Onyx Modifies Carfilzomib EU Trial - Analyst Blog

Onyx Pharmaceuticals Inc. (ONXX) recently said that it plans to expand its phase III (FOCUS) trial, which is being conducted to support the European filing of carfilzomib as a treatment for relapsed and refractory myeloma. The company is conducting the FOCUS trial to evaluate the efficacy and tolerability of carfilzomib in patients with relapsed and refractory myeloma.

Onyx Pharma plans to change the primary endpoint of the trial to overall survival from progression-free survival. The company intends to enroll 300 patients instead of 84.

In February, the US Food and Drug Administration (FDA) granted fast track status to carfilzomib for the treatment for patients with relapsed and refractory multiple myeloma.

Earlier, in December last year, Onyx Pharma reported positive results on the candidate from a phase IIb trial (003-A1). The results showed that patients 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.

On the basis of these results, Onyx Pharma initiated the submission of a rolling New Drug Application (NDA) for gaining accelerated approval of carfilzomib for relapsed and refractory multiple myeloma. The company expects to complete the submission by mid-2011.

Onyx Pharma 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. The company plans to initiate a mid-stage trial of the candidate in 2011.

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.

Global Nexavar sales, recorded by partner Bayer AG (BAYRY), amounted to $934.0 million and $257.4 million for the full year and fourth quarter 2010, respectively, reflecting an increase of 11% and 9%.

During the fourth quarter, Onyx Pharma saw an improvement in Nexavar sales in the Asia-Pacific region, led primarily by Japan and China. Additionally, the company was granted reimbursement for Nexavar for the treatment of liver cancer in South Korea. The company also expects to receive reimbursement for Nexavar in Taiwan by year end.

The improvement in Nexavar’s performance is encouraging as the drug had performed below expectations in the first nine months of 2010.

Further, Onyx Pharma expects Nexavar sales to amount to $975 million to $1.025 billion in 2011, reflecting a year-over-year increase of 5% to 10%. Moreover, Nexavar sales are anticipated to experience double-digit growth in the Asia-Pacific region.

Our Take

We currently have a Neutral recommendation on Onyx Pharma, which is supported by a Zacks #3 Rank (short-term Hold rating). Going forward, we expect investor focus to remain on the approval status of carfilzomib.

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