Deal Watch: After Novartis Deal, GSK Increases Vaccine Emphasis With GlycoVaxyn Buyout

Sanofi moves into ROR gamma T R&D for potential autoimmune therapies in collaboration with Lead Pharma, while Intrexon acquires Belgium’s ActoGeniX and its platform technology for creating a novel class of biotherapeutics targeting the oral and GI tracts. Teva heads off dispute with Eagle, bringing in new bendamustine formulation.

“The Pink Sheet” regularly provides commentary and perspective on key business deals. Here’s a summary of the most noteworthy transactions taking place between Feb. 6 and Feb. 19.

GlaxoSmithKline/GlycoVaxyn

GlaxoSmithKline PLC is promising to maintain the “agility and autonomy” of vaccine biotech GlycoVaxyn AG following the big pharma’s purchase of the Swiss company for $190 million in cash, announced Feb. 11. The move, which values GlycoVaxyn at $212 million, underlines the importance GSK attaches to conjugated vaccines and to the company’s research: GSK says it will take the next several months to develop ways of working with GlycoVaxyn to achieve an innovative collaboration (Also see "GSK Acquires Conjugated Vaccine Expertise With GlycoVaxyn Purchase" - Pink Sheet, 11 Feb, 2015.).

GSK took a small stake in GlycoVaxyn in 2012 when it agreed to collaborate on the development of several bacterial vaccines [See Deal]. The U.K. pharma now has snapped up the rest of GlycoVaxyn’s shares after the firm announced robust clinical responses with its first vaccine to enter clinical trials, a candidate for extra-intestinal pathogenic Escherichia coli (ExPEC) that is in Phase I studies with partner Janssen Pharmaceuticals Inc. Janssen has rights to continue development of the ExPEC vaccine alone after proof-of-concept is achieved [See Deal].

Vaccines are one of the three main areas of focus for GSK that will be strengthened also by the acquisition of Novartis AG’s vaccine portfolio for $7 billion, expected to close in the first half of this year (Also see "EU Clears GSK-Novartis And Mylan-Abbott Deals, With Minor Conditions" - Pink Sheet, 29 Jan, 2015.). Conjugated vaccines have an antigenic carrier protein attached to the bacterial antigen to enhance the latter’s immunogenicity, and account for more than 30% of the global vaccines market.

GlycoVaxyn brings together the genes to produce conjugated vaccines within a single bacterium, and then uses those bacteria to manufacture and harvest antigenic particles. This bioconjugation method is expected to be more efficient, quicker and more reliable than currently used chemical-based conjugation methods, particularly for difficult-to-make bacterial vaccines: GlycoVaxyn has been working on Shigella, Staphylococcus aureus and pneumococcal invasive disease vaccines.

Sanofi/Lead Pharma

French pharma Sanofiis moving into the promising ROR gamma T space through a multi-year collaboration with Dutch biotech Lead Pharma announced Feb. 18. Specific financial terms were not disclosed.

ROR gamma T (retinoic acid receptor-related orphan receptor gamma) is a key regulator of the interleukin-17 cytokine immune pathway implicated in T-cell differentiation. This pathway can drive processes in chronic autoimmune-related inflammatory indications, Sanofi explained.

Under the agreement, the two firms will collaborate on early-stage R&D with a goal of producing clinical candidates for development within three to four years. Lead gets an undisclosed upfront payment and will be eligible for R&D cost reimbursement, regulatory and commercial milestones and royalties on global sales of any products resulting from the partnership. Sanofi will be responsible for clinical development and worldwide marketing and commercial rights to such products.

Intrexon/ActoGeniX

Maryland biotech Intrexon Corp. is acquiring Belgium’s ActoGeniX NV and its TopAct technology platform in a $60 million deal split equally between cash and stock. The deal, announced Feb. 13, follows quickly after Intrexon netted $95.2 million in a follow-on public offering in January [See Deal].

The TopAct technology enables the molecular engineering of food-grade microbes (Lactococcus lactis) to generate products ActoGeniX calls ActoBiotics that provide in situ expression of novel biotherapeutic proteins and peptides, such as cytokines, enzymes, hormones and monoclonal antibodies, to the oral and gastrointestinal tracts. The Belgian biotech says these candidates could provide therapies for autoimmune, allergic, metabolic, oral and GI indications.

With the transaction, Intrexon obtains two clinical candidates – AG013, a therapeutic peptide for prevention and attenuation of oral mucositis, and AG014, which secretes an anti-tumor necrosis factor antibody to treat inflammatory bowel disease with localized delivery. Both are currently in Phase I.

Genzyme/Voyager

Genzyme Corp. and Voyager Therapeutics Inc. will utilize each other’s expertise in the field of adeno-associated virus gene therapy to discover, develop and sell therapies for severe neurological diseases. The large-molecule division of Sanofi paid $100 million up front, including $65 million cash, a $30 million equity investment and undisclosed in-kind contributions under a deal announced Feb. 11 [See Deal].

Voyager also could earn up to $745 million in development and sales milestones, plus tiered royalties. In addition to holding options to license new treatments discovered during the collaboration (exercisable following proof-of-concept human trials), Genzyme also gets ex-U.S. rights to a handful of in-progress compounds, including Phase I VYAADC01 for Parkinson’s disease and preclinical VYFXN01 for Friedreich’s ataxia. It will also co-commercialize in the U.S. VYHTT01, which is in preclinical studies for Huntington’s disease, with both firms splitting profits in that territory. (Voyager’s lead program for amyotrophic lateral sclerosis, the preclinical VYSOD101, is not included in the deal.)

The alliance is the first major partnership for Voyager, which was formally established just a year ago and is working off of intellectual property licensed from the University of California, San Francisco, University of Massachusetts Medical School and Stanford University[See Deal].

Hospira/Pfenex

On the heels of its $17 billion acquisition by Pfizer Inc., Hospira Inc. licensed exclusive global rights to develop, manufacture and sell Pfenex Inc.’s Phase Ib/IIa PF582, a biosimilar of Genentech Inc.’s Lucentis (ranibizumab) for wet age-related macular degeneration (Also see "Hospira Bulks Up Pfizer’s Established Products Unit, But Won’t Speed A Split" - Pink Sheet, 9 Feb, 2015.). Hospira and Pfenex also may collaborate on other products in the future, including co-development of other ophthalmic biologic VEGF-A inhibitors [See Deal].

The alliance, which was announced Feb. 10 and has a 20-year term, furthers Hospira’s biosimilars business, which was one of the main attractors for Pfizer. Hospira already markets such products in Europe, while Pfizer has several biosimilars in the pipeline, all within the hematology, oncology and immunology areas.

In exchange for adding PF582 to its stable, Hospira pays $51 million up front (upon U.S. antitrust clearance), $291 million in development and sales milestones, and double-digit escalating royalties. PF582 is expected to start Phase III in 2016 with results potentially in 2017; Genentech’s first patent expiry on Lucentis also is expected in 2017. Pfenex and Hospira will split the Phase III equivalence trial costs equally, although Pfenex’s share is capped at $20 million ($10 million of which will be set off as a credit against the royalties to which it is entitled).

Teva/Eagle

Teva Pharmaceutical Industries Ltd. is evergreening its Treanda (bendamustine) franchise by licensing commercial rights to a new rapid-infusion formulation of bendamustine that would offer a shorter infusion time than the Israeli firm’s current product – and settling a patent dispute with Eagle Pharmaceuticals Inc. at the same time.

Under the deal announced Feb. 17, New Jersey-based Eagle will receive $30 million up front and can earn up to $90 million in milestones as well as double-digit sales royalties in exchange for U.S. and Canadian commercialization rights to EP-3102 [See Deal]. EP3102 provides Teva with a bendamustine alternative that can be rapidly infused (over 10 minutes, based on clinical data) and doesn’t require reconstitution before the drug is given, offering a convenience advantage over Treanda. Eagle’s product is under FDA review for treatment of chronic lymphocytic leukemia and non-Hodgkin lymphoma.

Treanda, which Teva gained through its 2011 acquisition of Cephalon Inc., has patent protection through at least 2026, but Teva believes generics could be launched as early as September 2015 (the company says 17 competitors have filed ANDAs) (Also see "With Cephalon Deal, Teva Sees Opportunities For Niche Branded Drugs and Drug/Device Combinations" - Pink Sheet, 5 May, 2011.). Treanda holds U.S. orphan drug exclusivity in both the CLL and NHL indications through March 2015 and October 2015, respectively (‘3102 also has orphan drug status for NHL and CLL). In addition to in-licensing ‘3102, Teva is trying to extend its bendamustine franchise through an easier-to-use liquid formulation it launched last year.

As part of the agreement, the partners will settle their pending patent infringement case regarding Teva’s U.S. patent 8,791,270, “Bendamustine pharmaceutical compositions,” with Eagle agreeing to enter a consent judgment. As a result, Teva will waive its orphan drug exclusivities in NHL and CLL.

Actavis/TPG/Mayne

Before announcing that its branded drugs division would take on (and presumably benefit from the reputation of) the Allergan Inc. name, Actavis divested assets to a pair of biopharmaceutical companies to clear the way for finalizing its merger with Allergan (Also see "Actavis Puts Greater Emphasis On Branded Rx By Taking Allergan Name" - Pink Sheet, 18 Feb, 2015.).

On Feb. 9, it sold off the U.S. rights to the severe acne microbial product Doryx (doxycycline hyclate delayed-release tablets) and related assets to Mayne Pharma Ltd. for $50 million. Actavis will package, distribute and promote the drug until May 2 pursuant to the agreement. Mayne was the original developer of Doryx [See Deal].

Then, on Feb. 13, Actavis sold the Aptalis Pharmaceutical Technologies unit, also known as PharmaTech – focused on pharmaceutical outsourcing and R&D in the U.S., Canada and Europe – to global private investment firm TPG. The financial terms were not disclosed. Actavis said the acquirer will focus PharmaTech on growth and development of innovative products, while the divestiture will enable it to increase focus on supporting its existing global supply chain network.