By Lisa Seachrist
Washington Editor
BioCryst Pharmaceuticals Inc. said marketing partner R.W. Johnson Pharmaceutical Research Institute (RWJPRI) has initiated the Phase III program for its flu pill (RWJ-270201) in North America and Europe in time to catch the end of this year's flu season.
The initiation of the trials triggered a $4 million milestone payment to BioCryst and means the oral neuraminidase inhibitor could be available for marketing during the 2001-02 flu season.
"We're ecstatic; we couldn't be happier," said John Uhrin, vice president of corporate development for Birmingham, Ala.-based BioCryst. "From the beginning we focused on the 2001-2002 flu season for when we would market this product. With the start of Phase III, we are still on track."
RWJ-270201 (formerly BCX-1812) is a once-a-day oral formulation to treat influenza. The drug was designed to treat and prevent viral influenza by inhibiting the enzyme neuraminidase, which is essential for viral replication. The drug is active on both A and B strains of influenza.
RWJPRI has begun a series of Phase III studies to test the drug's ability to fight the flu. The studies will include patients at high risk for complications as well as healthy people. Under the terms of the agreement with BioCryst, RWJPRI and Ortho-McNeil, both Johnson & Johnson companies, have full responsibility for and control of all aspects of further development of the compound. That deal was struck almost 17 months ago when the product was still in the preclinical stage.
"It's pretty phenomenal they could take a drug all the way to a Phase III program in less than 17 months," Uhrin said.
Uhrin said BioCryst and RWJPRI were scheduled to meet to discuss the specifics of the Phase III plan in the next few weeks. However, he also noted RWJPRI was committed to following the flu season into the Southern Hemisphere in order to complete the Phase III program.
BioCryst's stock (NASDAQ:BCRX) closed on Tuesday at $25, up $3.187, or 15 percent.