Recently, Onyx Pharmaceuticals (ONXX) came out with positive data from a phase IIb study of carfilzomib at the 51st annual meeting of the American Society of Hematology (ASH) in New Orleans. We are pleased to see that carfilzomib was found to be well-tolerated in heavily pre-treated relapsed and refractory multiple myeloma patients. The company also stated that enrollment of 269 patients in this trial has been completed and data should be available in the second half of 2010. We believe favorable data could support a potential new drug application (NDA) filing by year-end 2010.

Additionally, Onyx reported safety data from another study that showed carfilzomib can be used in patients over a long period of time even for those who are suffering from other illnesses. Carfilzomib was added to Onyx’s portfolio following the company’s acquisition of Proteolix for an upfront cash payment of $276 million during the third quarter of 2009. We believe that the acquisition of Proteolix has resulted in a significant addition to Onyx’s cancer pipeline.

A late-stage, multiple myeloma study to evaluate carfilzomib in combination with Celgene Inc‘s (CELG) Revlimid and the anti-inflammatory steroid dexamethasone is expected to start in 2010. FDA approval of carfilzomib, potentially in 2011, would provide further options to patients who have not responded to other multiple myeloma drugs. Carfilzomib is also being evaluated in early stage studies for solid tumor cancers.

While there’s no cure for multiple myeloma, on approval, carfilzomib will compete with Velcade, sold in the US by Takeda Pharmaceutical and overseas by Johnson & Johnson (JNJ). Multiple myeloma, the second most common hematologic cancer, results from an abnormality of plasma cells usually in the bone marrow. More than 50,000 people are living with the disease in the US and approximately 20,000 new cases are diagnosed annually. More than 180,000 people suffer from multiple myeloma globally with approximately 86,000 new cases being diagnosed annually. Onyx can enter the $4 billion myeloma market as soon as 2011 if the FDA evaluates the drug under an accelerated six month review process.

Zacks Investment Research

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