January 13, 2010 -  Another first to come out of Alabama:  BioCryst receives approval to market the first commercial drug in Japan. (Just two months ago according to the Triangle Business Journal, the U.S. Department of Health and Human Services bought $22.5 million worth of the H1N1 flu treatment from the Birmingham, Ala.-based biotechnology company.  

Wednesday, January 13, 2010

By Jimmy DeButts Staff   

Nearly a quarter century after its founding BioCryst Pharmaceuticals Inc. has approval to market its first commercial drug.

The Birmingham-based biotech firm, launched in 1985, said Wednesday its partner Shionogi & Co. Ltd. has received marketing and manufacturing approval for its flu drug Peramivir in Japan. BioCryst (Nasdaq: BCRX) will receive a $7 million milestone payment from Shionogi after intravenous Peramivir received regulatory approval.

BioCryst may receive future commercial event milestone payments of up to $95 million from Shionogi, according to a news release.

Shionogi intends to commercially launch Peramivir as RAPIACTA in Japan, pending the product's National Health Insurance price listing, the release said.

"This first approval of a BioCryst discovered drug is a major step in our journey towards building an enduring and successful biopharmaceutical company," BioCryst CEO Jon P. Stonehouse said.

Stonehouse, who became CEO in January 2007, expects Peramivir's success to pave the way for future BioCryst commercial drugs. He said the key was building strong clinical development and regulatory teams in the past three years to complement the firm's research operations.

"It’s taken a while to get here but the fact that we’ve gotten here is huge," Stonehouse said. "It reinforces that we have a great discovery engine in Birmingham. There’s more to come.”

The company launched out of the University of Alabama at Birmingham has had a series of positive announcements this week. On Tuesday, BioCryst said Peramivir had been approved in Mexico to treat flu patients. That was a day after it said it inked deals with two international partners to push Peramivir toward the commercial market in the Middle East, North Africa, Russia and Europe. BioCryst is partnering with Merck Serono to get Peramivir into the Europe, Russia, Canada and Singapore markets. The firm is working with Hikma Pharmaceuticals PLC for the Middle East and North Africa region, excluding Israel.