* German conglomerate Bayer AG is offering to pay up to $8 billion to settle over 18,000 lawsuits in the U.S. from plaintiffs who allege that its top-selling weedkiller Roundup causes cancer, Bloomberg News reported, citing people familiar with the negotiations.
* Novo Nordisk A/S, best known for its diabetes therapies, booked second-quarter net profit of 9.60 billion Danish kroner, or 4.03 kroner per share, down from 10.34 billion kroner, or 4.26 kroner per share, in the year-ago period. Net sales for the quarter were 30.04 billion kroner — up 10% year over year from 27.41 billion kroner — as sales from the company's diabetes and obesity segment rose 10% year over year to 25.24 billion kroner.
* AstraZeneca PLC said Tagrisso extended the lives of previously untreated patients with non-small cell lung cancer whose cancers have spread in the body and whose tumors have epidermal growth factor receptor mutations — meeting an endpoint of a late-stage study called Flaura. The study met its primary endpoint in July 2017, showing that the drug extended the time patients lived without the disease worsening or without the patient dying.
M&A and capital markets
* Bayer AG agreed to acquire the remaining 59.2% stake in BlueRock Therapeutics LP for an upfront cash payment of $240 million. The German pharmaceutical giant established BlueRock — which develops heart and nervous system therapies — in 2016 under a joint venture with Versant Ventures.
Drug and product pipeline
* Sarepta Therapeutics Inc. said its muscular dystrophy gene therapy caused an adverse reaction in a boy enrolled in a clinical study. Cambridge, Mass.-based Sarepta is studying SRP-9001 in male patients ages 4 to 7 years old over 48 weeks, plus a 96-week extension study, according to the U.S. Food and Drug Administration's clinical trials database.
An incident submitted to the FDA's adverse event reporting system for approved therapies said the patient developed rhabdomyolysis, a serious illness associated with Duchenne muscular dystrophy. Rhabdomyolysis is a rare disease that causes rapid death of muscle tissue and can lead to kidney damage or failure.
* Dublin-based Amarin Corp. PLC's expects a delay in the U.S. FDA's decision over the company's application for expanded use of Vascepa. The company is looking to add a new indication for Vascepa based on results from a study called Reduce-It, which showed the prescription-only treatment successfully cut the risk of heart-related events such as heart attacks and stroke in certain patients.
* The U.S. FDA rejected Kala Pharmaceuticals Inc.'s application for its KPI-121 0.25% therapy to treat symptoms of dry eye disease. The company's application was backed by data from one phase 2 and two phase 3 studies that evaluated the efficacy and safety of the topical treatment in about 2,000 patients with the disease.
* Merck KGaA is banking on its newer multiple sclerosis product Mavenclad to pick up the slack as sales of Rebif continued to decline in the second quarter. "Mavenclad is also very, very profitable. From the second half of this year onwards, we expect more Mavenclad contributions than Rebif decline," Merck CEO Stefan Oschmann said during the company's Aug. 8 earnings call.
Rebif's second-quarter sales were hit by a difficult competitive situation in Europe and North America's interferon markets as well as competition from oral dosage forms, resulting in an organic sales decline of 16.1% to €331 million. Sales of Mavenclad — an oral short-course treatment for MS — more than tripled in the same period to €61 million.
The day ahead
Early morning futures indicators pointed to a lower opening for the U.S. market.
In Asia, the Hang Seng was down 0.69% to 25,939.30, and the Nikkei 225 gained 0.44% to 20,684.82.
In Europe, around midday, the FTSE 100 was down 0.20% to 7,272.47, and the Euronext 100 slipped 0.74% to 1,042.14.
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