Alexion's Orloff, Head of Research inks his first licensing deal.

NEW HAVEN: Alexion Pharmaceuticals, Inc. [Nasdaq:ALXN] has entered into what can be a hundreds of millions of dollar licensing deal for drugs by Halozyme Therapeutics, Inc. [Nasdaq:HALO] a relatively small public biotech based in San Diego.

The agreement provides Alexion with the opportunity for “exclusive development of up to four targets, including a next generation subcutaneous formulation of ALXN1210," the company’s next generation [in development] replacement of Soliris, Alexion’s flagship drug.

Alexion will pay $40 million up front and potentially as much as $160 million for each of the four targeted therapies dependent on sales and regulatory milestones.

infectiousNEW HAVEN: Melinta Therapeutics, Inc. [NASDAQ: MLNT] has entered an agreement to acquire the infectious disease business from The Medicines Co. [NASDAQ: MDCO]. The acquisition includes the purchase of three marketable products - recently approved and launched Vabomere (vaborbactam/meropenem), and established commercial products Orbactiv (oritavancin), and Minocin IV (minocycline).

Melinta expects this transaction to create a “focused portfolio of high-value marketed assets with noteworthy commercial synergies.” Adding, “the combined infectious disease product portfolio of Melinta and The Medicines would enhance Melinta's multi-channel strategy of delivering antibiotic solutions for ABSSSI (acute bacterial skin and skin structure infections) and gram-negative infections within the hospital, emergency department, and community settings.”

migraineNEW HAVEN: Biohaven Pharmaceutical [NYSE: BHVN] has completed enrollment in Study BHV3000-302, the company’s second “pivotal Phase 3 clinical trial examining the efficacy and safety of rimegepant in the acute treatment of migraine.”

The company plans to announce its topline results for the migraine program in the first quarter of 2018. Together the two  trials enrolled approximately 3,000 subjects. The company says it expects the result “to support a robust assessment of the efficacy of rimegepant in the acute treatment of migraine as required by the FDA for registration.”

Investors are apparently waiting however, the company stock has pulled back to $22 per share on December 1, from its high of $39 in September. The company first went public in May of 2017 at $17.91 per share.

Vlad Coric, M.D., Chief Executive Officer at Biohaven, said, "Completion of enrollment in this second migraine trial in only about four months underscores both the priority of the CGRP program within Biohaven and the very high unmet need for innovative therapies to better treat migraine attacks.”

HEALERBRANFORD: Thetis Pharmaceuticals, a research level bio-tech founded in 2011 by by ex-Pfizer R&D executives and healthcare investors, announced the receipt of a Fast-Track Small Business Innovation Research (SBIR) Grant from the National Institutes of Health for $2.3 million.. The grant will support development of Thetis’ TP-317 candidate as oral therapy for treatment of ulcerative colitis.

Thetis CEO Mathias: "A fundamentally new approach."

Gary Mathias, Co-founder and Chief Executive Officer, said, “TP-317 offers a fundamentally new approach to IBD treatment based on active resolution of inflammation and the promotion of tissue regeneration without suppressing the immune system. The grant will support the advancement of this promising, potential new therapy into the clinic.”

Preclinical efficacy studies are being conducted in collaboration with Dr. Daniel Rosenberg, Professor of Medicine at the University of Connecticut. Dr. Rosenberg commented: “TP-317 delivers a natural bioactive lipid known as Resolvin E1 that regulates the inflammatory response.”

Thetis is funded by Connecticut Innovations, Inc. and is a member of the Technology Incubation Program at University of Connecticut Health.

Dr. Vince O’Neill, Chief Medical Officer of BioXcel Therapeutics, says company potentially breaking new ground in cancer treatment.

BRANFORD: BioXcel Therapeutics (“BTI”), a research stage [founded in 2005], announced a research collaboration with San Francisco based the publicly traded Nektar Therapeutics [Nasdaq: NKTR] with a $6 billion market cap, research/development stage bio-tech.

The companies will “explore the novel combination of Nektar’s NKTR-214, a CD122-biased agonist, and BTI’s BXCL701, a small molecule immune-modulator and DPP 8/9 and FAP inhibitor, for the treatment of multiple oncology indications.”

According to the companies, the goal of this collaboration is to leverage “the complementary mechanisms of NKTR-214 and BXCL701 to boost the body’s own immune system and overcome local immunosuppressive mechanisms in the tumor microenvironment. The collaborative research studies will evaluate the potential of the therapies in preclinical mouse models of pancreatic and prostate cancer.”

bioscience roadmapNEW HAVEN: Two New Haven based biotechs, Melinta Therapeutics [Nasdaq:MLNT] and Biohaven [NYSE:BHVN] have both just begun new clinical trials.

Melinta Therapeutics, Inc. which has developed the FDA approved antibiotic Baxelda, to treat MRSA and other skin infections, has initiated a Phase 2 clinical study of topical Radezolid for the treatment of mild-to-moderate acne vulgaris.

The Melinta study will enroll approximately 48 individuals with moderate-to-severe facial acne vulgaris. The company hopes to demonstrate that the twice daily application will create at least an “almost clear” condition. The study is expected to complete enrollment in the second half of 2018.


naderNEW HAVEN: Alexion Pharmaceuticals, Inc. [NASDAQ: ALXN] is adding some bioscience chops to its board appointing Francois Nader, M.D.

The company says “Nader is an accomplished leader in the biopharmaceutical industry with a proven track record of building and transforming companies, launching rare disease therapies, and creating significant shareholder value.”

Just last week in an editorial recognizing the gaps in Alexion’s board, Business New Haven, Conntact.com called for an expansion of bioscience experience on the board, as the company seeks to create a new drug pipeline, dependent on licensing and or acquisitions.