This week started with celebrations of America’s birthday, and it has been dominated—biotech-wise—by America’s government. The Obama administration continued its high-profile involvement in the life sciences by updating its Precision Medicine Initiative, easing limits on doctors who want to fight opioid addiction, and stopping a clinical trial in one of the hottest biomedical fields, cancer immunotherapy.
The role of government in all of this? Unfortunately, that question fades into the background as we think about what it means when too many of our fellow citizens are at mortal risk during a routine traffic stop.
But the news in our little corner of the world doesn’t stop. Mergers—or threats thereof—deals, fundings, and all kinds of data keep on keeping on. With heavy hearts, let’s get to the roundup.
—It’s not clear if the U.S. Congress will come to terms on a package of healthcare reforms and funding known as 21st Century Cures. Part of that package includes funding for the Joe Biden-led “Cancer Moonshot” program, another is a bill to fight opioid addiction. But the Obama administration took unilateral action this week on addiction, hailed as a good step in fighting the opioid epidemic. Drug giant Pfizer (NYSE: [[ticker:PFE]]) also said it would abide by strict marketing guidelines for opioids, in response to a lawsuit brought against other painkiller peddlers by the city of Chicago.
—Another health scourge was in the news: hepatitis. British medical journal The Lancet published a study, funded by the Bill and Melinda Gates Foundation, that showed viral hepatitis has become the seventh leading cause of death globally, up from tenth in 1990. Drugs to treat hepatitis C have made huge leaps in effectiveness, providing cures where none previously existed, but also controversial leaps in price. Gilead Sciences (NASDAQ: [[ticker:GILD]]) drew measured praise last week for releasing a (slightly) more modestly priced hepatitis C combination drug, but the goodwill evaporated this week. STAT was among the outlets to report that Gilead has also quietly raised prices on older HIV drugs, ostensibly to drive prescriptions toward newer alternatives.
—On to M&A news: The big deal is one that hasn’t happened (yet). San Francisco’s Medivation (NASDAQ: [[ticker:MDVN]]), co-owner of prostate cancer drug enzalutamide (Xtandi), remains biotech’s hottest target. Pfizer (NYSE: [[ticker:PFE]]), Sanofi (NYSE: [[ticker:SNY]]), and Celgene (NASDAQ: [[ticker:CELG]]) all signed confidentiality agreements this week to enter talks, with a price likely to soar past $10 billion.
— Bristol-Myers Squibb (NYSE: [[ticker:BMY]]) shelled out $95 million upfront to acquire privately held Cormorant Pharmaceuticals and its experimental cancer treatment, which could complement the New York-based pharma’s own immuno-oncology drugs.
—Rare disease drug developer Amicus Therapeutics of Cranbury, NJ, acquired MiaMed for a preclinical program that aims to correct a genetic protein deficiency that leads to seizures and other neurological problems.
—Pfizer is considering a $20 million bid for bankrupt Bind Therapeutics, a fraction of what Bind once raised from investors.
—Emerging from bankruptcy, KaloBios Pharmaceuticals of Brisbane, CA, announced it has restricted former CEO Martin Shkreli’s ability to sell his shares. Shkreli lost his KaloBios post after he was arrested last year on federal fraud charges.
—The biggest clinical news of the week comes from Seattle, where Juno Therapeutics (NASDAQ: [[ticker:JUNO]]) reported that three patients have died since May in a Phase 2 trial of the company’s lead CAR-T therapy—a closely watched type of cancer immunotherapy that uses a patient’s own immune cells. The FDA has halted the trial, and Juno’s share price dropped 28 percent after hours on Thursday.
—XBiotech (NASDAQ: [[ticker:XBIT]]) also took a hit from clinical data. The Austin, TX-based firm’s shares are down 41 percent this week after it released Phase 3 trial results for its colon cancer drug over the long weekend. The Street’s Adam Feuerstein dissected the company’s claims, calling them “absurd.”
—Biogen (NASDAQ: [[ticker:BIIB]]) of Cambridge, MA, received good news in Europe: approval for multiple sclerosis treatment daclizumab (Zinbryta), doubling up its nod from the FDA.
—Moderna Therapeutics, a Cambridge, MA-based biotech developing technology to coax the body into producing its own drugs, added Vertex Pharmaceuticals (NASDAQ: [[ticker:VRTX]]) as a partner. The two companies will work together to develop a new cystic fibrosis treatment.
—Pernix Therapeutics (NASDAQ: [[ticker:PTX]]) of Morristown, NJ, cut 23 percent of staff to overhaul its sales strategy.
Photo “Half-Staff” courtesy of Peter Kaminski via a Creative Commons license.