cafepharma’s detailpiece

At the Wachovia Securities Healthcare Conference, Onyx Pharmaceuticals (NASDAQ: ONXX) presented recent financial results and information regarding ongoing studies for its lead product, Nexavar. Juliana Woods, VP of Investor Relations discussed financial performance and overall development programs. Henry Fuchs, M.D., discussed clinical trials in more detail. The presentation can be heard in its entirety at: http://www.wsw.com/webcast/wa48.

Nexavar has been approved in the EU and the US for liver cancer and it has been approved in more than 60 countries for kidney cancer. Nexavar has been shown to have a dual effect on cancer via inhibition of members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply).  Its proven success in prolonging survival times in patients with liver and renal cancer and its ease of administration (it is taken orally by pill in the patient’s home) has led to accelerating revenue growth.

For the first three quarters in 2007, net sales of Nexavar have grown approximately 20 million per quarter (247 million in overall sales for the first nine months of 2007). Onyx is conducting numerous studies to expand usage and maximize the potential of Nexavar. Dr Fuchs mentioned one researcher’s promising finding using twice the labeled dose of Nexavar in kidney cancer patients. The increased dose was tolerated by most of the patients and led to remission in a number of patients with complete remission in some. Dr Fuchs said that there are efforts under way to study this dose and replicate its results in other clinics.

There are clinical studies underway in additional liver cancer regimens, breast cancer, and melanoma. If Nexavar can replicate its ability to prolong survival times in metastatic breast cancer and melanoma patients, Onyx should see significantly increased revenues. In the U.S. Onyx co-promotes Nexavar with Bayer. Bayer has full promotion rights outside of the U.S.

The Onyx team did not address Nexavar’s patent protection strategy or expected patent lifespan. They did point out that Nexavar is the only systemic drug approved for liver cancer in the U.S. However, bio-similars are already an issue in the E.U. and will become more of an issue in the U.S.

Should Nexavar prove to be as successful in improving treatment options in other cancers as it has been in liver and kidney cancer, both patients and investors will benefit.