With President Trump holed up in New Jersey, rattling his saber at Kim Jong-un and Mitch McConnell and ignoring his own commission’s advice on the opioid crisis, there was still life sciences news from the nation’s capital. The FDA reported that generic drug approvals are set to hit a record; the agency under Commissioner Scott Gottlieb has moved this summer to increase generic competition and lower the nation’s high drug prices.
Meanwhile, drug-price hawks can sharpen their talons on a report this week from The New York Times and ProPublica. The joint investigation showed that pharmaceutical firms, insurers, and drug-buying middlemen have cut backroom deals that force patients to buy branded drugs even when cheaper generics are available.
Across the country, new data shed new light on closely-watched programs, new startups emerged, and companies came together. Let’s round it all up.
—Japan’s SoftBank Vision Fund invested an eye-popping $1.1 billion in Roivant Sciences, a biotech group that acquires shelved drugs on the cheap and forms new companies around them. Two of those companies, Axovant Sciences (NASDAQ: AXON) and Myovant Sciences (NASDAQ: MYOV), are publicly traded and closed some of the biggest biotech IPOs in the past few years.
—Last Friday, Auris Surgical Robotics of San Carlos, CA, unveiled $280 million in funding that the device company plans to use to develop robots that enable doctors to perform less invasive lung cancer surgeries.
STARTUPS & UPRISINGS
—The nonprofit Silverstein Foundation, founded by OrbiMed Advisors venture capitalist Jonathan Silverstein, launched Prevail Therapeutics to develop Parkinson’s disease treatments. RegenXBio (NASDAQ: RGNX) and OrbiMed are also involved. The news comes as multiple treatments for various symptoms of Parkinson’s are close to market.
—Karius, a Bay Area maker of infectious disease tests, raised a $50 million Series A round from Lightspeed Ventures and others.
—Hedge fund Scopia Capital Management turned up the heat on Acorda Therapeutics (NASDAQ: ACOR), which lost patent protection for its lead drug earlier this year and was forced to restructure. Scopia reported a 16.5 percent stake in Acorda and pushed the company to sell. Acorda insists it should stay independent and bring its two late-stage Parkinson’s disease drugs to market.
MERGERS AHEAD… OR NOT
—Fresenius paid $30 a share, or $2 billion, to acquire Lawrence, MA-based NxStage Medical (NASDAQ: NXTM), the developer of a portable hemodialysis system for patients dealing with kidney failure.
—Celgene (NASDAQ: CELG) turned down its option to acquire privately held Sutro Biopharma. Instead, the firms will narrow their development partnership to four of Sutro’s preclinical cancer drugs. Celgene will have the option to take control of the drugs as they near clinical studies.
—Chapel Hill, NC-based Cempra (NASDAQ: CEMP) agreed to merge with Melinta Therapeutics of New Haven, CT. Melinta gains a public stock listing, and Cempra has new life for antibiotic solithromycin, which the FDA rejected in December due to concerns about liver injury.
—Menlo Park, CA, biotech Dermira (NASDA: DERM) is paying Roche $135 million for global rights to the drug lebrikizumab, which is ready to start Phase 2 eczema studies.
—Pfizer (NYSE: PFE) announced it would spend $100 million to expand its facility near Raleigh, NC, for gene therapy manufacturing. One year ago, the giant drug maker acquired Chapel Hill gene therapy startup Bamboo Therapeutics.
—Ann Arbor, MI-based Esperion Therapeutics (NASDAQ: ESPR) reported positive results from a Phase 2 study that combined its experimental anti-cholesterol drug bempedoic acid with two other heart medicines, ezetimibe (Zetia) and atorvastatin (Lipitor). Data suggest Esperion might have a cheaper oral alternative to the new anti-PCSK9 cholesterol drugs from Amgen and Regeneron Pharmaceuticals. Shares climbed 26 percent, and Esperion raised $152 million in a stock offering.
—Bay Area cancer-detection startup Grail and its merger partner Cirina reported in the New England Journal of Medicine that its liquid biopsy technology seemed to work better than current standards to detect nasopharyngeal carcinoma, a type of head-and-neck cancer. Grail’s president told Bloomberg News that a test for the cancer, prevalent in Southeast Asia, could be Grail’s first product.
—MyoKardia (NASDAQ: MYOK) released early Phase 2 data showing its drug mavacamten improved blood flow in patients with obstructive hypertrophic cardiomyopathy, a thickening of the heart walls. The South San Francisco, CA, biotech’s shares shot up more than 80 percent on the news.
—Gemphire Therapeutics (NASDAQ: GEMP) said its cholesterol-lowering drug gemcabene hit its main goal in a Phase 2 study, but a stronger than expected placebo response dimmed those results and sent the Livonia, MI, company’s shares down nearly 50 percent.
—FibroGen (NASDAQ: FGEN) released early Phase 2 results that showed its drug pamrevlumab improved lung function in patients with idiopathic pulmonary fibrosis. The San Francisco biotech’s share price rose more than 50 percent.
—This week, we unveiled the seven finalists for top Boston biotech CEO in the first-ever Xconomy Awards. The nominees come from startups and publicly traded companies new and old. The winner will be announced on Sept. 26.
Ben Fidler and Frank Vinluan contributed to this report.