Deals Shaping The Medical Industry, October 2017

Derived from Strategic Transactions, Informa’s premium source for tracking life sciences deal activity, the Dealmaking column is a survey of recent health care transactions listed by relevant industry segment – In Vitro Diagnostics, Medical Devices, and Pharmaceuticals – and then categorized by type – Acquisition, Alliance, or Financing. This month’s column covers deals announced in September 2017.

IN VITRO DIAGNOSTICS

Alliances

Angle PLC

Qiagen NV

Angle PLC and Qiagen NV will co-promote each other’s liquid biopsy solutions for cancer detection. (Sep.)

To the deal Angle contributes its Parsortix system, which captures and harvests circulating tumor cells (CTCs), including mesenchymal cells, from a patient’s whole blood sample to detect a variety of solid tumors including breast, prostate, lung, and colorectal. Qiagen states that the system is highly complementary with its own AdnaTest diagnostics, which also isolate and detect CTCs from whole blood and are offered for the diagnosis of breast, ovarian, prostate, and colon cancers. The initial focus of the partnership will be on breast and prostate cancer.

Biocartis NV

Genomic Health Inc.

Biocartis Group NV and Genomic Health Inc. agreed to work together to develop an in vitro diagnostic version of Genomic Health’s Oncotype DX Breast Recurrence Score test that will run on Biocartis’ Idylla platform. (Sep.)

Oncotype DX Breast Recurrence Score analyzes 21 genes in a breast tumor biopsy to provide patient-specific information regarding types of chemotherapy that are most likely to benefit the patient. Traditionally, clinicians send out tests to Genomic Health for analysis. Under the current agreement, the partners will work together to develop an assay that can be run on the Idylla PCR-based platform right in the user’s facility, resulting in faster analysis and score availability. Genomic Health gets exclusive global rights to develop and sell the breast cancer assay on the Idylla platform, and has an option to expand the scope of the deal to include additional oncology and urology tests. The company paid $3.3mm up front and is responsible for milestones and royalties. Development work will begin later this year, with expected commercialization initially in Europe (starting in France and Germany) in 2019.

Financings

Celcuity Inc.

Oncology diagnostics firm Celcuity Inc. netted $24.4mm through its initial public offering of 2.76mm common shares (including the overallotment) at $9.50. The company originally filed to sell 2mm shares for between $8-10. (Sep.)

Investment Banks/Advisors: Craig-Hallum Inc.

T2 Biosystems Inc.

Diagnostics firm T2 Biosystems Inc. netted $16.45mm through the follow-on sale of 4.38mm common shares at $4. (Sep.)

Investment Banks/Advisors: Canaccord Genuity Inc.; Cantor Fitzgerald & Co.; Janney Montgomery Scott Inc.; WBB Securities LLC

MEDICAL DEVICES

Mergers & Acquisitions

NuVasive Inc.

Vertera Spine

NuVasive Inc. is acquiring fellow spinal device maker Vertera Spine for an undisclosed sum. (Sep.)

Closely held Vertera uses porous polyetheretherketone (PEEK) technology to develop interbody implants for use in spinal fusion. By adding Vertera to its portfolio, NuVasive becomes the only device firm to sell porous interbody solutions comprised of both PEEK and titanium materials. Vertera offers the FDA-approved COHERE cervical interbody fusion device and COALESCE lumbar interbody fusion device. Last year Nuvasive bought private musculoskeletal device firm Ellipse Technologies for $380mm in cash plus a potential $30mm revenue-based earn-out.

Teleflex Inc.

NeoTract Inc.

Teleflex Inc. agreed to acquire privately held US urology device company NeoTract Inc. (Sep.)

Teleflex will provide $725mm in cash up front as well as a potential earn-out of $375mm, payable in four separate installments (the first of which could total $75mm) based on the achievement of certain NeoTract product sales goals during 2018-2020. It expects to finance the acquisition by borrowing against an existing credit facility and a potential note offering. The transaction, which was already approved by both boards, enables Teleflex to expand its urology products (one of its multiple business units, which also include anesthesia, cardiac care, emergency medicine, interventional access, respiratory care, surgical, and vascular access), and gives it access to a new urological condition, benign prostatic hyperplasia (BPH), with the addition of NeoTract's UroLift system. The minimally invasive device, used for urinary tract symptoms resulting from BPH, received the CE mark in 2010 and FDA approval in 2013. Through an outpatient procedure, the system uses a small needle to place a permanent implant that opens the urethra to relieve prostate pressure without cutting, heating, or removal of the tissue. Teleflex's existing international salesforce will help boost UroLift sales, particularly outside the US. (Currently NeoTract's sales presence is mostly focused in the US.) UroLift joins Teleflex's other urological offerings, which includes bladder management catheters, collection devices, catheterization accessories, urology and endourology surgical products, and procedure trays for the home health care and hospital markets. NeoTract, which was founded in 2004 through device company incubator ExploraMed, brought in venture financing totaling $137mm through backers including JJDC, New Enterprise Associates, Quadrille Capital, and Windham Venture Partners. The company had 2016 revenues of $51mm and its 2017 sales are projected to be between $115-120mm. Investment Banks/Advisors: Guggenheim Partners LLC (Teleflex Inc.); JP Morgan & Co. (NeoTract Inc.)

Alliances

Alliqua BioMedical Inc.

Argentum Medical LLC

Argentum Medical LLC paid $3.8mm to buy the TheraBond antimicrobial wound dressing line from Alliqua BioMedical Inc., which will use about half of the proceeds to repay existing debt. (Sep.)

TheraBond dressings, with SilverTrak technology, provide controlled release of ionic silver to kill pathogens for up to seven days, while also transferring excess fluid and exudate to the absorbent outer layer of the dressing. The products, including contact and island dressings, as well as wraps, are indicated for surgical sites, burns, and a variety of wound types. Argentum plans to sell TheraBond alongside its Silverlon silver-plated nylon antimicrobial dressings.

Cohera Medical Inc.

Terumo Corp.

Cohera Medical Inc. granted Terumo Corp. exclusive rights to sell its Sylys surgical sealant in Japan. (Sep.)

The terms of the long-term deal include the potential for Terumo to hold rights to future indications of the product as well. Sylys is a resorbable, synthetic sealant designed to help reduce anastomotic leakage in gastrointestinal surgical procedures including colon resection. It is used together with standard closure techniques such as staples and sutures, and helps to support the incision line during the first critical healing days when leakage is most likely to happen. Terumo offers a wide range of health care products across the cardiac, vascular, and blood management areas. In the general hospital market, the company’s surgical recovery offerings include Japan’s first sprayable adhesion barrier gel, designed to prevent post-surgical adhesion of organs and tissues which are normally separate.

Cooper Cos. Inc.

CooperSurgical Inc.

Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd. sold off its Paragard intrauterine device to CooperSurgical Inc. for $1.1bn in cash. (Sep.)

Cooper also gets Teva's Buffalo, NY manufacturing facility. Paragard is an IUD that is inserted into a women's uterus as a long-term birth control solution and is currently sold only in the US (TTM revenues of approx. $168mm). The device is a T-shaped plastic frame with a copper wire coiled around the stem and two copper sleeves along the arms that release copper continuously into the uterus. Cooper will fund the acquisition with a new $1.1bn bridge loan and the transaction is expected to close by the end of 2017 pending antitrust clearance. The divestiture is part of Teva's longer term strategy to focus more on CNS and respiratory and exit other areas. Investment Banks/Advisors: Ernst & Young; Morgan Stanley & Co. (Teva Pharmaceutical Industries Ltd.); Guggenheim Partners LLC (CooperSurgical Inc.)

Integra LifeSciences Holdings Corp.

Natus Medical Inc.

Natus Medical Inc. agreed to acquire some of Integra LifeSciences Holdings Corp.'s neurosurgery product lines, including Integra's' Camino intracranial pressure (ICP) monitoring system. Integra is divesting the assets per FTC regulations as a condition of its pending $1bn acquisition of Codman Neurosurgery (a division of J&J's DePuy Synthes) announced in February 2017. The product lines have combined 2016 revenues of an estimated $50mm. (Sep.)

Natus will pay $47.5mm in cash, funding the transaction with cash on hand and from a credit facility. Camino, which Integra gained as a result of its 1999 acquisition of NeuroCare (now renamed Integra NeuroCare), is used in catheters to monitor ICP in the brain. In addition to Camino, the deal also includes for Natus US rights to fixed-pressure shunts (Integra sells under brands that include Atlas, Contour-Flex, and Equi-Flow), as well as Codman's DuraForm dural graft implant, standard external ventricular drainage (EVD) catheters, and cerebrospinal fluid (CSF) collection systems (pending the consummation of the acquisition). Used in procedures to repair or replace the patient’s dura mater, DuraForm is a collagen-based biocompatible dural substitute. For the critical care setting, external EVD devices drain CSF from the patient's ventricles to help relieve ICP. Codman's offerings include the BactiSeal catheter, which contains antimicrobials rifampin & clindamycin on its surface to reduce gram positive bacteria, and the EDS3 system (and related supplies) for CSF draining and collection. Within neurology, Natus already offers its own neurodiagnostic and monitoring devices for neurological dysfunction, epilepsy, sleep disorders, and newborn care, but the addition of Integra's products gives Natus entry to the neurosurgical market.

OptMed Inc.

Synecoun

OptMed Inc. granted Synecoun exclusive rights to market its surgical adhesive BondEase in China, Taiwan, and the Hong Kong territories. (Sep.)

Synecoun made an undisclosed equity investment up front, and will provide a second tranche of the investment at a later date. BondEase is a biocompatible methylidene malonate polymer delivered through an ergonomic device, and provides for single-layer application and rapid drying time. Synecoun, which adds the product to its own portfolio of wound healing offerings, is responsible for further financial and development requirements prior to approval of BondEase in its territories.

Financings

Cooper Cos. Inc.

CooperSurgical Inc.

CooperSurgical Inc. entered into a $1.1bn bridge loan concurrent with its $1.1bn pending product acquisition of PARAGARD IUD from Teva Pharmaceutical Industries Ltd. The company plans to use the loan proceeds to fund the acquisition. (Sep.)

Investment Banks/Advisors: Guggenheim Partners LLC (CooperSurgical Inc.)

PolarityTE Inc.

Regenerative medicine firm PolarityTE Inc. grossed $15.2mm through the private sale of $15.2mm of its Series F preferred shares, which convert into 552,727 common at $27.50. Investors also received warrants to purchase 276k shares at an exercise price of $30. (Sep.)

PHARMACEUTICALS

Mergers & Acquisitions

Catalent Inc.

Cook Group Inc.

Cook Pharmica LLC

Catalent Inc. agreed to acquire privately held contract development and manufacturing organization (CDMO) Cook Pharmica LLC. (Sep.)

Catalent will pay $950mm--$750mm in cash at closing and the remaining $200mm in earn-outs (comprised of equal $50mm installments) paid annually over the next four years--representing over five times the CRDO's revenues of $179mm (for the 12-month period ended June 30, 2017). Catalent plans to fund the purchase with a concurrent bridge loan facility of up to $700mm, a public common stock offering, and cash on hand. Cook, which was established in 2004 as part of Cook Medical, is mainly focused on biologics development, clinical and commercial mammalian cell culture manufacturing, drug substance formulation, finished-dose manufacturing, and parenteral product manufacturing and packaging. Cook's offerings are complementary to Catalent, which is best known for its oral, injectable, and respiratory delivery technologies, biologics offerings (including formulation and bioconjugate development and cell-line engineering), and analytical services. Looking to increase its capabilities in these areas, Catalent will benefit from the addition of Cook's expertise in process, analytical, and formulation development; its biomanufacturing capacity (including filling/finishing of vial or prefilled syringes and cartridges, lyophilization facilities, and real-time automated inspection, labeling, and bulk packaging on-site); as well as its related products and services. Investment Banks/Advisors: JP Morgan & Co. (Catalent Inc.)

Merck & Co. Inc.

Rigontec GMBH

Merck & Co. Inc. will pay €115mm ($136.9mm) up front to acquire Rigontec GMBH, a privately held biotech developing immuno-oncology therapies targeting the retinoic acid-inducible gene I (RIG-I) pathway in the innate immune system. The deal also includes up to €349mm in development, regulatory, and commercialization earn-outs. (Sep.)

Three-year old Rigontec was spun out of the University of Bonn and is developing its lead candidate RGT100 in Phase I trials for solid tumors and lymphoma. The compound targets the RIG-I receptor to activate the body’s innate immune response and produce interferons or silence certain genes, both resulting in tumor cell death. The company notes that in addition to cancer, the technology can be applied to infectious and inflammatory disease therapies as well. The acquisition enhances Merck’s immuno-oncology pipeline and gives the company additional assets that potentially be used in combination with other of the Big Pharma’s projects. Rigontec raised about €30mm through its Series A round shortly after foundation from a syndicate of investors that includes Boehringer Ingelheim Venture Fund, Forbion Capital Partners, High-Tech Grunderfonds, MP Healthcare Venture Management, NRW.BANK, Sunstone Capital, and Wellington Partners Life Sciences.

Ultragenyx Pharmaceutical Inc.

Dimension Therapeutics Inc.

Ultragenyx Pharmaceutical Inc. offered to acquire Dimension Therapeutics Inc. for $5.50 per share in cash (a 43% premium to the prior 10-day trading average) or $138mm. (Sep.)

The offer comes on the heels of a proposal from REGENXBIO (which was already approved by the board) back in August to acquire Dimension for $3.41 per share in cash or $85.4mm. Ultragenyx will leverage its advanced clinical and regulatory expertise along with its commercial infrastructure to Dimension's rare metabolic disease-focused gene therapies. The company plans to maintain a gene therapy development unit and manufacturing team at Dimension's MA facilities. Ultragenyx submitted marketing applications for two candidates in the last year in the US and EU. Investment Banks/Advisors: Centerview Partners LLC (Ultragenyx Pharmaceutical Inc.); MTS Health Partners (Dimension Therapeutics Inc.)

Alliances

AbbVie Inc.

Amgen Inc.

AbbVie Inc. and Amgen Inc. have settled litigation surrounding the latter's intellectual property related to a proposed biosimilar adalimumab named Amgevita/Amjevita. Under the settlement, Amgen receives a non-exclusive global license to AbbVie's Humira-related IP. AbbVie will grant patent licenses for the use and sale of Amgevita/Amjevita worldwide, on a country-by-country basis. Amgen expects to launch the drug on October 16, 2018 in most EU countries, on January 31, 2023 in the US, and on certain dates in other countries in which AbbVie has intellectual property. AbbVie will receive sales royalties. Humira is a blockbuster TNF-alpha antagonist sold for various conditions including arthritis, Crohn's disease, colitis, and psoriasis. (Sep.)

AbbVie Inc.

Bristol-Myers Squibb Co.

AbbVie Inc. and Bristol-Myers Squibb Co. agreed to test a combination of the former's antibody drug conjugate ABBV399 with BMS's PD-1 antagonist Opdivo (nivolumab) in c-Met overexpressing non-small cell lung cancer (NSCLC). (Sep.)

The ABBV399/Opdivo combo trial is currently in Phase Ib and is sponsored by AbbVie. The companies are evaluating its tolerability and efficacy in patients with advanced c-Met overexpressing NSCLC who failed one prior line of chemotherapy. Opdivo is marketed for non-small cell lung, renal, head and neck, colorectal, and bladder cancers, as well as melanoma and Hodgkin's lymphoma. It is currently awaiting approval for stomach and liver cancers, and is in preclinical through Phase III studies for various other cancers including esophageal, brain, small cell lung, squamous cell, urethral, myeloma, mesothelioma, ovarian, prostate, peritoneal, fallopian tube, pancreatic, breast diffuse large B-cell lymphoma, non-Hodgkin's lymphoma, follicular lymphoma, cervical, endometrial, soft tissue sarcoma, chronic myelogenous leukemia, biliary, and chronic lymphocytic leukemia. ABBV339 is currently in Phase I for solid tumors.

AbCellera Biologics Inc.

GlaxoSmithKline PLC

AbCellera Biologics Inc. and GlaxoSmithKline PLC are collaborating to discover monoclonal antibodies (mAbs) against an undisclosed membrane protein target. (Sep.)

AbCellera will use its high-throughput single-cell antibody screening platform to identify the antibodies. The company will generate a panel of the lead mAbs, which GSK will subsequently be able to license, develop, and market therapeutics from. Over the past two years, AbCellera has entered into various other antibody drug discovery collaborations with pharma and biotech companies including Pfizer Inc., Teva Pharmaceutical Industries Ltd., and Merck & Co. Inc.

Abivax

Evotec AG

Evotec AG and Abivax are teaming up to discover and develop small molecule therapies for various serious viral infectious diseases. (Sep.)

Abivax's antiviral platform is based on a chemical library of more than 1k small molecules that block viral replication by inhibiting mRNA biogenesis. It targets the formation of RNA-protein complexes in the nucleus or the cytoplasm of the infected cell during viral infection. Abivax will use the technology to identify hits and will conduct in vitro and in vivo pharmacology studies. Evotec will use its discovery platform to optimize the candidates and perform early development including pharmacology, ADME, computational chemistry, and mechanism of action studies. The parties will initially focus on targets for RSV, influenza, and dengue, which have already been identified by Abivax. Abivax gets commercial rights to any resulting drugs. The company has used its IP to successfully create its Phase II HIV compound ABX464.

Airway Therapeutics LLC

Glycotope GMBH

Airway Therapeutics LLC received exclusive global rights to use Glycotope GMBH's GlycoExpress cell line technology to produce AT100. (Sep.)

Airways's lead program AT100 is a preclinical recombinant human surfactant protein D aimed at preventing bronchopulmonary dysplasia in premature infants. GlycoExpress human cell lines produce new biotherapeutics that express human glycosylation structures to improve bioavailability and bioactivity, but without immunogenicity. It can produce a wide range of biologics, including antibodies difficult-to-express proteins such as AT100. Airway will use GlycoExpress to optimize the manufacturing of AT100 and enable high-yield production.

Allergan PLC

Lyndra Inc.

Allergan PLC and Lyndra Inc. agreed to collaborate on the development of oral, once-weekly formulations of Allergan's existing Alzheimer's disease (AD) therapeutics. (Sep.)

In addition to an AD candidate, Allergan may select another compound within any therapeutic area to develop as part of the deal. In exchange, Lyndra will receive $15mm up front and $90mm in development and regulatory milestones for the two programs. The partnership will leverage Lyndra's ultra-long-acting sustained-release oral dosage delivery platform (invented at and licensed from MIT), which converts both large- and small-molecule daily-dosed medications into a weekly or monthly schedule, enabling linear drug release and sustaining therapeutic serum levels for seven days or more. Lyndra says its technology is designed to optimize the pharmacokinetic profile of the dosage form and promote better patient compliance versus daily medication regimens. Although specific compounds were not yet disclosed, Allergan already markets the oral daily AD drugs Namenda/Namenda XR (memantine HCl) and Namzaric (donepezil/memantine ER) and has some AD candidates in its pipeline, including the Phase II CPC201 (donepezil/solifenacin; acquired in its 2016 buy of Chase Pharmaceuticals) and preclinical and Phase I selective muscarinic receptor agonists licensed from Heptares last year.

Amarin Corp. PLC

HLS Therapeutics Inc.

Amarin Corp. PLC licensed HLS Therapeutics Inc. rights to register, commercialize, and distribute its hypertriglyceridemia drug Vascepa (icosapent ethyl) in Canada. (Sep.)

HLS will pay Amarin $5mm up front, up to $60mm in development, regulatory, and sales milestones, plus tiered double-digit royalties. HLS will handle and fund regulatory and commercialization activities, while Amarin will offer help with local filings, supply the finished product, maintain intellectual property, and continue developing and funding the REDUCE-IT cardiovascular outcomes study. If approved, Vascepa would be the first available pure omega-3 fatty acid prescription product in Canada. Under previous tie-ups, Eddingpharm has rights in China, Hong Kong, Macao, and Taiwan, while Kowa co-promotes the drug in the US.

Amgen Inc.

Simcere Pharmaceutical Group

Amgen Inc. has teamed up with Simcere Pharmaceutical Group in an exclusive agreement to develop and commercialize in China four undisclosed Amgen biosimilars aimed at inflammation and cancer. (Sep.)

The parties will co-develop the biosimilars. Amgen will handle marketing approvals and manufacturing, while Simcere will be responsible for distribution and commercialization in China. Amgen gets a limited right to co-promote the drugs. The deal comes on the same date that Amgen settled Humira-related intellectual property litigation surrounding a proposed biosimilar adalimumab. AbbVie granted Amgen non-exclusive licenses for the use and sale of the biosimilar (named Amgevita/Amjevita) worldwide.

Amylon Therapeutics BV

ProQR Therapeutics BV

Amylon Therapeutics, a neurology-focused biotech concurrently spun off from ProQR Therapeutics NV, exclusively licensed the latter's RNA-based pipeline for rare, hereditary CNS disorders. (Sep.)

ProQR retains a majority ownership in Amylon and could receive future milestones and royalties from resulting CNS products the start-up develops. ProQR's lead CNS program ATA010 is an oligonucleotide designed using RNA repair technology to induce modulation in an amyloid precursor protein to prevent the incorporation of the toxic amyloid beta peptide, thus stopping its cascade and subsequent disease-progression aggregation. ProQR licensed exclusive rights to Leiden University Medical Center's IP related to antisense oligonucleotide therapeutics in the field of amyloid-beta related disease under a 2016 agreement. Amylon will first focus on the compound's development in HCHWA-D (hereditary cerebral hemorrhage with amyloidosis of the Dutch type). Also known as Katwijk’s disease, the rare condition is caused by a genetic mutation that leads to the accumulation of the destructive amyloid beta peptide in the brain and often leads to strokes at mid-adulthood. Another possible ATA010 indication is cerebral amyloid angiopathy (CAA; a condition related to HCHWA-D), which causes hemorrhagic stroke in elderly patients. ProQR also has preclinical candidates for Friedreich’s ataxia (QRX6) and Alzheimer's (QRX203) and Huntington's diseases (QRX704). The deal enables ProQR to allocate Amylon resources to its CNS compounds, while simultaneously advancing RNA candidates for severe rare genetic diseases outside CNS; its own pipeline includes programs in cystic fibrosis and eye and skin diseases housed in separate business units.

Aptevo Therapeutics Inc.

Saol Therapeutics Inc.

Aptevo Therapeutics Inc. sold off three of its marketed immunostimulants to Saol Therapeutics Inc. for up to $74.5mm, including $65mm up front, a sales milestone payment of up to $7.5mm, and $2mm related to accounts receivable. (Sep.)

Aptevo had been marketing the therapies since the company was spun off of Emergent BioSciences Inc. back in 2015. Saol now gets its hands on WinRho SDF, for hemolytic disease of newborn infants and immune thrombocytopenic purpura; HepaGam B for prevention and treatment of hepatitis B; and Varizig for varicella zoster virus exposure in immunocompromised patients. Aptevo off-loaded the products in order to focus on core pipeline and commercial assets including Ixinity, a recombinant factor IX therapy for hemophilia B, and candidates in the works based on the company’s ADAPTIR protein therapeutic platform. The cash influx will be put towards repayment of debt under a 2016 loan agreement with MidCap Financial. For Saol, the deal helps the firm expand its rare disease focus in addition to underserved neurological disorders, the company’s main therapy area.

Arcus Biosciences Inc.

Otsuka Holdings Co. Ltd.

Taiho Pharmaceutical Co. Ltd.

Arcus Biosciences Inc. granted Taiho Pharmaceutical Co. Ltd. an option to license exclusive rights in Asia (including Japan but excluding China) to develop and commercialize cancer immunotherapies from its pipeline. (Sep.)

Taiho will pay $35mm during the first three years of the agreement, and can exercise its option to any clinical-stage candidates over a five-year period. If it takes a license to any project, Arcus gets an option payment and up to $275mm per candidate in development, regulatory, and sales milestones, plus royalties in the high-single to mid-double digits. Arcus did not detail which compounds are involved, but the company notes that it is on track to have at least four in clinical trials by the end of 2018. Its pipeline currently includes AB122, a PD-1 antibody, and the TIGIT antibody AB154, as well as a CD73 inhibitor and AB928, an A2aR/A2bR antagonist. Taiho was one of the investors in Arcus's $70mm Series B round, which closed in 2016 and was heavily oversubscribed.

AstraZeneca PLC

NewLink Genetics Corp.

AstraZeneca PLC and NewLink Genetics Corp. entered a trial collaboration to study the combination of AZ’s PD-L1 inhibitor durvalumab with NewLink’s IDO inhibitor indoximod in Phase II trials for metastatic pancreatic cancer. (Sep.)

Indoximod is in Phase II trials for solid and blood cancers including breast, prostate, pancreatic, brain, non-small cell lung cancers, melanoma, and acute myelogenous leukemia. Durvalumab is marketed for bladder cancer, in Phase III for head and neck, NSCLC, small cell lung cancer, and squamous cell carcinoma, and about two dozen other trials for additional solid and liquid tumors. The initial trial under the collaboration will examine the durvalumab/indoximod combo together with the standard-of-care chemo regimen gemcitabine/Abraxane in a Phase II trial to evaluate efficacy and safety. The partners will also conduct a smaller trial looking at just durvalumab in combination with gemcitabine/Abraxane. While NewLink is acting as the sponsor for the collaboration, the partners will equally fund all related activities.

Basilea Pharmaceutica Ltd.

Basilea Pharmaceutica International Ltd.

Cardiome Pharma Corp.

Basilea Pharmaceutica International Ltd. licensed Cardiome Pharma Corp. exclusive rights to distribute its antibiotic Zevtera (ceftobiprole) in more than 30 European countries (excluding Nordic countries) and Israel. (Sep.)

Cardiome will pay CHF5mm ($5.3mm) plus pre-specified regulatory and commercial milestones. Basilea will supply Cardiome with ceftobiprole at a transfer price and Cardiome is in charge of regulatory and commercial activities in the licensed territories. The drug has approval in 13 countries in Europe, and is also sold under the Mabelio brand. The IV cephalosporin antibiotic is used for treating gram-positive and gram-negative bacteria including methicillin-susceptible and resistant Staphylococcus aureus and Pseudomonas, as well as community- and hospital-acquired pneumonia. Under previous tie-ups, Grupo Biotoscana has rights in Latin America, Unimedic Pharma in Sweden, Denmark, Norway, and Finland, and Hikma Pharmaceuticals in the Middle East and North Africa region.

Basilea Pharmaceutica Ltd.

Basilea Pharmaceutica International Ltd.

Shenzhen China Resources Gosun Pharmaceutical Co.

Basilea Pharmaceutica International Ltd. licensed Shenzhen China Resources Gosun Pharmaceutical Co. (CR Gosun) exclusive rights to develop, manufacture, and commercialize its IV antibiotic Zevtera (ceftobiprole) in China, Hong Kong, and Macao. (Sep.)

In exchange Basilea will receive CHF3mm ($3.1mm) up front and up to CHF145mm in regulatory and commercial milestone payments. CR Gosun will fund and handle all development and regulatory activities. Basilea will initially supply CR Gosun with the product at a transfer price. Once CR Gosun takes over manufacturing Basilea is entitled to tiered double-digit sales royalties. Zevtera is approved in 13 European countries for the treatment of gram-positive and gram-negative bacteria including methicillin-susceptible and resistant Staphylococcus aureus and Pseudomonas, as well as community- and hospital-acquired pneumonia. It is also sold under the brands Mabelio and Zeftera. Earlier this month Basilea licensed Cardiome Pharma exclusive rights to sell the drug in more than 30 European countries (excluding Nordic countries) and Israel. It has previous tie-ups with Grupo Biotoscana (Latin America), Unimedic Pharma (Sweden, Denmark, Norway, and Finland), and Hikma Pharmaceuticals (MENA region).

Bicycle Therapeutics Ltd.

Bioverativ Inc.

Bioverativ Inc. and Bicycle Therapeutics Ltd. teamed up to discover and develop bicyclic peptide therapies for hemophilia and sickle cell disease. (Sep.)

The agreement involves Bicycles, or bicyclic peptides that combine the attributes of antibodies, small molecules, and peptides in one molecule that has high selectivity and affinity, and can penetrate and bind to specified targets. Bicycle Therapeutics will use the platform to discover two programs and bring them through lead optimization, after which point Bioverativ takes over preclinical and clinical development, marketing, and commercialization. Bioverativ pays $10mm up front, $4.2mm in R&D funding, and up to $410mm in total milestones for both programs, plus tiered single to low-double-digit royalties (Strategic Transactions estimates 1-29%). Bioverativ spun out of Biogen earlier this year with Biogen’s hemophilia assets under its belt. The company sells Biogen’s Aprolix and Eloctate for hemophilia B and A, respectively, and is also developing BIVV009, a biologic for the autoimmune condition cold agglutinin disease that it gained through the acquisition in May of True North Therapeutics.

BioQ Pharma

Cooper Pharma

Moroccan branded generics and OTC drug manufacturer and distributor Cooper Pharma licensed commercialization rights in Morocco to BioQ Pharma's ropivacaine ReadyfusOR for post-surgical pain indications. (Sep.)

BioQ's single-use, point-of-care CE-marked device ReadyfusOR contains a dispenser pre-filled with a generic drug (in this deal, the local anesthetic 0.2% ropivacaine) and an administration line, which is attached to an infusion catheter. BioQ is also developing ReadyfusOR kits filled with drugs for multiple applications in addition to anesthesia and sedation, including oncology and infectious diseases. The current deal with Cooper will help BioQ gain traction in emerging markets. Cooper has nine distribution centers and three manufacturing sites in Morocco and under a separate 2015 joint venture with Cipla and the Pharmaceutical Institute, Cooper established a Moroccan facility that is producing respiratory and neurological disease drugs with a focus on the manufacture of metered-dose inhalers and sprays. Cooper's existing CNS portfolio already has its own versions of halothane and isoflurane inhalable general anesthetic solutions and the anxiolytic sedative tablet Anxiol (diazapem), in addition to multiple other analgesics, antispasmodics, antidepressants, antiepileptics, as well as drugs for Alzheimer's disease and psychotic disorders.

Boehringer Ingelheim GMBH

Gubra ApS

Boehringer Ingelheim GMBH is collaborating with Danish CRO Gubra ApS to develop novel compounds for obesity. (Sep.)

The alliance seeks to identify novel peptides which are able to regulate food intake. In exchange for licensing any products resulting from the joint R&D program, BI would pay Gubra up to €250mm in up-front and success-based development and sales milestones in addition to staggered up to double-digit royalties on worldwide net sales. The tie-up leverages Gubra's expertise in design, synthesis, characterization, and in vivo testing with BI's expertise in cardiometabolic and its other ongoing R&D programs, including the dual acting glucagon/GLP-1 agonist and the long-acting amylin analog development. Gubra has other existing collaborations with Sanofi for diabetes and obesity-focused peptides.

Bristol-Myers Squibb Co.

Halozyme Therapeutics Inc.

Using its Enhanze technology, Halozyme Therapeutics Inc. agreed to develop subcutaneous formulations of Bristol-Myers Squibb Co.'s immuno-oncology drugs. (Sep.)

Halozyme has already successfully used Enhanze in new versions of other cancer products that are now approved, including Roche's Rituxan/MabThera and Herceptin, and in the immunology area, with Baxalta's Hyqvia. (Concurrent with the BMS agreement, Halozyme expanded its deal with Roche to add exclusive development rights to a new target.) Enhanze is a recombinant version of a naturally occurring human hyaluronidase enzyme (rHuPH20), which helps facilitate the subcutaneous delivery of biologics. Enhanze degrades hyaluronan in the extracellular matrix, increasing bulk fluid flow in the subcutaneous area and aiding in the dispersion and absorption of therapeutics administered with drug delivery technology. In exchange for access to Enhanze, BMS will pay $105mm up front. Initially the Big Pharma will focus on drugs interacting with PD-1 (the company markets the PD-1 antagonist Opdivo), and has the option to add more targets--up to a maximum of 11--in the next five years. BMS is also responsible for up to $160mm in development, regulatory, and sales milestones for each of the targets, plus additional milestones for combination products, and sales royalties.

China Medical System Holdings Ltd.

Destiny Pharma

Destiny Pharma licensed China Medical System Holdings Ltd. rights to develop and commercialize its anti-infective assets in China and certain other Asian countries with the exception of Japan. (Sep.)

As part of the agreement, CMS will make a £3mm ($4mm) equity investment in Destiny. Destiny is also eligible for sales milestones and may also make a manufacturing margin on any product that it supplies for CSM. The two parties will work together on R&D activities. Destiny is creating infectious disease therapies using its XF drug development platform. Its lead program is Phase IIb-ready XF73, a gel-based light-activated candidate for post-surgical Staphylococcus aureus infections including MRSA. The company also has earlier-stage programs and its intellectual property is protected by multiple patents extending into 2030. Concurrent with the agreement, Destiny went public netting £14mm in its IPO.

Daewoong Pharmaceutical Co. Ltd.

HanAll BioPharma Co. Ltd.

Harbour BioMed

HanAll Biopharma Co. Ltd. (majority owned by Daewoong) licensed Harbour BioMed rights to develop, manufacture, and commercialize two programs in Greater China, including Hong Kong, Macau, and Taiwan. (Sep.)

Included in the agreement are Phase I HL036, an anti-TNF ophthalmic solution for dry eye and other inflammatory ocular diseases, and preclinical HL161, an anti-FcRn monoclonal antibody for treating pathogenic IgG-mediated autoimmune diseases including pemphigus vulgaris, neuromyelitis optica, idiopathic thrombocytopenic purpura, and myasthenia gravis. HanAll receives up to $81mm in up-front payments and development, registration, and sales milestones, plus sales royalties. HL036 was being jointly developed by HanAll with Daewoong. HanAll's antibody candidates were discovered using transgenic mouse platforms. The company expects to commence a Phase I trial of HL161 in late 2017 as a subcutaneous injectable formulation. HanAll plans to move HL036 into a Phase II US trial in November 2017 in collaboration with ophthalmic firm Ora.

Eagle Pharmaceuticals Inc.

SymBio Pharmaceuticals Ltd.

Eagle Pharmaceuticals Inc. granted SymBio Pharmaceuticals Ltd. Japanese rights to develop and sell bendamustine HCl ready-to-dilute (RTD) and rapid infusion (RI) formulations. (Sep.)

SymBio pays $12.5mm up front, regulatory and sales milestones, and royalties. It will also be responsible for all regulatory activities related to market approval of the two formulations in its territory. Bendamustine is marketed for the treatment of chronic lymphocytic leukemia, relapsed/refractory non-Hodgkin’s lymphoma, and mantle cell lymphoma. SymBio already sells a lyophilized powder formulation in Japan under the brand Treakisym and anticipates approval of the RTD and RI versions in 2020. Teva sells it in the US as Bendeka under a 2015 license from Eagle.

Eisai Co. Ltd.

Ono Pharmaceutical Co. Ltd.

Eisai Co. Ltd. partnered with Ono Pharmaceutical Co. Ltd. to develop a hepatocellular carcinoma therapy combining Eisai’s Lenvima (lenvatinib) with Ono’s Opdivo (nivolumab). (Sep.)

The companies will immediately commence a Phase Ib trial in Japan to study safety and efficacy. Both drugs have development history in the indication: Opdivo, a monoclonal antibody against PD-1, has been approved for HCC in the US and is in Phase III in Japan, while Lenvima is awaiting approval in Japan. Opdivo is already on the market for melanoma, NSCLC, renal cancer, Hodgkin’s lymphoma, and head and neck, bladder, and colorectal cancers. It is also approved for stomach cancer and in a variety of clinical trials for additional solid and blood cancers. Lenvima, a VEGFR/RET/FGF tyrosine kinase inhibitor, is marketed for thyroid cancer, approved for renal cancer, and also in other blood and solid tumor studies.

Eyevance Pharmaceuticals LLC

Nicox SA

Nicox Ophthalmics, Inc.

Nicox Ophthalmics Inc. licensed Eyevance Pharmaceuticals LLC rights to commercialize its Zerviate (cetirizine) ophthalmic solution 0.24% in the US. (Sep.)

Eyevance will pay $6mm up front, up to $37.5mm in sales milestones ($30mm triggered by annual sales of $100mm and above), $5mm in milestones tied to near-term manufacturing objectives managed by Nicox, and tiered sales royalties of 8-15%. Eyevance will receive pre-launch manufacturing support from Nicox, which will handle and fund scale-up activities for product manufacturing. Zerviate received FDA approval in May 2017 and is the first available topical cetirizine formulation for treating ocular itching associated with allergic conjunctivitis. Cetirizine is an antihistamine and the active ingredient in UCB's allergy medication Zyrtec. Eyevance was founded earlier this year and Zerviate represents its first asset.

Foundation Consumer Healthcare

Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd. sold off selected women's health assets to Foundation Consumer Healthcare (owned by affiliates of Juggernaut Capital Partners and Kelso and Company) for total consideration of $675mm. (Sep.)

The brands divested include Plan B One-Step, Take Action, Aftera, and Next Choice One Dose emergency contraceptives. Total 2016 annual sales of the products were $140mm (EV to sales multiple of 4.8x). Simultaneously, Teva sold off other women's health brands for contraception, fertility, menopause and osteoporosis to CVC Capital Partners for $703mm in cash. The divestments are part of re-aligning Teva's strategy to focus on core areas of CNS and respiratory. Investment Banks/Advisors: Morgan Stanley & Co. (Teva Pharmaceutical Industries Ltd.); Barclays Bank PLC (Foundation Consumer Healthcare)

Glythera Ltd.

Iontas Ltd.

Iontas Ltd. will use its fully human antibody libraries to discover antibodies against specific targets for Glythera Ltd. (Sep.)

The companies will together select multiple antibodies resulting from the deal, and Glythera has an option to license exclusive global development, manufacturing, and commercialization rights to use the antibodies in the development of antibody-drug conjugates for hard to treat cancers. ADCs will be designed with Glythera’s PermaLink platform, which is a stable and controlled conjugation technology made up of a portfolio of linker designs. Iontas gets undisclosed R&D milestones on each ADC created under the deal. Glythera was spun out of the University of Bath in 2007. The company hopes to have its first ADC candidate in clinical trials by 2019.

Johnson & Johnson

Janssen Pharmaceutica NV

Provention Bio Inc.

Start-up Provention Bio Inc. licensed two clinical-stage GI assets from Janssen Pharmaceutica NV--JNJ40346527 for Crohn’s disease and JNJ42915925/CNTO3157 for ulcerative colitis. (Sep.)

JNJ40346527, renamed PRV6527 by Provention, is a colony stimulating factor-1 (CSF-1) receptor inhibitor expected to enter Phase IIa in H1 2018 for Crohn’s, a disease for which there is no approved oral treatment. The other licensed program, now known as PRV300, is a toll-like receptor 3 (TLR3) monoclonal antibody, which Provention will study in a Phase I/II trial for moderate-to-severe ulcerative colitis. The firm also believes the compound can potentially treat viruses including influenza. Just two months ago, Provention licensed its first program from Vactech Oy, gaining a preclinical enterovirus vaccine. The start-up raised $28.4mm back in April and will use those funds to develop its three programs.

MEI Pharma Inc.

Presage Biosciences Inc.

Presage Biosciences Inc. granted MEI Pharma Inc. exclusive global rights to develop, manufacture, and sell the oral CDK-4 inhibitor voruciclib, which has been tested in Phase I cancer trials. (Sep.)

Presage gets $2.9mm up front; up to $181mm in development, regulatory, and sales milestones (including $2mm upon dosing of the first patient in the first registration trial and up to $2.9mm in additional pre-approval milestones); and mid-single-digit royalties. (Strategic Transactions estimates 4-6%.) Presage licensed voruciclib from Pirimal in 2014 after Piramal had discontinued development. MEI will work on the candidate both as a monotherapy and in combination with other anticancer therapies including venetoclax, which has shown synergistic activity when combined with voruciclib for chronic lymphocytic leukemia. MEI's pipeline already includes lead project pracinostat, an HDAC inhibitor in late-stage trials for AML, myelodysplastic syndrome, and myelofibrosis; ME401, in Phase I for CLL and follicular lymphoma; and ME344, in Phase II for HER2-negative breast cancer.

Monopar Therapeutics LLC

Onxeo SA

Onxeo SA granted Monopar Therapeutics LLC exclusive global rights to develop, manufacture, and sell its oral mucositis candidate Validive (clonidine). (Sep.)

Onxeo brought the candidate through Phase II trials, but upon hearing in late 2015 from the FDA that two Phase III trials would be required for registration in the US, the company decided that it would only move forward with development if it found a suitable partner. Monopar has now paid $1mm up front and committed to up to $108mm in milestones (including $15.5mm for regulatory achievements), and up to double-digit royalties. Validive is a mucoadhesive buccal tablet indicated for the treatment of severe oral mucositis caused by chemo or radiation in patients with head and neck cancer. The compound is the second in Monopar’s pipeline. The company is also developing MNPR101 (formerly huATN-658), a humanized monoclonal antibody for advanced solid cancers, with partner Cancer Research UK.

Nuvelution Pharma Inc.

Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd. agreed to partner with Nuvelution Pharma Inc. to develop and commercialize Austedo (deutetrabenazine) tablets for the treatment of Tourette's Syndrome in the US. (Sep.)

Under the terms, Nuvelution will fund and manage the clinical development of Austedo (currently in Phase I trials for Tourette's) and Teva will lead the regulatory process and commercialize the drug. The agreement is based on a risk-sharing funding framework with a success-based investment return for Nuvelution in which Teva will pay Nuvelution a pre-arranged return on its invested capital upon FDA approval. Austedo is a vesicular monoamine transporter 2 (VMAT2) inhibitor already approved by the FDA for the treatment of tardive dyskinesia in adults and for the treatment of chorea associated with Huntington’s disease. Inhibition of VMAT2 decreases the amount of dopamine released in key regions of the brain, thereby inhibiting the involuntary movements that characterize several neurological disorders. Nuvelution was founded in 2015 with an initial investment round from Clarus Ventures and Novo AS and seeks to commit capital in collaborations of between $50mm and $500mm.

Palatin Technologies Inc.

Fosun International Ltd.

Shanghai Fosun Pharmaceutical Group Co. Ltd.

Palatin Technologies Inc. is licensing Shanghai Fosun Pharmaceutical Group Co. Ltd. (Fosun) exclusive development and commercialization rights in China, Taiwan, Hong Kong, and Macau to its Rekynda (bremelanotide) for female sexual dysfunction (FSD) indications. (Sep.)

Fosun also gets nonexclusive manufacturing rights within the territory and nonexclusive worldwide (except in North America) R&D and manufacturing rights to investigational compounds containing bremelanotide. Fosun will cover all costs associated with development, regulatory, sales, marketing, and commercialization activities, and could pay a total of $105mm: $5mm up front, a $7.5mm milestone upon Chinese regulatory approval, and up to $92.5mm in sales milestones, in addition to high-single- to low-double-digit royalties (Strategic Transactions estimates 7-29%) within the licensed territories. Bremelanotide is a synthetic peptide analog of a hormone intended to activate the melanocortin pathway, which is known to be involved in sexual response. In Phase III trials (completed in August 2016) for the on-demand treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women, bremelanotide (administered subcutaneously using a single-use autoinjector pen) met both efficacy endpoints and the company anticipates an NDA filing during Q1 2018. HSDD, the single-largest specific FSD diagnosis, is associated with personal distress and characterized by decreased sexual desire. The deal enables Fosun to enter the women's health arena (its current product portfolio focuses on cancer and cardiovascular, CNS, gastrointestinal, infectious, and metabolic disease therapeutics), while allowing Palatin to increase its worldwide market penetration for the candidate. Under a January 2017 agreement, AMAG Pharmaceuticals licensed exclusive North American rights to Rekynda, for which Palatin could receive up to $465mm.

Pfizer Inc.

SpringWorks Therapeutics LLC

Pfizer Inc. has created SpringWorks Therapeutics and licensed the start-up four of its rare disease programs. (Sep.)

SpringWorks concurrently in-licensed from Pfizer four clinical-stage assets, all aimed at diseases for which there are no approved therapies. The Phase III-ready gamma secretase inhibitor nirogacestat (PF03084014) is targeting desmoid tumor and SpringWorks will develop it with help from the Desmoid Tumor Research Foundation. Also ready for Phase III is the MEK 1/2 inhibitor PD0325901 for neurofibromatosis to be developed with the Children’s Tumor Foundation. Phase I senicapoc (PF05416266) is a Gardos channel blocker for hereditary xerocytosis and PF0445784 is a Phase I FAAH inhibitor for post-traumatic stress disorder to be assessed in collaboration with Cohen Veterans Bioscience.

Pulmatrix Inc.

Vectura Group PLC

Pulmatrix Inc. licensed Vectura Group PLC rights to develop, manufacture, and commercialize its Phase II chronic obstructive pulmonary disease candidate PUR0200 in the US. (Sep.)

Vectura and/or its partners will pay for all development costs. Pulmatrix will provide the PUR0200 data package and help transfer of development and manufacturing activities to Vectura. Pulmatrix will receive a $1mm technology access fee upon the achievement of agreed-upon development criteria. Vectura will pay the company a mid-teen percentage of future revenues (Strategic Transactions assumes 14-16%) based on the development and commercialization of PUR0200 and any products that contain PUR0200. Once-daily PUR0200 incorporates the long-acting muscarinic antagonist tiotropium bromide and is delivered via Pulmatrix's iSPERSE (inhaled Small Particles Easily ReSpirable and Emitted) dry powder technology. Under a June 2015 tie-up, Mylan NV has ex-US development rights to the COPD compound.

Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd. divested selected women's health assets to private equity firm CVC Capital Partners (Fund VI) for $703mm in cash. (Sep.)

The portfolio of divested products are for contraception, fertility, menopause and osteoporosis and includes (marketed and sold outside of the US) Ovaleap, Zoely, Seasonique, Colpotrophine, and Actonel among others. Total annual net sales for the products in 2016 were $258mm (2.72x EV to sales multiple). Simultaneously the company sold off other women's health assets (including Plan B One-Step and value emergency contraception brands) to Foundation Consumer Healthcare for $675mm in cash. Earlier this month, Teva divested its PARAGARD IUD business. The transactions are part of the company's plans to narrow its focus to CNS and respiratory within global specialty medicines. Investment Banks/Advisors: Morgan Stanley & Co.

Financings

Acceleron Pharma Inc.

Acceleron Pharma Inc. netted $216mm in a follow-on public offering of 6.2mm common shares (including full exercise of the 810.8k over-allotment option) at $37. The company will use the proceeds to fund clinical trials for its pulmonary hypertension compound (expected to initiate a Phase II trial for PAH in H1 2018) and its neuromuscular candidates, including focal muscle disorder treatment ACE083 (in Phase II trials for facioscapulohumeral dystrophy and Charcot-Marie-Tooth disease). (Sep.)

Investment Banks/Advisors: Citigroup Inc.; JP Morgan & Co.; Leerink Partners LLC

Acer Therapeutics Inc.

Acer Therapeutics Inc. (rare disease therapeutics) received $15.7mm (includes $5.7mm in conversion of convertible notes) from new and existing investors at $9.47 per share led by TVM Capital Life Sciences. The company expects to use the offering proceeds to advance lead candidate EDSIVO (for Vascular Ehlers-Dalos Syndrome) through NDA submission in H1 2018.The financing took place concurrently with Acer completing its pending merger with Opexa Therapeutics Inc. (Sep.)

Aldeyra Therapeutics Inc.

Aldeyra Therapeutics Inc. (developing therapies for diseases related to endogenous aldehyde toxicity) netted $27mm through the follow-on offering of 3.97mm common shares (including full exercise of the overallotment) priced at $7.25. The company will use some of the proceeds for ongoing development of candidates including its lead program ADX102, which is being developed in different formulations. An ophthalmic solution is in Phase III for noninfectious anterior uveitis and Phase II for allergic conjunctivitis and dry eye syndrome. Topical ADX102 is in Phase III for Sjögren-Larsson syndrome and oral ADX102 is in earlier-stage studies for Sjögren-Larsson syndrome and SSADH deficiency. (Sep.)

Investment Banks/Advisors: Cantor Fitzgerald & Co.; Laidlaw & Co.

Array Biopharma Inc.

Array Biopharma Inc. (small-molecule therapies mainly for cancer) netted $243mm through it latest public offering of 24mm common shares (including the overallotment) at $10.75. Proceeds will support pipeline development, including work on proprietary candidates and compounds in partnerships with AstraZeneca, Roche/Genentech, Loxo Oncology, and Cascadian Therapeutics. (Sep.)

Investment Banks/Advisors: Cowen & Co. LLC; JP Morgan Chase & Co.; Piper Jaffray & Co.; Stifel Nicolaus & Co. Inc.; SunTrust Banks Inc.; Wells Fargo Securities LLC

Ascendis Pharma AS

Ascendis Pharma AS netted $126.8mm through the public sale of 3.8mm American Depositary Shares at $35.50. Each ADS represents one ordinary share. The company plans to use the proceeds to complete development of, gain regulatory approval for, and prepare for commercialization of its growth hormone, and also for development of other candidates, including parathyroid hormone and C-Type natriuretic peptide. Ascendis' candidates incorporate its TransCon sustained-release technology. (Sep.)

Investment Banks/Advisors: Bank of America Merrill Lynch; Credit Suisse Group; JP Morgan & Co.; Wedbush PacGrow Life Sciences; Wells Fargo Securities LLC

Bellerophon Therapeutics Inc.

Bellerophon Therapeutics Inc. (developing drugs and devices for cardiopulmonary diseases) grossed $23.4mm through the private sale of 19.4mm units at $1.205 (a 12% premium) to lead investors Puissance Capital Management and Venrock Healthcare Capital Partners, which were joined by returning investors including New Mountain Capital and Linde North America. Each unit consists of one common share and a five-year warrant to buy a share at an exercise price of $1.242. (Sep.)

BioCryst Pharmaceuticals Inc.

BioCryst Pharmaceuticals Inc. netted $86.5mm through the follow-on public offering of 17.9mm common shares (including full exercise of the overallotment) at $5.15 each. The company will use the proceeds for ongoing development of BCX7353, which is currently in Phase II for hereditary angioedema. (Sep.)

Investment Banks/Advisors: Barclays Bank PLC; HC Wainwright & Co.; JP Morgan Chase & Co.

BiondVax Pharmaceuticals Ltd.

BiondVax Pharmaceuticals Ltd. (developing the Phase II universal flu vaccine candidate M001) netted $9.45mm through the follow-on public offering of 1.67mm American Depositary Shares (including full exercise of the overallotment option) priced at $6. Each ADS represents 40 ordinary shares. The company will use some of the proceeds for ongoing development of M001 and to build a mid-sized factory in Jerusalem. (Sep.)

Investment Banks/Advisors: Joseph Gunnar & Co.

Catalent Inc.

Catalent Inc., to help finance its concurrent $950mm buy of fellow CRO Cook Pharmica LLC, entered into a $700mm senior unsecured bridge loan facility commitment with Morgan Stanley., JP Morgan Chase, Royal Bank of Canada, RBC Capital Markets, Bank of America Merrill Lynch, and Merrill Lynch Pierce Fenner & Smith Inc. Catalent is also using cash on hand and proceeds from a concurrent public equity offering to fund the acquisition of Cook, and doesn’t expect to borrow under the facility, but it is there if it needs the extra money. (Sep.)

Curis Inc.

Curis Inc. (cancer therapies) netted $35.6mm through the public sale of 20mm common shares at $1.85. The funds will support continued development of CUDC907 (HDAC/PI3K inhibitor in Phase II for diffuse large B-cell lymphoma), and current and optioned therapeutics under the company's alliance with Aurigene, including CA170 (PD-L1 antagonist; Phase I), CA327 (PD-L1/TIM3 antagonist; preclinical), and CA4948 (IRAK4 inhibitor; preclinical). (Sep.)

Investment Banks/Advisors: Robert W. Baird & Co. Inc.

Deciphera Pharmaceuticals Inc.

Deciphera Pharmaceuticals Inc. (developing small-molecule cancer therapies) netted $129mm through its initial public offering of 8.17mm common shares (including partial exercise of the overallotment) at $17. The company had originally hoped to sell 6.25mm common shares for between $15-17 apiece when it filed earlier this month. (Sep.)

Investment Banks/Advisors: JMP Securities LLC; JP Morgan Chase & Co.; Nomura Securities International Inc.; Piper Jaffray & Co.

DelMar Pharmaceuticals Inc.

DelMar Pharmaceuticals Inc. (oncology) netted $9.3mm through a registered direct offering of 8mm common shares at $1.25, a 6% premium to the market average. HC Wainwright was the placement agent. The company's lead candidate VAL083 has been approved in China for chronic myelogenous leukemia and lung cancer, and is in US trials for glioblastoma multiforme (Phase I/II) as well as non-small cell lung cancer and ovarian cancer (preclinical). (Sep.)

Investment Banks/Advisors: HC Wainwright & Co.

Destiny Pharma

Infectious disease-focused Destiny Pharma has gone public on the London Stock Exchange, netting £14mm ($18mm) through a placing of 9.73mm ordinary shares at £1.57 with existing and new institutional and other investors. (Sep.)

Investment Banks/Advisors: Cantor Fitzgerald & Co.

Epizyme Inc.

Epizyme Inc. (epigenetic cancer therapies) netted $151mm through a public offering of 10.56mm common shares (including the overallotment) at $15.25. The proceeds, together with existing available funds, will support development and future market launch of lead candidate tazemetostat for solid and blood cancers, and will also be put towards additional R&D and corporate activities. (Sep.)

Investment Banks/Advisors: Jefferies & Co. Inc.; Leerink Partners LLC; Morgan Stanley & Co.

Evotec AG

Evotec AG (research and development for pharma and biotech companies) secured a €75mm ($90mm) loan from the European Investment Bank. The financing will be over a period of four years and will mature seven years after draw down. The company will use the funds for R&D for its EVT Innovate segment (building a pipeline of partnered disease-modifying product opportunities). (Sep.)

Exicure Inc.

Exicure Inc. (developing immunomodulatory and gene silencing drugs) raised $20mm in a private placement financing. Existing investors participated including AbbVie Ventures and selected individual investors, and were joined by Katalyst Securities and other individual investors. Immediately prior to raising the funds, Exicure reverse merged with a special purpose acquisition corporation to become public. (Sep.)

Incyte Corp.

Incyte Corp. grossed $650.1mm through a public offering of 4.95mm common shares at $131.46. The company has two marketed oncology therapies (Jakafi (ruxolitinib) and Iclusig (ponatinib)) and over a dozen others in development, as well as two dermatology candidates in trials and partnered projects for RA, lupus, dermatitis, and cancer. (Sep.)

Investment Banks/Advisors: Bank of America Merrill Lynch

Innovation Pharmaceuticals Inc.

Innovation Pharmaceuticals Inc. (formerly Cellceutix Corp.) entered a purchase agreement with Aspire Capital Fund, which will buy up to $30mm in Innovation common stock, at the company's discretion and at market price, over a three-year period. Innovation will use the funds to support its pipeline, which contains Prurisol (abacavir acetate), an oral Phase II psoriasis candidate; p53 modulator Kevetrin (thioureidobutyronitrile) for ovarian cancer (Phase IIa) and advanced solid tumors (Phase I); and broad-spectrum defensin mimetic antibiotic brilacidin, in Phase II for skin infections, ulcerative proctitis (an inflammatory bowel disease), and oral mucositis in head and neck cancer, and also in preclinical studies for possible use in dermatology and autoimmune indications. (Sep.)

Insmed Inc.

Respiratory disease-focused Insmed Inc. netted $378mm through a follow-on public offering of 14.12mm common shares (including the overallotment) priced at $28.50 each. The company will use the funds for ongoing clinical trials of its Phase III amikacin liposome inhalation suspension for refractory nontuberculous mycobacteria lung disease caused by Mycobacterium avium complex and for activities tied to regulatory approval and commercialization, initially in the US and later in Japan and other countries. Additional funds will support product manufacturing and to continue developing Phase II INS1007 for non-cystic fibrosis bronchiectasis. (Sep.)

Investment Banks/Advisors: Evercore Partners; Goldman Sachs & Co.; Leerink Partners LLC; Stifel Nicolaus & Co. Inc.

Intra-Cellular Therapies Inc.

Intra-Cellular Therapies Inc. (neuronal signaling pathway-based psychiatric disorder therapeutics) netted $141mm through a public offering of 9.7mm common shares at $15.50. The company will apply most of the proceeds (which it expects will last through mid-2020) to lead candidate lumateperone (ITI007; an oral 5HT-2A receptor antagonist/dopamine receptor antagonist/serotonin reuptake inhibitor), including its prelaunch and commercialization expenses pending regulatory approval in schizophrenia (for which it's in Phase III with an NDA filing expected mid-2018) and bipolar disorder indications (in Phase III); further development in bipolar disorder, behavioral disturbances in dementia (including Alzheimer's disease), depressive disorders, and other potential indications; ITI007's prelaunch expenses in behavioral disturbances in dementia (including AD); and preclinical and clinical development of ITI007 as a long-acting injectable. Some money will also fund Intra-Cellular's PDE1 inhibitor program (including ITI214, in Phase I/II for Parkinson’s disease), new and ongoing R&D, and manufacturing costs. (Sep.)

Investment Banks/Advisors: BTIG LLC; Canaccord Genuity Inc.; Cantor Fitzgerald & Co.; JP Morgan & Co.; Ladenburg Thalmann & Co. Inc.; Leerink Partners LLC

Iovance Biotherapeutics Inc.

Cancer drug developer Iovance Therapeutics Inc. publicly sold 7.7mm common shares at $6.50 for net proceeds of $47mm. Some of the funds will support ongoing clinical work, including Phase II studies of the tumor infiltrating lymphocyte (TIL) therapy LN144 for metastatic melanoma, and LN145, a TIL in Phase II for cervical cancer and squamous cell carcinoma of the head and neck. (Sep.)

Investment Banks/Advisors: Chardan Capital Markets; HC Wainwright & Co.; Jefferies & Co. Inc.; Oppenheimer & Co. Inc.; Wells Fargo Securities LLC

Juno Therapeutics Inc.

Juno Therapeutics Inc. (cellular immunotherapies for cancer) netted $272.8mm through a public offering of 7mm common shares (including the overallotment) at $41. The company concurrently issued its partner Celgene 659,145 shares at $41 ($27mm) through a separate private placement under the terms of their 2015 deal. (Sep.)

Investment Banks/Advisors: Barclays Bank PLC; JP Morgan Chase & Co.; Leerink Partners LLC; Morgan Stanley & Co.; Raymond James & Associates Inc.; Wedbush PacGrow Life Sciences; Wells Fargo Securities LLC

Kadmon Corp. LLC

Kadmon Corp. LLC (aka Kadmon Holdings Inc.) netted $60mm in a follow-on equity offering of 21.3mm common shares (including full exercise of the 2.8mm overallotment shares) at $3. The offering also included five-year warrants to purchase an additional 7.4mm common shares at a strike price of $3.35. The company plans to use the proceeds from this offering and a concurrent $15.5mm RDO to fund development of its products including KD025, lead candidate in Phase II development for AI and fibrotic disease indications. (Sep.)

Investment Banks/Advisors: HC Wainwright & Co.; Jefferies & Co. Inc.; Piper Jaffray & Co.

Kadmon Corp. LLC

Kadmon Corp. LLC netted $15.5mm in a registered direct offering through the sale of 5.5mm common shares at $3 (10% discount to prior 10-day market average). The offering also included five-year warrants to purchase 2.2mm additional common shares at a strike price of $3.35. Concurrently, Kadmon netted $60mm in a follow-on equity offering. The company plans to use the offering proceeds to fund development of its products including KD025, lead candidate in Phase II development for AI and fibrotic disease indications. (Sep.)

Krystal Biotech Inc.

Krystal Biotech Inc. (gene therapies focused on rare dermatological diseases) netted $42.4mm in its initial public offering of 4.6mm shares (including full exercise of the overallotment) at $10. The company originally planned to offer 3mm shares at a price range of $9-11. (Sep.)

Investment Banks/Advisors: Ladenburg Thalmann & Co. Inc.

Marinus Pharmaceuticals Inc.

Marinus Pharmaceuticals Inc. (psychiatric and epilepsy therapeutics) netted $32.9mm through the public offering of 9.33mm shares at $3.75mm. The company will use the proceeds to fund continued development of its GABA A receptor agonist ganaxolone (originally licensed from Purdue in 2004). The company recently announced that results of a Phase II study of oral ganaxolone in children with CDKL5 disorder (a severe, rare genetic epilepsy) demonstrated significant seizure-frequency reduction in most patients, supporting the compound's advancement into a late-stage clinical trial as Marinus' lead pediatric orphan epilepsy program. It's also evaluating ganaxolone in other indications, including postpartum depression (Phase II), status epilepticus (seizure of prolonged duration; Phase I), and other pediatric orphan indications, including genetic epilepsies (PCDH19 and Lennox Gastaut and Dravet syndromes) and inherited neurological disorders (Angelman, Fragile X, and Rett syndromes). (Sep.)

Investment Banks/Advisors: JMP Securities LLC

MediWound Ltd.

MediWound Ltd. (developing a proteolytic enzyme technology for wound treatment) netted $20.7mm through the public sale of 4.4mm ordinary shares at $5. Some of the funds will support continued work on EscharEx, a topical debridement therapy in Phase II trials for chronic and hard-to-heal wounds. (Sep.)

Investment Banks/Advisors: Aegis Capital Corp.; Cowen & Co. LLC; Oppenheimer & Co. Inc.; SunTrust Banks Inc.; Wells Fargo Securities LLC

Nabriva Therapeutics AG

Antibiotics developer Nabriva Therapeutics PLC netted $75.2mm through the follow-on public sale of 9.4mm ordinary shares at $8.50 each. The company will use some of the proceeds for ongoing development of Phase III lefamulin for community-acquired bacterial pneumonia and for regulatory activities. (Sep.)

Investment Banks/Advisors: Bank of America Merrill Lynch; Morgan Stanley & Co.; Needham & Co. Inc.; SunTrust Banks Inc.; Wedbush PacGrow Life Sciences

Newron Pharmaceuticals SPA

Italian biotech Newron Pharmaceuticals SPA (trades on the SIX Swiss Exchange) raised CHF27mm ($27.8mm) through the private placement of 2mm new ordinary shares at CHF13.50 (a 21% discount) to institutional investors. The CNS-focused company will use the proceeds (which it expects to last through to 2019) to accelerate drug development, particularly for evanamide (NW3509), a Phase II voltage gated sodium channel (VGSC) modulator for schizophrenia for which the company plans to start two trials during 2018. Newron will also put the money toward in-licensing or acquiring additional programs to build up its pipeline, which also has Phase II/III serotonin 1A (5-HT1A) receptor agonist sarizotan for Rett syndrome (for which it has both US and EU orphan drug status and is targeting an approval filing next year). (Sep.)

Investment Banks/Advisors: Jefferies & Co. Inc.; Kempen & Co.

Portola Pharmaceuticals Inc.

Portola Pharmaceuticals Inc. (therapies for thrombosis and other hematologic diseases) netted $330.9mm through the follow-on offering of 6.35mm common shares priced at $55. The company will use the money to fund US launches and manufacturing costs for its thrombosis drug Bevyxxa (betrixaban) and AndexXa (andexanet alfa) for hemorrhage. Additional proceeds will support the ongoing Phase I/II trial of cerdulatinib for blood cancers. (Sep.)

Investment Banks/Advisors: Citigroup Inc.; Cowen & Co. LLC; Goldman Sachs & Co.; Morgan Stanley & Co.; William Blair & Co.

Sophiris Bio Inc.

Through a $10mm term loan agreement with Silicon Valley Bank, Sophiris Bio Inc. (cancer and urology therapeutics) initially borrowed $7mm and will get the remainder at its discretion and contingent upon achieving one of two goals by December 31, 2018. (Sep.)

Summit Therapeutics PLC

Summit Therapeutics PLC (working on therapies for Duchenne muscular dystrophy and Clostridium difficile infection) netted $18.9mm through the public sale of 1.68mm American Depositary Shares (including full exercise of the overallotment) at $12. Each ADS represents five ordinary shares. The company plans to use the funds for ongoing development of Phase II ridinilazole for C. difficile, and for other R&D activities. (Sep.)

Investment Banks/Advisors: Canaccord Genuity Inc.; HC Wainwright & Co.; JMP Securities LLC; Needham & Co. Inc.

Synergy Pharmaceuticals Inc.

Synergy Pharmaceuticals Inc. (therapies for gastrointestinal diseases) secured a $300mm senior loan from CRG. The first $100mm tranche was received immediately. Based on certain financial and revenue milestones, an additional $100mm will be received on or before February 28, 2018, and two additional tranches of up to $50mm each will be paid on or before March 29, 2019. The loan matures on June 30, 2025 and bears interest at 9.50% per year with interest-only payments for the first five years (payable quarterly), followed by 12 equal quarterly installments of principal and interest during the final three years of the term, which converts to an eight-year interest only period if certain milestones are achieved. The company can opt to prepay outstanding loan amounts during the term. Synergy will use the proceeds to commercialize its constipation drug Trulance (plecanatide). (Sep.)

ZAI Lab Ltd.

Chinese drug developer Zai Labs Ltd. completed its initial public offering in the US, netting $139.5mm through the sale of 8.33mm American Depositary Shares (representing 8.33mm common) at $18 per ADS. Earlier this month, the company stated that it hoped to sell 5.88mm ADSs at a range of $16-18. (Sep.)

Investment Banks/Advisors: Citigroup Inc.; JP Morgan Chase & Co.; Leerink Partners LLC