. The deal with BMS is timely as just days before, Summit announced it would be reducing internal discovery-stage research, including general work with Seglins, to instead focus on development of its candidates for Duchenne muscular dystrophy (the Phase I utrophin up-regulator SMTC1100, partnered globally with BioMarin) and C. difficile infections (the preclinical antibiotic SMT19969). Summit does however plan to advance its own Seglin compound, a preclinical OGA inhibitor for neurodegenerative tauopathies such as Alzheimer’s, until it reaches a certain technical milestone, and will then evaluate the future of the program. Earlier this quarter, BMS signed another drug discovery alliance with Prosetta, which is using its protein-protein interaction technology to identify for the Big Pharma viral infection candidates.

Bristol-Myers Squibb Co.

Synergy Pharmaceuticals Inc.

Bristol-Myers Squibb Co. has licensed gastrointestinal drug developer Synergy Pharmaceuticals Inc. its Phase IIa oral nucleoside analog FV100 for shingles (herpes zoster). The deal includes assets and certain liabilities. (Aug.)

Synergy pays $1mm up front and is responsible for regulatory milestones, plus additional milestones for when net sales hit or exceed $125mm. The company will also pay single-digit royalties. In preclinical studies, FV100 was significantly more potent than the marketed shingle treatments acyclovir, valacyclovir, and famciclovir. The compound was discovered by FermaVir, which Inhibitex bought in 2007. Earlier this year, FV100 was one of the candidates that BMS gained through its $2bn acquisition of Inhibitex; the primary draw of that deal for BMS was actually the HCV nucleotide polymerase inhibitor INX189/BMS986094, but days ago BMS discontinued trials after a heart failure death in Phase II. Synergy, which merged with Callisto Pharmaceuticals in a $124mm stock swap this past July, has been developing two GI agents, both guanylate cyclase C agonists: lead plecanatide, in Phase II/III for idiopathic constipation and in preclinical for constipation-predominant IBS; and SP333 in preclinical for inflammatory bowel diseases. Synergy plans to apply the patient-reported outcome tools used with these compounds to develop FV100 for additional indications such as shingles-associated pain and post-herpetic neuralgia.

Bristol-Myers Squibb Co.

Vical Inc.

Bristol-Myers Squibb Co. has received nonexclusive global rights to DNA drug delivery company Vical Inc.’s DNA immunization technology to produce antibodies for human therapeutic use. (Sep.)

Vical will also occasionally supply its Vaxfectin adjuvant in certain quantities. The company’s DNA technology designs and constructs plasmids, or closed loops of DNA, encoding a particular therapeutic protein, plus short DNA segments that control the protein’s expression. The plasmids can also be used to deliver antigens from viruses, bacteria, or parasites, or tumor antigens, for purposes of developing vaccines. Vaxfectin adjuvant is a mixture of a cationic lipid and a neutral phospholipid that self assembles to form liposomes. These cationic liposomes are mixed with a plasmid, protein, and peptide vaccine to improve the vaccine’s effectiveness by boosting immune responses, especially antibody responses, to expressed immunogens. Vical is combining Vaxfectin with two of its preclinical vaccine programs for cytomegalovirus infection before and during pregnancy, and Type II herpes simplex virus. BMS’s last antibody deal was in 2011, when it in-licensed Innate Pharma’s KIR inhibitor IPH2102, in Phase I for acute myeloid leukemia. Less than a week ago, the Big Pharma received rights to another discovery technology, Summit Therapeutics PLC’s Seglin platform, to develop carbohydrate-targeting drug candidates.

Cipher Pharmaceuticals Inc.

Institut Biochimique SA

Cipher Pharmaceuticals Inc. (cardiovascular, dermatology, and pain therapeutics) has licensed exclusive Canadian marketing and distribution rights to Swiss pharma Institut Biochimique SA’s Betesil patch, a self-adhesive plaster that contains 0.1% betamethasone valerate, for inflammatory skin diseases including plaque psoriasis and eczema. (Aug.)

Institut Biochimique, which will provide the product, gets $Cdn100k ($99.9k) up front and regulatory milestones. Betesil is applied once a day; it is cut to fit the specific size of a lesion, eliminating the risk of contact with the steroid on healthy skin. The drug has already been approved in the UK and is in Phase III in Canada. The transaction will enable Cipher to expand its Canadian presence. In May Cipher received US FDA approval for its severe acne product, Absorica, but it is pending approval in Canada, where a response is expected in Q1 2013. Cipher already markets Durela in Canada for moderate-to-severe pain.

Covidien PLC

Mallinckrodt LLC

Xanodyne Pharmaceuticals Inc.

Continuing to strengthen its portfolio in preparation for a spin off from Medtronic Minimally Invasive Therapies’s Covidien Ltd., Mallinckrodt PLC (branded and generic pain and addiction treatments) has acquired Roxicodone (oxycodone, 5, 15, and 30 mg dosages) from Xanodyne Pharmaceuticals Inc. (formerly focused on pain management). The transaction includes all rights to the drug’s NDA. (Aug.)

Roxicodone, an immediate-release formulation available in the US for moderate-to-severe pain, was originally developed by Elan, which divested the product along with three other pain medications to aaiPharma in October 2003. Two years later, as it was in the midst of filing for Chapter 11 bankruptcy, aaiPharma sold all of its pharma assets to Xanodyne for $209mm. (AAIPharma Services later emerged from bankruptcy and has established a CRO business.) Now Xanodyne is in a similar situation, winding down operations amid hundreds of lawsuits involving injuries and deaths from its formerly marketed propoxyphene drugs Darvon and Darvocet (acquired from Eli Lilly). The current deal is Xanodyne’s second divestment: in June 2012 the company sold acute pain product Zipsor to Depomed for $26mm. In December 2011, Covidien announced it would be spinning off Mallinckrodt sometime in 2013 due to the many differences between its pharmaceutical and medical device offerings. Mallinckrodt, which is the largest US opioid supplier, will operate as an independent public company with multiple generic opioids as well as branded drugs including Sumavel DosePro (migraine) and Duexis (rheumatoid arthritis, osteoarthritis, and GI ulcers), both in-licensed just a couple months ago from Zogenix and Horizon Pharma, respectively.

DARA BioSciences Inc.

Seyer Pharmatec Inc.

Midatech Pharma US Inc. (oncology and supportive care products) has chosen Puerto Rican specialty pharmaco Seyer Pharmatec Inc. to exclusively sell its breast cancer treatment Soltamox (tamoxifen) in the Commonwealth of Puerto Rico. (Aug.)

Soltamox is the first and only FDA-approved oral liquid tamoxifen formulation, which is used as a first-line treatment for breast cancer patients who cannot swallow pills. DARA gained rights to it through the January 2012 acquisition of Oncogenerix, which held exclusive rights in the US and its territories and possessions from Rosemont Pharmaceuticals. DARA hopes to launch Soltamox later this year, and looks forward to Seyer’s help at expanding the product’s availability into the Puerto Rico market. Seyer’s other products include the cough/cold therapies Broncotron and Panatuss, Kola-Pectin for stomach upset and diarrhea, and the prenatal multivitamin Obstetrix.

DepoMed Inc.

Johnson & Johnson

Janssen Pharmaceuticals Inc.

Johnson & Johnson’s Janssen Pharmaceuticals Inc. has licensed non-exclusive rights to Depomed Inc.’s Acuform gastric retentive drug delivery technology. Janssen has also gained other rights to specific Acuform patents. (Aug.)

Depomed gets $10mm up front and low single-digit royalties from the sale of Nucynta ER (tapentadol) in the US, Canada, and Japan from July 2, 2012 until December 31, 2021. Depomed may also receive a one-time sales milestone if predetermined quarterly sales goals are met. Nucynta is an analgesic for moderate-to-severe chronic pain and neuropathic pain to which Grunenthal granted J&J US, Canadian, and EU rights in 2003; that deal has been expanded over the years to include additional countries. Numerous companies have licensed Depomed’s Acuform, including Ironwood Pharmaceuticals (for a GI treatment), Covidien (for use with four undisclosed products), and J&J’s Janssen Pharmaceutica NV (for a fixed-dose combination of canagliflozin and extended-release metformin for Type II diabetes).

Dyax Corp.

Kadmon Corp. LLC

Kadmon Corp. LLC (drug development for cancer, neurodegenerative and infectious diseases, and immune disorders) has licensed exclusive worldwide rights to Dyax Corp.’s DX2400, a preclinical matrix metalloproteinase 14 (MMP-14) inhibitor for solid tumors. (Sep.)

Dyax gets an up-front payment, as well as development and sales milestones, and tiered--up to double-digit--royalties. DX2400 was discovered using Dyax’s phage display technology. The compound, which is in IND-enabling studies, has shown promising results in early models of breast, melanoma, and prostate cancers by promoting the inhibition of primary tumor growth, metastasis, and angiogenesis. DX2400 will be the fifth oncology project in Kadmon’s pipeline. The company’s other candidates range in development from preclinical to Phase II, and include indications such as non-small cell lung, pancreatic, colorectal, breast, and hepatocellular cancers. Licensing DX2400 builds on Kadmon’s already-successful relationship with Dyax: the two partnered in July 2011 when Kadmon licensed non-exclusive rights to some of Dyax’s antibody phage display libraries for its drug discovery work.

Genmab AS

Johnson & Johnson

Janssen Biotech Inc.

Johnson & Johnson’s Janssen Biotech Inc. has licensed exclusive global development and marketing rights to antibody company Genmab AS’s HuMax-CD38 (daratumumab), which is in Phase I/II for relapsed refractory multiple myeloma, plus a back-up anti-CD38 compound. (Aug.)

Genmab gets $135mm up front consisting of a $55mm license fee and an $80mm investment from Johnson & Johnson Development Corp., which has purchased 5.4mm Genmab shares at $14.82 (a 30% premium). J&JDC will now own a 10.73% stake in Genmab, which is also eligible for up to $1.1bn in development, regulatory, and sales milestones, plus tiered double-digit royalties. Janssen will assume responsibility for all future development and commercialization activities. While Genmab is in charge of completing the ongoing Phase I/II studies, Janssen will fund them. The MAb is in Phase I/II as a monotherapy and in combination with Celgene’s Revlimid, which is already approved as a second-line treatment of relapsed or refractory multiple myeloma in tandem with chemotherapy. Janssen is also planning to develop HuMax-CD38 for acute myeloid leukemia, diffuse large B-cell lymphoma, plasma cell leukemia, follicular lymphoma, mantle cell lymphoma, and acute lymphoblastic leukemia. HuMax-CD38 has broad-spectrum killing ability; it targets the CD38 antigen, which is highly expressed on multiple myeloma cells. It is the first known antibody that blocks the ecto-enzymatic activity of CD38, enabling it to annihilate both multiple myeloma and plasma leukemia cells. The transaction--the largest antibody alliance so far this year, followed by Celgene’s $500mm option arrangement with Inhibrx for a preclinical program in an undisclosed therapeutic area--comes just a month after Genmab agreed to use its DuoBody technology to create and develop bispecific antibodies for several disease targets (up to 10 programs) that Janssen selects. Since going public in its $180mm IPO twelve years ago, Genmab has signed quite a few notable partners, including Roche, GSK, and Novartis. Gilead Sciences Inc.

Japan Tobacco Inc.

Torii Pharmaceutical Co. Ltd.

Japan Tobacco Inc. has licensed its Japanese pharma subsidiary Torii Pharmaceutical Co. Ltd. exclusive rights to market a single-tablet HIV treatment containing JTK303 (elvitegravir) in Japan. (Aug.)

Torii will pay its parent Y2.7bn ($34.3mm) up front. JT plans to file an NDA in Japan during FYE March 31, 2013. Once approved, Torii will solely commercialize the anti-HIV single-tablet regimen. The new convenient once-daily, single-tablet treatment contains JT’s HIV integrase inhibitor JTK303, Gilead Sciences Inc.’s HIV reverse transcriptase inhibitors Emtriva (emtricitabine) and Viread (tenofovir disoprxil fumarate), and Gilead's pharmaco-enhancing agent cobicistat, which designed to increase blood levels of JTK303. In the US, the combo drug is currently sold by Gilead as Stribild. JT in-licensed Japanese rights to the HIV therapies Emtriva and Viread in 2003, and the drugs are currently being marketing by Torii. In March 2005, JT granted Gilead worldwide rights (excluding Japan) to JTK303.

IBA Molecular Inc.

Piramal Healthcare Ltd.

Piramal Imaging SA

Indian company Piramal Enterprises Ltd.’s diagnostic imaging unit Piramal Imaging SA has licensed IBA Molecular Inc. (PET and SPECT imaging products) US and European manufacturing and distribution rights to its lead candidate, Phase III radiopharmaceutical 18F-florbetaben. (Aug.)

Labeled with the fluorine 18 radioisotope, 18F-florbetaben is a PET imaging tracer that helps identify beta-amyloid plaques in the brain, a key indicator for Alzheimer’s disease. Results from a recent Phase III study (the first to overlay MRI and PET data to accurately match florbetaben gray matter uptake in AD patients in six defined brain regions) showed that the visual assessment procedure with 18F-florbetaben had 100% sensitivity and 92% specificity, and confirmed the compound binds to beta-amyloid on regional (brain sections) and subject (whole brain) levels. Concurrent with its founding earlier this year, Piramal gained the imaging agent only months ago in a deal with Bayer HealthCare Pharmaceuticals AG. In fact Piramal acquired Bayer’s entire molecular imaging portfolio, including two other development-stage radiopharmaceuticals: a gallium-68-labeled candidate for localized prostate cancer, and FSPG, an F-18 labeled compound that targets the cystine/glutamate exchanger in certain tumors. Bayer exercised an option to license 18F-florbetaben from originator Avid Radiopharmaceuticals (since taken over by Lilly) in 2007. IBA was spun off from its parent, cancer device developer Ion Beam Applications SA, in April 2012 as a separate company to focus on Ion Beam’s global radiopharmaceutical business. IBA is jointly owned by Ion Beam and investment firm SK Capital Partners. In the neurology area, IBA’s only branded product is the technetium-labeled agent Neurolite for evaluation of regional cerebral perfusion abnormalities in CNS diseases.

ImmuNext Inc.

Johnson & Johnson

Janssen Biotech Inc.

Johnson & Johnson’s Janssen Biotech Inc. has licensed exclusive global development and commercialization rights to ImmuNext Inc.’s (oncology and immunology therapeutics) preclinical cancer immunotherapies, which antagonize the VISTA (V-region immunoglobulin-containing suppressor of T-cell activation) signaling pathway. (Sep.)

ImmuNext gets money up front as well as development and commercialization milestones that could reach over $150mm, plus royalties on resulting products. The company will also receive sponsored research support. While Janssen and ImmuNext will jointly perform R&D activities, Janssen alone will be in charge of clinical development and marketing. VISTA is a newly identified negative checkpoint regulator which may be the key to increasing a patient’s immunity to solid and liquid cancers; the VISTA IP is designed to prevent the immune system from shutting down, likely caused by the cancer. The in-licensed compounds were developed using technology discovered by ImmuNext’s CSO, Randolph Noelle, PhD, in his Dartmouth and King’s College London labs. Noelle and CEO David DeLucia were also co-founders of ImmuRx, which was formed to out-license an adjuvant vaccine technology also developed by Noelle. ImmuNext was spun off from Dartmouth last year and has raised under $1mm in angel funding. In addition to the VISTA cancer program, it is also working on a technology to turn off the immune system, which would target conditions such as multiple sclerosis, lupus, and Crohn’s disease. The deal with ImmuNext is just one of three that Janssen has penned in the last few months; other recent partners include West Pharmaceutical (for a self-injection product) and Genmab(which, in two separate arrangements, licensed Janssen rights to its Phase I/II HuMax-CD38 for refractory multiple myeloma, and its DuoBody IP to create bispecific antibodies to disease targets).

Johnson & Johnson

Janssen Biotech Inc.

Vascular Pharmaceuticals Inc.

Concurrent with its $16mm Series A venture round, Vascular Pharmaceuticals Inc. (diabetes) has granted Johnson & Johnson’s Janssen Biotech Inc. the exclusive right to acquire the company. (Sep.)

Janssen has provided money up front and will pay contingent milestones in order to buy Vascular Pharma after it has finished a planned Phase II study of VPI2690B, a compound currently in preclinical trials for diabetic nephropathy. An IND filing is expected in 2H 2013. Formed in 2005 by the University of North Carolina, Chapel Hill’s Dr. David Clemmons, Vascular Pharma is developing therapeutic antibodies for complications due to diabetes, such as diabetic atherosclerosis, retinopathy, and obesity. Over the last two months Janssen Biotech has penned four other alliances, but this is the first diabetes transaction. Others have been with ImmuNext for preclinical cancer immunotherapies, West Pharmaceutical Services to develop a self-injection product, and two separate agreements with Genmab to create bispecific antibodies and for rights to Genmab’s Phase I/II HuMax-CD38 for relapsed refractory multiple myeloma.

MacroGenics Inc.

Servier SA

Building on a relationship that began with a separate deal almost a year ago, Servier SA has once again optioned rights to early-stage projects from MacroGenics Inc. (therapies for autoimmune and infectious diseases and cancer). This time, the French pharmaco has its sights on three of MacroGenics’ preclinical anticancer DART (Dual-Affinity Re-Targeting) compounds. (Sep.)

Servier paid $20mm up front for options to exclusively develop and sell the candidates worldwide, excluding the US, Canada, Mexico, Japan, Korea, and India (all territories where MacroGenics retains rights). The companies will together fund and conduct early development activities, up until the point where Servier needs to make a decision on the options. (It can exercise its option for one compound prior to IND submission, and for each of the other two following completion of an initial Phase I trial.) MacroGenics could receive option fees and preclinical milestones totaling $80mm, and up to $1bn in development, regulatory, and sales milestones for all three candidates, plus tiered double-digit royalties. Throughout the life of the collaboration, development costs will be shared on all compounds post-option exercise. MacroGenics uses its DART technology to create bi-specific antibodies that allow a single molecule to target two different antigens. The three candidates that are part of the deal are in preclinical studies for both solid and liquid tumors. In December 2011, MacroGenics granted Servier an option to license exclusive rights to its MGA271, a Phase I mAb for solid tumors that targets the B7-H3 immune regulator. Further building its oncology pipeline (the company only has one marketed cancer drug), Servier also holds an option for ex-US rights to new cancer candidates discovered by Galapagos NV under an October 2011 deal.

Medivir AB

Novadex Pharmaceuticals AB

Infectious disease-focused Medivir AB has acquired preclinical antiviral assets from fellow Swedish biotech Novadex Pharmaceuticals AB. (Sep.)

Novadex receives undisclosed money up front plus potential milestones. Under the agreement, Medivir gets a portfolio of antiviral programs including nucleotide polymerase inhibitors, intellectual property, and prodrug technologies that can be used to improve the overall pharmacokinetic properties of protease inhibitors and nucleoside analogues. The licensed assets will allow Medivir to enhance its hepatitis C and antiviral platform. Its lead compound simeprevir (TMC435) is a Phase III protease inhibitor being co-developed with Janssen Pharmaceuticals.

Merck KGAA

Symphogen AS

Symphogen AS (therapies for autoimmune and infectious diseases and cancer) has granted Merck KGAA exclusive worldwide rights to develop and sell its lead project Sym004, an antibody mixture in Phase I/II trials for advanced KRAS wild-type metastatic colorectal cancer patients, who have previously responded to treatment with standard chemo and a marketed anti-EGFR monoclonal antibody. (Sep.)

The compound is also being in a Phase II trial in squamous cell carcinoma of the head and neck patients, who have failed anti-EGFR-based treatment. Merck paid €20mm ($25mm) up front, and could hand over an additional €225mm in development and regulatory milestones, plus up to €250mm in combined sales milestones and royalties. Sym004 is comprised of two antibodies that work together to block ligand binding, receptor activation, and downstream signaling, while at the same time inducing EGFR internalization and degradation to stimulate removal of EGFR receptors from the surface of cancer cells. The project’s successful development served as the catalyst to a second tranche earlier this year in Symphogen’s 2011 €100mm financing. Merck adds Sym004 to its already-strong cancer business. The company’s second-largest product in terms of revenue is Erbitux (cetuximab), which generated €855mm in sales for 2011. The drug’s primary indication is squamous cell carcinoma of the head and neck, and it received FDA approved in July for the additional indication of KRAS mutation-negative EGFR-expressing metastatic colorectal cancer when used in combination with the chemo regimen FOLFIRI (irinotecan, 5-fluorouracil, and leucovorin).

Merz GMBH & Co. KGAA

Merz Pharmaceuticals LLC

Shionogi & Co. Ltd.

Shionogi Inc.

Merz Pharmaceuticals LLC, the US division of private Germany drug company Merz GMBH & Co. KGAA’s Merz Pharma Group (which also does business as Merz Pharma GMBH & Co. KGAA) has acquired the orphan product Cuvposa (glycopyrrolate) from Shionogi & Co. Ltd.’s US subsidiary Shionogi Inc. (Aug.)

Merz will continue to provide caregiver access to the drug via Shionogi’s existing relationships with Diplomat Specialty Pharmacy and Anda Inc. (Watson’s distribution business). Cuvposa is a long-acting muscarinic antagonist that prevents stimulation of acetylcholine receptors to treat sialorrhea, or chronic severe drooling associated with neurological diseases, in particular in children who have cerebral palsy. (Approximately 10-30% of pediatric cerebral palsy patients suffer from sialorrhea.) The drug, which is packaged in a cherry-flavored oral liquid solution, was the first ever (and still only) medicine approved for this indication in the US in July 2010, and it launched in April 2011. Shionogi & Co. acquired Cuvposa through its 2008 takeover of Sciele Pharma (which was renamed Shionogi Inc.) Prior to approval, glycopyrrolate was used off-label to treat sialorrhea; the drug has traditionally been prescribed for peptic ulcers and as a drying agent during mouth surgeries. More recently, biotechs such as Pearl Therapeutics and Elevation Pharmaceuticals have been developing inhaled glycopyrrolate as a respiratory agent for COPD. In the US, Merz Pharmaceuticals LLC’s only other marketed CNS product currently is Xeomin, a botulinim toxin injection for cervical dystonia to decrease the severity of abnormal head position and neck pain. Parent firm Merz, though, sells multiple treatments for neurological and psychiatric diseases, and it was the first to ever launch a drug, memantine, for moderate-to-severe Alzheimer’s disease.

More Pharma Corp.

Oculus Innovative Sciences Inc.

Mexican drug distributor More Pharma Corp has licensed exclusive rights to sell Oculus Innovative Sciences Inc.'s (dermatology, oral care, wound care, and surgical products) Microcyn-based wound care products in Mexico, South/Central America, and the Caribbean. (Aug.)

More Pharma paid $5.1mm up front and will immediately begin transitioning sales and marketing efforts for the products in Mexico. (Activities in the other territories are forthcoming, pending completion of regulatory approval; More Pharma will bear all related costs.) Microcyn has been approved by the FDA, received the CE Mark, and was approved/launched in Mexico in 2003. The technology behind the products helps to prevent infection and moisten, clean, and debride complex wounds and burns. It is highly effective in the treatment of burns, diabetic foot ulcers, and varicose vein ulcers/stasis ulcers, and has been shown to reduce the need for oral antibiotics. Last year, Oculus granted Eloquest Healthcare rights to sell the products in the US. More Pharma will use its sales force of over 200 to sell the Microcyn line in its territories. The company’s other OTC offerings include treatments for flu symptoms, cold/cough, and oral inflammation, in addition to prescription products for dermatological, cardiovascular, respiratory, and musculoskeletal conditions.

Mylan Inc.

Mylan Pharmaceuticals Inc.

Pfizer Inc.

Mylan NV (generics) has settled patent litigation with Pfizer Inc. regarding Mylan Pharmaceuticals Inc.’s ANDA for tolterodine tartrate ER 2- and 4-mg capsules for treating overactive bladder in patients showing symptoms of urge urinary incontinence, urgency, and frequency. Tolterodine tartrate is the generic equivalent of Pfizer's Detrol LA. Under terms of the settlement, Mylan can start selling the drug either as an authorized generic or under its own ANDA on January 1, 2014--or earlier under limited circumstances--and no later than March 1, 2014, subject to FDA approval. For fiscal year ending June 31, 2012, generic Detrol LA generated US sales of about $599mm. (Sep.)

Mylan Inc.

Pfizer Inc.

Pfizer Inc. and Mylan NV have entered into an exclusive long-term deal for the development, manufacture, marketing, and distribution of generic drugs in Japan. (Aug.)

The alliance helps Pfizer expand in Japan its Established Products business, which sells 58 pharmaceuticals, and allows Mylan--with over 380 drugs in its portfolio covering various therapeutic areas and another 125 development-stage candidates--to gain market share in a territory where Mylan has been hampered by poor distribution and marketing. There is a small overlap of products from both firms, but duplicates will be removed. Mylan will handle research, development and manufacturing of the drugs, while the Big Pharma is in charge of commercialization activities. Pfizer will sell the products under its own brand, though Mylan’s name will also appear with the hopes that joint labeling will help increase sales. The Japanese generics market currently ranks sixth; hopefully the collaboration will help the country climb higher on that list. The companies will continue to maintain their own facilities in Japan, but will share costs and split revenues. It is possible that under the collaboration 100 new drugs may hit the market by 2015. Earlier this month the parties penned an agreement, also for the Japanese market; Mylan's Mylan Specialty LP subsidiary licensed Pfizer exclusive rights to market and sell the next-generation EpiPen injection.

Nanobiotix SA

PharmaEngine Inc.

Nanobiotix SA (nanomedicine for cancer drug development) has granted PharmaEngine Inc. (treatments for cancer and Asia-prevalent diseases) exclusive rights to develop and sell its Phase I radiotherapy adjunct NBTXR3 in the Asia-Pacific region, including Australia, China, India, Japan, Korea, and Taiwan. (Aug.)

PharmaEngine paid $1mm up front, and has committed to an additional $56mm in development and commercialization milestones, plus up to double-digit tiered royalties. Nanobiotix retains the option to take back rights for the entire licensed territory, excluding China and Taiwan, in exchange for termination payments and certain royalties. NBTXR3 is the lead compound resulting from Nanobiotix’s NanoXray technology, which was designed to enhance the effectiveness of radiotherapy using nanoparticles that are activated in vivo by x-rays and help increase the dose of radiotherapy delivered directly to a tumor without harming surrounding healthy tissue. The candidate (in development in the EU as a Class III medical device and in the US as a drug) is a nanoparticle formulation of hafnium oxide crystals. In addition to soft tissue sarcoma, PharmaEngine will fund development of NBTXR3 in two more indications.

Novartis AG

Novartis Pharma AG

QLT Inc.

Valeant Pharmaceuticals International Inc.

Valeant Pharmaceuticals International Inc. has acquired QLT Inc.’s US rights to Visudyne (verteporfin), a light-activated therapy for wet age-related macular degeneration. (Sep.)

Visudyne is a two-stage treatment that works when verteporfin is intravenously administered and then activated by light from a non-thermal laser, causing occlusion of the abnormal blood vessels associated with AMD. The dual therapy incorporates verteporfin-related IP that QLT licensed from the University of British Columbia in 1988 and the light-activated part comes out of a mid-1990s deal between QLT and Ciba Vision (now Novartis Pharma AG). QLT and Novartis eventually restructured their agreement and as of January 2010 QLT had exclusive US sales and marketing rights to Visudyne and Novartis was responsible for commercialization outside the US. Under the current transaction, Valeant is paying QLT $112.5mm up front, of which $62.5mm is for the rights to the Visudyne assets in the US, and the remaining $50mm is for royalty rights on ex-US sales--under that Novartis Pharma agreement--and the right to supply Visudyne to Novartis in its territories. QLT may also receive up to $5mm relating to its laser program development in the US, and up to $15mm associated with Novartis’ non-US royalties and a royalty on any new indications approved for Visudyne. Valeant will manufacture the drug and supply it to ex-US countries. During 2011, Visudyne had revenues of $21mm in the US and $14mm outside the US.

Novartis AG

Novartis Pharmaceuticals Corp.

Selexys Pharmaceuticals Corp.

Novartis Pharmaceuticals Corp. has been granted an exclusive option to acquire closely held Selexys Pharmaceuticals Corp. (therapeutics for inflammatory and thrombotic diseases) after it completes a Phase II study of the anti-P-selectin antibody SelG1, which recently finished Phase I for vaso-occlusive crisis, a major complication in patients with sickle cell disease. (Sep.)

The deal is worth up to $665mm, including money up front and acquisition and earn-out payments. Concurrent with the equity investment from Novartis, ten-year-old Selexys has closed on a $23mm Series A venture round, bringing the total money it has raised to date to over $26.5mm. The recent money will be used to advance SelG1 through Phase II and move SelK1, an anti-PSGL-1 antibody, through Phase I for Crohn’s disease; both antibodies have been developed using IP licensed from the University of Oklahoma. SelG1 has had orphan drug status in the US since 2008 and is designed to help the 50% of sickle cell patients that do not respond to hydroxyurea, the only drug that has been approved for the condition. The transaction is a departure of sorts for Novartis, which has been focused on penning alliances for cancer treatments throughout most of this year.

Oncodesign SA

Sanofi

Oncodesign SA (drug discovery tools for oncology therapeutics) will apply its Nanocyclix medicinal chemistry technology to several of Sanofi’s kinase target programs in development. Specific projects and therapeutic areas were not disclosed. (Sep.)

Over the course of the four-year collaboration, Oncodesign could get up to a total of €130mm ($170mm) in technology access fees and development, regulatory, and commercialization milestones. Sanofi could also hand over low single-digit sales royalties. Nanocyclix is based on macrocyclization, a process that enables the design and synthesis of selective kinase inhibitors based on shape complementarity in the ATP binding site, and also provides for the improvement of pharamacokinetic properties. This is Oncodesign's second partnership surrounding the Nanocyclix platform. The first deal, signed in January 2012, called for Oncodesign to utilize the technology to produce LRRK2 kinase inhibitors for Ipsen to use in the potential development of Parkinson’s disease therapeutics. The current tie-up with Sanofi expands on a relationship between the partners that began in 2009. At that time, Oncodesign signed a two-year service contract with the Big Pharma to supply and develop experimental cancer models based on patient-derived tumor tissue that Sanofi could use for new drug development.

Open Monoclonal Technology Inc.

Pfizer Inc.

Open Monoclonal Technology Inc. (developing human therapeutic antibodies) has licensed Pfizer Inc. rights to use its OmniRat platform for antibody R&D in undisclosed therapeutic areas. (Sep.)

OmniRat uses transgenic rats to generate and engineer fully human antibodies with high specificity and affinity that can be manufactured easily. Using animals to create these antibodies offers several benefits such as it’s faster, more cost-effective, and eliminates the need for humanization or lead optimization. Studies have shown that OmniRat can effectively produce antibodies like wild-type rats and cover different epitopes than mice. OMT and the Big Pharma have used the technology to successfully generate antibodies that bind to various different targets with subnanomolar affinities. Earlier this month, OMT signed a similar agreement with WuXi PharmaTech.

Paion AG

An undisclosed company has licensed German biotech Paion AG rights to distribute the short-acting anesthetic remifentanil in Germany. Paion also secured the option of gaining licenses in other European Union countries. (Aug.)

Paion paid €100k ($123k) up front, and the partners have also signed a supply agreement. Remifentanil, a mu opioid receptor agonist that went generic last year, is used primarily in total intravenous anesthesia (TIVA), where it can be continually administered (the drug has a 3-10 minute half-life). GSK originally developed remifentanil and launched it as Ultiva in 1996. A few years later, Abbott acquired GSK’s US anesthesia business, including Ultiva. Paion, which anticipates realizing revenues from remifentanil--representing the company’s first marketed product--starting next year, believes the drug will be a good complement to its remimazolam (formerly CNS7056), also a short-acting IV anesthetic, in Phase II for procedural sedation. Incidentally remimazolam, which Paion got its hands on through the 2008 takeover of CeNeS Pharmaceuticals, is also a GSK-originated compound. (The CeNeS deal, which brought Paion several other neurology candidates, helped diversify Paion’s pipeline away from thrombolytics.) Paion says it plans to acquire other anesthesia medications in the near future. Late last year the company undertook major cost-cutting measures, reducing its workforce by half and lowering salaries of management and board members, so that it could focus on core business functions, including out-licensing remimazolam (Ono Pharmaceutical already has Japanese rights, and Yichang Humanwell Pharmaceutical holds an exclusive option in China).

Par Pharmaceutical Cos. Inc.

Anchen Pharmaceuticals Inc.

Shire PLC

TWi Pharmaceuticals Inc.

Shire PLC has settled patent infringement litigation with TWi Pharmaceuticals Inc. and its authorized distributor Anchen Pharmaceuticals Inc. (a subsidiary of Par Pharmaceutical ) relating to TWi's ANDA for a generic version of Shire's ADHD drug Intuniv (guanfacine hydrochloride). Under terms of the settlement, TWi will manufacture the generic for Anchen, which will sell it in the US starting on July 1, 2016 or possibly earlier in limited situations. Shire will receive royalties and may allow Anchen to sell authorized generic versions of Intuniv supplied by Shire, which would result in Shire getting a significant royalty. The US patents involved in the litigation were 6,287,599 and 6,811,794. (Sep.)

Pfizer Inc.

Visterra Inc.

Visterra Inc. (mostly focused on developing infectious disease therapeutics) will use its technology to help Pfizer Inc. identify and develop therapeutic antibodies. (Sep.)

The Big Pharma will pay Visterra money up front, research funding, R&D milestones, and royalties on any resulting products. The collaboration is the first for five-year-old Visterra. The company has used its antibody design platform to develop its lead candidate VIS410, a preclinical MAb for seasonal and pandemic influenza. Just two weeks ago, Pfizer signed an antibody deal with VLST, out-licensing its Phase II-ready CP870893 anti-CD40 cancer MAb.

Pfizer Inc.

VLST Corp.

Pfizer Inc. has licensed VLST Corp. (developing therapeutics for cancer and autoimmune and inflammatory disorders) exclusive rights to its Phase II-ready CP870893 anti-CD40 monoclonal antibody for cancer. (Aug.)

Pfizer gets a 5% equity stake in VLST and will retain co-exclusive rights to the candidate as an oncology vaccine. CP870893 is designed to activate antigen-presenting cells and inhibit tumor growth. The Big Pharma had studied the compound in Phase I but discontinued its development in September 2010. Pfizer is transferring the IND to VLST, which his planning to use funds from its June 2012 Series B tranche to support Phase II efficacy trials. VLST believes that the drug is most promising when used in combination with chemotherapy. The agreement is in line with Pfizer’s goal of managing its cancer portfolio and giving those out-licensed compounds the best chance for success.

Quintiles Transnational Corp.

Sinclair IS Pharma PLC

Quintiles Transnational Holdings Inc. will market Sinclair IS Pharma PLC’s (dermatology, dental, and wound healing treatments) dermo-cosmetic products and medical devices in Mexico for the next 10 years. (Sep.)

Quintiles will be in charge of submitting regulatory filings, importing products, warehousing and distribution, promoting to dermatologists and plastic surgeons, and marketing activities. Quintiles will sell Atopiclair (sodium hyaluronate) for mild-to-moderate atopic dermatitis; Kelo-cote to prevent and reduce the appearance of abnormal scars; Sebclair (alglycera) for seborrhoeic dermatitis; Bio-Taches (biotanoid) for hyperpigmentation disorders; XClair (sodium hyaluronate cream) for radiation dermatitis; and Papulex (nicotinamide) for mild-to-moderate acne. Quintiles has served Mexico for about 16 years, so it is very familiar with the regulatory and marketing requirements there. It has also been expanding its commercial services business in emerging markets in recent months via entry into Russia and Brazil.

Rhizen Pharmaceuticals SA

TG Therapeutics Inc.

TG Therapeutics Inc. (oncology) has agreed to co-develop Rhizen Pharmaceuticals SA’s (immune, metabolic, respiratory, and inflammatory disease therapies) preclinical PI3K inhibitor TGR1202 (formerly RP5264) globally, excluding India, for hematological cancers and autoimmune diseases. (Aug.)

TG paid an undisclosed fee up front and committed to specific milestones pertaining to development of the compound until Phase II trials. Under terms of the deal, either company may exercise an option that will give TG full global rights to develop and sell TGR1202. If the option is exercised, Rhizen will get an additional up-front fee and milestones that could exceed $250mm, plus royalties and sublicense profits. Rhizen retains responsibility for the global manufacturing and supply to TG of the active ingredient in TGR1202; it will also contribute backup molecules, giving TG the opportunity to develop additional therapies. TGR1202 is a selective inhibitor of the PI3K delta isoform, which is thought to be responsible for the proliferation and survival of B-cell lymphocytes in cases of B-cell related lymphomas. An IND filing for the compound is expected by the end of the year. TG will develop TGR1202 alongside its own B-cell lymphocyte therapy Utuxin (ublituximab), which just received IND approval in May and is slated to begin Phase I/II trials shortly.

Sanofi

Genzyme Corp.

Impax Laboratories Inc.

Global Pharmaceuticals Corp.

Sanofi’s Genzyme Corp. has settled a patent infringement lawsuit it had filed against branded and generics drug company Impax Laboratories Inc. in March 2009. Under terms of the agreement, Genzyme has granted Impax a license to sell its generic form of Renvela (sevelamer carbonate 800mg tablets) on March 16, 2014, or earlier under certain circumstances. It also granted Impax licenses to sell the generic oral suspension version of Renvela, and Renagel (sevelamer HCl 400mg and 800mg tablets) on September 16, 2014, or earlier. Both therapies are used to control serum phosphorous in patients with chronic kidney disease on dialysis, and together brought in $392mm in sales during the first half of 2012. Impax’s generics division Global Pharmaceuticals Corp. will market the products upon launch. (Sep.)

Financings

Achillion Pharmaceuticals Inc.

Infectious disease-focused Achillion Pharmaceuticals Inc. has netted $41.7mm through the sale of 6.4mm common shares at $6.57 (market average) to funds managed by QVT Financial LP. The money will support ongoing development of its lead hepatitis C candidates sovaprevir (ACH1625; Phase II), ACH2684 (Phase I), and ACH3102 (Phase I). (Aug.)

Arrowhead Research Corp.

Arrowhead Pharmaceuticals Inc. (peptide-drug conjugates--from the recent Alvos acquisition--and RNAi therapeutics for cancer, obesity, and hepatitis B) netted $6.1mm in a registered direct offering of 2.3mm shares at $2.76 (a 23% discount). Individual backer James Mellon led the existing shareholders group, which provided half of the financing. The remainder was from a new investor, a large health care-focused fund. Buyers also received four-year warrants to purchase 1.7mm shares for $3.25. Rodman & Renshaw was the placement agent. (Aug.)

Investment Banks/Advisors: Rodman & Renshaw Capital Group Inc.

Biogen Idec Inc.

GlaxoSmithKline PLC

Human Genome Sciences Inc.

Biogen Inc. has sold to a DRI Capital-managed fund its royalty and other rights pertaining to Benlysta (belimumab) for systemic lupus erythematosus. (Sep.)

In the latter half of 2008, Biogen licensed GlaxoSmithKline PLC and its then-partner (currently division) Human Genome Sciences Inc. exclusive rights to a European patent claiming a method of treating autoimmune diseases using an antibody to B-lymphocyte stimulator, which Benlysta targets, and Biogen was entitled to royalties. Under the current deal, HGS and GSK will make royalty payments to DRI instead of Biogen. DRI pays Biogen $18.3mm up front--which covers sales royalties of Benlysta from October 2011 through March 2012--plus, during the period between April 2012 and September 2014, additional money based on multiples of royalties that will vary by year and territory in which the royalties are generated. After September 2014, DRI collects all the royalties with some exceptions, including a one-time payment triggered if cumulative royalties to DRI exceed a certain amount. Benlysta received FDA approval in March 2011 and European approval four months later. By selling off long-term Benlysta royalties, Biogen gets money earlier to put towards the upcoming launch of products for multiple sclerosis, hemophilia, and amytrophic lateral sclerosis.

BioTie Therapies Corp.

Institutional and strategic investors have bought €20mm ($25mm) in Biotie Therapies Corp. (treatments for mainly CNS conditions, but also inflammation, COPD, and fibrotic liver disease) stock. The company sold 46.5mm shares for €0.43, a 4% discount. The placement agents were Nomura Code Securities and Nordea Bank Finland. Concurrent with the PIPE, Biotie received a separate €10mm investment from Selincro (nalmefene) partner Lundbeck, which as a result now has a 4.6% equity stake. Biotie says the money from both of these fundraises will be used to support approval of Selincro for alcohol dependence (the EU regulatory filing was submitted in December 2011), plus Phase IIb studies of tozadenant in Parkinson’s disease (for which it's licensed exclusively to UCB). (Sep.)

Investment Banks/Advisors: Nomura Securities International Inc.; Nordea Bank

Catalyst Pharmaceutical Partners Inc.

Catalyst Pharmaceuticals Inc. (developing in-licensed treatments for cocaine addiction and epilepsy) netted $5.6mm in a registered direct offering of 4mm shares at $1.50, a 7% discount. Investors also received five-year warrants to buy 1.2mm shares for $2.08. The placement agent was Roth Capital Partners. (Aug.)

Investment Banks/Advisors: Roth Capital Partners

Horizon Pharma Inc.

Horizon Pharma PLC (neurology, muscloskeletal, and inflammation therapeutics) has netted $81.1mm through the follow-on public offering of 24.6mm common shares (including the overallotment) at $3.50. The investors also received five-year warrants to buy another 10.7mm shares at $4.57. The company will use the money for commercialization activities for its Duexis (for rheumatoid arthritis, osteoarthritis, and to decrease the risk of developing upper gastrointestinal ulcers) and Rayos (for rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, ankylosing spondylitis, asthma, and chronic obstructive pulmonary disease). (Sep.)

Investment Banks/Advisors: Cowen & Co. LLC; JMP Securities LLC; Stifel Nicolaus & Co. Inc.

Infinity Pharmaceuticals Inc.

Infinity Pharmaceuticals Inc. (therapeutics for cancer and inflammation) has netted $83.1mm through the follow-on public offering of 6.1mm common shares (including the overallotment) at $14.50. The proceeds will be used to continue development of IPI145 for inflammation (Phase II) and hematologic malignancies (Phase I), and also for retaspimycin (IPI504), which is in Phase II for non-small cell lung cancer. (Aug.)

Investment Banks/Advisors: JP Morgan & Co.; Morgan Stanley & Co.

Intercept Pharmaceuticals Inc.

Intercept Pharmaceuticals Inc. (bile acid receptor targets) has filed for its initial public offering, planning to sell 4.3mm shares for $13-15. (Sep.)

Since its founding ten years ago, Intercept has been researching bile acid signaling, which is involved in metabolic, immune, and inflammatory pathways. The company discovered that certain receptors such as farnesoid X (FXR) mediate and regulate the biological effects of bile acids in the liver. In 2004, Intercept acquired the bile acid analog obeticholic acid (OCA) from Italy’s University of Perugia, where the agent was discovered by Intercept co-founder Roberto Pelliciari, PhD, in a collaboration with GSK to develop FXR agonists, antagonists, and modulators. Intercept is now focused on a Phase III trial of OCA as a second-line treatment of primary biliary cirrhosis, a rare condition that often leads to liver failure. The biotech anticipates using the Phase III data to prepare regulatory filings in the US and Europe. The orphan drug candidate is ideal for patients who cannot tolerate ursodiol, the current standard of care. Last year, Intercept partnered OCA in Japan and China with Dainippon Sumitomo Pharma, which has the option to add other Asian territories. Intercept is also investigating additional indications for OCA in Phase II, including portal hypertension, nonalcoholic steatohepatitis, and bile acid diarrhea. Besides OCA, Intercept’s other pipeline projects (both in preclinical studies) are the TGR5 agonist INT777 for Type II diabetes, and the dual FXR/TGR5 agonist INT767 for chronic kidney diseases involving progressive fibrosis that leads to kidney failure. The company also has an alliance with Servier, which holds global rights outside of the US and Japan to TGR5 agonists for Type II diabetes and other metabolic diseases (this deal excludes INT777). Intercept is majority owned by Italian investor Genextra, which along with other backers has put $124mm into Intercept through four rounds, including a $30mm Series C financing completed less than a month ago and led by OrbiMed Advisors. Investment Banks/Advisors: BMO Financial Group; Bank of America Merrill Lynch; Needham & Co. Inc.; ThinkEquity Partners LLC; Wedbush PacGrow Life Sciences

MediciNova Inc.

Until August 20, 2014, MediciNova Inc. (in-licenses therapeutics across neurological, respiratory, cancer, gynecological, and musculoskeletal indications) may sell Aspire Capital Fund LLC up to $20.6mm in common stock. (Aug.)

MediciNova has already drawn down $999k by selling 606.1k shares at $1.65, an 11% discount. In addition, in consideration for entering into the agreement, the company issued an additional 363.6k shares to Aspire. In future tranches, the timing and amount of which MediciNova controls, Aspire may purchase up to a maximum of 2.3mm shares, which would prevent the investor from owning more than 19.99% of MediciNova’s outstanding stock. Each forthcoming transaction may take place on any business day as long as shares are closing at $1 or higher, and Aspire may buy up to 50k shares at a time (this will possibly increase to 1mm shares), but cannot exceed $500k in purchases in one business day. MediciNova will price the shares based on two different formulas. Should it present Aspire with a regular purchase notice, the price will be either the lowest sale price on the date of sale, or the average of the three lowest closing prices for the 12 business days preceding the draw down, whichever of those is lower. If MediciNova uses a volume-weighted average price purchase notice, then the investor will pay either the closing sale price on the date of sale, or 95% of the volume-weighted average price on the purchase date, whichever is lower. The spec pharma will apply the proceeds towards it lead candidates, both in Phase II: MN221 (bedoradrine) for acute exacerbations of asthma and COPD, and MN166 (ibudilast) for progressive MS, drug addiction, and chronic neuropathic pain.

Neuralstem Inc.

One week after signing Q Therapeutics Inc. as its first partner for a minimally invasive spinal cord delivery device, Neuralstem Inc. (generates commercial supplies of neural stem cells for the treatment of CNS diseases) has netted $6.5mm in a registered direct offering of 7mm shares for $1, a 45% premium. Aegis Capital was the placement agent. (Sep.)

Investment Banks/Advisors: Aegis Capital Corp.

OxThera AB

OxThera AB (develops treatments for hyperoxaluria) raised SEK39mm ($5.9mm) in a rights issue that will support the company’s ongoing Phase I/II clinical trial of Oxabact in treating primary hyperoxaluria. Existing shareholders HealthCap, Industrifonden, and Q-Med contributed to the financing. (Sep.)

Pluristem Therapeutics Inc.

Pluristem Therapeutics Inc. (allogeneic cell therapies for cardiovascular indications) has netted $34.6mm through the public offering of 9.2mm common shares (including the overallotment) at $4. Investors also received five-year warrants to buy another 2.8mm common shares at $5. (Sep.)

Investment Banks/Advisors: Jefferies & Co. Inc.; Maxim Group LLC; Needham & Co. Inc.; Oppenheimer & Co. Inc.

pSivida Corp.

pSivida Corp. (drug delivery to the back of the eye) netted $5mm through the registered direct offering of 2.5mm shares at $2.15 (a 16% discount) and five-year warrants to buy 624k shares at $2.50. Rodman & Renshaw was the placement agent. (Aug.)

Investment Banks/Advisors: Rodman & Renshaw Capital Group Inc.

Pure Bioscience Inc.

Pure Bioscience Inc. (developed the silver dihydrogen citrate antimicrobial) has netted $4.4mm through the follow-on public offering of 4.34mm common shares (including the overallotment) at $1.10 each. (Sep.)

Investment Banks/Advisors: Aegis Capital Corp.

Regulus Therapeutics Inc.

Regulus Therapeutics Inc. (single-stranded oligonucleotide therapeutics) has filed for its initial public offering. (Aug.)

RNA interference biotechs Alnylam Pharmaceuticals and Isis Pharmaceuticals established Regulus in 2007 with exclusive licenses to their oligonucleotide IP. Regulus is pursuing these assets in the area of microRNAs (miRNAs), which are small non-protein-coding pieces of RNA (20-25 nucleotides long) that are key regulators of gene expression and are involved in many biological processes including immune response, metabolism, and stem cell differentiation. Since miRNAs are mutated in several diseases, Regulus is developing single-stranded microRNA therapeutics that mirror the miRNA targets and inhibit specific miRNAs that are up-regulated. (Regulus holds rights to the Tuschl III patent series, a key set of IP in the miRNA field.) The company has advanced its early-stage pipeline through several Big Pharma partnerships. In two separate alliances with GSK, Regulus is working on candidates for HCV (against the miRNA-122 target) and immune-inflammation (miRNA-155). Under an agreement with Sanofi, Regulus is developing fibrosis and hepatocellular carcinoma agents, both inhibiting miRNA-21 (licensed from the University of Wuerzburg). Regulus also has projects for metabolic diseases (miRNA-33a and 33b, from NYU) and glioblastoma (miRNA-10b). The biotech plans to select two lead candidates to bring into clinical trials, and hopes to file its first IND in 2014. Just days before filing to go public, the company snagged two new collaborators, Biogen Idec, which acquired an undisclosed equity stake, and AstraZeneca. (GSK and Sanofi also own stock in Regulus. And they, along with Isis, have each indicated an interest in buying shares in the IPO.) In the AZ deal, Regulus is licensing three preclinical microRNA targets (including miRNA33) in cardiology, metabolic disease, and cancer. (AZ has also agreed to invest $25mm in a private placement concurrent with completion of the IPO.) And Biogen is teaming up with Regulus to discover microRNA biomarkers in multiple sclerosis patients. Regulus raised an initial $10mm from Alnylam when the joint venture was created, then completed a $20mm Series A round in March 2009. Investment Banks/Advisors: BMO Financial Group; Cowen & Co. LLC; Lazard LLC; Needham & Co. Inc.; Wedbush PacGrow Life Sciences

Repros Therapeutics Inc.

Repros Therapeutics Inc. (reproductive and metabolic disorders) has raised $23.6mm through the sale of 2.2mm common shares at $11 (a 3% discount) to several institutional investors. The company will use the funds to continue developing its two Phase II drug candidates Androxal for Type II diabetes and hypogonadism, and Proellex for uterine fibroids and endometriosis. (Sep.)

Tranzyme Inc.

Tranzyme Inc. (developing therapies for gastrointestinal and metabolic disorders) has netted $10.8mm through the registered direct public offering of 3mm common shares (including the overallotment) at $3.85 each (an 8% discount). (Sep.)

Investment Banks/Advisors: Cowen & Co. LLC; JMP Securities LLC

RESEARCH, ANALYTICAL EQUIPMENT & SUPPLIES

Mergers & Acquisitions

Becton Dickinson & Co.

BD Biosciences

Sirigen Group Ltd.

Becton Dickinson & Co.’s BD Biosciences (cell analysis and instrumentation) has acquired private polymer dye manufacturer Sirigen Group Ltd. Sirigen’s investors--including Seraphim Capital Fund, Oxford Capital Partners, IQ Capital, NESTA, and YFM Private Equity--realized a 2.5-4x step-up from the transaction. (Based on the £10.3mm ($16.3mm) that Sirigen has raised over its lifetime, the acquisition could be valued at £26-42mm.) (Aug.)

Sirigen was founded in February 2003 and two years later exclusively licensed from the University of California, Santa Barbara seven key patents protecting conjugated polymers. The company took this IP and created its High Sensitivity Fluorescence (HSF) technology, which is used to prepare polymer dyes that have much better fluorescence signaling than organic dyes or phycobiliproteins, and can identify cell populations with a broader range of receptor density. Sirigen produces both simple base polymer dyes, and polymer tandem dyes, which have a base donor dye linked to a second fluorescent acceptor dye. The company plans to further develop these two types so that they can be easily multiplexed and used in multi-color flow cytometry. HSF polymer dyes are four-to-ten times brighter and can achieve maximal absorption of excitation light, avoiding the limitations of reporter dyes used in conventional fluorescent detection. Besides research tools, the HSF platform also has applications in molecular diagnostics, drug discovery, and DNA sequencing. BD Biosciences already incorporates some of Sirigen’s dyes into its products; BD’s antibody reagents used in flow cytometry are conjugated to Sirigen’s Brilliant Violet. The acquisition is BD Bioscience’s first transaction since divesting its Discovery Labware division to Corning Life Sciences this past April.

BGI-Shenzhen

Complete Genomics Inc.

BGI-Shenzhen (genomics technology) is paying $108mm to acquire public DNA sequencing firm Complete Genomics Inc., which will receive $3.15 in cash per share--a 43% premium based on the ten-day average prior to June 5, when Complete announced it would be restructuring and seeking out strategic alternatives. (Sep.)

BGI is also loaning Complete up to $30mm in convertible promissory notes. The first draw down will be for $6mm on or around October 1, 2012. Complete may borrow the rest in $6mm increments once per calendar month starting in November 2012 at 6% interest per annum. The notes mature either on September 30, 2014, the occurrence of a change in control, or a loan default, whichever event happens first. Complete was established in 2005 with the goal of becoming the first company to sequence whole human genomes at $1k each. The firm completed a $50mm IPO in November 2010, but several months ago announced a restructuring program that eliminated 55 jobs and deferred capital expenditures, giving way for the company to reduce costs and explore strategic alternatives. Complete performs high throughput whole genome sequencing and analysis services via its Complete Genomics Analysis (CGA) platform, which integrates DNA sequencing, informatics, and data management software. Specifically, Complete has created DNA nanoball arrays, which are long single-molecules of connected nucleotides that have been packed onto a silicon chip and later rolled up into small particles. Using combinatorial probe-anchor ligation technology, the company can read the DNA fragments using small concentrations of reagents. Complete says CGA achieves nearly a 100% consensus accuracy rate in reading the nucleotides in the genome, and produces research-ready genomics data at a significantly lower cost than purchasing and using commercial DNA sequencers to process, assemble, and analyze the raw data. Complete is aiming to gain CLIA certification so that it can supply genome sequencing for clinical use. In 2011, the company suffered a $72.3mm net loss on $19.3mm in revenues. It had $39.3mm cash on hand at the end of June 2012. The current transaction expands the US reach of China-based BGI, which operates both nonprofit and commercial genome sequencing units concentrating on agricultural, animal, and human genetic research. Investment Banks/Advisors: Jefferies & Co. Inc. (Complete Genomics Inc.); Citigroup Inc. (BGI-Shenzhen)

Merck KGAA

EMD Millipore

Biochrom AG

EMD Millipore, the life sciences division of Merck KGAA, has paid an undisclosed sum to buy privately owned cell culture media specialist Biochrom AG. (Aug.)

Biochrom was formed in 1981 and recognized sales of €13mm ($16.4mm) during 2011. The company provides liquid cell culture media, buffer solutions, enzymes, reagents, and antibiotics for biopharmaceutical research and development. Biochrom also maintains research partnerships for the continuing discovery of new products. It is currently working on a culture medium for human pluripotent stem cells, and serum replacement solutions for mesenchymal stem cells. Millipore looks forward to expanding its customer base and product offerings through the acquisition, particularly with the availability of Biochrom’s liquid cultures, serum-free products, and disposable packaging options. Biochrom’s Berlin, Germany operations will remain intact, and the company will operate as part of Millipore’s Process Solutions business. The deal is the first expansion for Millipore since it was acquired by Merck KGAA in 2010 for $7.2bn.

Financings

Fluidigm Corp.

In its first public offering since a 2011 IPO, research products firm Fluidigm Corp. netted $56.4mm through the sale of 4.2mm common shares (including the overallotment) at $14.25. The company develops and sells microfluidic systems for gene expression, genotyping, and resequencing applications. (Aug.)

Investment Banks/Advisors: Cantor Fitzgerald & Co.; Cowen & Co. LLC; Leerink Swann & Co.; Oppenheimer & Co. Inc.; Piper Jaffray & Co.