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North American Vaccine Accelerates Timeline For Seeking Approval for Meningitis Vaccine.

COLUMBIA, Md., April 12 /PRNewswire/ -- North American Vaccine (Amex: NVX) announced today that it has significantly advanced the timeline for preparing and submitting an application for regulatory approval to sell its group C meningococcal conjugate vaccine in the United Kingdom. The company now anticipates that during the fourth quarter of 1999 it will file with the U.K. regulatory authorities the application for approval of its group C meningococcal conjugate vaccine. In the United Kingdom, meningococcal meningitis is the leading cause of death in children one to four years of age. In the United States, outbreaks of group C meningoccal disease have recently been reported with high mortality rates, and the U.S. Centers for Disease Control and Prevention is developing public health strategies for using conjugate vaccines in preventing meningococcal disease. The Company anticipates that the combined US/European market for a group C meningococcal conjugate vaccine will be approximately $300 million per year.

"The decision to accelerate the timeline for seeking regulatory approval was prompted by several very promising meetings held with regulatory authorities and public health officials in the U.K. regarding the company's conjugate vaccine. In many respects, the company could not have scripted a better exchange with the regulatory and public health authorities," stated Dr. Randal Chase, CEO and President of North American Vaccine. "Those meetings focused on the results of clinical trials, the status of manufacturing operations and the public health need for the vaccine. We are now preparing our manufacturing operations to be well positioned to participate in a broad- based public health initiative to vaccinate a large segment of the population in the United Kingdom to prevent outbreaks of serious meningitis."

In addition to being the leading cause of death in infants in the United Kingdom, there have been periodic outbreaks of group C meningococcal meningitis among college students over the past few years resulting in several deaths. The U.K. Public Health Laboratory Service (PHLS) has received reports of more than 1,000 cases of meningoccocal meningitis annually since 1991, reaching a peak incidence of approximately 2,400 cases for the 1997/1998 reporting period. The PHLS estimates that group C meningococci account for 35% to 45% of all cases and more than 50% of the cases reported among college students. Further, N. meningitidis has become the leading cause of bacterial meningitis in children and young adults in the United States, with an estimated 2,600 cases each year and a case fatality rate exceeding 10%. Attack rates are highest among children 3-12 months of age and group C meningococci accounted for approximately 45% of all cases.

North American Vaccine previously reported comparative data from a safety and immunogenicity study of its group C meningococcal conjugate vaccine conducted by the PHLS in toddlers. In that study, the company's vaccine was compared, head to head against group C meningococcal conjugate vaccines manufactured by Chiron Corporation and Wyeth Lederle. The results of the study indicate that, after a single dose, the company's group C meningococcal conjugate vaccine significantly outperformed the competitor vaccines in generating bactericidal antibodies and anti-group C meningococcal IgG antibodies. One hundred percent (100%) of toddlers who received the company's vaccine achieved very high functional antibody responses. The results from this study revealed no serious adverse events and minimal local injection site reactions, which is consistent with results published from other clinical studies of this vaccine.

In an earlier study, the company's group C meningococcal vaccine was included in a U.K. clinical study involving 30 adults, each of whom received a single dose of the vaccine. The results from that study revealed no serious adverse events and minimal local injection site reactions. Further, 97% of the subjects developed a greater than ten-fold increase in bactericidal antibodies and more than a four-fold increase in IgG antibodies specific to group C meningococcus. Over a six-month follow-up period, antibody avidity increased indicating the successful induction of a T-cell dependent antibody response. The data also demonstrated that the company's conjugate vaccine induced a functional antibody response, which exceeded that elicited by a group A/C meningococcal polysaccharide vaccine.

The company's group C meningococcal conjugate vaccine is participating in a school-leaver (adolescent) clinical study being conducted in the United Kingdom and is to participate in an expanded safety study involving children and adolescents being sponsored by the PHLS. The results of these studies will be provided by the PHLS and included in the company's submission slated for fourth quarter of this year.

Meningococcal infection is a common and important cause of bacterial meningitis throughout the world. The populations at risk include adults, young children and infants. In Europe and the Americas, group C meningococcus is a leading cause of meningococcal infections which can cause permanent brain damage and death. Currently there is no polysaccharide conjugate vaccine licensed for the prevention of group C meningococcal infections and no vaccine available for infants and children less than two years of age.

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 http://www.nava.com.

This press release contains certain forward looking statements, which are made pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995, including the timing for regulatory filings, the timing for completion of the clinical studies, the timing of the availability of the data from the PHLS, the prospects for regulatory approval and sales of the company's products, and market estimates. Investors are cautioned that forward looking statements involve risks and uncertainties which may affect the company's business and prospects, including without limitation uncertainties relating to clinical trials, requirements for regulatory approval of products, nature of competition, effective marketing, limited production capacity and product development, all as discussed in the company's filings with the U.S. Securities and Exchange Commission to which the reader's attention is directed.
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Publication:PR Newswire
Geographic Code:4EUUK
Date:Apr 12, 1999
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