SCIO, another one that could be real interesting
(as well as very risky) the next few days. I am already long...this came out late this afternoon.
Scios back to FDA panel with lead drug candidate
By Lisa Richwine
WASHINGTON, May 23 (Reuters) - Scios Inc. (NASDAQ:SCIO) returns to a U.S. advisory panel on Friday seeking an endorsement for its leading drug candidate, heart failure treatment Natrecor, a product regulators turned down two years ago.
Natrecor, given intravenously, is designed to treat hospital patients with acute flare-ups of congestive heart failure, a chronic condition that afflicts about 5 million Americans. If approved, Natrecor would be the first new heart failure treatment in more than 10 years.
It also would be the first approved product for Sunnyvale, California-based Scios.
"It's key. Scios equals the Natrecor franchise for now," said equities analyst Mark Monane of Needham & Co., who predicted annual sales for the product could hit $300 million.
A Food and Drug Administration advisory panel recommended approval for Natrecor in 1999, but the agency later rejected the company's application. Regulators asked for more data comparing the drug to intravenous nitroglycerin, the standard treatment.
On Friday, Scios will present data from a study comparing the two treatments to an FDA advisory committee, and the panel is expected to vote on whether to recommend marketing approval.
The study of 489 patients with acute heart failure found that Natrecor did better than nitroglycerin in quickly relieving symptoms such as shortness of breath.
"We have really demonstrated (Natrecor) was better than current standard of care," Scios Chief Scientific Officer George Schreiner said in an interview.
Congestive heart failure most often occurs when heart muscle is damaged from coronary artery disease, depriving heart muscles of oxygen. High blood pressure also can be a cause. Symptoms result from congestion that develops as fluid backs up into the lungs and leaks into tissue.
Flare-ups can occur when patients forget to take daily medication or eat too much.
Natrecor, known generically as nesiritide, is a genetically engineered version of a natural heart hormone that works by causing causing blood vessels to dilate and relax, easing blood flow.
Side effects, including low blood pressure, were no higher for Natrecor than with nitroglycerin, Schreiner said.
Industry analysts said they expected Scios to win FDA approval this time because the company's data showed clear benefits and some panel members supported the drug during its last review.
"They've got more to go on this time around," said analyst Eric Schmidt of SG Cowen Securities, who predicted peak annual sales of $200 million or higher.
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