FDA OKs preemie vaccine MedImmune cleared to market RespiGam

January 20, 1996|By Timothy J. Mullaney | Timothy J. Mullaney,SUN STAFF

MedImmune Inc. yesterday won the right to market its pneumonia vaccine for premature infants in the United States, setting the 7-year-old Gaithersburg biotechnology company on the path to as much as $100 million in annual sales and profitability by 1998 or 1999.

The U.S. Food and Drug Administration approved MedImmune's RespiGam for prevention of respiratory syncytial virus (RSV) in infants. Most RespiGam will be administered to premature babies because they often have weak immune systems that place them at higher risk of developing serious complications such as pneumonia when they contract RSV.

"It's the single most common cause of hospitalization for kids under 1 year old in the U.S.," said Val G. Hemming, a pediatrician at the Uniformed Services University of the Health Sciences in Bethesda. "Infection is ubiquitous in kids that age, and the ones who do the worst are those who were born too soon."

FDA Commissioner David A. Kessler said RespiGam is the first drug that reduces serious RSV disease in high-risk infants. The drug is licensed for use in premature infants and children under 2 with bronchopulmonary dysplasia, a chronic breathing disorder resulting from long-term reliance on artificial respiration.

The FDA said 90,000 children are hospitalized annually for RSV disease and 4,500 die of its complications. Babies who develop RSV complications often are forced to return to intensive care and to use ventilators, which Dr. Hemming said can set back their development by up to three months.

RespiGam can reduce or prevent RSV complications, but is not a cure. The development of RespiGam continued through a bruising FDA approval process that included a humiliating 1993 rejection of MedImmune's research by an FDA advisory panel. MedImmune stock fell from $31.25 a share to $3.50 over a year, and the drop sparked a stockholder lawsuit that was settled for $4.2 million last month.

Mark E. Kaufmann, MedImmune's manager of strategic planning and investor relations, declined to say by how much the company thinks RespiGam will boost its sales. The company has announced plans for a new stock sale, and federal law bars MedImmune from most public statements advertising or promoting the offering.

Until now, MedImmune had only one approved drug, and, like most biotech start-ups, has consistently lost money. It lost $14.1 million in the first nine months of 1995.

But analysts at Morgan Stanley & Co. and Scott & Stringfellow Inc. have estimated that RespiGam sales will quickly reach any

where from $82 million to $100 million, at an average price of $4,543 per course of treatment.

Yesterday, MedImmune announced that it has expanded its sales team to 56 members from 16 in anticipation of the FDA's decision.

The drug will also be sold by representatives for American Home Products, MedImmune's marketing partner.

The company is still deciding where it will make RespiGam, which is produced by a contract manufacturer for now. MedImmune is considering proposals from officials in Maryland and Ohio, each offering financial aid if MedImmune puts the plant in its state.

The factory is expected to create 50 to 100 jobs.

"I would expect a decision in the near future," Mr. Kaufmann said, adding that the competition appears to have heated up since the announcement that the Cleveland Browns will move to Baltimore.

"If we believe [the aid packages] are similar, or Maryland's is better, we would prefer to locate in Maryland."

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