Marketing Authorization for DTaP and DTaP-IPV Issued by Austria
COLUMBIA, Md., April 29 /PRNewswire/ -- North American Vaccine (Amex: NVX) announced today that it has been advised that the Austrian regulatory authorities have issued a marketing authorization for North American Vaccine's DTaP vaccine, a combined diphtheria, tetanus, acellular pertussis vaccine, as well as the Company's DTaP-IPV (injectible polio virus) vaccine. These approvals are part of an ongoing effort to gain entry across all of Europe for the Company's acellular pertussis products.
"These approvals represent continued progress toward increasing the number of markets for the Company's products," stated Randal Chase, Ph.D., Chief Executive Officer and President of North American Vaccine. "Chiron Behring has been appointed the distributor of these products in Austria and Germany, and we are presently planning the launch strategy. We look forward to revenue from these markets later in 1999."
The acellular pertussis toxoid component of the DTaP and the DTaP-IPV vaccines consists of a monocomponent purified pertussis toxoid that has been detoxified with hydrogen peroxide. The Company's DTaP-IPV 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 Company's DTaP-IPV vaccine or the Company's DTaP vaccine experienced hypotonic- hyporesponsive (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.
North American Vaccine, Inc. is engaged in the research, development, production and sale of vaccines for the prevention of human infectious diseases. North American Vaccine news releases are available on the Company's web site at nava.com.
For further information contact: Stephen Keith, Vice President-Marketing & Sales, North American Vaccine, Inc., 10150 Old Columbia Road, Columbia, Maryland 21046 (410) 309-7100. |
