Time to bid an adieu to 2013. Xconomy will go on a little holiday break once Christmas rolls around next week, so this’ll be the last roundup of the year. True to form in what’s been a wild year for biotech—the Nasdaq Biotechnology Index is up more than 50 percent since Jan. 2— it’s jam-packed. Happy holidays everyone.
—The Personal Genome Project, George Church’s big plan to sequence 100,000 human genomes in the U.S., hasn’t hit that ambitious goal, but it has spawned a new startup. Boston-based Curoverse bagged $1.5 million in seed funding from a group of investors this week to develop an open source computational storage platform that houses massive amounts of genomic data. The system, called Arvados, has been used so far to power Church’s Personal Genome Project at Harvard University. I spoke with Curoverse CEO Adam Berrey about the differences between Curoverse and its competitors, like Mountain View, CA-based DNAnexus, and the company’s plan to roll out Arvados to the public in 2014.
—It wasn’t too long ago that Columbia University professor Samuel Sia was sketching the floorplan for a biotech incubator in the middle of Manhattan. That vision is now becoming real, as Sia’s Harlem Biospace has become Manhattan’s first operational incubator for biotech startups. Since opening in November, Harlem Biospace has filled up with 16 nascent companies occupying 22 of its 24 workstations. I talked to a few of the on-site entrepreneurs, as well as Sia, about the venture.
—Waltham, MA-based Trinity Pharma Solutions has been bootstrapping it for about eight years. But this week it decided to finally give up some equity in return for $15 million in venture cash from Health Enterprise Partners to help it grow. The company, a spinout of consulting firm Trinity Partners, sells an analytics platform known as AgileM, which aggregates information about a drug’s sales and helps interpret the data via predictive algorithms.
—The latest study of Cambridge, MA-based Vertex Pharmaceuticals (NASDAQ: VRTX) cystic fibrosis drug ivacaftor (Kalydeco) wasn’t the success the company was hoping for, but it still has a chance to be good enough to expand the reach of the drug. Vertex reported ivacaftor didn’t hit its main goal of significantly improving the lung function of patients with at least one copy of the so-called R117H gating mutation. But Vertex still plans to seek FDA approval for patients in that group that are 18 and over—the 50 patients in the study fitting that description showed a 9.1 percent improvement in lung function over the course of the 24 weeks they were treated.
—Could the…fourth time be the charm for Watertown, MA-based pSivida (NASDAQ: PSDV)? Alimera Sciences (NASDAQ: ALIM), the company’s development partner for eye drug Iluvien, said late Thursday that the FDA has changed its stance and won’t require a new clinical trial with at least 12-months of follow-up before considering approval of the drug. Instead, Alimera is now in labeling discussions with the FDA and will file a formal reply to the agency’s complete response letter in the first quarter of 2014. The FDA has rejected Iluvien, a treatment for diabetic macular edema, three times already—most recently in October. Psivida’s shares jumped more than 40 percent on the news. It stands to get a $25 million payday from Alimera if the FDA approves Iluvien.
—Lexington, MA-based Cubist Pharmaceuticals’ (NASDAQ: CBST) experimental antibiotic CXA-201 succeeded in the second of two Phase III trials. The drug proved just as effective as generic antibiotic meropenem at treating complicated intra-abdominal infections. The drug, which Cubist acquired from San Diego, CA-based Calixa Therapeutics a few years ago, already showed promising results in a late-stage study of patients with complicated urinary tract infections. Cubist will file approval applications with regulators in the U.S. and Europe next year based on those results.
—Cambridge-based OvaScience (NASDAQ: OVAS) suffered a setback earlier this year when FDA concerns caused it to halt a clinical trial for its most advanced product, Augment. So the company cut a deal with R.J. Kirk’s Intrexon (NASDAQ: XON) this week to try to speed up the development of the next-generation in-vitro fertilization procedure its developing behind Augment, called OvaTure. OvaScience is paying Intrexon $2.5 million in stock up front and will hand out another $2.5 million stock payment in a year. The deal also includes commercial milestones and royalties.
—The Michael J. Fox Foundation for Parkinson’s Research awarded Cambridge-based Neurophage an $822,000 grant to help fund preclinical research on drug candidate NPT088’s potential effect on alpha-synuclein deposits—proteins that build up in the brain in people with Parkinson’s Disease. It’s the second grant the foundation has awarded Neurophage since 2012.
—An FDA advisory panel recently rejected Bedminster, NJ-based Amarin’s (NASDAQ: AMRN) plan to expand approval of its fish oil pill into patients with mixed dyslipidemia—high levels of cholesterol in the blood. Amarin first cut its workforce as a result, and now its CEO, Joseph Zakrzewski, has stepped down. Amarin announced Zakrzewski’s “retirement” this week, and replaced the outgoing CEO with current president John Thero.
—New York-based Retrophin pulled its hostile $4 per share bid for Point Richmond, CA-based Transcept Pharmaceuticals (NASDAQ: TSPT), claiming the bid is no longer “compelling” given the company’s dwindling cash position. Transcept, which has staunchly resisted Retrophin’s overtures, fired back by saying that Retrophin didn’t present a “credible” way of financing a bid. Transcept has said that it will liquidate if it can’t find a buyer.
—Separately, Retrophin, which currently trades over the counter, is looking to make the jump to Nasdaq. Martin Shkreli’s rare disease outfit, which made a series of deals last week, wants to raise up to $40 million through an IPO, according to a prospectus filed with the SEC.
—Just a year after joining with AstraZeneca to pay close to $7 billion for diabetes drugmaker Amylin Pharmaceuticals, New York-based Bristol-Myers Squibb (NYSE: BMY) is backing out of the field altogether. Bristol has agreed to sell its stake in a massive diabetes joint venture to its partner, AstraZeneca, for $2.7 billion up front, potentially another $1.4 billion in milestones, and a $225 million kicker once certain unspecified assets are transferred over. The collaboration between the two includes several diabetes drugs ike saxagliptin (Onglyza), exenatide (Byetta), exenatide extended release (Bydureon), and dapagliflozin (Forxiga).