EXOME

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

Bio Roundup: Trump Health, Cholesterol Wars, 23andMe OK & More

Xconomy National — 

Trump administration health officials were out on the stump this week, talking tough about drug prices and healthcare value, encouraging the private sector to take the lead but letting everyone know the federal government is willing to push.

In the debate over high drug prices, arguably no class of drug has been punished more by insurers than the new cholesterol fighters called PCSK9 inhibitors. Two came to market in 2015, chalking up relatively meager sales for their owners. We’ll find out this weekend if one of them can change insurers’ minds with better data. Meanwhile, a rival drug company thinks it can undercut the PCSK9 blockers and fired its first salvo this week.

We’ve also got an insurance megamerger, an approval of a direct-to-consumer genomics test, nine-digit deals, and more to round up, so let’s get to it.

POLICY AND POLICIES

—-In the latest healthcare megamerger, insurer Cigna (NYSE: CI) announced an agreement to acquire pharmacy benefits manager Express Scripts (NYSE: ESRX) in a cash and stock deal valued at $67 billion.

—FDA commissioner Scott Gottlieb challenged insurers to change a “rigged payment scheme” and bring more biosimilar drugs to market in the U.S. The FDA has approved nine cheaper alternatives to biologic drugs, but only three are available. An insurance industry representative deflected blame to drug companies.

—Gottlieb’s boss, new U.S. Health and Human Services secretary Alex Azar, outlined his priorities in a speech to a group of hospital executives. Among them were patients’ control of their own health records, more price transparency, and better use of experimental models within Medicare and Medicaid.

—UnitedHealthcare (NYSE: UHC) CEO Dan Schumacher told the New York Times that its customers would start to see a share of the rebates that United negotiates with drug companies. Both Azar and Gottlieb praised the move in their speeches this week.

DATA AND APPROVALS

—A 23andMe genetic test for cancer risk received FDA approval, allowing the company to sell directly to consumers. The test screens for genetic mutations associated with higher risks for breast, ovarian, and prostate cancers.

—Long-term (and long-expected) data for the anti-cholesterol PCSK9 inhibitor alirocumab (Praluent) are due this weekend. As the cardio community waited, Esperion Therapeutics (NASDAQ: ESPR) released results for the first of five Phase 3 trials for its rival drug bempedoic acid and discussed its anticipated price.

—Acne drug olumacostat glasaretil failed two Phase 3 trials, knocking down shares of owner Dermira (NASDAQ: DERM) 60 percent Monday.

G1 Therapeutics (NASDAQ: GTHX) reported positive preliminary results from a Phase 2 study of trilaciclib, which is meant to protect the healthy cells of patients receiving chemotherapy for previously untreated small cell lung cancer.

NEWCOS, NEW CASH, AND MORE

—Experts at Massachusetts Eye and Ear have joined with the Usher 2020 Foundation to form a nonprofit called Odylia Therapeutics to push stalled experimental gene therapies into human clinical testing.

—In the latest funding announcement for New York biotechs, Prevail Therapeutics raised $75 million to advance a potential gene therapy for a rare, aggressive form of Parkinson’s disease.

—Cyteir Therapeutics raised $29 million that will support a “synthetic lethality” cancer drug it aims to bring into clinical testing in mid-2019.

—Unum Therapeutics and Homology Medicines moved forward with IPO plans. Unum’s filings revealed two patient deaths and a recent clinical hold for a study testing its lead cancer immunotherapy.

—Merck (NYSE:MRK]]) paid $300 million for partial rights to Eisai’s lenvatinib (Lenmiva) and will test it alongside its immunotherapy pembrolizumab (Keytruda) in several cancers. Lenvatinib is already approved for thyroid and kidney cancers.

—Celgene (NASDAQ: CELG) paid San Diego’s Vividion Therapeutics $101 million upfront to develop drugs for cancer, inflammatory diseases, and neurodegenerative conditions.

—The Roivant Sciences unit Enzyvant is preparing to file for FDA approval of a treatment, licensed from Duke University, for a rare immunodeficiency disorder. In other Roivant news, the company unveiled its latest subsidiary, Metavant, built around a diabetes drug licensed from San Diego’s Ligand Pharmaceuticals (NASDAQ: LGND).

—Two years after landing $51 million for her oncology startup, Adicet Bio president and CEO Aya Jakobovits is unexpectedly stepping down. She will remain on the board of directors.

—This week we unveiled our latest life sciences event, What’s Hot in Boston Biotech, which will take place at the Broad Institute on May 16. Nobel laureate Craig Mello, geneticist Eric Lander, and more will be there to cover topics ranging from RNA interference to the effect of gene therapy on the U.S. healthcare system.

Ben Fidler and Frank Vinluan contributed to this report.

Map courtesy of Dave Winer via Creative Commons.