Onyx Pharmaceuticals, Inc. ( ONXX ) recently provided an update on its performance in 2012 and its plans for 2013.
Kyprolis Off to a Strong Start
Oncology product Kyprolis, which was launched in late July 2012, is off to a solid start with 2012 sales expected to cross $62 million. Strong adoption trends and rapid account penetration should ensure continued strong ramp of Kyprolis sales. The company estimates that about 25% of the 10-15k targeted patient population has received Kyprolis as of October 2012.
Onyx Pharma is currently evaluating Kyprolis in other studies including the FOCUS study which is being conducted to support the European filing of Kyprolis as a treatment for relapsed and refractory myeloma. Interim results should be out in the second half of 2013. The company is also looking for partnership deals in other countries where marketing authorization could be gained on the basis of US approval.
Stivarga Shows Promise
Oncology product, Stivarga, which has been developed by Bayer ( BAYRY ), could be a blockbuster. Stivarga gained FDA approval for the treatment of metastatic colorectal cancer (mCRC) in late September 2012, a month ahead of expectations. Bayer is also seeking FDA approval for Stivarga for treating patients suffering from metastatic and/or unresectable gastrointestinal stromal tumors (GIST). Bayer is looking to expand Stivarga's label further and is planning to initiate two phase III studies this year - one in second-line hepatocellular carcinoma (HCC) and the other in CRC following resection of liver metastases.
Nexavar Label Expansion Efforts
Onyx Pharma continues to work on expanding Nexavar's label. Nexavar, which is currently approved and marketed worldwide for the treatment of HCC or liver cancer and advanced renal cell carcinoma (RCC) or advanced kidney cancer, recently fared well in a late-stage study conducted in patients suffering from with locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer. A supplemental new drug application (sNDA) for the thyroid indication could be filed in 2013.
Another late-stage study is being conducted in patients suffering from locally advanced or metastatic HER2-negative breast cancer.
Another breast cancer candidate, PD-0332991 (PD-991), which is being developed with Pfizer ( PFE ), is scheduled to enter into a phase III study this year.
Onyx Pharma, which was a one-product company until a year back, has successfully transformed into a multi-product company. With two recent product approvals (Kyprolis and Stivarga) in its bag and Nexavar continuing to perform well, Onyx Pharma looks all set for growth. We expect 2013 to be a catalyst-filled year for Onyx Pharma as the company works on expanding the labels of currently marketed products and progresses with the development of other candidates.
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