North American Vaccine Inc. said yesterday that it had won a key regulatory approval in Europe for a vaccine for children, and expects the vaccine's sales to help fuel revenue growth this year.
The Columbia-based vaccine developer said German regulatory authorities gave marketing approval to the company's combined injectable vaccine for diphtheria, tetanus, pertussis -- or whooping cough -- and polio.
The DTaP-IPV vaccine was approved for use in infants and children up to six years of age, and will be marketed and distributed in Germany under an agreement with Chiron Behring, one of the largest vaccine distributors in Germany.
With its population of 84 million and its strong health care network, Germany is considered one of Europe's key markets for new drugs and medical products.
Steven Keith, North American's vice president for marketing and sales, said the company had not yet set a price for the vaccine, but estimated that consumers would pay $30 to $40 per injection.
Randal Chase, North American's new chief executive and president, said the approval represented "a significant milestone" for the company and "establishes North American Vaccine as a serious competitor in a rapidly expanding international vaccine market."
North American's combined vaccine is marketed in Sweden, Denmark and Finland. It generated $1 million in sales in 1998, according to the company's latest financial report. The company hopes to land approvals in Austria, Norway and Poland.
Chase said the company, which reported a net loss of $56.6 million last year on revenue of $8.4 million, expects its sales in Germany to increase revenue. The company estimates the German market potential for combination vaccines for children at $50 million annually.
Shares in North American Vaccine closed yesterday at $7.125, up 18.75 cents.
Pub Date: 2/02/99