Bio Roundup: Barron Joins GSK, Sage Bounces Back, Valeant Dumps Addyi

Xconomy National — 

Call it a week of second chances. Multiple biotechs breathed new life into drugs sorely in need of it. Sage Therapeutics proved a drug that had failed a trial a rare form of epilepsy could be the first ever approved therapy for postpartum depression. Otonomy, reviving a hearing loss drug thought to be on the scrap heap. And investors of Sprout Pharmaceuticals reclaimed, for a pittance, a drug they once sold to Valeant Pharmaceuticals for $1 billion.

Meanwhile, Ohio voters rejected the latest legislative attempt to curb drug prices, Maine residents supported Medicaid expansion, and patient advocates campaigned for changes to the Republican tax bill. Those stories and much more below.


—Senator Kamala Harris (D-CA) demanded that Alkermes (NYSE: ALKS) hand over documents related to its marketing of Vivitrol, an opioid addiction treatment. Reports earlier this year suggested the firm’s tactics were anticompetitive. It’s unclear if the inquiry will grow beyond Harris, who does not have subpoena power, as this McClatchy report points out.

—A long list of patient advocacy groups protested the potential repeal of the Orphan Drug Tax Credit, which gives drug companies a tax break on their R&D to treat rare diseases. The repeal has been floated as part of the ongoing Republican effort to overhaul the U.S. tax code.

—Ohio voters rejected the Ohio Drug Price Relief Act. The measure was meant to lower prescription drug prices by mandating the state would pay no more for prescription drugs than the discounted rate given to the Department of Veteran Affairs. A similar bill, Proposition 61, was defeated in California in 2016.

—More than 60 percent of Maine voters cast their ballots to expand Medicaid to as many as 70,000 low-income people. But Gov. Paul LePage, a Republican, vowed to reject the expansion unless the legislature could find a way to pay for it, the Portland Press Herald reported.


—GlaxoSmithKline named Genentech veteran and, most recently, Calico research chief Hal Barron its new chief scientific officer and president of R&D. The move received a rousing ovation on Wall Street, which sent GSK shares climbing close than 2 percent.

—Amgen (NYSE: AMGN) is the latest big pharmaceutical company taking an axe to its R&D operations, cutting 200 people from its Thousand Oaks, CA, headquarters, and in South San Francisco, STAT reported.


—Sage Therapeutics (NASDAQ: SAGE) plans to seek approval of experimental drug brexanolone after reporting positive results from two Phase 3 trials in women with postpartum depression—a condition with no approved therapies. Shares of the company surged more than 50 percent.

—An experimental drug from Otonomy (NASDAQ: OTIC) that flunked its first Phase 3 study in Meniere’s disease has been revived. The San Diego biotech announced this week that a second Phase 3 study—a trial the company had suspended before it was completed—was successful. News that the company plans to review those results with the FDA for possible approval sent its stock price soaring more than 150 percent.

—Shares of Five Prime Therapeutics (NASDAQ: FPRX) fell more than 34 percent after the company offered the first glimpse of data from a small study combining its experimental drug cabiralizumab with Bristol-Myers Squibb’s (NYSE: BMY) nivolumab (Opdivo) in pancreatic cancer patients. The data were contained in an abstract released in advance of the presentation of the data at the Society for Immunotherapy of Cancer’s annual meeting.

—Mixed news this week for privately held Millendo Therapeutics of Ann Arbor, MI: Its lead compound ATR-101 will advance to Phase 2b after positive results led to an early halt of a Phase 2 trial in congenital adrenal hyperplasia, a rare endocrine disease. But the firm’s other Phase 2 compound, MLE4901, will get the axe.

—Shares of Selecta Biosciences plummeted more than 54 percent after the company disclosed disappointing data from a Phase 2 study of prospective gout drug SEL-212. Selecta plans to test higher doses of SEL-212 in the same study before moving into pivotal testing.


—The FDA cleared Cellectis (NASDAQ: CLLS) to resume testing an experimental “off the shelf” type of CAR-T immunotherapy, so long as it institutes a variety of measures meant to curb potential safety problems. The agency had suspended testing of Cellectis’s UCART123 after a patient died in a Phase 1 trial.

—The FDA also ok’d several approved drugs in new indications. Genentech saw its alectinib (Alcensa) approved to treat non-small cell lung cancer with an ALK-positive mutation, and its vemurafenib (Zelboraf) was cleared to treat Erdheim-Chester disease, a rare blood cancer.

—Seattle Genetics (NASDAQ: SGEN) got the nod for its brentuximab vedotin (Adcetris) in two types of cutaneous T-cell lymphoma.

—The FDA also cleared Keryx Pharmaceuticals (NASDAQ: KERX) to sell ferric citrate (Auryxia) to patients with iron deficiency anemia and chronic kidney disease who aren’t on dialysis. The drug was first approved in 2014 for CKD patients on dialysis.

—Merck (NYSE: MRK) won FDA approval of letermovir (Prevymis), a drug meant to prevent the deadly cytomegalovirus infections that can occur in patients who get stem cell transplants.

—Dynavax Technologies (NASDAQ: DVAX) got the FDA’s nod for its hepatitis B vaccine Heplisav-B. Approval of the two-dose vaccine covers all known subtypes of the virus in adults.


—Amid lackluster sales, Valeant Pharmaceuticals (NYSE: VRX) reached a deal to sell sex drive drug flibanserin (Addyi) back to the former owners of Sprout Pharmaceuticals for a fraction of the $1 billion it spent to acquire the Raleigh, NC, company and its drug in 2015.

—Boston-based Partners Healthcare raised $171.1 million for two of its funds, which invest in early-stage life science companies.

—Sanofi paid South San Francisco, CA-based Principia Biopharma $40 million for rights to an experimental drug it plans to develop for multiple sclerosis and potentially other neurological diseases.

—Exonics Therapeutics raised a $40 million round led by The Column Group, marking the latest step in an emerging race to use gene editing or gene therapy techniques to treat Duchenne muscular dystrophy.

—Oyster Point Pharmaceuticals emerged from stealth with a $22 million Series A round that the San Francisco biotech will use to develop treatments for dry eye and other ocular diseases.

Frank Vinluan and Alex Lash contributed to this report.