Child vaccine cleared by FDA Md. company allowed to market Certiva for whooping cough


July 31, 1998|By Mark Guidera | Mark Guidera,SUN STAFF

North American Vaccine Inc. yesterday won a long-awaited Food and Drug Administration approval to market its new whooping cough vaccine for children in the United States.

The approval, which took the Beltsville-based company almost two years to land, marks the first U.S. product approval for the 12-year-old biotechnology company.

"This is really big for us," said Stephen M. Keith, vice president for sales and marketing for North American. "Clearly, the U.S. is a big market, and we're confident the vaccine will do well gaining market share."

Shares of North American Vaccine rose 43.75 cents to $14.31 yesterday.

The U.S. market for whooping cough vaccines is the largest, estimated at $300 million annually. Keith declined to comment specifically on how much of the market the company believes it can get.

North American's vaccine for pertussis, or whooping cough, will be marketed under the name Certiva; it has been marketed for about a year in Denmark and Sweden.

Pertussis, which is considered very contagious, most often strikes infants and young children, and causes coughing, gasping and choking spells ending with a "whoop" of indrawn breath.

Certiva is made from an inactivated part of the pertussis bacteria, rather than from the whole bacteria, eliminating some side effects.

North American will compete for a share of the $300 million market with SmithKline Beecham PLC, American Home Products Corp. and Rhone Poulenc SA, all of which have begun marketing pertussis vaccines in the United States.

Keith said North American, in which Canadian biotechnology company BioChem Pharma has a 31 percent stake, is not concerned about its late entry into the field.

"The clinical trials demonstrated that the vaccine is safe and very effective," Keith said. "We're very optimistic, especially since we have Abbott as our marketing partner."

Under a 1996 licensing agreement, Abbott Laboratories of Abbott Park, Ill., will market Certiva to U.S. pediatricians.

North American will market the vaccine to state and federal health agencies. Abbott, which will pay North American an undisclosed royalty on Certiva sales, has a sales force of 500 targeting the pediatric market in the United States.

$9 to $18 per immunization

The vaccine is expected to sell for $9 to $18 per immunization. It is estimated that about 25 million children are immunized against the disease annually in the United States.

Keith said North American, which employs 260, has not determined how large a sales force it will need to market Certiva to the government-sponsored market.

The company expects to begin selling and shipping the vaccine late this fall or winter. The vaccine will be produced at North American's plant in Beltsville.

Sharon Mates, president of North American, said the approval "firmly establishes North American as a long-term player in a rapidly expanding vaccine market."

Analysts originally forecast that the FDA would approve Certiva by the end of last year, but the approval was delayed when the FDA requested additional information about the vaccine and the results of clinical trials.

Help for other products

North American, which lost $11.8 million on revenue of $834,000 during the first quarter of this year, expects revenue from Certiva to help it accelerate development of some of its other 15 experimental vaccines.

Top priorities include getting approval to expand Certiva's use to the adolescent and adult markets, and seeking regulatory approvals for a combination vaccine for diphtheria, tetanus and TC acellular polio, Keith said.

Pub Date: 7/31/98

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