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Bio Roundup: Little Rhody, More for Migraine, Opioid Bills & More

Xconomy National — 

The U.S. Senate had a rare moment of agreement, overwhelmingly passing a package of opioid-related bills. Up the East Coast, life-science players in Rhode Island are working to bring different local factions together and boost the state’s economy. Across the country, a similar effort is underway in Los Angeles.

There were also plenty of headlines stemming from bad behavior, alleged or otherwise, inside Big Pharma, and the usual collection of deals, data, regulatory decisions, and fundraising. Whatever our differences across the aisle, we can all agree upon one thing: It’s roundup time.

POLICY & ECONOMY

—An hour south of Boston, Rhode Island locals want to build a thriving life sciences hub centered along the capital Providence’s riverfront. There are tensions—as well as opportunities for convergence—between various local groups. This week, we explored how limited resources and Rhode Island’s checkered economic development history add challenges to the efforts.

—Voting 99 to 1, The U.S. Senate approved a bipartisan slate of bills to address the opioid crisis. It now must be reconciled with the House version, which critics say contains a provision that could restart the so-called War on Drugs and expand the prison population.

—Los Angeles trails San Diego and the Bay Area in California life-science activity. A new initiative, BioLA, aims to boost the profile of Los Angeles County, which includes the city of L.A., Santa Monica, home of Kite Pharma, and Thousand Oaks, where BioLA partner Amgen (NASDAQ: AMGN) is headquartered.

LEGAL MANEUVERS

—California sued AbbVie (NYSE: ABBV) for allegedly using kickbacks and other schemes to boost sales of best-selling anti-inflammatory medicine adalimumab (Humira). AbbVie says the allegations are “without merit.”

—Stung by bribery scandals and revelations that it hired Donald Trump’s longtime “fixer” Michael Cohen, Novartis (NYSE: NVS) said this week it would tie employee bonuses to ethical behavior.

—Clovis Oncology (NASDAQ: CLVS) and two executives will pay the SEC more than $20 million to settle charges of misleading investors with overblown claims about the effectiveness of their cancer drug rociletinib (Roci).

—Oxfam reported that several large drug makers are legally taking advantage of tax laws to shift high-profit assets and avoid billions of dollars in payments. An AbbVie spokesperson told FiercePharma the report was “misleading.”

—A second GlaxoSmithKline (NYSE: GSK) scientist has pleaded guilty in a plot to steal the drug maker’s trade secrets in Pennsylvania and move them to a biotech in China.

TRIALS & APPROVALS

—A ProPublica investigation showed that African-Americans and other minorities are underrepresented in cancer clinical trials, which not only deprives them of early access to potential life-extending treatments but also weakens the underlying research.

—The FDA approved Teva Pharmaceutical (NYSE: TEVA) migraine drug fremanezumab (Ajovy), heating up competition in this new class of drugs. Teva priced its injectable drug on par with the Amgen migraine therapy that the FDA approved in May.

—Viking Therapeutics (NASDAQ: VKTX) emerged in the race to treat nonalcoholic steatohepatitis. In a mid-stage study, the company’s drug VK2809 had an impact on several markers of nonalcoholic fatty liver disease, a precursor to NASH, without serious side effects. Shares nearly doubled.

—Britain’s drug-pricing watchdog, the National Institute for Health and Care Excellence, cited cost when it rejected Novartis therapy tisagenlecleucel (Kymriah) in adults with diffuse large B-cell lymphoma. As it did last month with the Gilead Sciences (NASDAQ: GILD) rival CAR-T treatment Yescarta, NICE said there is no evidence the treatment is better than rescue chemotherapy. NICE did previously, however, clear Kymriah for use in children.

—The FDA cleared Mersana Therapeutics to resume an early-stage study of an experimental cancer drug two months after Mersana disclosed that a trial volunteer died. Mersana will monitor patients more closely and try less frequent dosing. Shares fell more than 20 percent.

—Wiconsin biotech Stemina Biomarker Discovery discussed with Xconomy’s Jeff Buchanan its ongoing autism study and a potential test to detect the disorder early in at-risk kids.

—The FDA found no new safety issues in a post-marketing review of antipsychotic drug pimavanserin (Nuplazid) from Acadia Pharmaceuticals (NASDAQ: ACAD), boosting shares more than 24 percent in late-day trading Thursday. The review began after reports of deaths and serious side effects in patients taking the drug.

—The Committee for Medicinal Products for Human Use, which helps guide drug approval decisions in Europe, rejected eteplirsen (Exondys 51), the Duchenne muscular dystrophy drug from Sarepta Therapeutics (NASDAQ: SRPT), for the second time. Sarepta still plans to explore a path forward in Europe and will seek more advice from regulators there next year.

DEALS & DOLLARS

—Indigo Ag raised a $250 million Series E round to support more R&D on microbials and expand its grain-selling software platform.

—Five months after emerging with $300 million in funding, South San Francisco, CA-based Allogene late last week revealed plans for an IPO to finance clinical testing of cancer cell therapies made from donor T cells rather than a patient’s own T cells.

—Amicus Therapeutics (NASDAQ: FOLD) became the latest biotech to place a bet on gene therapy, paying $100 million to buy Celenex and its 10 experimental gene therapies for lysosomal storage diseases. Celenex is a spinout of Nationwide Children’s Hospital in Columbus, OH, a top gene-therapy testing center.

—Stem-cell therapy developer ViaCyte is teaming up with CRISPR Therapeutics (NASDAQ: CRSP) on a gene-editing treatment for type 1 diabetes treatment.

—Elanco (NYSE: ELAN) raised $1.5 billion in its IPO, completing the Greenfield, IN, animal health company’s separation from parent Eli Lilly (NYSE: LLY).

—Galera Therapeutics of Malvern, PA, raised a $150 million Series C round to advance a drug meant to prevent one of the dangerous side effects of radiation therapy for cancer.

—San Francisco-based uBiome, which helps people understand how their microbiomes affect health, is moving into therapeutics. The company raised $83 million in Series C financing, which it will use to develop drugs that could treat cancer, autoimmune disease, and obesity.

—Takeda Pharmaceutical paid Molecular Templates (NASDAQ: MTEM), of Austin, TX, $30 million to co-develop cancer drugs that target the CD38 protein, which is widely expressed on multiple myeloma cells. Molecular Templates shares surged 52 percent.

—Silverback Therapeutics extended its Series A round of funding to $47.5 million, with Celgene (NASDAQ: CELG and Alexandria Venture Investments joining earlier backer OrbiMed.

—Y-mAbs Therapeutics (NASDAQ: YMAB) raised $96 million from its IPO, which will use to test two neuroblastoma drugs.

Ben Fidler and Frank Vinluan contributed to this report.

Photo of U.S. Capitol by Kevin Dooley via a Creative Commons 2.0 license.