National Marketing Authorization for DTaP-IPV Issued by Germany
Company's Combination Vaccine Now Approved
For Sale in Europe's Largest Vaccine Market
COLUMBIA, Md., Feb. 1 /PRNewswire/ -- North American Vaccine (Amex: NVX) announced today that the German regulatory authorities have issued a national marketing authorization for North American Vaccine's DTaP-IPV vaccine, a combined diphtheria, tetanus, acellular pertussis and inactivated injectable polio vaccine. This approval establishes North American Vaccine's presence in the largest vaccine market in Europe with a population of over 80 million and the market potential for such a combination vaccine is approximately $50 million annually.
"This approval represents a significant milestone and further establishes North American Vaccine as a serious competitor in a rapidly expanding international vaccine market," stated Randal Chase, Ph.D., Chief Executive Officer and President of North American Vaccine. "We expect that the German marketing authorization for DTaP-IPV, together with the recent FDA approval of Certiva(TM), will serve as a solid foundation for revenue growth in the coming year."
Under the German marketing authorization, the DTaP-IPV vaccine will be utilized for active immunization against diphtheria, tetanus, pertussis (whooping cough) and polio in infants. The DTaP-IPV will be marketed and distributed in Germany by Chiron Behring, which is one the largest and most widely respected vaccine marketing organizations in that country. "This approval is the result of a concerted effort by the Company and its collaborators Statens Serum Institut of Copenhagen, Denmark and Chiron Behring of Marburg, Germany," stated Dr. Stephen Keith, Vice President-Marketing and Sales at North American Vaccine. "We anticipate that, with the demonstrated safety and efficacy of our acellular pertussis vaccine and the marketing expertise and strength of Chiron Behring, our DTaP-IPV vaccine will be well received in this important vaccine market."
The acellular pertussis component of the DTaP-IPV vaccine consists of a monocomponent purified pertussis toxoid that has been detoxified with hydrogen peroxide. This vaccine has been used universally in Denmark since 1997 and no serious vaccine associated adverse events have been reported after administration of more than 300,000 doses of the vaccine since the product was first launched. This is consistent with the data from the safety and efficacy studies submitted to support approval. In those studies none of the infants and children who received the DTaP-IPV or the DTaP vaccine experienced hypotonic hyporesponsiveness (collapse) episodes and the rates of local reactions, such as soreness, redness and swelling, were very low. Moreover, surveillance and epidemiologic studies in Goteborg, Sweden for more than a decade, along with results from efficacy trials and a Swedish effectiveness study, establish that the Company's pertussis toxoid protects vaccine recipients and induces herd immunity.
The detoxification technology used in the manufacture of the pertussis toxoid contained in the DTaP-IPV vaccine was developed by scientists at the National Institutes of Health and is the subject of U.S. and foreign patents licensed exclusively to North American Vaccine. North American Vaccine produces the monocomponent acellular pertussis toxoid and Statens Serum Institut (SSI) manufactures the remaining components and will formulate the final product. The DTaP-IPV vaccine manufactured by SSI, and incorporating the Company's acellular pertussis toxoid, has previously been approved in Sweden, Denmark, Finland and the Company and SSI are anticipating further regulatory authorizations in other European countries. |
