FDA Panel Slams Cell Therapeutics, Oncothyreon Slumps, Biotech’s Healthcare Victory, & More Seattle-Area Life Sciences News
The days are getting longer, spring is in the air, and hope is springing eternal for the Mariners. But a couple of Seattle biotech companies got clobbered this week.
—Seattle-based Cell Therapeutics (NASDAQ: CTIC) suffered a humiliating public beatdown this week at a long-awaited FDA advisory panel. The FDA committee voted 9-0 against the company’s application to market pixantrone for patients with non-Hodgkin’s lymphoma. FDA cancer drug boss Richard Pazdur—whose body language practically screamed that this was a waste of his time—said the company was essentially asking him to approve the drug based on “a single incomplete trial.” Cell Therapeutics isn’t saying what its fallback plan is, but one analyst suggested that after nearly 20 years, and burning through $1.4 billion of investor’s money, it may be time to shut the doors.
—Cell Therapeutics wasn’t the only cancer drug company in town to feel a kick in the ribs. Seattle-based Oncothyreon reported that its partner, Merck KGaA, has halted all clinical trials of its experimental immune-booster for cancer after a patient in an exploratory trial developed encephalitis, an inflammation of the brain. Oncothyreon (NASDAQ: ONTY) will have to wait a while to find out if the adverse event was caused by the drug or something else, but many investors didn’t want to wait for the answer: The company’s stock immediately lost more than one-fourth of its value.
—In between breaking news, we at Xconomy are getting ready for a big event we’re organizing at the University of Washington next Monday that will bring together biotechies and computer people. It’s called “What’s Your Breakthrough Idea?” Lee Hood and Nathan Myhrvold are keynoters at this event, and I took a moment to show how these two big thinkers have forged a close relationship over the years to stay on the leading edge of their respective fields.
—President Obama and Congress made history this week by enacting healthcare reform into law, but few of the analyses coming out of the other Washington have had much to say about how this will affect the business of developing innovative new drugs. Richard Gayle dove into the bill and offered up a shrewd analysis about how biotech essentially got more of what it wanted in this bill than the President himself.
—It seems like a month ago already, but I ran a wrapup piece on Seattle biotech’s marquee gathering of the year—Life Science Innovation Northwest. This piece offered a preview of coming attractions from Alder Biopharmaceuticals, Tekmira Pharmaceuticals, Acucela and other companies that don’t make the headlines all that often—yet.
—OncoGenex Pharmaceuticals (NASDAQ: OGXI), the Bothell, WA-based developer of cancer drugs, added a couple familiar names to its board of directors. Jack Goldstein, the former president of Chiron, is the new chairman, while H. Stewart Parker, the founder and longtime CEO of Seattle-based Targeted Genetics, is taking another seat on the board.
—MDRNA (NASDAQ: MRNA), offered up its fourth quarter financial report (which, by the way, is pretty darn late at this point in March). The report said that MDRNA was down to just $1.7 million in cash heading into 2010. Even though it raised $7.5 million in January, it only has enough on hand to operate “well into the second quarter of 2010.”
—Theraclone Sciences, the Seattle-based developer of antibody drugs, disclosed in a regulatory filing that it has collected another $1.5 million for its drug development programs from an undisclosed investor. Theraclone followed up that disclosure with a press release that said its Japanese partner, Zenyaku Kogyo, exercised an option to develop one of Theraclone’s antibodies in Japan for pandemic and severe seasonal flu. Theraclone said it has received $9 million so far under the collaboration, which could be worth as much as $18 million through early-stage clinical trials, and more milestones and royalties if the antibody becomes a marketed product.