StivargaTreatment for Colorectal Cancer, Gastrointestinal Stromal Tumor, Hepatocellular Carcinoma
Update: Stivarga (regorafenib) Now FDA Approved - September 27, 2012
U.S. FDA Grants Priority Review to the New Drug Application for Bayer's Regorafenib to Treat Patients with Metastatic Colorectal Cancer
WAYNE, N.J. and SOUTH SAN FRANCISCO, Calif., June 28, 2012 /PRNewswire/ -- Bayer HealthCare and Onyx Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has granted priority review designation to Bayer HealthCare's New Drug Application (NDA) filed end of April 2012 for the oral multi-kinase inhibitor regorafenib, for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed after approved standard therapies.
The FDA grants priority review to medicines that provide a treatment where little or no adequate therapy exists. Under the Prescription Drug User Fee Act (PDUFA), the FDA will complete its review within six months from the receipt of the NDA submission, rather than the standard 10-month review cycle.
The submission was based upon data from the pivotal, global Phase III CORRECT study.
About RegorafenibRegorafenib is an investigational oral multi-kinase inhibitor and is currently being investigated in clinical trials for its potential to treat patients with various tumor types.
Regorafenib is an investigational agent and is not approved by the FDA, EMA or other health authorities.
Regorafenib is one of several cancer compounds in Bayer's development pipeline. In 2011, Bayer entered into an agreement with Onyx Pharmaceuticals, Inc., under which Onyx will receive a royalty on any future global net sales of regorafenib in oncology. Bayer and Onyx will co-promote regorafenib in the U.S.
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
About Onyx Pharmaceuticals, Inc.
Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com.
Bayer® and the Bayer Cross® are registered trademarks of Bayer.
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
This news release contains "forward-looking statements" of Onyx within the meaning of the federal securities laws. These forward-looking statements include, without limitation, statements regarding the potential expansion of Onyx's product portfolio, the possibility of royalty payments to Onyx from the sale of regorafenib, and the timing, progress and results of clinical development and the regulatory approval process. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: Nexavar being our only approved product; we may never receive marketing approval for Kyprolis (carfilzomib) or regorafenib; competition; failures or delays in our clinical trials or the regulatory process; dependence on our collaborative relationship with Bayer; if approved, we or Bayer, as the case may be, may be unsuccessful in launching, maintaining adequate supply of or obtaining reimbursement for Kyprolis or regorafenib; market acceptance and the rate of adoption of our products; pharmaceutical pricing and reimbursement pressures; serious adverse side effects, if they are associated with Nexavar, regorafenib or Kyprolis; government regulation; possible failure to realize the anticipated benefits of business acquisitions or strategic investments; protection of our intellectual property; the indebtedness incurred through the sale of our 4.0% convertible senior notes due 2016; and product liability risks. Reference should be made to Onyx's Annual Report on Form 10-K for the year ended December 31, 2011 filed with the Securities and Exchange Commission, as updated by Onyx's subsequent Quarterly Reports on Form 10-Q, under the heading "Risk Factors" for a more detailed description of these and other risks. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.
SOURCE Bayer HealthCare Pharmaceuticals Inc.
CONTACT: Bayer Media Contact: Rose Talarico, +1-973-305-5302, firstname.lastname@example.org; Onyx Contacts: Investors: Amy Figueroa, Senior Director, +1-650-266-2398; Media: Danielle Bertrand, Senior Manager, Corporate Communications, +1-650-266-2114
Web Site: http://www.bayer.com
Posted: June 2012
- FDA Expands Approved Use of Stivarga (regorafenib) to Treat Hepatocellular Carcinoma - April 27, 2017
- FDA Approves Stivarga for Advanced Gastrointestinal Stromal Tumors - February 25, 2013
- FDA Approves Stivarga for Advanced Colorectal Cancer - September 27, 2012
- Bayer Submits New Drug Application for Regorafenib for the Treatment of Gastrointestinal Stromal Tumors (GIST) - August 30, 2012
- Bayer Submits New Drug Application for Regorafenib for the Treatment of Metastatic Colorectal Cancer - May 23, 2012