By Randall Osborne
West Coast Editor
Aches and pains overtook BioCryst Pharmaceuticals Inc., whose stock dropped 53 percent Thursday on news that its partner, R.W. Johnson Pharmaceutical Research Institute (RWJPRI), will not carry out its plan to start two clinical studies in high-risk elderly patients of RWJ-270201, a neuraminidase inhibitor pill for influenza.
"We still have a drug in Phase III [trials]," said Randall Pittman, chief financial officer of Birmingham, Ala.-based BioCryst, noting worldwide trials in the general public, which began early this year and triggered a $4 million milestone payment to BioCryst, are ongoing. (See BioWorld Today, Feb. 9, 2000.)
The company's shares (NASDAQ:BCRX) closed Thursday at $7.187, down $8, after trading as low as $4.25 during the day.
RWJPRI, a Johnson & Johnson company, blamed "logistical considerations" for the delay in trials with the elderly, but Wall Street was skeptical, and RWJPRI said a new drug application (NDA) would not be filed until 2002, later than expected.
"I don't think there's ever been a published date, but there was some market expectation it would be filed next year," Pittman said.
"The whole process is really in [RWJPRI's] hands," he added. "They're continuing with trials as we speak, and development plans have not been canceled or shelved, anything like that. We just heard this for the first time [Wednesday] afternoon."
Meirav Chovav, an analyst with Salomon Smith Barney in New York, called the move by RWJPRI "very puzzling." She wrote in a research note that, "three weeks ago, during the ICAAC [Interscience Conference on Antimicrobial Agents and Chemotherapy] infectious disease meeting, J&J representatives . . . told us directly that everything was on track with the program and that market concerns about problems with the program were unfounded."
There had been rumblings in January about potential FDA holdups in the start of Phase III trials in the U.S., and officials from both companies said the trials were on track. (See BioWorld Today, Jan. 10, 2000, p. 1.)
Chovav, who was traveling Thursday and could not be reached, wrote that, "while J&J is now stating that the delay is due to logistical reasons only, we are concerned about the implications as to the future of the drug."
Marc Monseau, spokesman for RWJPRI, said the company's policy barred him from commenting.
"I really can't get into specific details about any of our clinical programs, including this one," Monseau told BioWorld Today. "What I can tell you is that is has nothing to do with safety and efficacy."
With flu season in North America just weeks away, the BioCryst delay means one less combatant in the flu-drug arena. Relenza, an inhaled neuraminidase inhibitor marketed by Glaxo Wellcome Inc., a U.S. subsidiary of London-based Glaxo Wellcome plc, has been approved as was Tamiflu (oseltamivir phosphate, formerly GS4104), developed by Gilead Sciences Inc., of Foster City, Calif., and licensed to Hoffmann-La Roche Inc., of Nutley, N.J.
Relenza was developed by Melbourne, Australia-based Biota Holdings Ltd., licensed to Glaxo, and approved in the summer of 1999. (See BioWorld Today, July 28, 1999.)
Tamiflu, an oral neuraminidase inhibitor, was approved in October 1999. Relenza and Tamiflu are the only approved drugs that fight A and B strains of influenza and reduce the duration of flu symptoms. (See BioWorld Today, Oct. 29, 1999.)
In June, Roche filed a new drug application for use of Tamiflu and Tamiflu oral suspension in children 12 months and older. A month earlier, the company asked the FDA to expand the label to include the prevention of naturally occurring influenza in adults and adolescents 13 years and older. (See BioWorld Today, June 19, 2000, and May 24, 2000.)
Pittman said BioCryst has about $70 million in cash, with a net loss last year of $5.3 million, a burn rate that "varies, but that's our most recent."