Shares in North American Vaccine Inc. tumbled more than 16 percent yesterday as word hit Wall Street that the Food and Drug Administration has requested more information about its whooping cough vaccine, Certiva.
The stock closed at $18.56, down $3.62 a share.
Neither the FDA nor the Beltsville-based company would disclose what information has been requested. But Dr. Sharon Mates, the company's chief executive officer, said the company wasn't asked to conduct additional costly and time-consuming human clinical trials to show that the drug is safe or effective.
The stock's slide actually dates to Jan. 2, when it closed at $25.
Ronald J. Stern, an analyst who follows the company for Buckingham Research Group in New York, said that the FDA delay, while unexpected, was not critical because it didn't involve questions about safety or effectiveness. "If they were calling for new trials, then I'd be worried," he said.
"The thing people have to remember is that, when it comes to vaccines for children, the FDA is very cautious -- and rightly so. I'm convinced they'll get approval this quarter," Stern said.
He also noted that, once the FDA approves the vaccine, Certiva should get into the market quickly and see strong sales.
The reason, said Stern: It will be backed by a 500-member pediatrics sales force of Abbott Laboratories, of Abbott Park, Ill. The pharmaceutical giant, which has a strong presence in pediatrics, licensed the rights to market Certiva in the United States. Abbott will pay North American Vaccine $3 million upon FDA approval for Certiva, and $23 million in additional payments as certain sales milestones are achieved.
On yesterday, Mates expressed disappointment that the company hasn't received approval to market the drug in the United States yet. The company had expected FDA approval by the end of last year.
"Clearly, I am disappointed. I'd prefer to have licensure to market [Certiva]," said Mates.
In the meantime, several competitors, including British-based SmithKline Beecham PLC, and Connaught Laboratories, based in Pennsylvania, have landed approvals to market their new pertussis vaccines.
North American has approvals to market Certiva in Denmark and Sweden.
But the U.S. market for whooping cough vaccines is the largest -- estimated at $300 million annually.
In a meeting with the FDA late last week, at which the additional information was requested, Mates said, the FDA "conveyed that we are on the final steps for licensure. We are all on the same page."
North American Vaccine said it has the requested information available and planned to get it to the FDA shortly. The company now projects marketing approval for the vaccine by the end of the current quarter -- March 31 -- or soon thereafter.
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.
Certiva was developed using a piece of the pertussis bacteria, thereby causing fewer side effects than traditional whooping cough vaccines which use the entire bacteria.
Those vaccines were linked to brain damage and less severe side effects in a small percentage of children, resulting in some European countries banning their use.
North American Vaccine's application to market the vaccine has been under consideration since an October 1996 FDA advisory panel met to discuss the merits of the request.
That panel made no formal recommendation to the FDA on whether the vaccine should be approved or not, but some panel members said it was unclear from the data how effective the vaccine was.
Pub Date: 1/13/98