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Abbott Laboratories Ends Certiva(TM) Marketing Agreement; NeisVac-C(TM) Produces Immunologic Memory after Single Toddler Dose
COLUMBIA, Md., Oct. 5 /PRNewswire/ -- North American Vaccine announced today that Abbott Laboratories has elected to terminate its agreement with the Company to market Certiva(TM) to private physicians in the United States. Certiva(TM) is the Company's approved combination diphtheria, tetanus and acellular pertussis (DTaP) vaccine. Limitations in acellular pertussis production had made it difficult to expand Certiva(TM) private market sales. Acellular pertussis production improvements announced in June are expected to allow for improved Certiva(TM) sales as well as production of NeisVac-C(TM), the Company's group C meningococcal conjugate vaccine.
Abbott's termination will be effective following a nine-month transition period. There are no refunds of past payments, payments to re-acquire marketing rights or any other type of termination penalty associated with Abbott's decision. During the transition period, North American Vaccine will determine the most effective method of serving the private market. The Company will continue its commitment to distribute Certiva(TM) to state and federal government purchasers. Agreements with Statens Serum Institute and Chiron Behring for European marketing of Certiva(TM) remain in place. North American Vaccine believes that domestic interest in Certiva(TM) remains high due to its low incidence of severe adverse reactions. Certiva(TM) also has demonstrated the ability to reduce the incidence of pertussis in all age groups when used as the only pediatric DTaP vaccine during a study in Goteburg, Sweden.
Based on the Company's previously adopted production plan, North American Vaccine is currently using its production facility to begin a manufacturing campaign of NeisVac-C(TM). The United Kingdom has recently announced a mass group C meningococcal vaccination program that is expected to include NeisVac- C(TM). North American Vaccine has suspended production of Certiva(TM) during the initial phase of the NeisVac-C(TM) campaign for the UK, and anticipates resuming Certiva(TM) production after that initial phase is complete.
Dr. Randal Chase, Chief Executive Officer and President of North American Vaccine, stated, "We are committed to successfully producing both Certiva(TM) and NeisVac-C(TM). Certiva(TM) has been well received by government purchasers and we are confident we can expand on current sales to both the government and private physician markets as our production improves. In the meantime, we look forward to having the opportunity to help curb the meningococcal infection problem being experienced in the UK through a successful launch of NeisVac-C(TM)."
Dr. Peter Richmond of the UK's Public Health Laboratory Service (PHLS) presented results of a comparative toddler clinical trial for group C meningococcal conjugate vaccines at the Interscience Conference on Antimicrobial Agents and Chemotherapy meeting in San Francisco last week. NeisVac-C(TM) elicited significantly higher antibody levels in toddlers after a single dose, compared to the other vaccines in the study. Functional antibody levels that kill the disease-causing bacteria were significantly higher after six months with NeisVac-C(TM), indicating excellent immunologic memory. This result suggests that long-term protection may be provided in children over one year of age after a single dose. The results from this single dose toddler trial are consistent with the data from previous multiple dose clinical studies performed by the PHLS in infants in which NeisVac-C(TM) elicited significantly higher bactericidal antibodies than other vaccines in the studies.
North American Vaccine, Inc. is engaged in the research, development, production and sales 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. |
