Regeneron's (REGN +3.15%) Eylea treatment improved vision and maintained that improvement over two years in a Phase III trial of patients with diabetic macular edema (DME).
DME is a leading cause of blindness in younger and middle-aged adults; Eylea could potentially treat over 6M sufferers globally.
Regeneron and partner Bayer (BAYRY) are waiting for U.S. and EU approval of Eylea to treat DME; the therapy has already been authorized for other indications, including wet age-related macular edema. (PR)
While the vaccines unit was initially on the table with animal health as part of the possible trade for MRK’s over-the-counter drugs business, NVS may now sell the vaccines unit separately in a deal that could be valued at ~$1B.
NVS and MRK are still talking but agreeing on valuation is proving difficult, so NVS has informally talked to Eli Lilly (LLY -0.1%) and Bayer (BAYRY, BAYZF) about the animal health business, according to the report.
Johnson & Johnson's (JNJ -0.8%) Janssen Research & Development unit says the FDA has rejected the approval of its blood thinner Xarelto as oral anticoagulant used to reduce the risk of stent thrombosis in patients with acute coronary syndrome. Since aprroving the drug in July 2011, the agency has expanded its use for treating certain blood clots and reducing their recurrence, and is currently approved for six clinical uses in the United States. Xarelto is co-marketed by JNJ and Bayer (BAYRY.PK)
Seattle Genetics (SGEN -1.9%) is all over the board today after being pelted with news-related issues. Initially, the stock popped after announcing it had struck a new antibody drug conjugate collaboration deal with Bayer (BAYRY.PK) worth up to $520M, only to collapse on reports that it had temporarily halted studies of its Lymphoma drug Adcetris due to safety concerns over reports of pancreatitis.
Merck (MRK -1.3%) gets no love today from the FDA's approval of Liptruxet late Friday, as the stock is likely dragged down with the rest of the big pharma names on the back of a CNBC report that criticizes their earnings so far. The article points to the fact that pharmaceutical companies have seen a 4.7% contraction in earnings, and a 3.2% drop in revenue this quarter. Why? Morningstar's Damien Cover says there are two primary reasons: FX impact, especially from the yen, and intensified generic competition from patent losses.
In an effort to broaden its women's contraceptive offerings, Bayer (BAYRY.PK +0.4%) has agreed to buy Conceptus (CPTS +19.5%) for around $1.1B. The company says that within the next 10 business days it will launch a tender offer to acquire all of CPTS's stock at $31, a 20% premium to Friday's close. The deal is expected to close by middle of the year.
A new and potential blockbuster drug from Bayer (BAYRY.PK +4%), Regorafenib, could significantly increase the survival prospects of people with gastrointestinal cancer, according to new research published in U.K. medical journal The Lancet. The study also showed survival rates for patients with metastatic bowel cancer improved by taking the drug as well, though not as significantly. Bayer has tagged Regorafenib as one of its most significant new pipeline products.
Ardea Biosciences (RDEA -0.1%) says it's earned a $7.5M milestone payment from Bayer (BAYRY.PK) under the terms of their April 2009 global license agreement to develop and commercialize RDEA's mitogen-activated ERK kinase inhibitor compounds for cancer and other indications. The milestone was triggered by the recent initiation of Phase 2 clinical studies. Separately, Gabelli says it's raised its stake in the company from 7.9% to 8.94%.
Onyx Pharmaceuticals (ONXX +4.7%) says that Bayer (BAYRY.PK) has submitted a New Drug Application to the FDA seeking approval for the oral multi-kinase inhibitor regorafenib for the treatment of patients with metastatic colorectal cancer. Regorafenib is a Bayer compound, and Onyx will receive a royalty on global net sales. Separately, Bernstein initiates the shares with an Outperform rating.
Shares of Onyx Pharma (ONXX +3.2%) jump after Bayer (BAYRY.PK) said a Phase III trial showed its drug regorafenib prevented gastrointestinal tumors from worsening, and the German drug giant will seek regulatory approval for the medicine based on the data. Bayer is paying Onyx a 20% royalty for the use of the drug in oncology.
Bayer (BAYRY.PK -2%) and Regeneron (REGN -1%) lose their U.K. patent fight on Eylea, a potential blockbuster VEGF Tarp-Eye treatment produced jointly by the two companies. A London Court has ruled that the drug infringes a patent held by Roche (RHHBY.PK -1.4%) subsidiary Genentech.
Bayer AG (BAYRY.PK +3%) moves higher after announcing its partner Janssen Research & Development has submitted a supplemental new drug application to the FDA for its oral anticoagulant Xarelto, also known as rivaroxaban, in combination with standard antiplatelet therapy to reduce the risk of cardiovascular events in patients with acute coronary syndrome.
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