Bio Roundup: Trumpcare Is Mean, SCOTUS Says Go, Merck’s Myeloma No

Xconomy National — 

What exactly does the American Health Care Act, the Republican proposal to replace Obamacare, currently look like? Few people know, because the Senate version is being negotiated behind closed doors in Washington D.C. without any public hearings.

We do know President Trump now thinks the version of the AHCA that squeaked through the House is “mean.” When he celebrated the House vote he called it “incredibly well crafted,” “really incredible,” and “ultimately a great plan.”

He’s not the only one with a change of heart. According to recent national polls, the AHCA doesn’t have majority support in any single state. But some unspecified form of the legislation lurches forward, possibly towards a Senate vote before Independence Day.

We’ve got the latest on the mysterious bill, a patient networking group’s thoughts on it, and the rest of this week’s healthcare and biotech news below. Let’s get to it.

LIVE, FROM CAPITOL HILL…

—A key Senate committee held a hearing on prescription drug prices Wednesday, but there wasn’t much drug-price talk. Democrats used it to scold Republicans for hammering out the Senate version of Trumpcare in secret. In fact, committee chair Lamar Alexander left during the hearing to meet with the president and other GOPers about the health bill. According to the Associated Press, during that meeting, Trump told senators to come up with something more humane because the House version was “mean.”

—Sen. Ron Wyden (D-OR) introduced a bill to require drug makers to justify their cost increases. Last month, he crafted legislature to make negotiations between drug makers and insurers’ agents, called pharmacy benefit managers, more transparent.

—Meanwhile, in its second poll since January, Cambridge, MA-based patient networking group PatientsLikeMe reported that a majority of its members—all of whom have chronic diseases like multiple sclerosis or major depressive disorder—don’t want to see the Affordable Care Act repealed.

Politico reported Thursday that the White House is mulling an executive order on drug prices; top officials are meeting today.

—A Supreme Court decision this week could have an effect on drug prices. The justices voted unanimously to give Novartis’s generic unit Sandoz a victory over Amgen (NASDAQ: AMGN), essentially saying Sandoz could move more quickly to bring an approved biosimilar (and cheaper) version of Amgen’s filgrastim (Neupogen) to market. Removing delays from biosimilars hitting the market could shave billions of dollars off drug costs in the long run.

STARTUP NEWS

—New York’s latest biotech incubator, LaunchLabs, debuted at the Alexandria Center for Life Science this week with 13 tenants. The facility joins a growing list of New York biotech startup spaces, but few options exist for companies that grow beyond incubation stage—something one Alexandria executive told Xconomy it is “actively working on.”

—Celgene (NASDAQ: CELG) paid $33 million for an option to license up to four blood cancer drugs developed by Dragonfly Therapeutics, the Cambridge, MA, startup co-founded by cancer research pioneer Tyler Jacks and backed by an unusual group of family offices.

MIT Technology Review wrote about a startup, Darwin Life, which aims to use a controversial DNA-transfer technique to help women over 40 get pregnant.

—British VC firm Medicxi tapped Novartis and Google to help back a new $300 million fund, Medicxi Growth 1, for growth-stage biotechs in Europe.

CLOSER TO THE HEART

—In a 10,142-patient study published in the New England Journal of Medicine, Johnson & Johnson’s (NYSE: JNJ) diabetes drug canagliflozin (Invokana) cut the risk of heart attacks and strokes, but as Forbes reported here, it also increased the chance patients might have to get their toes amputated. A similar drug from Eli Lilly (NYSE: LLY), empagliflozin (Jardiance), didn’t show such risk in a large trial a few years ago. AstraZeneca (NYSE: AZN) has its own study underway for rival dapagliflozin (Farxiga).

—The drug evaluation group ICER said that the anti-cholesterol drug evolocumab (Repatha) should be priced even lower than ICER’s previous recommendation from 2015, when evolocumab and its competitor alirocumab (Praluent) were approved. ICER issued its report after analyzing Amgen’s FOURIER study, which is following the progress of 27,000 patients on evolocumab.

BEST PRACTICES

—Two lengthy features in the New York Times and NPR, published on the same day, detailed practices Waltham, MA-based Alkermes (NASDAQ: ALKS) has used to boost sales of naltrexone (Vivitrol), a once-struggling drug that has flourished as the opioid crisis has worsened in the U.S.

STOPS AND STARTS

—Merck (NYSE: MRK) paused enrollment in two Phase 3 studies that combine its cancer immunotherapy drug pembrolizumab (Keytruda) with other therapies in multiple myeloma patients. Merck said there were “reports of death” in the pembrolizumab groups. The news is fresh evidence of some of the safety perils involved in combining immunotherapy drugs with other treatments.

—Cambridge, MA-based Acceleron Pharma (NASDAQ: XLRN) scrapped development of experimental cancer drug dalantercept after the drug failed a Phase 2 trial in kidney cancer.

—Shares of San Diego, CA-based Regulus Therapeutics (NASDAQ: RGLS) fell 16 percent after the company disclosed it will stop developing two drugs, including its lead program for hepatitis C. Partner AstraZeneca also sent rights back to a third Regulus program.

—Biosimilar maker Coherus BioSciences (NASDAQ: CHRS) got a stop sign Monday from the FDA, which asked for more information and analysis as it reviews Coherus’s version of pegfilgrastim (Neulasta) for approval. Coherus shares immediately slumped 31 percent and remain down.

—Longtime Biogen (NASDAQ: BIIB) CFO Paul Clancy left the Cambridge company to join struggling Alexion Pharmaceuticals (NASDAQ: ALXN), which has completely overhauled its executive team. According to a note from Barclays analyst Geoff Meacham, Alexion might write off its $8.4 billion buyout of Synageva Biopharma. After Clancy’s move, Biogen shares fell 3 percent and Alexion shares climbed 9 percent.

—Seres Therapeutics (NASDAQ: MCRB) started a Phase 3 study of its microbiome treatment for recurrent C. difficile infection nearly a year after the drug failed a Phase 2 trial, triggering a $20 million milestone payment from partner Nestle Health Science.

SHARE MOVERS, BUYOUT RUMORS

—Shares of Cambridge-based Epizyme climbed nearly 11 percent after the company posted Phase 2 data on tazemetostat in a variety of blood cancers. CEO Robert Bazemore said in a statement the company will meet with the FDA later this year “to determine potential registration paths” for the drug.

—Chicago-based Avexis (NASDAQ: AVXS), developing what could be the first gene therapy for the rare disease spinal muscular atrophy, said it plans to begin a pivotal trial for patients with the most deadly form, Type 1, in the third quarter. Shares climbed 9 percent.

—Athenex (NASDAQ: ATNX) raised $66 million in an IPO that the Buffalo, NY-based biotech will use to fund Phase 3 studies for two potential cancer drugs.

—An early look at Selecta Biosciences’ (NASDAQ: SELB) Phase 2 study of an experimental gout drug showed a reduction in gout flares. The news nudged shares up about 8 percent.

—Buyout rumors continued to swirl around Waltham, MA-based cancer drug maker Tesaro (NASDAQ: TSRO), with the latest news reports suggesting Sanofi and Gilead Sciences (NASDAQ: GILD) have expressed interest in the company.

Alex Lash and Frank Vinluan contributed to this report.