By Randall Osborne
Two years after the FDA approved its first drug against a virus that can cause pneumonia in children, MedImmune Inc. has submitted a biologics license application (BLA) for second product designed to prevent the disease.
The first drug, a polyclonal antibody called RespiGam, was approved in January 1996. The second is a humanized monoclonal antibody called MEDI-493, which has been given the trade name Synagis. Both products target respiratory syncytial virus (RSV), which can be fatal when it afflicts high-risk infants and young children.
"We hope the FDA might be able to approve [Synagis] in time for the RSV season, which means during the fall of next year," said Mark Kaufmann, associate director of strategic planning and investor relations for MedImmune, of Gaithersburg, Md.
Synagis, given by intramuscular injection, is expected to replace RespiGam, which is administered by infusion, he said. "Some of the major adverse events [with RespiGam] were infusion-related," Kaufmann said. "A lot of times you have problems with fluid overload."
The efficacy of Synagis may be construed as better, he added.
"The data will have to be seen as a whole for both products," Kaufmann said. "We haven't compared them side by side. But if you look at the two pivotal trials, we showed a 55 percent reduction in RSV hospitalization for RespiGam, and 41 percent for Synagis."
On the other hand, the polyclonal antibody RespiGam may be viewed as better in certain cases. "Other antibodies are in there, and some physicians may opt for that quality in the product," Kaufmann said. "RespiGam will not be discontinued."
MedImmune is considering improved formulations of the RSV drug. "Right now, we own the RSV franchise worldwide, and we want to keep that," Kaufmann said. "I wouldn't say this is the end [of RSV products]." No new drugs for the virus are in the clinic yet, he said.
In July, MedImmune reported positive Phase III trial results with Synagis. Earlier this month, the company signed a worldwide marketing alliance worth up to $60 million with Abbott Laboratories, of Abbott Park, Ill. (See BioWorld Today, July 17, 1997, p. 1, and BioWorld Today, Dec. 2, 1997, p. 1.)
Also this month, SmithKline Beecham plc, of London, agreed to pay more than $85 million for the worldwide marketing rights to MedImmune's human papillomavirus vaccine, which is in Phase I trials. (See BioWorld Today, Dec. 12, 1997, p. 1.)
MedImmune's stock (NASDAQ:MEDI) closed Monday at $41.50, up $0.625. *