We’ll kick off this week’s roundup with two more FDA approvals of drugs brought to market by Big Pharma companies but originated in biotech labs. Biotechs have come to represent a big part of medicines that come to market, especially when innovation and medical need come into play most clearly.
According to this Nature study published a couple months ago, 107 different companies originated the 162 products that were approved by the FDA from 1998 to 2012 after a priority review—“the primary arena for both technological innovation and medical advances in drug development,” the author writes.
Of those companies, 67 were biotechs and 40 were pharma. The paper, from former biotech executive Donald Drakeman (now a VC in London), goes into more detail, not just about the prevalence of biotech-originated therapeutics, but the sector’s cost efficiency. It’s a good read, please do have a look. His numbers stop after 2012, but we’d be shocked if the trends have reversed, as Big Pharmas become ever more focused on the late clinical development and marketing end of the pipeline.
Also waiting in this week’s pipeline of news: our scoop on Seattle biotech Allozyne being sold off in pieces, Gilead Sciences gets bad news, and hints that Novo Nordisk might reinvest in Seattle. Let’s get to the roundup.
—Xconomy reported that the FDA approved HyQvia, a treatment for adults with primary immune disorders. It combines a disease-fighting immunoglobulin product by Deerfield, IL-based Baxter (NYSE: BAX) with a genetically engineered enzyme from San Diego’s Halozyme Therapeutics (NASDAQ: HALO). The FDA halted development of Hyqvia in 2012 after raising concerns that patients were generating antibodies against Halozyme’s flagship product, a recombinant human hyaluronidase, or rHuPH20. Getting market clearance for HyQvia is a significant milestone for the company and a crucial validation of Halozyme’s core technology, CEO Helen Torley said.
—The FDA on Wednesday approved naloxegol (Movantik), a treatment for opioid-induced constipation that was originally developed by San Francisco-based Nektar Therapeutics (NASDAQ: NKTR). Nektar licensed the drug to AstraZeneca in 2009 when it had completed Phase 2 trials. AZ paid $125 million upfront and threw in nearly $100 million more last fall when U.S. and European regulators agreed to review naloxegol for approval. This week’s FDA approval will make Nektar eligible for some of the remaining $140 million in milestone payments. Nektar can also earn up to $375 million in additional sales milestones and royalties down the road.
—Xconomy reported Thursday that Seattle biotech Allozyne, once an ambitious graduate of the local Accelerator incubator, is being sold off in pieces. Most was sold to MedImmune, the biotech division of AstraZeneca, earlier this year, and Allozyne’s chairman told Xconomy he’s looking for a taker for Allozyne’s lead product, a longer-acting version of the multiple sclerosis drug beta interferon.
—Viking Therapeutics, a San Diego firm spun out through a licensing deal with Ligand Pharmaceuticals (NASDAQ: LGND), was poised to go public, as of this writing. The firm is offering 5 million shares at an expected price between $10 and $12 a share. The company licensed five drugs from Ligand, targeting diabetes and other metabolic and endocrine disorders. At $11 a share, the company would raise gross proceeds … Next Page »
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