Jenkins Gets Mad, Bernie Gets His Pen, & CRISPR Gets IPO and J-Lo
If you’re among those frustrated by the lack of talk about health and science in the three presidential debates, this week perhaps brought you a wee consolation prize. The steady drip of hacked Hillary Clinton-related emails showed her campaign team questioning then-candidate FDA commissioner Robert Califf’s ties to the pharma industry. The staff also crowed over Clinton’s tweet—a reaction last summer to the first revelations about Martin Shkreli’s price gouging—that sent biopharma stocks downhill.
Bernie Sanders is no longer a presidential candidate, but he continued his pharma-bashin’ ways with a letter to Ariad Pharmaceuticals (NASDAQ: ARIA) questioning the firm’s price hikes for cancer drug ponatinib (Iclusig). The hikes were first reported earlier this month by Adam Feuerstein of The Street.
If politicians flogging drug makers doesn’t slake your thirst for health and science in the national conversation, how about J-Lo taking on DNA-disrupting baddies on a TV show called C.R.I.S.P.R.?
No word yet if—ahem—Gene Hackman will co-star.
You think that’s funny? Wait til you get a load of this week’s roundup.
TOP STORIES
—The hepatitis C drug telaprevir (Incivek) from Vertex Pharmaceuticals (NASDAQ: VRTX) was once the fastest drug launch in history before competition wiped it off the map in three years. In a feature this week, Vertex CEO Jeff Leiden said the collapse was a result of “hubris” and “blindness.” Xconomy detailed the drug’s rise and fall, and the steps Vertex is taking to prevent its new dominant cystic fibrosis business from suffering the same fate.
—Xconomy reported Monday that Tom Daniel, Celgene’s (NASDAQ: CELG) former president of research and early development, left the Summit, NJ, company over the summer to start Catalysis Advisors in San Diego. For the past decade, Daniel and Celgene executive vice president George Golumbeski formed one of the best-known deal-making duos in biopharma.
—A team led by gene therapy researcher Jennifer Adair at the Fred Hutchinson Cancer Research Center has refashioned a common blood-spinning medical device into an automated tabletop “gene therapy in a box.” Doctors who work on cutting-edge stem cell treatments say it could help spread gene therapy practice, if regulators allow it to be used for clinical trials.
—John Jenkins, the director of the FDA’s office of new drugs, isn’t done criticizing eteplirsen (Exondys 51), the Duchenne muscular dystrophy drug from Sarepta Therapeutics (NASDAQ: SRPT) that Jenkins’ bosses approved last month after an internal tug of war. Jenkins was one of many FDA staffers who stood against the approval. In a speech this week before the National Organization of Rare Disorders in Arlington, VA, Jenkins had harsh words, including this: “The path taken by Sarepta is not a good model for other development programs.” His slides are here.
THE REGULATORS’ THUMBS GO UP AND DOWN
—Eli Lilly (NYSE: LLY) won FDA approval for the first new treatment in 40 years for soft tissue sarcoma, a type of cancer. The special “accelerated” approval means Lilly must conduct a successful Phase 3 trial to maintain the FDA’s green light.
—The FDA also approved the atezolizumab (Tecentriq), developed by Roche’s Genentech group, for patients with metastatic non-small cell lung cancer that fits a certain genetic profile. Genentech, Merck, and Bristol-Myers Squibb are all vying to treat lung cancer with immunotherapy drugs, and they rolled out data at a medical conference earlier this month.
—Data from atezolizumab and other “checkpoint inhibitors” will soon be part of Xconomy’s new cancer immunotherapy trial resource. It debuted this week with a compilation of data from the other main type of immunotherapy: genetically modified T cells.
—European regulators approved Onivyde, a pancreatic cancer drug developed by Cambridge, MA-based Merrimack Pharmaceuticals (NASDAQ: MACK). Shire holds rights to the drug in Europe.
—The FDA suspended a trial of chronic pain drug fasinumab, citing safety issues. Teva Pharmaceutical Industries (NYSE: TEVA) paid Regeneron Pharmaceuticals (NASDAQ: REGN) $ 250 million last month to co-develop fasinumab, part of a class of drugs with a checkered safety history.
—Shares of South Plainfield, NJ-based PTC Therapeutics (NASDAQ: PTCT) fell more than 30 percent after the FDA refused to reconsider its rejection of its Duchenne muscular dystrophy drug ataluren (Translarna). PTC said it would continue to appeal to higher levels within the agency.
TRIALS AND TRIBULATIONS
—Shares of Alkermes (NASDAQ: ALKS) climbed more than 38 percent after the company reported positive data from the third of three Phase 3 trials of experimental depression drug ALKS-5461.
—Partners Theravance Biopharma (NASDAQ: TBPH) and Mylan (NASDAQ: MYL) reported positive Phase 3 data for their lung disease treatment revefenacin and expect to ask for marketing approval next year.
—Celgene reported early results for a pill called mongersen for Crohn’s disease, an important drug in its pipeline. The data, from a small trial that wasn’t placebo controlled, drew a mixed reaction from analysts.
—Gilead Sciences (NASDAQ: GILD) said it would move its experimental treatment for fatty liver disease into Phase 3 trials despite Phase 2 data that The Street described as “hard to interpret.”
—Shares of Rigel Pharmaceuticals (NASDAQ: RIGL) fell more than 22 percent after fostamatinib, a drug for a rare platelet disease, failed the second of two Phase 3 trials. (The first one fared better.) Rigel said it still plans to talk to the FDA about potential approval.
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