FDA OKs lung drug MedImmune cleared to market Synagis, a lifesaver for infants

'Breakthrough product'

Announcement comes after market closes

shares up all week

Pharmaceuticals

June 20, 1998|By Kristine Henry | Kristine Henry,SUN STAFF

MedImmune Inc. yesterday won government go-ahead to market its new drug for a potentially life-threatening respiratory disease in premature infants and young children.

Synagis, which was approved for sale by the U.S. Food and Drug Administration, was developed to prevent serious respiratory syncytial virus, or RSV, a disease that causes pneumonia and bronchitis and is especially serious for premature infants.

According to MedImmune, 4,500 children in the United States die of RSV every year and 85,000 are hospitalized for it.

"We're really happy to get the product approved. We think it's a breakthrough product that will protect infants," said Julie Adamou, a project manager at MedImmune.

"It also has a lot of potential to bring us to the next stage to be an earnings-driven company."

On Tuesday, the company announced that it had spent more than $10 million to buy out two of the drug's patent holders with the aim of keeping a higher percentage of future Synagis earnings. The announcement sent MedImmune's shares up $3 to $50.75 and they gained another $5.50 Wednesday.

MedImmune closed yesterday at $56.75 before the company announced the FDA approval.

Caroline Copithorne, a biotechnology analyst at Prudential Securities Inc., said many people had expected the drug to be approved, although the news came sooner than expected.

"They got some run-up and I think they'll continue to see more," Copithorne said. "This is a down-the-road event, not just a today event."

Copithorne said Synagis sales had been expected to reach $300 million by 2000, but will likely be even stronger because the FDA approved the drug for a broad range of patients.

MedImmune already makes a drug called RestiGam that treats the same disease as Synagis. But RestiGam is more difficult to administer and has proved to be less effective.

It was thought that the FDA would likely approve Synagis for the same patient population as RestiGam -- infants with bronchopulmonary dysplasia and those born prematurely.

Instead, the FDA approved Synagis for use on children at "high risk" of respiratory syncytial virus -- a broader definition that will allow doctors to prescribe it to more patients.

MedImmune tests found that Synagis, which can be administered by injection in a doctor's office, reduced respiratory syncytial virus hospitalizations by 55 percent, compared with RestiGam's 41 percent.

Synagis is administered once a month during the times the virus is most prevalent -- generally between October and April.

More than 90 percent of this year's supply of Synagis will be produced at a Boehringer Ingelheim Pharma KG facility in Biberach, Germany, if the FDA approves the site.

The approval is expected in the next few months.

Eventually, Synagis will be produced at MedImmune's new facility in Frederick. Construction of the site is complete, Adamou said, but it will likely be at least a year or two before the facility is validated by the FDA.

MedImmune has a marketing agreement with Abbott Laboratories in which Abbott's Ross Products Division will co-promote Synagis in the United States. Outside the country, the International Division of Abbott Laboratories has the exclusive right to market and distribute the drug.

MedImmune is one of the state's first biotechnology start-ups to become profitable. The company reported net income of $13.2 million for the first quarter ended March 31, compared with a loss of $14.3 million in the first quarter of 1997.

Pub Date: 6/20/98

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