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Roche-Sarepta sign gene therapy deal; US FDA rejects ViiV's HIV-1 treatment


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Roche-Sarepta sign gene therapy deal; US FDA rejects ViiV's HIV-1 treatment

Top news

* Roche Holding AG is acquiring the commercial rights to Sarepta Therapeutics Inc.'s investigational gene therapy SRP-9001 to treat Duchenne muscular dystrophy outside the U.S. for $1.15 billion upfront payment in cash and stock. Sarepta will also be eligible to receive up to $1.7 billion in milestone and royalty payments for the muscle disorder gene therapy.

* The U.S. Food and Drug Administration rejected ViiV Healthcare Ltd.'s investigational two-drug regimen, which includes the company's long-acting combination of cabotegravir and Johnson & Johnson's Edurant, for treating HIV-1 infection in virologically suppressed adults. ViiV — which is majority-owned by GlaxoSmithKline PLC — said the reasons mentioned by the FDA relates to chemistry manufacturing and controls.

* The U.S. Environmental Protection Agency on Dec. 21 filed papers in a federal appeals court backing Bayer AG's appeal to overturn a verdict that ordered the company to pay $25 million to a person who claimed that his cancer was caused by the company's weedkiller Roundup.

* Gilead Sciences Inc. said its hepatitis C medicine Vosevi has been approved in China. Vosevi — a once-daily single-tablet regimen — was approved in the U.S. and EU in 2017.

On the policy front

* The cadre of Democratic attorneys general who are defending the Affordable Care Act are pondering whether to try to get an expedited review by the U.S. Supreme Court of an appeals court ruling that has left the 2010 healthcare law in limbo — a state of ambiguity that could go on for years. On Dec. 18, the U.S. Court of Appeals for the 5th Circuit said the ACA's requirement for eligible Americans to buy health insurance — the individual mandate — was unconstitutional after the Republican-controlled Congress in December 2017 zeroed out the tax penalty to enforce it.

M&A and capital markets

* Sanofi said it will begin a tender offer for its $2.5 billion acquisition of the immuno-oncology company Synthorx Inc. Under the agreement, Sanofi will acquire all the outstanding shares of Synthorx for $68 apiece.

* Johnson & Johnson acquired Lexington, Mass.-based TARIS BioMedical Inc., a privately held company that specializes in developing a drug delivery technology to treat bladder diseases, including cancer. Financial terms of the deal were not disclosed.

Drug and product pipeline

* Intra-Cellular Therapies Inc.'s Caplyta was approved in the U.S. to treat schizophrenia in adults, while Eisai Co. Ltd.'s Dayvigo also won U.S. FDA approval for insomnia in adults. Similarly, the U.S. FDA granted accelerated approval to AstraZeneca PLC and Daiichi Sankyo Co. Ltd.'s medicine Enhertu to treat certain patients with breast cancer who are ineligible for surgery.

* Evoke Pharma Inc. and Nabriva Therapeutics PLC are again seeking U.S. FDA approval for their respective medicines. Evoke is hoping to snatch a win for its nasal spray Gimoti to treat a gastrointestinal disorder called gastroparesis, while Nabriva is seeking the regulator's nod for Contepo to treat complicated urinary tract infections. The U.S. regulator also accepted Sunovion Pharmaceuticals Inc.'s resubmitted marketing application for apomorphine to treat motor fluctuations in patients with Parkinson's disease.

* BeiGene Ltd. said China's National Medical Products Administration accepted an application seeking expanded use of Bristol-Myers Squibb Co.'s Revlimid, combined with Roche's Rituxan, to treat certain patients with a type of blood cancer. BeiGene markets Revlimid in China under an exclusive deal with Celgene Corp., which was acquired by Bristol-Myers in a $95 billion deal.

* Lexicon Pharmaceuticals Inc.'s diabetes drug Zynquista beat placebo and matched Eli Lilly and Co.'s Jardiance in reducing blood sugar levels in certain patients with type 2 diabetes.

* Stealth BioTherapeutics Corp.'s stock plummeted on Dec. 20 after its experimental therapy elamipretide failed to treat primary mitochondrial myopathy — a genetic disorder affecting the skeletal muscles.

* Scientists at the U.K.'s Wellcome Sanger Institute and the Broad Institute of MIT and Harvard are getting closer to creating a comprehensive map of genes necessary for cancer survival, which could help speed up the discovery of new drug targets and development of new cancer medicines.

Operational activity

* Sutter Health settled its antitrust lawsuit with California and unions and employers in the state for $575 million, adding to the healthcare industry's fight over hospital consolidation. The Northern California-based health system was accused of anti-competitive practices that lead to higher prices for patients in Northern California than other regions of the state. Along with the payout, Sutter Health agreed to a list of operational changes, including no longer using "all-or-nothing" contracting, which requires insurers to include all Sutter Health facilities in their plans.

* Laval, Quebec-based Bausch Health Companies Inc. acquired the license to develop and commercialize Novaliq GmbH's eye disease drug NOV03 in the U.S. and Canada. Meanwhile, the Canadian company agreed to settle an intellectual property lawsuit against Indian drugmaker Glenmark Pharmaceuticals Ltd. involving the plaque psoriasis treatment Bryhali.

* The European Medicines Agency's staff has been reduced to 775 from 897 after it moved to Amsterdam from London following Brexit, Endpoint News reported.

The day ahead

Early morning futures indicators pointed to a higher opening for the U.S. market.

In Asia, the Hang Seng rose 0.13% to 27,906.41, and the Nikkei 225 was up 0.02% to 23,821.11.

In Europe, around midday, the FTSE 100 was up 0.46% to 7,617.20, and the Euronext 100 climbed 0.07% to 1,153.34.

Click here to read about today's financial markets, setting out the factors driving stocks, bonds and currencies around the world ahead of the New York open.

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