Onyx Pharmaceuticals Inc. (ONXX) recently announced disappointing news with the company deciding to delay the filing of its New Drug Application (NDA) for carfilzomib with the US Food and Drug Administration (FDA).
The filing, which has been pushed out to mid-2011, came on the back of Onyx Pharma’s meeting with the Chemistry, Manufacturing and Controls (CMC) review division of the FDA. In the meeting, the regulatory body has asked for additional CMC information on the manufacturing of carfilzomib.
Onyx Pharma was previously planning to file the NDA by the end of 2010. The company was planning to seek accelerated approval of the candidate. Carfilzomib is currently in multiple trials for the treatment of patients with multiple myeloma and other cancers.
Onyx Pharma added that it had come across certain minor variations in a recent manufacturing-scale checking. These variations are expected to be related to equipment temperature difference, and the company plans to provide the FDA with additional information related to these variations.
In September, Onyx Pharma had entered into an agreement with a Japanese company, Ono Pharmaceutical Co. Ltd., for the development and commercialization of carfilzomib and ONX 0912, in Japan. ONX 0912, the follow-up version of carfilzomib, is currently in phase I testing.
We currently have a Neutral recommendation on Onyx Pharma, which is supported by a Zacks #3 Rank (short-term Hold rating). The delay in the filing time-line for carfilzomib is disappointing, given the fact that Onyx Pharma currently markets only one product, Nexavar (cancer), with a lot of hope pinned on carfilzomib, its lead pipeline candidate.
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