Onyx Pharmaceuticals (ONXX-NASDAQ) is probably as happy as you could imagine that it partnered with Bayer (BAY-NYSE/ADR). ONXX shares are up 60% after they announced that an independent data monitoring committee has reviewed the safety and efficacy data from the companies’ pivotal Phase 3 trial in patients with advanced hepatocellular carcinoma (HCC), or primary liver cancer. The trial met its primary endpoint resulting in superior overall survival (OS) in those patients receiving Nexavar tablets versus those patients receiving placebo and noted that there was no demonstrated difference in serious adverse event rates between the two treatment arms (Nexavar and placebo). Based on these conclusions, the DMC recommended that the trial be stopped early and it will allow all patients enrolled in this trial access to Nexavar.
Liver cancer is a disease that has very limited approved systemic therapies, so the companies are going to be filing with regulatory agencies. The two companies also reported that they plan to submit the results from the trial to the American Society of Clinical Oncology (ASCO), for presentation at its annual meeting, June 1-5, 2007.
Primary liver cancer, is the most common form of liver cancer and is responsible for about 90 percent of the primary malignant liver tumors in adults. It is the fifth most common cancer in the world. Since Nexavar is already approved in 50 countries for kidney cancer, the street is deciding that the approvals for this could occur much sooner than would have otherwise been expected.
ONXX shares are up over 50% pre-market, and before this the stock had a market cap of $535 million; BAY shares are up only about 0.5% on the news. ONXX has been a volatile name, and you’ll see its 52-week trading range is $10.38 to $29.10 and this stock had reached nearly $60.00 back in 2004.
Jon C. Ogg
February 12, 2007
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