The European Commission approves Regeneron Pharmaceuticals' (NASDAQ:REGN) Eylea (aflibercept) for the treatment of visual impairment caused by diabetic macular edema (DME). The new indication complements its current approvals for wet age-related macular degeneration (AMD) and macular edema following central retinal vein occulsion (CRVO).
Bayer HealthCare Pharmaceuticals (OTCPK:BAYRY -2.4%) (OTCPK:BAYZF -1.7%) and development partner Onyx Pharmaceuticals (AMGN -0.3%) report that the 537-patient Phase 3 clinical trial evaluating the safety and efficacy of Nexavar (sorafenib) plus capecitabine for the treatment of advanced breast cancer failed to achieve its primary endpoint of improving progression-free survival (PFS). Nexavar is currently approved in over 100 countries for other cancers.
The companies are evaluating Nexavar in a variety of different cancers. Bayer has exclusive marketing rights to the product ex. U.S. and Japan. They co-promote it in America and share profits globally.
Compugen (CGEN) achieves the first preclinical milestone in the development of one of the two checkpoint protein candidates discovered by Compugen that are the basis for its collaboration with Bayer HealthCare (BAYRY) (BAYZF). The company is now eligible to receive a $1.2M milestone payment from Bayer.
The two firms formalized their partnership last August in a deal that could bring up to $530M to Compugen in milestone payments plus royalties on commercial sales of therapeutic antibodies developed by Bayer against the checkpoint proteins.
Europe's Committee for Medicinal Products for Human Use (CHMP) recommends that the European Medicines Agency (EMA) approve Bayer's (BAYRY) (BAYZF) Stivarga (regorafenib) as a treatment for adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib. Stivarga is currently approved for the treatment of metastatic colorectal cancer (mCRC).
CHMP's decision is based on a Phase 3 clinical trial that showed a statistically significant improvement in progression-free survival (PFS) in patients receiving regorafenib plus best supportive care (BSC) compared to patients receiving placebo plus BSC. Median PFS in the test group was 4.8 months versus 0.9 months in the control arm.
Europe's Committee for Medicinal Products for Human Use (CHMP) recommends that the European Medicines Agency (EMA) approve Regeneron Pharmaceuticals' (REGN) Eylea (aflibercept) injection as a treatment for visual impairment due to diabetic macular edema (DME). Eylea is currently approved as a treatment for neovascular (wet) age-related macular degeneration (AMD) and macular edema following central retinal vein occlusion (CRVO).
Regeneron and Bayer Healthcare (BAYRY) (BAYZF) are collaborating on the global development of Eylea. Regeneron has exclusive rights to the product in the U.S. while Bayer Healthcare has the license for exclusive marketing rights ex. U.S. where the companies equally share the profits from Eylea sales. In Japan, Regeneron receives a percentage of net sales.
Regeneron Pharmaceuticals (REGN) reports that collaboration partner Bayer HealthCare (BAYZF) (BAYRY) has submitted an application to the EMA for marketing authorization in the European Union for Eylea (aflibercept) for the treatment of macular edema following branch retinal vein occlusion (BRVO).
The U.S. FDA approved the drug for the treatment of wet Age-related Macular Degeneration (AMD) in November 2011 and for Central Retinal Vein Occlusion (CRVO) in September 2012. The EMA has also approved Eylea for wet AMD and Macular Edema following CRVO.
Regulatory submissions have been made to the FDA for Macular Edema following BRVO and in the EU for Diabetic Macular Edema.
Regeneron has exclusive rights to Eylea in the U.S. Bayer HealthCare has exclusive marketing rights ex-U.S. (the companies equally share the profits). In Japan, Regeneron receives a percentage of sales.
The deal that will strengthen Boston's portfolio of products for treating peripheral vascular disease, with the company to receive systems used in cardiology, radiology and peripheral vascular procedures.
Notable points conveyed by Merck (MRK) CEO Ken Frazier in his investor presentation: Consumer business sales to Bayer (BAYRY) was 7x sales, expected to close in 2H; CV collaboration: Adempas (riociguat) lauched in U.S., E.U. and Japan, Variciguat (BAY 102) in Phase 2 trial, $1B upfront payment to Bayer.
Cancer immunotherapy candidate MK-3475 BLA filed, granted priority review.
Nine Phase 3 trials underway; ten near-term new product launches possible; ten markets deliver 70% of MRK revenue; top 50 customers expected to deliver 50% of revenue by 2016.
Grow EPS off the 2014 base; deliver industry-leading ROC to shareholders.
Merck's (MRK) consumer care business includes well-known brands like Claritin, Afrin, and Coppertone. "The combination of Merck Consumer Care's complementary portfolio of products and geographic reach with Bayer's will create a global consumer care business better positioned to serve consumers around the world," says Bayer (BAYZF, BAYRY) Chairman Dr. Marijn Dekkers.
Merck CEO Kenneth Frazier: "By unlocking value in Merck Consumer Care, we’re able to further our goal of being the premier research-intensive biopharmaceutical company through targeted investments that strengthen our product portfolio and enhance our pipeline.”
The U.S. regulator denies Bayer's (BAYRY +0.01%) request to change its aspirin labeling to include the claim of preventing heart attacks in patients with no history of cardiovascular disease. It cites the lack of data supporting the claim that the preventive benefits to a first attack outweigh the higher risks of bleeding in the stomach and brain.
There is evidence that the benefits of taking aspirin by patients who have already experienced a coronary event outweigh the increased risks of bleeding.
A 2010 study by Scottish researchers showed that aspirin did not prevent heart attacks or strokes in asymptomatic high risk people. The incidence of coronary events was similar to placebo.
Aspirin generated 916M euros ($1.27B) in sales last year.
Reckitt Benckiser ceases its efforts to buy Merck's (MRK -0.3%) OTC business saying that the bidding has gotten out of hand. Yesterday, Bayer (BAYRY +1.2%) reportedly offered to trade its animal health business to Merck plus cash. This would appear to give it the upper hand versus Reckitt considering comments from Merck CEO Ken Frazier that each of his firm's businesses needs to be a top player or get out. Its animal health business is a laggard but adding Bayer's would vault it into the top tier.
Bayer is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. At the same time Bayer creates value through innovation, growth and improved earning power. <br /> <br />Bayer HealthCare AG researches, develops, manufactures and markets...More