EXOME

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

Bio Roundup: Travel Ban, Pharma in DC, Biogen Splits, PCSK9 Wins

Xconomy National — 

Folks had just clocked out last Friday when the Trump Administration announced a travel ban that threw airports around the country into chaos. That announcement set the tone for this week in life sciences. Many in biopharma blasted Trump’s order and tried to grapple with its implications. At the same time, a handful of the industry’s top CEOs flew to Washington for a meeting with the President, who promised to speed the drug approval process, lower drug prices, and overhaul the FDA. Meanwhile, the future of the Affordable Care Act remains undecided, and Tom Price’s controversial candidacy for the top healthcare seat in the country crept forward despite vehement opposition from Democrats.

And that was just some of the news to come out of biopharma this week. We’ve got those headlines and much more below.

THIS WEEK IN WASHINGTON

—The life sciences industry has outsized clout on Capitol Hill, but its top lobbying groups have kept mostly quiet about President Trump’s refugee and immigration executive order barring U.S entry to people from seven predominantly Muslim countries—even as many individual biotech executives damned the order.

—The Wall Street Journal reported on many companies, among them Spark Therapeutics, rethinking travel plans in the wake of the order.

—The head of the lobbying group PhRMA, meanwhile, joined the CEOs of several large pharmaceutical and biotech companies for a sit-down with Trump to discuss a variety of topics, from the regulation of drugs to how much they cost. Fear that the administration might lower the bar for drug approvals, however, drew criticism from many in the industry. Here’s more from STAT and C&EN.

—Republicans pushed forward with the nomination of Tom Price to lead the Department of Heath and Human Services despite continued protests from Democrats, according to the Washington Times.

—Republicans are also backtracking from plans to repeal Obamacare as they struggle to find a replacement, the New York Times reports.

TOP STORIES IN BIOTECH

—Amgen (NASDAQ: AMGN) reported that its PCSK9-blocker, the cholesterol lowering drug, evolocumab (Repatha), lowered the risk of heart attacks and strokes in a 27,500-patient trial—news badly needed to convince insurers to pay the drug’s high price tag. Amgen didn’t disclose the magnitude of the drug’s benefit, however, so it’s unclear how big of a victory this is yet.

—Another major U.S. insurer, UnitedHealthcare (NYSE: UNH), chose to cover the first-ever spinal muscular atrophy drug, nusinersen (Spinraza), from Biogen (NASDAQ: BIIB). But while UHC’s policy is less restrictive than that of rival insurer Anthem, it nonetheless imposes a series of limitations that could still prevent many patients from getting treatment—like five-year-old Hunter Davis.

—Bioverativ (NASDAQ: BIVV), the blood disease spinoff of Biogen (NASDAQ: BIIB), officially launched this week as a fully independent company. Xconomy examined the rationale behind the split, and the challenges the companies will face to prove they can create more value apart, rather than together.

FUNDINGS & DEALS

—Drug discovery startup Vividion Therapeutics launched with $50 million in venture backing and former top Celgene (NASDAQ: CELG) dealmaker Tom Daniel in a key executive role.

—Watertown, MA-based Tarveda Therapeutics, a cancer drug developer formerly known as Blend Therapeutics, raised a $30 million Series D round and added Versant Ventures as a new investor.

—South San Francisco-based Calithera (NASDAQ: CALA) got $45 million up front and an $8 million equity investment from Incyte (NASDAQ: INCY), in a deal to develop a Calithera drug for cancers and blood diseases.

—Another South San Francisco company, Exelixis (NASDAQ: EXEL), got $50 million for handing Japanese rights to its kidney cancer drug, cabozantinib (Cabometyx), to Takeda Pharmaceutical.

—Royalty Pharma paid $90 million for the royalty rights to an experimental heart drug being developed by Cytokinetics (NASDAQ: CYTK) and partner Amgen.

—New York-based Mustang Bio, a subsidiary of publicly traded Fortress Biotech (NASDAQ: FBIO), raised $94.5 million to continue developing an experimental cell therapy for brain cancer.

DATA DUMPS & EXPLANATIONS

—Seres Therapeutics (NASDAQ: MCRB) said it figured out why a mid-stage clinical trial for its microbiome drug, SER-109, failed, and how to get better results the next time. It’s unclear when Seres will get the chance to prove it, however.

—An anemia pill from San Francisco, CA-based FibroGen (NASDAQ: FGEN) succeeded in the first two of several Phase 3 clinical trials, setting the stage for possible approval in China. But the big test for FibroGen will come when larger, longer trials produce data next year.

—Novan (NASDAQ: NOVN) shares plummeted 75 percent after the Morrisville, NC-based company’s acne drug flunked one of two late-stage clinical trials.

—Shares of Cambridge-based Dimension Therapeutics (NASDAQ: DMTX) fell more than 54 percent after the data debut of the company’s gene therapy for hemophilia disappointed investors.

—Catabasis Pharmaceuticals’s (NASDAQ: CATB) shares, meanwhile, dove 68 percent on the failure of an experimental Duchenne muscular dystrophy drug, edasalonexent.

TheStreet.com reported that New York-based Stemline Therapeutics (NASDAQ: STML) raised $45 million in a stock offering a day after it failed to disclose a patient died in a clinical trial of its experimental cancer drug.

IN OTHER NEWS…

—Two biotechs to recently report failed clinical trials—Ophthotech (NASDAQ: OPHT) and Cerulean Pharma (NASDAQ: CERU)—each hired advisory firms to conduct strategic reviews.

Science was the latest to take an in-depth look at mysterious messenger RNA drugmaker Moderna Therapeutics.

Frank Vinluan contributed to this report.

Photo of JFK airport protest courtesy of flickr user Luminary Traveler via a Creative Commons license.