Key Developments: Bayer AG (BAYZF.PK)

Bayer AG Asks Japan to Approve Riociguat For Pulmonary Hypertension-DJ
Friday, 17 May 2013 03:22am EDT 

Dow Jones reported that Bayer AG has filed its Riociguat drug for the treatment of chronic thromboembolic pulmonary hypertension for regulatory approval in Japan. The Company submitted Riociguat in early February 2013 for regulatory approval in the United States and the European Union.  Full Article

Bayer AG To Acquire Herbal Medicine Maker Steigerwald Arzneimittelwerk GmbH-Reuters
Thursday, 16 May 2013 07:41am EDT 

Reuters reported that Bayer AG said it agreed to buy privately held Steigerwald Arzneimittelwerk GmbH (Steigerwald), a maker of herbal treatments. The Company added that Steigerwald generated sales of EUR 61.3 million (USD 78.8 million) in 2012 with 180 staff. It did not disclose financial terms of the takeover.  Full Article

Bayer AG Gets FDA Approval For Advanced Prostate Cancer Drug; Bayer AG And Algeta ASA To Co-Promote Xofigo in United States-DJ
Wednesday, 15 May 2013 02:14pm EDT 

Dow Jones reported that Federal regulators approved a new drug from Bayer AG to treat certain types of advanced prostate cancer. The drug, which will be sold with the brand name Xofigo, is meant to treat prostate cancer that has spread to the bones, but not other organs, in men who have previously received separate therapy designed to lower testosterone. Testosterone is a hormone that can stimulate prostate cancer growth. The drug will cost USD 69,000 for a complete course of therapy, which would be six injections given at four-week intervals. Xofigo was initially under development by Algeta ASA. In 2009 Bayer AG entered into an agreement with Algeta ASA to get the drug to the marketplace. Bayer AG and Algeta ASA will co-promote Xofigo in the United States. Algeta ASA in a statement said the drug's production is underway and is expected to be available in a few weeks.  Full Article

Stepan Co To Acquire North American Polyester Resins Business From Bayer AG's Bayer MaterialScience
Tuesday, 30 Apr 2013 06:00am EDT 

Stepan Co announced that it has reached an agreement with Bayer MaterialScience to acquire North American Polyester Resins business, including the production facility located in Columbus, Georgia. The definitive agreement is projected to close within four to six weeks. Financial terms of the transaction were not disclosed.  Full Article

Bayer AG's Bayer HealthCare LLC To Acquire Conceptus, Inc
Monday, 29 Apr 2013 02:30am EDT 

Bayer HealthCare LLC announced that it has signed a merger agreement with Conceptus, Inc., the California-based developer of the Essure procedure, the non-surgical permanent birth control method, which is sold in the United States and other countries. Within the next ten business days, Bayer will launch a public tender offer to acquire all shares in Conceptus, Inc. The transaction values Conceptus, Inc. at approximately USD1.1 billion (approx. EUR852 million) representing USD31.00 per share in cash. Closing is subject to customary conditions, in particular anti-trust approval in the U.S., and is expected by mid-year 2013. Bayer HealthCare, is a subgroup of Bayer AG.  Full Article

Bayer AG Confirms FY 2013 Sales Guidance
Thursday, 25 Apr 2013 02:48am EDT 

Bayer AG announced that it confirms its sales forecast for 2013. The Company continues to expect sales for the full year 2013 to increase by 4% to 5% to approximately EUR 41 billion, based on unchanged currency assumptions. According to I/B/E/S Estimates, analysts on average are expecting the Company to report fiscal year 2013 revenue of EUR 41,496.19 million.  Full Article

US Court Finds Bayer AG’s Yaz Contraceptive Patent Claims Invalid-Reuters
Tuesday, 16 Apr 2013 01:04pm EDT 

Reuters reported that a federal appeals court has ruled against Bayer AG, reversing a ruling by a lower court and finding that parts of a patent for the Company’s Yaz oral contraceptive were invalid. The United States Court of Appeals for the Federal Circuit ruled on April 16, 2013 that a district court in Nevada had erred in finding two claims of a patent for the contraceptive to be not invalid. It reversed the ruling. The patent expires on June 30, 2014.  Full Article

Bayer AG And Monsanto Co. Enter Into Licensing Agreement-DJ
Tuesday, 16 Apr 2013 09:35am EDT 

Dow Jones reported that Bayer AG said its CropScience unit and Monsanto Co. have entered into a series of licensing agreements for next-generation and enabling technologies in plant biotechnology. Monsanto Co. will provide Bayer AG’s CropScience with a royalty-bearing license to technology in some soybeans in the United States and Canada. CropScience will also receive a royalty-bearing license regarding soybeans in Brazil with an option to a royalty-bearing license in other Latin-American countries in the future. CropScience has also been granted stacking-rights under certain conditions and it will grant Monsanto licenses to evaluate enabling technologies for corn rootworm control and herbicide tolerance. Financial details were not disclosed.  Full Article

Bayer AG's Investigational Riociguat Granted U.S. FDA Priority Review For Pulmonary Arterial Hypertension And Inoperable Or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension
Monday, 8 Apr 2013 02:30am EDT 

Bayer AG's Bayer HealthCare announced that the New Drug Application (NDA) for oral investigational compound riociguat has been accepted for filing and granted priority review by the U.S. Food and Drug Administration (FDA) for the treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or with persistent or recurrent CTEPH after pulmonary endarterectomy (PEA) and pulmonary arterial hypertension (PAH). Both CTEPH and PAH are life-threatening diseases. CTEPH is a form of pulmonary hypertension in which blood clots and thromboembolic occlusion of pulmonary vessels leads to increased pressure in the pulmonary arteries. PAH is a disease characterized by elevated pressure in the pulmonary arteries. Under the Prescription Drug User Fee Act (PDUFA), the FDA aims to complete review within six months of the 60-day filing receipt of the NDA submission (eight months total), rather than the standard 12-month review cycle.  Full Article

Bayer AG's Colorectal Cancer Treatment Stivarga Approved In Japan-DJ
Monday, 25 Mar 2013 04:26am EDT 

Dow Jones reported that Bayer AG said that Japan's Ministry of Health, Labor and Welfare has approved Stivarga tablets for the treatment of patients with unresectable, advanced/recurrent colorectal cancer. The approval is based on results from the pivotal Phase III CORRECT study that demonstrated an improvement in overall survival and progression-free survival compared to placebo in patients with metastatic CRC whose disease had progressed after approved standard therapies. Stivarga is an oral multi-kinase inhibitor that inhibits various kinases within the mechanisms involved in tumor growth and progression - angiogenesis, oncogenesis and maintenance of the tumor microenvironment.  Full Article

EU watchdog backs Bayer acne drug for certain patients