The headline of the year in biotech has been IPOs. But this week, the news centered around a bunch of companies at the other end of the journey from startup to public company, those just coming out of the woodwork. Those stories and more below:
—Cambridge, MA-based Pronutria emerged from stealth mode this week. Flagship Ventures has already poured $10.8 million into the two-year-old startup, which aims to make foods and medicines with “pharmaconutrients,” or pharmacologically active nutrients—like fish oil in GlaxoSmithKline’s Lovaza. Pronutria’s plan is to use an in-house library of DNA sequences to make purified forms of proteins found in the human diet that have health benefits, and deliver them in precise doses.
—The field of Alzheimer’s disease drug development is littered with failures. For newly-formed, Lexington, MA-based startup Alzheon, that represents an opportunity. Alzheon plans to grab castoff Alzheimer’s drugs, refine them, and develop them to work for a more specific group of patients. Alzheon started up with one drug already in its portfolio: it in-licensed ALZ-801, a successor to the drug tramiprosate, from Quebec-based Bellus Health. I spoke with CEO Martin Tolar about Alzheon’s plans for ALZ-801, and the type of drugs the company is shopping for in the drug development scrap yard.
—Arch Venture Partners and Polaris Partners got a windfall when they bought deCode Genetics out of bankruptcy and flipped it to Amgen (NASDAQ: [[ticker:AMGN]]) a few years later. Now, they’re going to see what kind of returns they can get by spinning out a new company, Cambridge, MA-based NextCode Health, with a license to deCode’s massive library of genomic information. Arch and Polaris provided NextCode with a $15 million Series A to get going. The company’s plan is to apply deCode’s platform to patient care, helping researchers interpret patients’ DNA samples and diagnose diseases faster.
—The third time was not the charm for Watertown, MA-based pSivida (NASDAQ: [[ticker:PSDV]]), as the FDA once again rejected the eye drug it has been developing with Alimera Sciences (NASDAQ: [[ticker:ALIM]]). The agency cited “clinical and statistical deficiencies” in pSivida’s and Alimera’s application, problems at the manufacturing facility where the drug is produced, and even recommended an advisory panel to help the two companies find the patient group that might benefit the best from treatment. Alimera and pSivida sell the drug in Europe as Iluvien, a treatment for diabetic macular edema.
—Boston-based Sideris Pharmaceuticals semi-emerged from stealth this week as well. The startup is built around an iron-chelating drug candidate—something that binds iron and removes it from the body—licensed from the University of Florida. Sideris secured both a $32 million Series A round from MPM Capital, Hatteras Venture Partners, and Osage University Partners, and a potential buyer in Novartis. Sideris doesn’t have a CEO as of yet, so it wasn’t quite ready to talk to the media, but it has given Novartis an exclusive option to buy it in a deal that could be worth $300 million in up front, acquisition, and milestone payments. The drug candidate, SP-420, was created by UF professor Raymond Bergeron.
—It was a rocky week for Boston-based Ziopharm (NASDAQ: [[ticker:ZIOP]]), which inked a partnership with Australia’s Mesoblast but saw shares plummet more than 20 percent after announcing plans to raise $50 million through a public stock offering. Ziopharm switched its strategy earlier this year after cancer drug palifosfamide flunked a late-stage clinical trial. It’s now all-in on synthetic biology, a path it has been pursuing through a partnership with billionaire biotech investor R.J. Kirk’s Intrexon (NASDAQ: [[ticker:XON]]). Mesoblast teamed up with Ziopharm and Intrexon this week to help with the effort.
—New York-based Delcath Systems (NASDAQ: [[ticker:DCTH]]) also lined up at the Wall Street ATM, looking to raise $7.5 million by selling about 21 million shares at $0.36 apiece. Delcath’s value has been all but wiped out this year after the FDA rejected its drug-device cancer treatment Melblez.
—Speaking of bad FDA news, Bedminster, NJ-based Amarin (NASDAQ: [[ticker:AMRN]]) said it would cut half its workforce after an FDA advisory panel voted against expanding approval of its fish oil pill into patients with mixed dyslipidemia.
—Lexington-based Cubist Pharmaceuticals (NASDAQ: [[ticker:CBST]]) filed a new drug application with the FDA for tedizolid phosphate, the antibiotic it acquired through its buyout of Trius Therapeutics earlier this year. Cubist wants approval to market the drug to treat patients with acute bacterial skin and skin structure infections.
—Bedminster-based NPS Pharmaceuticals (NASDAQ: [[ticker:NPSP]]) filed an application with the FDA to approve its experimental drug for hyperparathyroidism, a rare condition in which people don’t produce enough parathyroid hormone. NPS already won orphan drug status for the drug candidate, which it hopes to sell as Natpara. Shares of NPS have more than tripled this year as the company has begun selling its first drug, teduglutide (Gattex), a treatment for a rare disorder called short-bowel syndrome.
—An FDA advisory panel voted unanimously in favor of New Brunswick, NJ-based Johnson & Johnson’s (NYSE: [[ticker:JNJ]]) hepatitis C drug, simeprevir. Should the agency ultimately approve it, the drug, a protease inhibitor, would figure into the various oral, interferon-free cocktail regimens being developed to treat the disease.
