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Bio Roundup: Midterm Fallout, Alzheimer’s Search, Postpartum Panel

Xconomy National — 

There was plenty at stake in this week’s midterm elections, and not just in terms of political wins and losses. With congress now divided—Democrats took back control of the House and Republicans extended their majority in the Senate—the implications are significant for U.S. healthcare. Just a day after the results, for instance, Senate Majority Leader Mitch McConnell said the GOP would abandon its long-running quest to sink the Affordable Care Act. The reverberations are sure to affect other aspects of healthcare policy, the prescription drug pricing debate, the future of Medicare and Medicaid, and more.

We’ll examine some election news and early fallout below, along with the spate of new clinical data, emerging startups, and FDA decisions. Let’s tally up the votes and get to the roundup.

ELECTION REACTION

—In a press conference Wednesday, President Trump signaled willingness to work with Democrats in Congress on the regulation of drug prices, echoing comments he made before the election. But he also warned of taking a “warlike posture” with Democrats if the House investigates his administration.

—Perhaps the most direct midterm referendum on the public’s view of the drug industry—which remains rock-bottom, as it has for years—came in New Jersey. Longtime Celgene (NASDAQ: CELG) executive Bob Hugin ran for U.S. Senate against a Democratic incumbent, Bob Menendez, who was weighed down with his own baggage. Menendez beat Hugin 53 percent to 44 percent.

STAT reported that the drug industry donated record amounts of cash to political campaigns for a midterm cycle and, bucking a decade-long trend, began shifting its largesse to Democrats in the run-up to Election Day.

The Washington Post reported that the GOP will end its pursuit of an Obamacare repeal and will instead try to fix the ACA’s flaws on a bipartisan basis.

—Meanwhile, Iowa, Nebraska, and Utah—three conservative states—approved ballot measures to expand Medicaid under the ACA.

—GOP congressman Chris Collins (R-NY) was re-elected despite being charged in August for insider trading in the Australian biotech Innate Immunotherapeutics. Collins has denied any wrongdoing.

SOLVE ALZHEIMER’S, WIN A PRIZE

—Texans are offering millions of dollars in awards to boost research in neurodegenerative disease. A prize in San Antonio will focus on ideas that explain the cause of Alzheimer’s, and a Dallas-based foundation will start handing out annual awards for work on diseases, such as the devastating progressive supranuclear palsy (PSP), that involve the wayward protein tau.

—Eli Lilly (NYSE: LLY) quietly stopped work on a BACE inhibitor for Alzheimer’s it had studied in Phase 1, and in Phase 2 as part of a combination with an antibody drug. FierceBiotech has more.

FDA STOPS AND STARTS

—An FDA advisory panel voted overhelmingly in favor of brexanolone, from Sage Therapeutics (NASDAQ: SAGE). It will likely be the first drug specifically approved for postpartum depression. But it’s unclear how widely the treatment, which requires a continuous, 60-hour infusion under professional care, will be used.

—The FDA approved a biosimilar version of the Amgen (NASDAQ: AMGN) blockbuster drug pegfilgrastim (Neulasta), which boosts the immune systems of patients on chemotherapy. The biosimilar was developed by Coherus Biosciences (NASDAQ: CHRS).

––Shares of Voyager Therapeutics (NASDAQ: VYGR) fell 12 percent after the company disclosed that a placebo-controlled Phase 2 trial won’t be enough to support an approval application for its experimental gene therapy for Parkinson’s disease. Voyager said the FDA called the trial an “early phase exploratory study.” Voyager had previously indicated it may seek an accelerated review of the gene therapy.

—An experimental rosacea treatment from Israeli biotech Foamix Pharmaceuticals (NASDAQ: FOMX) succeeded in two late-stage clinical trials. Foamix will file for FDA approval of the drug, a foam version of the drug minocycline, next year.

—Animal health company Elanco (NYSE: ELAN) won an FDA nod for lubabregon (Experior), the first drug approved to reduce ammonia emissions from cattle. Elanco picked up the drug from former parent Eli Lilly, which had studied it as a possible type 2 diabetes treatment.

DRUG MONEY

—In a presentation to investors, Novartis (NYSE: NVS) said its experimental gene therapy for spinal muscular atrophy is worth more than $4 million per dose, which would make it the most expensive drug ever. Novartis expects to win FDA approval of the gene therapy, which it acquired when it bought AveXis, next year. Here’s more from Reuters.

—Shares of Alnylam Pharmaceuticals (NASDAQ: ALNY) fell close to 12 percent as initial revenues for its first approved product, patisiran (Onpattro), fell short of analyst estimates, generating $500,000 in its first seven weeks on the market.

—Medical device maker Resmed (NYSE: RMD) reached a deal to acquire healthcare software firm MatrixCare for $750 million.

—San Diego biotech MEI Pharma licensed the Japanese rights to its experimental cancer drug, ME-401, to Kyowa Hakko Kirin for $10 million upfront.

—Biomatics Capital Partners raised $300 million for its second fund, which will invest in startups developing diagnostics, drugs, and products for clinical care.

—Abeona Therapeutics (NASDAQ: ABEO) is paying RegenxBio (NASDAQ: RGNX) $20 million for rights to a RegenxBio gene therapy delivery tool to treat four lysosomal storage diseases. RegenxBio could get up to $180 million in the deal.

—Johnson & Johnson (NYSE: JNJ) paid Korean pharmaceutical company Yuhan $50 million upfront for rights to lazertinib, which is aimed at lung cancer that carries an EGFR mutation. If approved it would compete with several drugs including osimertinib (Tagrisso), from AstraZeneca, which the FDA cleared in April.

—The Blavatnik Family Foundation gave Harvard Medical School a $200 million gift, the largest in its history, to support life sciences research and new startups. The foundation, led by businessman and philanthropist Len Blavatnik, gave Harvard a $50 million gift in 2013 to help establish a biomedical accelerator and a life sciences fellowship program.

—Eli Lilly paid NextCure $25 million upfront, plus a $15 million equity investment, in a new partnership focused on discovering cancer immunotherapies.

—Provention Bio (NASDAQ: PRVB) agreed to take an Amgen (NASDAQ: AMGN) celiac disease drug into Phase 2b testing. The deal could pay the New Jersey biotech up to $150 million in milestones if the drug advances to Phase 3.

—Regulus Therapeutics (NASDAQ: RGLS) amended its partnership with Sanofi (NYSE: SNY), granting the French pharma an exclusive worldwide license to its drug mi-R21 for all indications, including Alport syndrome, a rare, inherited kidney disorder.

—AstraZeneca (NYSE: AZN) continued to trim its drug portfolio, selling rights to three older asthma and rhinitis drugs to Covis Pharma for $350 million.

NEW STARTS

Mirum Pharmaceuticals launched with $120 million in financing and a drug licensed from Shire (NASDAQ: SHPG) that is in mid-stage clinical testing for rare liver disorders.

–Cabaletta Bio became the latest cell therapy startup to emerge from the University of Pennsylvania, raising $38 million to develop treatments for autoimmune diseases.

—InCarda Therapeutics closed a $42 million Series B round to fund Phase 2 tests of its inhalable drug to treat paroxysmal atrial fibrillation.

ON THE OUTS

—Four months after Achaogen (NASDAQ: AKAO) laid off 28 percent of staff, the antibiotics developer announced more restructuring and plans to explore a sale of the company. Achaogen said it would focus its business on plazomicin (Zemdri), which was approved in June to treat complicated urinary tract infections.

—Mallinckrodt Pharmaceuticals (NYSE: MNK) disclosed that VTS-270 failed a Phase 3 trial in Niemann-Pick Type C disease. Mallinckrodt bought the drug when it acquired Sucampo Pharmaceuticals—which itself got the drug by acquiring Cydan Development spinout Vtesse.

—Struggling Merrimack Pharmaceuticals (NASDAQ: MACK) cut 60 percent of its workforce in the wake of its latest clinical setback, a Phase 2 failure of experimental drug MM-121 in lung cancer.

Alex Lash and Frank Vinluan contributed to this report.