North American Vaccine said yesterday that it has turned over to the Food and Drug Administration all of the additional information the agency had requested about its new whooping cough vaccine for children and is confident the drug will win U.S. marketing approval soon.
Shares in the Beltsville-based vaccine developer closed higher yesterday at $18.125, up $2.375, on the news.
"We feel very confident we'll have approval very soon," said Stephen M. Keith, vice president for sales and marketing for North American Vaccine.
Keith cautioned that there was no certainty that the vaccine, named Certiva, would get the green light from the FDA, but he said the company has been in close discussions with the agency and did not expect further delays.
If approved by the FDA, Certiva would be the first product the 12-year-old company, which employs 260, has won clearance to market in the United States.
The U.S. market for whooping cough vaccines is the largest, at an estimated $300 million annually.
Pertussis strikes more than 50 million worldwide, mostly children, annually. The disease causes coughing, gasping and choking spells ending with a "whoop" of indrawn breath.
The FDA's review of the vaccine has taken longer than the company and analysts had expected. FDA approval for Certiva, a combination vaccine that also prevents diphtheria and tetanus, originally had been forecast as coming by the end of last year.
In January, that estimate was bumped to March 31 after the FDA unexpectedly requested additional information. Neither the FDA nor the company would disclose specifically what information was requested, though the FDA did not call for additional human trials.
Yesterday, North American said that the FDA has advised the company that only a few steps remain before it makes a decision.
The company said the FDA is expected to begin an inspection of its manufacturing facilities in mid-May as part of its final review.
In the meantime, several competitors, including British-based SmithKline Beecham PLC, and Connaught Laboratories, based in Pennsylvania, already have begun marketing their new pertussis vaccines in the United States.
North American has approvals to market Certiva in Denmark and Sweden. The vaccine marketed in Sweden also provides protection against polio.
North American's Keith said the company is confident it can land a strong share of the whooping cough vaccine market despite a late entry.
He noted the company's marketing partner is Abbott rTC Laboratories of Abbott Park, Ill. The company has one of the largest pediatric market sales forces.
"Abbott has a very strong presence among pediatricians, and Certiva has a very strong safety and efficacy record," said Keith. "It's not always No. 1 in the market that gets the largest market share."
North American posted a loss of $43.8 million on $9.7 million in revenue last year.
Pub Date: 5/08/98