By Lisa Seachrist
The first of BioCryst Pharmaceuticals Inc.'s flu drugs that were part of a 1998 development and marketing deal with Johnson & Johnson (J&J) has proven positive in a Phase II trial.
The trial, conducted by J&J's R.W. Johnson Pharmaceutical Research Institute (PRI), of Raritan N.J., demonstrated the flu drug's ability to reduce the levels of virus in infected patients. The news sent Birmingham, Ala.-based BioCryst's stock (NASDAQ:BCRX) soaring to close at $32 a share, up $9.062, or 39.5 percent.
"These clinical results showed statistical significance for the primary endpoint," said Craig Rothenberg, a spokesman for J&J. "And, the safety evaluation showed the drug was well tolerated by patients. The clinical development team is now looking at the next steps."
The product, RWJ-270201 - formerly called BCX-1812 by BioCryst - is a small-molecule neuraminidase inhibitor. Neuraminidase is crucial to the replication cycle of influenza, promoting the release of new viral particles produced by infected cells. Inhibiting neuraminidase blocks the ability of the flu virus to spread from cell to cell.
With an estimated 120 million people in the North America, Western Europe and Japan likely to suffer from influenza this year, the potential market for drugs that can lessen the misery of the disease is huge.
The Phase II trial was a placebo-controlled randomized study that tested the ability of RWJ-270201 to reduce the viral titer in infected subjects compared to placebo. This study and all further development of the drug will be directed by PRI under the terms of the marketing and development agreement the two company's reached in 1998. (See BioWorld Today, Sept. 16, 1998, p. 1.)
BioCryst will receive milestone payments and royalties on worldwide sales of the product. Ortho-McNeil would market the product in the U.S. and Janssen-Cilag, of Antwerp, Belgium, and other J&J companies would market outside the U.S.
The J&J-BioCryst product, should it receive approval, likely would vie in a marketplace with two established flu therapies. Glaxo Wellcome plc's inhaled neuraminidase inhibitor flu therapy, Relenza, received marketing approval in July (see BioWorld Today, July 28, 1999, p. 1). Gilead Sciences Inc., of Foster City, Calif., and Hoffmann-LaRoche Inc., of Nutley, N.J., also have an oral neuraminidase inhibitor. A decision on its marketability could be made this year.