By Randall Osborne

Gearing up for FDA approval to sell its drug against a virus that can cause pneumonia in high-risk children, MedImmune Inc. has formed an exclusive worldwide marketing alliance worth up to $60 million with Abbott Laboratories and signed a manufacturing and supply agreement with Boehringer Ingelheim GmbH.

Gaithersburg, Md.-based MedImmune said in July the drug, a humanized monoclonal antibody called MEDI-493 (palivizumab), showed positive results in Phase III trials against respiratory syncytial virus (RSV) in infants. The company plans to file a biologic license application with the FDA by the end of this year. (See BioWorld Today, July 17, 1997, p. 1.)

Under terms of the deal with Abbott, of Abbott Park, Ill., MedImmune has received a $15 million payment and would get $30 million more upon approval to sell the drug in the U.S. and Europe. Another $15 million would come if Abbott reaches certain sales levels.

Two pacts were signed with Abbott. One is a threshold-based, copromotion deal in the U.S., and the other is a distribution agreement outside the country. MedImmune would be credited with all U.S. sales, with Abbott receiving a commission above designated thresholds and each company paying its own selling expenses.

The manufacturing alliance with Boehringer Ingelheim, of Ingelheim, Germany, is through Boehringer's subsidiary, Dr. Karl Thomae GmbH, of Biberach, which will supplement MedImmune's production capacity for MEDI-493. No terms were disclosed.

May Replace RespiGam

Healthy children and people with adequate immune systems often get a mild chest cold when infected with RSV, but in the U.S. about 90,000 high-risk children — those born prematurely or suffering from bronchopulmonary dysplasia — are hospitalized every year with severe forms of the disease, such as pneumonia and bronchiolitis. Of those patients, about 4,500 die.

Already on the market is MedImmune's polyclonal antibody product against RSV, called RespiGam, an immune globulin drug, the sales of which jumped from $500,000 in the third quarter of 1996 to $7 million in the third quarter of this year. The company began selling RespiGam in January 1996.

"We expect that MEDI-493 will replace RespiGam," said Julie Adamou, spokeswoman in investor relations for MedImmune.

MEDI-493 can be injected with one shot, making it more convenient to administer than RespiGam, which takes four hours to infuse in a hospital. The new drug also is easier to make, since it's engineered in the laboratory rather than formulated using donated blood. MEDI-493 is purer, too — thus more potent — because it's an engineered product that contains nothing but RSV antibodies.

"With RespiGam, you've got antibodies to RSV, but also antibodies to a lot of other things," Adamou said.

Although FDA approval typically takes a year, the company hopes to get MEDI-493 on the market by next October, the month when RSV cases start showing up in the Northern Hemisphere. "[The FDA] understands the nature of RSV, and the fact that it's a winter disease," Adamou said.

Based on news of the collaborations, Vector Securities International Inc., of Deerfield, Ill., upgraded MedImmune's stock (NASDAQ:MEDI) from "attractive" to "buy." Abbott's 600 office-based salespeople in the company's pediatrics division and MedImmune's sales staff of 50 will provide important leverage with pediatricians, according to an investors' report by Vector.

The transfer of technology to Boehringer is under way, and $200 million worth of MEDI-493 could be manufactured as early as 1998. Commission paid by MedImmune to Abbott on U.S. sales will be 30 to 35 percent when MEDI-493 sales reach an annual volume of $300 million, said the Vector report, which estimated revenues for MedImmune of $334 million by 2001.

As of Sept. 30, MedImmune had $30.78 million in cash, with a net loss of $40.18 million for the first nine months of 1997.

MedImmune's stock closed Monday at $42.125, up $3.875. *

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