Epirus Switzerland GmbH, of Zug, Switzerland, will earn up to $275 million in up-front, milestone and royalty payments under a new partnership with Orygen Biotecnologia Ltda, a joint venture of Brazilian pharmaceutical firms Eurofarma Laboratorios SA and Biolab Sanus Farmaceutica Ltda. The companies will work to register a biosimilar of Remicade (infliximab, Johnson & Johnson), BOW015, with Brazil’s National Agency of Sanitary Surveillance.
Shares in Amarin Corp. plc fell 61 percent Thursday following Wednesday’s surprise vote by the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommending against approval of the firm’s marketed fish oil-derived lipid-lowering drug Vascepa in a supplemental indication.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee broke with the recent track record of the agency in recommending against an application for a lipid-lowering agent based on a surrogate endpoint, asking instead for results of an ongoing cardiovascular outcomes trial before recommending approval.
Savient Pharmaceuticals Inc. said that it is committed to keeping Krystexxa on the market throughout and after its bankruptcy process. The struggling biotech filed Chapter 11 voluntarily in the Bankruptcy Court for the District of Delaware, along with a motion seeking authorization to pursue a sale process.
The FDA released briefing documents ahead of Wednesday’s Endocrinologic and Metabolic Drugs Advisory Committee meeting to consider approval of Amarin Corp.’s Vascepa as an add-on to statin therapy for patients with mixed dyslipidemia. The key question before the panel is whether to recommend approval now, or wait for results of the REDUCE-IT cardiovascular outcomes trial, which are due in Nov. 2016.
Osiris Therapeutics Inc. will sell its culture-expanded mesenchymal stem cell (ceMSC) business, including Prochymal, to Mesoblast Ltd. for up to $100 million including up-front and milestone payments.
SAN FRANCISCO – While the focus of the BIO Investor Forum was mainly on partnering and venture investment, no subject sparked more conversation and more interest than the exploding initial public offering (IPO) market and enabling provisions of the JOBS Act.
SAN FRANCISCO – New platforms for crowdfunding of biotech are cropping up as a potential solution to the eternal funding gap for new companies. Representatives from traditional venture investing and the newer crowdfunding paradigm discussed the problems and potential of bringing more and smaller investors into biotech at the early stages at the BIO Investor Forum in San Francisco.
SAN FRANCISCO – After years of watching and waiting, biotechs are seizing the opportunity to jump into the public markets while investors are eager and interested.
SAN FRANCISCO – Over the next two days, the BIO Investor Forum will be under way, drawing more than 600 attendees from more than 200 companies, and more than 220 investors. And the trends are positive.
