From CNBC Posted By: Mike Huckman
Almost exactly one year since Onyx Pharmaceuticals announced positive results of its drug Nexavar for liver cancer and the stock doubled in one day, the biopharmaceutical company is providing an example of the ups and downs of drug development and biotech investing.
On President's Day, Onyx issued this press release, saying it had stopped a clinical trial of Nexavar for lung cancer because it didn't look like it would meet its main goal of extending patients' lives.
In fact, Onyx Onyx Pharmaceuticals Inc and its partner Bayer say there were more deaths in a specific subset of patients who got Nexavar. The late-stage study had enrolled more than 900 previously untreated patients with non-small cell lung cancer at more than 140 clinical trial sites worldwide. The patients got chemo and Nexavar or chemo plus placebo.
The trial was stopped after a planned interim analysis and on the recommendation of a data safety monitoring committee. Officials say they just got the news over the holiday weekend.
In brief prepared remarks on a conference call this morning, Onyx CEO Hollings Renton said, "Clearly we are disappointed by the lung cancer results. (But) these results don't change our long-term outlook that Nexavar can become a standard of care across a number of tumor types."
Onyx and Bayer are testing Nexavar on skin cancer, pancreatic cancer, breast cancer and leukemia. Renton said Nexavar will become "a cornerstone of cancer care." Nonetheless, the stock fell even more during the conference call.
Officials said because of "the dynamics of the marketplace," they can't give sales guidance for this year and don't feel comfortable projecting profitability for the full year 2008, although there could be profitable quarters.
In a research note to clients this morning, Leerink Swann analyst Howard Liang writes, "...the early termination (of the clinical trial) for lack of efficacy was not expected. Removal of (lung cancer sales) projections would significantly reduce the earnings leverage that would have translated into large upside in valuation." [标签:content1][标签:content2]
作者:admin@医学,生命科学 2011-05-24 05:14