By Mary Welch
After setbacks the past two years, BioCryst Pharmaceuticals Inc. jumped ahead with a deal worth up to $55 million with Johnson & Johnson (J&J) to develop and market influenza drugs.
"We're hoping we've turned the corner on the bad news," said John Uhrin, vice president of corporate development for Birmingham, Ala.-based BioCryst.
Under the terms of the deal, focused on four influenza neuraminidase inhibitors, J&J paid BioCryst $6 million up front, and will pay another $6 million in a common stock equity investment. The remainder would come in milestone payments.
J&J gets exclusive worldwide rights to the inhibitors, including BioCryst's two lead product candidates: BCX-1812 and BCX-1827. The others are BCX-1898 and BCX-1923.
The orally administered compounds have shown potent activity in preclinical models against a broad spectrum of influenza A and B, Uhrin said.
BioCryst's deal was welcome news after its lead product, an ointment formulation of BCX-34 for plaque psoriasis failed in Phase II trial in April. Its topical cream formulation for treating cutaneous T-cell lymphoma and psoriasis, failed to achieve statistical significance in Phase III trials last year. (See BioWorld Today, April 30, 1998, p. 1, and Sept. 29, 1997, p. 1.)
The deals are between BioCryst and two J&J companies: R.W. Johnson Pharmaceutical Research Institute and Ortho-McNeil Pharmaceuticals Inc., both of Raritan, N.J
"We had done extensive preclinical work on [BCX-]1827 and, at the same time, we started to have interactive meetings with 10 multinational companies interested in the compounds," Uhrin said. "We, at that point, proceeded with [BCX-]1812. Hopefully, Johnson & Johnson will fully evaluate each compound, but BCX-1812 and [BCX-]1827 are the most fully developed, from a preclinical standpoint."
Full Responsibility For Development Goes To J&J
Preclinical data have not been disclosed. BioCryst and R.W. Johnson are working together to complete the additional studies required to start Phase I trials.
J&J now has full responsibility for developing and commercializing the compounds, and is "committed to an aggressive timetable," Uhrin said.
"We certainly don't want to overhype this," Uhrin told BioWorld Today. "[But,] as a potential $55 million deal, this is by far the biggest and most lucrative deal the company has made, and one of the largest in the neuraminidase inhibitor market."
Ortho-McNeil will market the products approved in the U.S., and Janssen-Cilag, of Antwerp, Belgium, and other Johnson & Johnson companies will market outside the U.S.
BioCryst's BCX compounds come from a new class of small molecules that work by inhibiting the influenza neuraminidase enzyme in a highly selective manner. Neuraminidase is crucial to the replication cycle of influenza, because it promotes the release of new viral particles produced by infected cells. Inhibition of neuraminidase blocks the ability of influenza to spread from cell to cell.
Other products in BioCryst's pipeline include BCX-34, a purine nucleoside phosphorylase inhibitor. The psoriasis ointment is "on hold indefinitely," but the company is still pursuing the compound in Phase I/II trials in an oral formulation for HIV, psoriasis and cutaneous T-cell lymphoma.
"At the end of the period, we will decide how to proceed with the oral formulation," Uhrin said. "We are currently escalating dosage and will look at the data early next year."
BioCryst is testing BCX-1470, a serine protease inhibitor for use during cardiopulmonary bypass surgery, in Phase I trials. The company's stock (NASDAQ:BCRX) closed Tuesday at $7, up $0.50. *