EXOME

all the information, none of the junk | biotech • healthcare • life sciences

Bio Roundup: Sage Postpartum Help, Biogen Bids Adu, Heart Beats & More

Xconomy National — 

One group of people in dire need of medical relief got good news this week. The first drug for postpartum depression was approved. With its complicated logistics, side effects, and potential high cost, it won’t be for everyone who experiences the condition—1 of every 9 U.S. women giving birth. But at least it’s an option. That’s more than Alzheimer’s patients and their doctors can say about aducanumab, the latest high-profile, high-cost failure in that frustrating field.

We reported on both those stories and a lot more, including clinical ups and downs and new fundings. Also this week: Reports from the American College of Cardiology conference in New Orleans and changes at the top of companies large and small. The world might be a bit less Roundup-Ready after this week, but we trust you’re still ready for our roundup.

TOP STORIES

The litany of Alzheimer’s failure continues. Biogen (NASDAQ: BIIB) said it would halt all work on aducanumab because two massive Phase 3 trials were unlikely to have any positive effect. The shutdown prompted a sell-off of Biogen shares. The news was abrupt but not shocking. No Alzheimer’s drug that targets the buildup of amyloid protein in the brain has succeeded. A hint that the trials weren’t going well came a year ago, when Biogen said it had to add more patients.

—Even in the wake of aducanumab’s failure, Biogen partner Eisai doubled down on another amyloid-busting Alzheimer’s drug, BAN2401, announcing that it has started a 1,500-patient Phase 3 trial meant to support an approval filing. BAN2401 posted promising Phase 2 results, but they were rife with caveats.

—The FDA approved brexanolone (Zulresso) from Sage Therapeutics (NASDAQ: SAGE), making it the first marketed medicine specially for postpartum depression, which afflicts hundreds of thousands of women in the U.S. each year. Brexanolone faces challenges. At a cost of as much as $34,000 per course, it requires a 60-hour continuous infusion in a health facility, and patients must be constantly monitored for loss of consciousness and a drop in oxygen levels.

—A year ago, two famous academic gene-editing groups each revealed new ways of diagnosing disease with CRISPR gene-editing technology. Now, each group has its own startup. Sherlock Biosciences this week spun out of the Broad Institute with $35 million in funding. Last year Mammoth Biosciences launched with technology licensed from the Jennifer Doudna lab at UC Berkeley.

—Ahead of the highly anticipated April 12 shareholder vote on Bristol-Myers Squibb’s (NYSE: BMY) proposed buyout of Celgene (NASDAQ: CELG), activist shareholder Starboard Value filed a presentation repudiating the deal. Bristol posted its own slideshow to defend the deal.

HEART MATTERS

—Researchers presented data from a 400,000-person study of the Apple (NASDAQ: [[AAPL]]) Watch’s ability to detect atrial fibrillation. Far from conclusive about the watch’s utility as a medical device, the study sparked both concern and cautious optimism among heart doctors at the American College of Cardiology conference in New Orleans. Stat took a deeper dive.

—Also at the ACC: More impressive data from the REDUCE-IT study of fish-oil pill Vascepa, made by Amarin (NASDAQ: AMRN). In September, the study showed a 25 percent reduction in the risk of heart attack and stroke, a remarkable result. (In November, the full data set exposed unanswered questions.) This week researchers said Vascepa lowered the risk of first and subsequent cardio events by 30 percent.

—The New England Journal of Medicine published the results of a Phase 1 study of a blood-clotting antibody meant to reverse the effects of the anti-clotting drug ticagrelor (Brilinta). If successful, the experimental PB2452 from PhaseBio (NASDAQ: PHAS) might be useful when ticagrelor patients need surgery or are suffering from a dangerous bleed. Shares climbed 70 percent.

TRIALS & TRIBULATIONS

—The FDA approved a regimen of chemotherapy and Roche’s immunotherapy atezolizumab (Tecentriq) for newly diagnosed patients with advanced small cell lung cancer, an aggressive form of the disease often tied to smoking.

—GlaxoSmithKline (NYSE: GSK) said that by year’s end it plans to ask regulators to approve its experimental multiple myeloma treatment GSK2857916. The drug targets cancerous B cells that carry the protein BCMA. Several other anti-BCMA programs, including some using the live cell therapy known as CAR-T, could also reveal results this year.

—Pfizer (NYSE: PFE) and Merck KgAA reported another failure of their immunotherapy avelumab (Bavencio) in ovarian cancer. FiercePharma has the details.

— Urovant Sciences (NASDAQ: UROV) reported that vibegron, an experimental treatment for overactive bladder, beat a placebo in Phase 3 testing. But vibregon didn’t best a generic competitor, and Urovant shares sank more than 21 percent.

—Emricasan, a potential treatment from Conatus Pharmaceuticals (NASDAQ: CNAT) for the fatty liver disease nonalcoholic steatohepatitis, failed a Phase 2b trial. But Conatus will continue the study and evaluate the treatment in “more advanced-stage” NASH patients, the company said in a statement.

—Shares of Dermira (NASDAQ: DERM) doubled after the Menlo Park, CA, biotech reported that lebrikizumab, its experimental atopic dermatitis drug, succeeded in a mid-stage study. If successful, the drug could pose a threat to dupilumab (Dupixent), a drug from Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi (NYSE: SNY).

—Aerpio Pharmaceuticals (NASDAQ: ARPO) reported that its lead drug, AKB-9778, failed a midstage study in diabetic retinopathy. Shares of the Cincinnati company tumbled more than 67 percent.

MONEY IN, MONEY OUT

Flagship Pioneering closed a new $824 million fund, the second so-called Special Opportunities fund the firm has raised to help fuel its more mature startups.

—Pfizer (NYSE: PFE) continued to roll up gene therapy assets, paying $51 million for 15 percent of Parisian biotech Vivet Therapeutics, which is developing a gene therapy for Wilson’s disease. Pfizer also gained an option to buy Vivet in the future.

—Johnson & Johnson (NYSE: JNJ) took a $700 million write-off for AL-8176, a one-time drug prospect for respiratory syncytial virus and human metapneumovirus that it acquired in its $1.75 billion buyout of Alios Biopharma in 2014. J&J wrote off $630 million for AL-8176 last year after halting clinical tests of the drug.

—Imara, a startup from accelerator Cydan Development, grabbed a $63 million Series B to back IMR-687, an experimental drug for sickle cell disease. Imara acquired IMR-687, which is currently in mid-stage testing, from Danish firm H. Lundbeck. Imara will test the drug in beta-thalassemia as well.

—Biohaven Pharmaceutical (NYSE: BHVN) is paying $105 million for a priority review voucher that it will use to speed up FDA review of rimegepant, its experimental oral migraine drug.

—Karuna Therapeutics closed a $68 million Series B round to continue developing an experimental drug called KarXT for neuropsychiatric disorders. KarXT is currently in Phase 2 testing.

—Merck (NYSE: MRK) and South San Francisco, CA-based NGM Bio have tacked two years onto their collaboration, which now expires in 2022. The highlight so far has been Merck’s license of NGM’s experimental treatment for the liver disease NASH. The lowlight was Merck’s return of obesity drug NGM386 and other so-called GDF15 receptor agonists after disappointing Phase 1 results.

EVENT HORIZON

—The program is coming together for our latest life-sciences event, “What’s Hot in Boston Biotech,” on May 21 in Cambridge, MA. We’ll be tackling the gene therapy boom, what’s next for Alzheimer’s research, diversity initiatives within biopharma, and more. You can grab tickets here.

PEOPLE ON THE MOVE

— Watertown, MA-based Forma Therapeutics said longtime CEO Steve Tregay is stepping aside. His replacement is Frank Lee, a pharma veteran who most recently spent 13 years at Genentech.

—Corcept Therapeutics (NASDAQ: CORT) hired Andreas Grauer away from Amgen (NASDAQ: AMGN) to serve as chief medical officer.

—Hsaio Lieu, senior vice president of early clinical development at Genentech, joined NGM Biopharmaceuticals to become its chief medical officer.

Ben Fidler and Frank Vinluan contributed to this report.