Onyx' Cancer Drug on Right Track - Analyst Blog

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Onyx Pharmaceuticals Inc. ( ONXX ) recently announced the US Food and Drug Administration's (FDA) acceptance of its new drug application (NDA) for carfilzomib, for review. The company is seeking to get carfilzomib approved as a treatment for patients with relapsed and refractory multiple myeloma.

We note that Onyx Pharma had initiated the submission of the rolling NDA earlier this year in January and completed the same at the end of September. The company's NDA submission is based on positive results on the candidate from a mid-stage trial (003-A1).

The trial demonstrated that patients, dosed with the said candidate, experienced an overall response rate of 24.1%, while the clinical benefit rate was higher at 34.2%. The duration of response was 8.3 months, while the median overall survival was 15.5 months. The patients, who enrolled in the study, had already received a median of five prior lines of therapy and their disease was refractory to their last therapeutic regimen.

We note that the FDA granted orphan drug designation to carfilzomib for the treatment of multiple myeloma in 2008. Following the drug's approval, this status will provide Onyx Pharma with seven years of US marketing exclusivity.

Onyx Pharma is currently conducting a randomized international phase III trial (ASPIRE or 009), to evaluate the combination of Celgene Corp. 's ( CELG ) Revlimid and low dose dexamethasone with or without carfilzomib in relapsed multiple myeloma patients.

The study, which is being conducted under the FDA's special protocol assessment ( SPA ) program, is expected to complete enrollment in the first half of 2012. Data from the study is expected to be released in the first half of 2013.

Additionally, Onyx Pharma is conducting a phase III study (FOCUS) to support the European filing of carfilzomib as a treatment for relapsed and refractory myeloma. Top-line data from the study is expected in the first half of 2012.

The company has 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-on version of carfilzomib, is currently in phase I testing. Onyx Pharma plans to initiate a mid-stage trial with ONX 0912 by year-end.

Our Recommendation

We currently have a Neutral recommendation on Onyx Pharma. The stock carries a Zacks #3 Rank (Hold rating) in the short-run. We believe that the approval of carfilzomib would be a major positive for Onyx Pharma, which currently has just one marketed product, Nexavar (cancer), in its portfolio.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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