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Biotech / Medical : NPSP NPS Pharmaceutical -- Ignore unavailable to you. Want to Upgrade?

To: mopgcw who wrote (191)	2/25/2004 4:12:11 PM
From: tuck	Respond to of 363

>>NEW YORK, Feb 25 (Reuters) - The chief executive of NPS Pharmaceuticals Inc. (NasdaqNM:NPSP - News) said he does not believe the company's experimental osteoporosis drug should have to carry the type of strong safety warning imposed on a similar drug from Eli Lilly. Hunter Jackson told participants at a Biotechnology Industry Organization (News - Websites) conference that the company's safety studies show less risk of bone cancer in rats than Eli Lilly and Co.'s (NYSE:LLY - News) new drug Forteo. Forteo carries a so-called black box warning, the strongest caution to patients and physicians that a drug carries a potentially serious side effect. Such warnings can substantially reduce a drug's sales potential. "Whether we will get a black box warning, I hesitate to predict," Jackson said. "We think there is a reasonable argument as to why we should not have a black box." Both drugs are bioengineered versions of human parathyroid hormone, which is released by the thyroid gland to keep a constant level of calcium in body tissues. Forteo is a fragment of the hormone while Preos is the full-length hormone. "We think we have a rationale as to why our product behaves differently," he said. Lilly officials were not immediately available for comment. The black box issue is important because it could give Preos an advantage over Forteo. The U.S. Food and Drug Administration (News - Websites) required Lilly to distribute patient-information leaflets and refrain from direct-to-consumer advertising. Lilly's drug received a black box warning after studies showed that at high doses, it raised the risk of cancer in rats. The effect was not seen in humans. NPS said in November that at low doses, its drug does not cause cancer in rats. However, at high doses, there was a higher incidence of cancer. The company said the risk was not as high as the risk associated with Forteo. "There has been some speculation that the easiest course for the FDA would be to give the class a warning," he said, referring to the new drug category containing Forteo and Preos. He said it was unusual for the FDA to impose the black box warning on Forteo based solely on rat data. NPS expects to file for U.S. marketing approval of Preos by the third quarter of this year, Jackson said. Jackson also said NPS is on track to release results from its late-stage clinical trial of the drug by the end of March. Both timelines are consistent with previous company forecasts. He said the company has not yet made a decision on whether it will form a partnership with a big drug company to market the drug. << Cheers, Tuck