Onyx Expects Early 2008 Launch For Nexavar In Liver Cancer
This article was originally published in The Pink Sheet Daily
Executive Summary
Firm expects more off-label use of Nexavar in liver cancer in second half of 2007.
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While Onyx Pharmaceuticals reported a net loss of $10.8 million, or $0.22 per share for the second quarter 2007, the firm had its "strongest quarter to date," with sales of Nexavar (sorafenib), co-marketed with Bayer, rising dramatically, especially ex-U.S., and with several milestones in sight. Under the Nexavar collaboration, Bayer posts all revenues from sales of the drug. Bayer said in its second quarter 2007 earnings report that Nexavar sales revenues were $81 million for the quarter, with $32 million in U.S. sales and $49 million in ex-U.S. sales - an increase of 160.9 percent over the same period last year (1 (Also see "Bayer Puts Marketing Muscle Behind Yaz" - Pink Sheet, 7 Aug, 2007.)). "We anticipate continued positive momentum over the next 18 months, with top-line sales growth, potential regulatory actions in liver cancer, results from ongoing Phase III and Phase II clinical trials and the continued expansion of our clinical development program," Onyx CEO Hollings C. Renton said. "With our collaborator Bayer, we are proactively pursuing a comprehensive development strategy across many tumor types," Renton said, including lung cancer, melanoma and liver cancer. The firm completed enrollment in its first Phase III non-small cell lung cancer study and initiated the first two randomized Phase II trials in its comprehensive breast cancer program. Nexavar, an oral multi-kinase inhibitor, was approved to treat advanced kidney cancer in December 2005. Bayer/Onyx announced the submission of an sNDA for the liver cancer indication June 27 (2 (Also see "Bayer/Onyx Submit Nexavar sNDA For Liver Cancer" - Pink Sheet, 27 Jun, 2007.)). The Emeryville, Calif., firm expects to launch Nexavar for liver cancer "early next year," Renton said in a same-day conference call with investors. Wall Street was upbeat about the firm's future, increasing revenue expectations and speculating that some of the growth will be due to off-label use of Nexavar for liver cancer. Bear Stearns analyst Akhtar Samad increased Nexavar worldwide sales estimates to $327 million for 2007, up from $285 million, "based on our expectation of increased off-label use for Nexavar in [hepatocellular carcinoma] in 2H07 and a strong launch in 2008." Friedman, Billings, Ramsey & Co. analyst Jim Reddoch said in an Aug. 8 note that his firm is maintaining its $137 million estimate for U.S. sales in 2007. "This includes a small amount of liver cancer sales as we have been hearing about off-label use of both Nexavar and Sutent in liver cancer," he wrote. "We do expect more in the second half of the year outside of the label," Renton said in response to an analyst question, while emphasizing that the firm is only promoting the drug for the kidney cancer indication. Potential competitors in the hepatocellular carcinoma setting include Pfizer's Sutent (sunitinib), which will go into Phase III in the indication in 2008, and Wyeth's mTOR inhibitor Torisel (temsirolimus) that it is developing with NIH. Torisel and Sutent are currently approved for renal cell carcinoma. -Pamela Taulbee ([email protected]) |