Onyx Pharmaceuticals Inc. (ONXX) recently announced that the U.S. Food and Drug Administration's (FDA) advisory committee is scheduled to review the company's new drug application (NDA) for Kyprolis (carfilzomib) on June 20, 2012. A final decision on the matter is expected by July 27, 2012, from the U.S. regulatory body. Onyx Pharma is looking to get Kyprolis approved for the treatment of patients with relapsed and refractory multiple myeloma (MM), who have received at least two prior therapies.
The company is currently studying Kyprolis in a late-stage study (ASPIRE) in combination with Celgene Corp.'s (CELG) Revlimid (lenalidomide) and low dose dexamethasone in patients with relapsed MM. The study is being conducted under the FDA's special protocol assessment (SPA). The company has also received scientific advice from the European Medicines Agency (EMA) on the design and planned analysis of the study.
We note that Onyx Pharma is banking heavily on the approval of Kyprolis as currently it just has one marketed product, Nexavar, in its portfolio. The company booked royalties of $72.0 million (up 7%) during the first quarter of 2012, from its collaboration with Bayer (BAYRY) for the development and marketing of Nexavar. The drug is currently marketed worldwide as a treatment for unresectable liver cancer and advanced kidney cancer.
Nexavar experienced impressive sales in the US along with increased demand in the emerging markets, especially Asia Pacific, in the first quarter.
Additionally, Onyx Pharma and Bayer are looking to expand Nexavar's label to boost sales. Late-stage trials of the drug are ongoing for lung and thyroid cancer.
We currently have a Zacks #1 Rank (short-term Strong Buy rating) on Onyx Pharma. We expect investor focus to remain on the approvability of Kyprolis and on the uptake and the label expansion of Nexavar.
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