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Bio Roundup: Roche-Spark Drags On, GSK Taps CRISPR, Diabetes News & More

Xconomy National — 

Is one of the bigger biopharma acquisitions of the year in trouble?

This past week, antitrust regulators once again delayed Roche’s planned $4.8 billion buyout of gene therapy developer Spark Therapeutics (NASDAQ: ONCE). The US Federal Trade Commission wants yet more information about the buyout, and overseas, the UK Competition and Markets Authority opened a separate investigation. The FTC doesn’t comment on cases it’s currently reviewing, so it’s unclear what is causing the delay. Yet the deal has now been pushed back four times.

Will any of this matter, however? As Reuters reports, Roche and Spark remain committed to the buyout. Already  21.1 percent of Spark shares have been tendered as of June 7. Yet Spark shares sank 10 percent on the latest delay, and its price is now 15 percent below Roche’s $114.50 per share bid—reflecting at least some jitters on Wall Street. And as BioPharma Dive suggests here, it’s at least possible that the heavy scrutiny of Roche/Spark portends similar problems for other biotech deals in the future.

You won’t see any more delays here though. Let’s get to the news, it’s roundup time.

DEALS & ALLIANCES

—GlaxoSmithKline (NYSE: GSK) inked a five-year drug research with CRISPR pioneer Jennifer Doudna’s group at UCSF to use the gene-editing technology to discover new drugs. As part of the deal, GSK will put $67 million into the newly formed Laboratory for Genomic Research, which will be staffed by both GSK employees and UCSF researchers. Here’s more from Science.

—Merck (NYSE: MRK) acquired Lexington, MA, startup Tilos Therapeutics to get ahold of a group of drugs that may help drive a bigger response to its cancer immunotherapies. Merck didn’t say how much it paid upfront for Tilos, but the deal could be worth $773 million.

—Shares of Synlogic (NASDAQ: SYBX) rose more than 29 percent after the Cambridge developer of “living medicines” expanded a partnership with Gingko Bioworks, a company that has technology to screen and engineer microbes. Synlogic aims to use the Ginkgo technology to start five new programs in the next year.

—Tessa Therapeutics and China-Singapore Guangzhou Knowledge City China formed a China-focused joint venture backed by $120 million. The joint venture will license and develop Tessa’s experimental cancer cell therapies for the Chinese market.

—-Danish pharmaceutical company Genmab inked a collaboration with Johnson & Johnson (NYSE: JNJ) unit Janssen Biotech to develop a follow-on drug to their multiple myeloma treatment daratumumab (Darzalex). Genmab could earn up to $275 million in milestone payments.

—Columbia University will team with Alexandria Real Estate Equities to create a new LaunchLabs biotech startup incubator next year at its Washington Heights campus. It’ll be the second LaunchLabs in New York City. The other is at the Alexandria Center for Life Science.

DATA UPS & DOWNS

—In a National Institutes of Health sponsored Phase 2 study, a two-week course of the experimental immunotherapy teplizumab delayed the onset of Type 1 diabetes by a median of two years in young patients at high risk of developing the disease. The results were published in the New England Journal of Medicine, and shares of the drug’s developer, Provention Bio (NASDAQ: PRVB), of Tewksbury, NJ, more than tripled. Here’s more from Science.

—Eli Lilly (NYSE: LLY) released data from a long-term study showing a 12 percent reduction in heart attacks and other cardiovascular events in patients treated with its diabetes drug dulaglutide (Trulicity). While those results are encouraging, Vantage notes that they fall short of data seen in tests of rival diabetes drugs from Novo Nordisk (NYSE: NVO).

—An experimental nonalcoholic steatohepatitis drug from CymaBay Therapeutics (NASDAQ: CBAY) failed its main goal in a mid-stage study. CymaBay executives pointed to encouraging signs in the data that could lead to a benefit for NASH patients later on, but shares nonetheless fell 40 percent.

—Savara (NASDAQ: SVRA), of Austin, TX, reported that its inhalable treatment for the rare lung disease autoimmune alveolar pulmonary proteinosis failed a Phase 3 trial. Shares fell 75 percent.

–The Roche antibody drug rituximab (Rituxan) beat standard of care treatment in a Phase 3 study of patients with the rare autoimmune disease pemphigus vulgaris, which causes the formation of painful blisters.

—Intermountain Healthcare and Amgen (NASDAQ: AMGN) subsidiary deCODE Genetics have started a study that will analyze the genomes of 500,000 patients from Intermountain’s clinics and hospitals in Utah and Idaho.

GREEN LIGHTS & RED ALERTS

—The FDA approved polatuzumab (Prolivy), a Roche antibody-drug conjugate, as a treatment alongside ritxumab (Rituxan) and chemo for diffuse large B-cell lymphoma patients who have failed multiple therapies.

—Merck racked up approvals for its immunotherapy pembrolizumab in newly diagnosed head and neck cancer patients with or without chemotherapy.

—The FDA cleared Amgen (NASDAQ: AMGN) and partner Allergan (NYSE: AGN) to begin selling Kanjinti, a biosimilar version of the Roche breast cancer drug trastuzumab (Herceptin).

—Opioid maker Insys Therapeutics (NASDAQ: INSY) filed for bankruptcy after paying the Department of Justice $225 million to settle charges that it illegally marketed the painkiller fentanyl (Subsys). Insys will sell its assets, including fentanyl, through the bankruptcy. Here’s more from The New York Times.

—Just two months after Achaogen (NASDAQ: AKAO) went bankrupt, another antibiotic developer, Tetraphase Pharmaceuticals (NASDAQ: TTPH), is in trouble. Tetraphase announced plans to reorganize, eliminate its internal research group, and focus all of its cash on the launch of the antibiotic eravacycline (Xerava). CEO Guy McDonald, who will step down on Aug. 1, noted that “the process of launching [a new antibiotic] requires a long runway and unwavering perseverance.”

—Catalyst Pharmaceuticals (NASDAQ: CPRX), which markets  amifampridine (Firdapse) for the autoimmune disorder Lambert-Eaton myasthenic syndrome, sued the FDA claiming the agency’s approval of a rival drug from Jacobus Pharmaceutical violates its drug’s marketing exclusivity. Reuters has more.

BIG BUCKS & STARTUPS

—Bain Capital raised $900 million for its second life sciences fund, which will make between 15 and 20 investments in startups developing drugs, medical devices, and diagnostics, the firm tells Bloomberg. Bain’s first life sciences fund raised more than $720 million in 2017.

—BlackThorn Therapeutics raised a new $76 million round, continuing a push to develop drugs for targeted subsets of patients with neurobehavioral diseases, an effort fueled by next-gen computing tools.

—Yale University spinout Artizan Biosciences closed a $12 million Series A to develop a pipeline of microbiome drugs.

—InGeneron added $23 million to its Series D financing round, which the Houston company will use to test an experimental stem cell treatment for rotator cuff tears.

—ADC Therapeutics boosted its Series E funding round by $76 million as the Swiss company presses ahead in clinical trials testing experimental therapies for blood cancers.

PEOPLE ON THE MOVE

—Citing a family health matter, Jennifer Cook stepped down as CEO of San Francisco cancer diagnostics developer Grail. She was succeeded by Grail director and former Juno Therapeutics and Dendreon executive Hans Bishop.

—In other executive moves, Tariq Kassum left Obsidian Therapeutics to become CEO of Celsius Therapeutics… former Synlogic chief scientific officer Paul Miller took on the same post at Artizan Biosciences… Ariel Jassie moved to eGenesis to become chief business officer and general counsel… and former Tesaro executive Joseph Farmer joined Akrevia Therapeutics as chief operating officer.

Frank Vinluan contributed to this report.