East Coast Life Sciences Roundup: Verdine, Ariad, Karyopharm, & More

10/11/13Follow @benthefidler

Though the public markets have recently been cozying up to biotech, in the form of a string of successful IPOs, one company offered a reminder this week that investors’ love for the sector is anything but unconditional. That and the rest of the life sciences news around the East Coast below:

—Greg Verdine made big news earlier this year when he gave up a tenured faculty position at Harvard University to become the CEO of a Cambridge, MA-based biotech startup, Warp Drive Bio, for about three years. But as National Biotech Editor Luke Timmerman explains, he’s doing more than that—he’s also trying to blaze a trail for scientific entrepreneurs by coming back to Harvard afterwards as a “professor of the practice” on a five-year renewable contract. Verdine spoke to Xconomy at length about his rationale.

—Investors jumped ship on Cambridge-based Ariad Pharmaceuticals (NASDAQ: ARIA) this week after it halted all of its ongoing clinical trials of the leukemia drug ponatinib (Iclusig) due to safety concerns. Though the FDA approved Ariad’s drug last year, it did so with a black-box warning instructing doctors to watch out for blood clots and liver toxicities. Unfortunately for Ariad, those toxicities have piled up at a higher-than-expected rate as the company has tracked more patients taking the drug, hoping to show it can compete with imatinib (Gleevec), the standard of care for chronic myeloid leukemia. Ariad hopes to eventually restart trials and prove that the drug is effective and safer at a lower dose. Investors didn’t feel like waiting around to find out—shares plummeted more than 65 percent on the news.

—Natick, MA-based Karyopharm raised $48.2 million from private investors in April to continue developing its lead cancer drug, and now it’s planning to add up to $80 million to its coffers through an IPO. Karyopharm wants to fund at least two—and potentially four—mid-stage clinical trials for its cancer drug, selinexor, that it hopes to kick off next year. Selinexor is supposed to work by protecting the body’s tumor-suppressing proteins by keeping them in the nucleus. Karyopharm aims to trade on the Nasdaq under the ticker symbol “KPTI.”

—Genocea Biosciences, Moderna Therapeutics, and Bluebird Bio (NASDAQ: BLUE) all told us their stories at our latest biotech event, “Boston’s Life Science Disruptors.” I attended the event at the Novartis Institutes for Biomedical Research, so if you missed it, here were my takeaways—and a slideshow to boot.

—Boston startup Mitokyne inked a $45 million in a Series A round and a potential buyout on the same day. Astellas Pharma, Longwood Founders Fund, MPM Capital, and Astellas Pharma all participated in the funding, and Astellas forged a five-year collaboration with Mitokyne giving the Japanese company the exclusive right to buy the biotech before the partnership expires. Mitokyne stands to receive up to $730 million in R&D funding, as well as up front, milestone, and acquisition-related payments. The buyout price itself would be worth more than $500 million, should Astellas pull the trigger. Mitokyne and Astellas will work to discover and develop drugs that target mitochondrial function to treat genetic, metabolic, or neurodegenerative disorders. Longwood’s Rich Aldrich and MPM’s Ansbert Gadicke joined Mitokyne’s board as part of the funding.

—Alkermes’ potential treatment for major depressive disorder, ALKS-5461, received a fast-track designation from the FDA this week. That means a couple things for Alkermes, according to CEO Richard Pops: ALKS-5461 can qualify for a priority review, which would speed the review of a new drug application; Alkermes can stay in close contact with the agency as its late-stage clinical trial unfolds; and Alkermes could make a “rolling” NDA submission, where portions of the application are submitted to the FDA as they are completed. Dublin, Ireland- and Waltham, MA-based Alkermes (NASDAQ: ALKS) wrapped up a mid-stage clinical trial for ALKS-5461 earlier this year, and is planning to begin a Phase 3 study next year.

—Takeda Pharmaceutical this week terminated a licensing deal with Immunomedics (NASDAQ: IMMU), handing worldwide rights to an anti-CD20 antibody back to the Morris Plains, NJ-based biotech. Immunomedics had signed a $620 million licensing deal for the drug candidate back in 2008 with Nycomed, which was acquired by Takeda in 2011. Nycomed originally agreed to develop the drug in non-cancer disease types like rheumatoid arthritis and paid Immunomedics $40 million up front for the rights to do so. But the relationship didn’t pan out, and Immunomedics filed arbitration proceedings this year, claiming that Nycomed breached the deal by improperly delaying development, and Takeda immediately decided to cut bait as a result. Immunomedics will still pursue the arbitration suit, and hopes to recoup damages from Takeda.

—The FDA this week accepted New York-based Keryx Pharmaceuticals’ (NASDAQ: KERX) new drug application for ferric citrate (Zerenex), meaning the regulatory review process for the drug will now begin. Keryx has no approved drugs on the market.

—New Brunswick, NJ-based Johnson & Johnson (NYSE: JNJ) acquired an NS5A inhibitor from GlaxoSmithKline (NYSE: [[ticke:GSK]]) as part of a plan to pursue its own all-oral, interferon-free regimen for hepatitis C. Financial terms weren’t disclosed.

—Lexington, MA-based SynapDx added Kevin Hrusovsky to its board of directors. Hrusovsky is the former CEO of Caliper Life Sciences, which as acquired by PerkinElmer in 2011. He stayed on at PerkinElmer after that as its president of life sciences and technology.

Ben Fidler is Xconomy's Deputy Biotechnology Editor. You can e-mail him at bfidler@xconomy.com Follow @benthefidler

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