Quarterly biopharma earnings added a little heat to the already high summer temperatures. Amongst several companies to report this week, the biggest news came from Gilead Sciences (NASDAQ: [[ticker:GILD]]), whose hepatitis C drugs have become some of the top revenue producers in the industry. But the company said this week that sales of Sovaldi and Harvoni, which share a common ingredient, sofosbuvir, have slowed with fewer patients starting on the drugs and prices undercut by fierce competition from AbbVie and Merck. Some observers’ minds instantly jumped to business—Gilead needs to pick up the acquisition pace to find its next big thing.
After all, Gilead’s $11 billion purchase of Pharmasset in 2011, roundly jeered as an overpay at the time, brought it sofosbuvir. But our minds jumped to politics. Will the critics who have used the original list prices of Sovaldi ($84,000) and Harvoni ($94,000) as a cudgel to swing against pharmaceutical greed acknowledge that competition brought down prices rather quickly? How about we start a pool? The changing dynamic of the hepatitis C market will be acknowledged in the presidential campaign: yes or no.
Speaking of pools, we need to jump in one to cool off. But first, let’s jump into this week’s roundup.
—Let’s start with clinical data. Shares of Cambridge, MA-based Tokai Pharmaceuticals (NASDAQ: [[ticker:TKAI]]) plummeted 78 percent after the company shut down a Phase 3 trial of prostate cancer drug galeterone early because the study was likely to fail. Three days after releasing the trial news, Tokai said it would ax 60 percent of its workforce, leaving it with 10 full-time employees.
—Summit, NJ-based Celgene’s (NASDAQ: [[ticker:CELG]]) lenalidomide (Revlimid) failed to extend the lives of patients with the most common form of non-Hodgkin’s lymphoma in a Phase 3 trial. The study is one of several Celgene is running to try to expand the use of its blockbuster blood cancer drug.
—Microbiome drug developer Seres Therapeutics (NASDAQ: [[ticker:MCRB]]) reported that SER-109—a mix of bacterial spores the company has been developing for recurrent clostridium difficile infections—failed a Phase 2 trial. Shares fell more than 75 percent.
— An experimental treatment from Tobira Therapeutics (NASDAQ: [[ticker:TBRA]]) for nonalcoholic steatohepatitis, an increasingly common liver disease, failed its main goal in a mid-stage trial. Tobira of South San Francisco, CA, said it found a silver lining in the data—a possible impact on the scarring in patients’ livers—and will move the drug forward. Investors didn’t buy the explanation, sending shares down 62 percent.
—The silver linings playbook was in full effect at the Alzheimer’s Association’s annual meeting in Toronto. Singapore-based TauRx Pharmaceuticals reported its drug LMTX failed a Phase 3 study, but said a 15 percent subset of the 981 patients actually fared well. Reaction to the company’s gold-from-straw analysis, and more Alzheimer’s news, including an update on Alzheon’s own attempts to breathe new life into a failed Alzheimer’s drug, is here.
—In Orlando, FL, gene therapy took center stage at the World Hemophilia Federation World Congress. Early yet promising evidence mounted that gene therapy could one day play a significant role in treating the chronic bleeding disease. Xconomy rounded up the latest updates from gene therapy players such as BioMarin Pharmaceutical (NASDAQ: [[ticker:BMRN]]), Spark Therapeutics (NASDAQ: [[ticker:ONCE]]), and UniQure (NASDAQ: [[ticker:QURE])).
—After an eight year stint as CEO of Eli Lilly (NYSE: [[ticker:LLY]]) and more than three decades at the Indianapolis pharma giant, John Lechleiter will retire at the end of the year. His tenure was marked by a steadfast emphasis of home-grown research over deal making.
—New York’s Kadmon Holdings (NASDAQ: [[ticker:KDMN]]) raised $75 million in an IPO. Shares closed Thursday at $9.60 apiece, down 20 percent.
—M&A Time: Diagnostics and lab test behemoth LabCorp (NYSE: [[ticker:LH]]) of Burlington, NC, bought San Diego’s prenatal diagnostic maker Sequenom (NASDAQ: [[ticker:SQNM]]) for $371 million, including assumed debt…Pfizer paid $40 million for Cambridge, MA-based Bind Therapeutics (NASDAQ: [[ticker:PFE]]) at a bankruptcy auction. It plans to shut Bind down and bring its assets in-house.
—Scientists said they pinpointed a gene tied to amyotrophic lateral sclerosis (ALS), work that was funded by the Ice Bucket Challenge of two summers ago.
—Farther up the development road, South San Francisco, CA-based Cytokinetics (NASDAQ: [[ticker:CYTK]]) expanded its relationship with Japan’s Astellas Pharma to include an ALS drug in Phase 3 trials.
—A consortium called CARB-X is pledging to give up to $350 million in grants to scientists developing antibiotics against drug-resistant bacteria. CARB-X will also run four accelerators—in San Francisco, Cambridge, MA, and two in the U.K. The funding is mainly coming from the U.S. government and the U.K.’s public-private AMR Centre.
—Patients with Prader-Willi Syndrome got bad news last week when Cambridge, MA-based Zafgen (NASDAQ: [[ticker:ZFGN]]) abandoned development of beloranib, which could have become the first drug approved for the disease in more than a decade. But as David Holley reports, an experimental treatment from Rhythm Pharmaceuticals has a chance to fill the void.
—Regulatory roulette: The FDA rejected Dextenza, a drug-delivery device for post-surgical pain from Ocular Therapeutix (NASDAQ: [[ticker:OCUL]]). Ocular blamed a manufacturing problem and expects approval once it’s resolved…South Plainfield, NJ-based PTC Therapeutics (NASDAQ: [[ticker:PTCT]]) said its Duchenne muscular dystrophy drug ataluren (Translarna) faces a regulatory delay in Europe. As TheStreet.com reports here, the drug is no closer to approval in the U.S.
—Cambridge-based Moderna Therapeutics, a developer of messenger RNA therapy, has filed papers to start the first clinical trial to come from its collaboration with AstraZeneca and its third overall to enter the clinic. The company has grown to 440 employees this year and has $1 billion in cash in the bank.
—Ben Fidler contributed to this report
