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Novartis Q3 net income up 14% YOY; Biogen-Eisai mull Alzheimer drug filing

Top news

* Novartis AG said its third-quarter 2019 core net income rose 14% in U.S. dollar terms to $3.21 billion, or $1.41 per share, from $2.82 billion, or $1.22 per share, in the year-ago period. The Swiss drugmaker also raised its sales and profit guidance for 2019.

* Biogen Inc. and Eisai Co. Ltd. said they plan to pursue regulatory approval of their Alzheimer's disease drug aducanumab with the U.S. Food and Drug Administration. The decision to file is based on a new analysis, conducted by Biogen in consultation with the FDA, of a larger dataset from the phase 3 clinical studies that were discontinued in March 2019 following a futility analysis.

Separately, Biogen reported its earnings. The company's third-quarter net income rose 13% to $1.69 billion, or $9.17 per share, compared to $1.49 billion, or $7.40 per share, in the same period a year ago. The company's revenue for the quarter increased by 5% to $3.60 billion, from $3.44 billion, in the third quarter of 2018.

* Four drug companies, including Teva Pharmaceutical Industries Ltd. and McKesson Corp., cited in a lawsuit from counties in Ohio seeking blame for the ongoing opioid epidemic have settled the so-called bellwether case for a total of $265 million. In addition, Teva is also nearing a comprehensive deal worth about $23 billion that would settle all cases being levied against it. Meanwhile, the four companies could resume discussions with plaintiff states and local governments Oct. 22 to try to reach a $48 billion settlement of all opioid lawsuits against them, Reuters reported.

* The U.S. FDA approved the expanded use of Johnson & Johnson's medicine Stelara for adult patients with moderately to severely active ulcerative colitis, a type of bowel disease. The drug is already approved to treat plaque psoriasis, psoriatic arthritis and Crohn's disease.

* After a swift three-month review period, the U.S. FDA approved Vertex Pharmaceuticals Inc.'s triple combination therapy Trikafta to treat certain patients with cystic fibrosis — an inherited disorder that affects the lungs and digestive system. The company has priced Trikafta at $311,503 annually.

M&A and capital markets

* Knight Therapeutics Inc. is acquiring a 51.21% stake in Biotoscana Investments SA from a controlling shareholder group that includes Advent International Corp. and Essex Woodlands Management Inc. for about 596 million Brazilian reais. After the transaction's closing, Knight will launch a mandatory tender offer to buy the remaining 48.79% stake in Biotoscana from public shareholders.

Drug and product pipeline

* Bristol-Myers Squibb Co. said a combination of its drugs Opdivo and Yervoy along with chemotherapy improved overall survival in patients with advanced non-small cell lung cancer in a clinical trial called CheckMate -9LA.

* Pfizer Inc. and OPKO Health Inc.'s medicine somatrogon increased the height of minors with growth hormone deficiency as effectively as Pfizer's other therapy Genotropin, according to results of a phase 3 clinical trial.

* Seattle Genetics Inc. said its tucatinib combination therapy was better than single therapies in treating certain patients with breast cancer, results of a mid-stage study showed. Seattle Genetics evaluated tucatinib — which it inherited following the acquisition of Cascadian Therapeutics Inc. in 2018 — in combination with trastuzumab, which is sold by Roche Holding AG as Herceptin, and chemotherapy capecitabine, against the Herceptin-chemo therapy combo alone.

* The U.S. FDA rejected an application filed by Assertio Therapeutics Inc. partner West Therapeutic Development LLC, which sought approval of a long-acting version of the medicine cosyntropin for use as a diagnostic drug in screening patients presumed to have adrenocortical insufficiency, a type of hormonal disorder.

* Aradigm Corp. said its drug Linhaliq, for treating a type of respiratory disease, is not likely to get the backing of the European Medicines Agency in November. The company, which had filed for bankruptcy protection in February, added that it is also seeking U.S. approval of the drug, known as Apulmiq in the country, for the same indication.

* United Therapeutics Corp. said the U.S. FDA approved the inclusion of new data from a late-stage study to the label of hypertension drug Orenitram. The company said that the treatment, in extended-release tablets, delays disease worsening when used with an approved oral background therapy for pulmonary arterial hypertension.

Operational activity

* Takeda Pharmaceutical Co. Ltd. exercised its option to acquire the exclusive license to develop and commercialize Cour Pharmaceutical Development Co. Inc.'s investigational autoimmune disorder drug CNP-101. Cour may receive up to $420 million in future payments, subject to the terms of the agreement.

* Foamix Pharmaceuticals Ltd. and LEO Pharma A/S settled a patent suit with Israel-based Teva Pharmaceutical Industries Ltd. regarding Finacea foam, a topical treatment for a chronic skin disease.

* Aerpio Pharmaceuticals Inc. shuffled its management as it plans to explore strategic alternatives — which may include a possible acquisition, merger or asset sale, among other things, to maximize shareholder value.

The day ahead

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

In Asia, the Hang Seng gained 0.23% to 26,786.20.

In Europe, around midday, the FTSE 100 lifted 0.37% to 7,189.91, and the Euronext 100 fell 0.11% to 1,091.46.

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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