Protocols

Novo helps birth startup advancing an AstraZeneca castoff with $15M; Japan’s Fuji Pharma wagers $50M on Alvotech’s biosimilars

→ With backing from Novo Holdings and a drug from AstraZeneca, Aristea Therapeutics is unveiling a $15 million Series A that will kickstart Phase II studies of its lead program, RIST4721. James Mackay, who used to run AstraZeneca-acquired Ardea Biosciences, is the founder and CEO of the San Diego-based startup. He’s staying mum on details about Aristea’s pipeline of treatments for serious inflammatory diseases, preferring instead to highlight the combined expertise of his crew of ex-Ardea execs: John Montana, SVP of development; Sara McCutchan, regulatory affairs manager; and DeAnne Reid, director of operations. Tiba Aynechi and Ken Harrison of Novo Ventures are joining the board.

Vertex says that its NaV1.8 inhibitor pain drug VX-150 came through in their third mid-stage proof-of-concept study, this time testing the therapy in patients with pain caused by small fiber neuropathy. “We are excited to now have three positive proof-of-concept studies that validate the potential role for NaV1.8 inhibitors to treat a variety of pain conditions,” said CEO Jeffrey Leiden. “These results show a potential path for the treatment of pain at a time when there is great clinical and societal need for new medicines. We continue to progress VX-150 toward pivotal development and also plan to advance additional NaV1.8 pain medicines into clinical development beginning in 2019.”

Fuji Pharma is teaming up with Iceland’s Alvotech to introduce more products to Japan’s burgeoning biosimilars market. As Alvotech continues to develop and manufacture its biosimilars in the areas of oncology, ophthalmology and autoimmune disease, Fuji will take over registration and commercialization of these assets in Japan. And to show its commitment for a longterm relationship, Fuji Pharma is acquiring a 4.2% stake in Alvotech for $50 million.

→ Adding a rare disease drug to its collection of royalty-earning assets, San Diego-based Ligand Pharmaceuticals $LGND has paid Palvella Therapeutics $10 million for rights to a Phase II/III treatment for a skin disorder called pachyonychia congenita. The money, says Ligand CEO John Higgins, will provide their partners with capital to complete registrational clinical trials.

→ Vertex CFO Thomas Graney has resigned. The bellwether Boston biotech says that COO Ian Smith will fill in on a temporary basis. Graney handed in his resignation letter on December 13 — outlined in an SEC filing Monday morning. UPDATE: After we reported this Monday, a startup named Generation Bio — helmed by Geoff McDonough — put out a notice that Graney had decided to jump over to become their CFO. So mystery solved.


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Biotech Investment Analyst
SV Health Investors Boston, MA
Director, Program Management
Contrafect Corporation New York, NY
Director, Translational Sciences
Cadent Therapeutics Cambridge, MA

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