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Bayer's Stivarga® (regorafenib) Tablets New Drug Application Granted Priority Review by U.S. FDA for the Treatment of Patients with Gastrointestinal Stromal Tumors

Monday, October 29, 2012

Bayer's Stivarga® (regorafenib) Tablets New Drug Application Granted Priority Review by U.S. FDA for the Treatment of Patients with Gastrointestinal Stromal Tumors11:03 EDT Monday, October 29, 2012WAYNE, N.J. and SOUTH SAN FRANCISCO, Calif., Oct. 29, 2012 /PRNewswire/ -- Bayer HealthCare and Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) announced today that the U.S. Food and Drug Administration (FDA) granted priority review to the New Drug Application (NDA) filed at the end of August 2012 for Stivarga® (regorafenib) tablets to treat patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with two kinase inhibitors. The submission was based upon data from the pivotal, global Phase III GRID study.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 aims to complete its review within six months from the receipt of the NDA submission, rather than the standard 10-month review cycle.  Stivarga is a Bayer compound developed by Bayer and jointly promoted by Bayer and Onyx in the U.S.  In 2011, Bayer entered into an agreement with Onyx, under which Onyx receives a royalty on all future global net sales of Stivarga in oncology. This priority review follows the recent FDA approval of Stivarga for the treatment of patients with metastatic colorectal cancer (mCRC) who had been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. About Gastrointestinal Stromal Tumors (GIST)GIST is the most common form of sarcoma (a type of cancer that develops from certain tissues, like bone or muscle) involving the gastrointestinal tract. In the United States, it is estimated that there are approximately 4,000-5,000 new cases of GIST diagnosed each year, of which about 1,500 have already metastasized at diagnosis. GIST may not cause any symptoms and may be found incidentally when the doctor is looking for other problems.[1,2,3]About Stivarga® (regorafenib) Stivarga is approved in the U.S. for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.[4] Stivarga is an oral multi-kinase inhibitor that inhibits various kinases within the mechanisms involved in tumor growth and progression ? angiogenesis, oncogenesis and the tumor microenvironment. In preclinical studies, Stivarga inhibits several angiogenic VEGF receptor tyrosine kinases that play a role in tumor neoangiogenesis (the growth of new blood vessels). It also inhibits various oncogenic and tumor microenvironment kinases including KIT, RET, PDGFR, and FGFR.Important Safety Information for Stivarga (regorafenib)WARNING: HEPATOTOXICITY: Severe and sometimes fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function prior to and during treatment. Interrupt and then reduce or discontinue Stivarga for hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis, depending upon severity and persistence.Obtain liver function tests (ALT, AST, and bilirubin) before initiation of Stivarga and monitor at least every 2 weeks during the first 2 months of treatment. Thereafter, monitor monthly or more frequently as clinically indicated. Monitor liver function tests weekly in patients experiencing elevated liver function tests until improvement to less than 3 times the upper limit of normal (ULN) or baseline values.In clinical trials, Stivarga was associated with an increased incidence of hemorrhage, including fatal hemorrhage. Permanently discontinue Stivarga in patients with severe or life-threatening hemorrhage and monitor INR levels more frequently in patients receiving warfarin.Hand-foot skin reaction (HFSR) (also known as palmar-plantar erythrodysesthesia [PPE]) and rash are the most frequently observed dermatological reactions with Stivarga. Temporarily hold and then reduce or permanently discontinue Stivarga depending on the severity and persistence of dermatologic toxicity.An increased incidence of hypertension has been observed with Stivarga. Do not initiate Stivarga until blood pressure is adequately controlled. Monitor blood pressure weekly for the first 6 weeks of treatment and then every cycle, or more frequently, as clinically indicated. Temporarily or permanently withhold Stivarga for severe or uncontrolled hypertension.Stivarga has been associated with an increased incidence of myocardial ischemia and infarction. Withhold Stivarga in patients who develop new or acute cardiac ischemia or infarction, and resume only after resolution of acute cardiac ischemic events.Reversible posterior leukoencephalopathy syndrome (RPLS) has been reported with Stivarga. Confirm the diagnosis of RPLS with MRI and discontinue Stivarga in patients who develop RPLS.Gastrointestinal perforation and fistula have been reported in patients treated with Stivarga. Permanently discontinue Stivarga in patients who develop gastrointestinal perforation or fistula.Treatment with Stivarga should be stopped at least 2 weeks prior to scheduled surgery. The decision to resume regorafenib after surgery should be based on clinical judgment of adequate wound healing. Stivarga should be discontinued in patients with wound dehiscence.Stivarga can cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.The most frequently observed adverse drug reactions (> or = 30%) in Stivarga-treated patients vs placebo-treated patients, respectively, were: asthenia/fatigue (64% vs 46%), decreased appetite and food intake (47% vs 28%), HFSR/PPE (45% vs 7%), diarrhea (43% vs 17%), mucositis (33% vs 5%), weight loss (32% vs 10%), infection (31% vs 17%), hypertension (30% vs 8%), and dysphonia (30% vs 6%).For full prescribing information, including BOXED WARNINGS, visit www.stivarga-us.com. About Oncology at BayerBayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer's oncology franchise now includes two oncology products and several other compounds in various stages of clinical development. Together, these products reflect the company's approach to research, which prioritizes novel targets and pathways with the potential to transform the way that cancer is treated across tumor types and stages of disease.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.STIVARGA® is a trademark of Bayer®. Bayer® and the Bayer Cross® are registered trademarks of Bayer.  Intended for U.S. Media OnlyForward-Looking StatementThis 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 results of clinical development, regulatory processes, safety and commercial potential of Stivarga (regorafenib). 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: competition; failures or delays in clinical trials or the regulatory process;  Onyx or Bayer, as the case may be, may be unsuccessful in launching, maintaining adequate supply of or obtaining reimbursement for Stivarga; market acceptance and the rate of adoption of Stivarga; pharmaceutical pricing and reimbursement pressures; serious adverse side effects, if they are associated with Stivarga; and government regulation. 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.[1] Joensuu H. Gastrointestinal stromal tumor (GIST). Annals of Oncology. 2006 September; Volume 17. Available on http://annonc.oxfordjournals.org/content/17/suppl_10/x280.full.pdf+html . Accessed October 19, 2012.[2] American Cancer Society Gastrointestinal Stromal Tumor (GIST) (Last Revised 2/1/2012). Available at http://www.cancer.org/acs/groups/cid/documents/webcontent/003103-pdf.pdf. Accessed October 12, 2012[3] Gold, J. Combined Surgical and Molecular Therapy: The Gastrointestinal Stromal Tumor Model. Annals of Surgery. 2006 August; 244(2): 176?184. Available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1602162/.  Accessed October 26, 2012.[4] STIVARGA Prescribing Information. September 2012. SOURCE Bayer HealthCare Pharmaceuticals Inc.For further information: Rose Talarico, Bayer HealthCare Pharmaceuticals, +1-973-305-5302, rose.talarico@bayer.com; Danielle Bertrand, Onyx Pharmaceuticals, Inc., +1-650-266-2114, OR Investors: Amy Figueroa, Onyx Pharmaceuticals, Inc., +1-650-266-2398