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Bio Roundup: 2019 Trials, Pilgrim Price Chat, Pre-Xmas Sales & More

Xconomy National — 

It’s beginning to look a lot like, well, the last roundup of the year, with plenty of news to pack in before our holiday breather. Whew. Before you fly off, or drive, or simply unplug, check out our preview of what could be next year’s top clinical studies; the tumult in big pharma’s on again-off again relationship with consumer healthcare; big names on the move in the nation’s capital; and a flurry of year-end deals.

All that and a lot more await you in the final 2018 roundup. Happy holidays, everyone. We’ll see you in January.

TOP STORIES

—This week Xconomy published its latest annual preview of the upcoming year’s most important clinical results. Our two-part list, here and here, includes studies in Alzheimer’s disease, hemophilia, Duchenne muscular dystrophy, nonalcoholic steatohepatitis, cystic fibrosis, and more.

—Xconomy spoke with Harvard Pilgrim Health Care chief medical officer Michael Sherman about drug prices, and whether value-based agreements, which tie a drug’s price to its real-world benefits for patients, can cut healthcare costs.

—Pfizer (NYSE: PFE) and GlaxoSmithKline (NYSE: GSK) agreed to merge their consumer health divisions and spin them off into a new entity, creating the largest such business in the world. With the move, the world’s top pharma companies continue to tighten their focus on developing prescription drugs.

—Bristol-Myers Squibb (NYSE: BMY) got in on the act, too, announcing that Japan’s Taisho Pharmaceutical has offered $1.6 billion for its European consumer health business.

—Sarepta Therapeutics (NASDAQ: SRPT) completed an FDA application for golodirsen, which aims to treat a genetic subset of Duchenne muscular dystrophy patients. Sarepta is seeking an accelerated approval of golodirsen, just as it did with eteplirsen (Exondys 51), which was controversially approved in 2016 for a different genetic subset of Duchenne patients.

BYE, BYE, BELTWAY?

—Sen. Lamar Alexander (R-TN) announced he would not run again in 2020. The chair of the Senate HELP committee was a key player in national healthcare policy. He protected NIH funding through the 21st Century Cures Act and, even though he opposed the Affordable Care Act, he worked with Sen. Patty Murray (D-WA) on an ill-fated compromise to stabilize its insurance markets.

—Top FDA deputy Rachel Sherman is retiring after nearly three decades at the agency. Her replacement will be Amy Abernethy, a top executive at Flatiron Health, a cancer medical-records firm and subsidiary of Roche. In February, Sherman said in an interview that succession planning was a problem at the FDA: “We’re getting old.”

DO THE DATA

—Surface Oncology (NASDAQ: SURF) disclosed that its lead cancer treatment showed toxic effects in a Phase 1 study that could limit its use at higher doses. The Cambridge biotech said it will instead focus on two other drugs in preclinical development.

—Sophiris Bio (NASDAQ: SPHS) said that a second dose of its prostate cancer drug, topsalysin, failed to give patients additional benefit in a mid-stage study. The biotech plans to proceed to Phase 3 based on positive single-dose data.

Pfizer and Astellas reported positive Phase 3 data for enzalutamide (Xtandi) paired with androgen deprivation therapy in metastatic hormone-sensitive prostate cancer.

—Lumateperone, an experimental drug from Intra-Cellular Therapies (NASDAQ: ITCI), failed a Phase 2 study in which it aimed to relieve symptoms of agitation in Alzheimer’s disease patients. The drug is under FDA review for schizophrenia and is also in late-stage trials for bipolar depression.

—Proteostasis Therapeutics (NASDAQ: PTI) delayed the release of the first data for an in-house three-drug cocktail for cystic fibrosis until early next year.

—G1 Therapeutics (NASDAQ: GTHX) said its cancer drug trilaciclib helped reduce the rates of severe neutropenia—dangerously low white blood cell counts—in cancer patients on chemotherapy in another Phase 2 study. But more patients on a placebo and chemo saw their tumors shrink than those on G1’s drug and chemo, and shares plummeted 42 percent.

APPROVAL-PALOOZA

—The FDA approved olaparib (Lynparza), from AstraZeneca (NYSE: AZN) and Merck (NYSE: MRK), as a maintenance treatment following chemotherapy for ovarian cancer patients with a BRCA mutation. The drug also succeeded in a Phase 3 study in ovarian cancer patients who have failed at least two treatments.

—The FDA delayed a decision on whether to approve Merck’s pembrolizumab as a monotherapy for a majority of patients with newly diagnosed, advanced non-small cell lung cancer by three months. As a monotherapy, pembrolizumab is currently approved only for NSCLC patients whose tumors express high levels of the protein PD-L1.

—Chinese regulators approved roxadustat, an anemia pill from Fibrogen (NASDAQ: FGEN) and its partners AstraZeneca and Astellas Pharma. The partners also reported positive results from five Phase 3 studies of roxadustat, but a safety analysis of more than 9,000 patients, due next year, will be key to gain U.S. and European approval.

—More FDA nods: Pembrolizumab (Keytruda) for advanced or metastatic merkel cell carcinoma; prucalopride (Motegrity) for constipation after previous approval in Europe; Herzuma, a biosimilar to trastuzumab (Herceptin), for HER2-positive breast cancer.

DEALS & DOLLARS

Versant Ventures unveiled its seventh fund, worth $600 million, to invest in biotech startups in North America and Europe. A companion fund worth $100 million will focus on Canadian startups. Versant reinvented itself after the recession, avoiding the fate of many of its biotech investment peers.

—A year after selling Ignyta to Roche for $1.7 billion, San Diego entrepreneur Jonathan … Next Page »

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