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Bayer Submits New Drug Application For Regorafenib For The Treatment Of Gastrointestinal Stromal Tumors (GIST)

WAYNE, N.J. and SOUTH SAN FRANCISCO, Calif., Aug. 30, 2012 /PRNewswire/ -- Bayer HealthCare and Onyx Pharmaceuticals (NASDAQ: ONXX) today announced that Bayer HealthCare has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the oral multi-kinase inhibitor regorafenib for the treatment of metastatic and/or unresectable gastrointestinal stromal tumors (GIST) in patients whose disease has progressed despite prior treatment.

Regorafenib is a Bayer compound developed by Bayer. 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 jointly promote regorafenib in the United States.

"The submission of regorafenib for the treatment of GIST marks an important milestone for Bayer, bringing us one step closer to potentially addressing a significant medical need for patients with this rare but aggressive disease," said Pamela A. Cyrus, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. "With the development of regorafenib and other oncology compounds, we remain committed to discovering and advancing cancer therapies for patients who are in need of new treatment options."

The submission is based on data from the pivotal Phase III GRID ( GIST – Regorafenib In Progressive Disease) trial, which showed that regorafenib plus best supportive care (BSC) significantly improved progression-free survival (PFS) compared to placebo plus BSC [HR=0.27 (95% CI 0.19-0.39), p<0.0001] in patients with metastatic and/or unresectable GIST who were previously treated with imatinib and sunitinib. The median PFS was 4.8 months in the regorafenib arm versus 0.9 months in the placebo arm and there was a positive trend in the regorafenib group in improving overall survival (OS) [HR=0.77 (95% CI 0.42-1.41), p=0.20]. In addition, the study design allowed patients receiving placebo to cross-over following disease progression.

In this study, the most frequently reported drug-related adverse events (greater than or equal to 25%) in regorafenib-treated patients versus placebo-treated patients, respectively, were hand-foot skin reaction (56.1% vs.13.6%), hypertension (48.5% vs. 16.7%), diarrhea (40.2% vs.4.5%), fatigue (38.6% vs. 27.3%) and oral mucositis (37.9% vs. 7.6%).  Results from the study were presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2012.

In addition, the FDA recently agreed that Bayer can proceed with its expanded access program (EAP) to provide regorafenib to patients diagnosed with GIST through qualified clinical sites participating in the EAP. For more information on this program, visit www.clinicaltrials.gov [NCT01646593].

About the GRID Study

GRID was a randomized, double-blind, placebo-controlled, multi-center, cross-over Phase III study of regorafenib for the treatment of GIST. It randomized 199 patients whose disease had progressed despite prior treatment with imatinib and sunitinib.

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