North American Vaccine Expects to File the NeisVac-C(TM) UK License Application Shortly
COLUMBIA, Md., Jan. 18 /PRNewswire/ -- North American Vaccine (Amex: NVX) stated today that it expects to satisfy the condition in its definitive acquisition agreement with Baxter International Inc. requiring the Company to use reasonable efforts to file the UK license application for NeisVac-C(TM), the Company's group C meningococcal conjugate vaccine, by January 21. North American Vaccine anticipates that it will finish preparation of the UK license application for NeisVac-C(TM) on Friday, January 21 and will provide the application to UK regulatory authorities on Monday, January 24. The Company is seeking approval of NeisVac-C(TM) for administration to children 12 months of age and older, adolescents and adults. The U.K. National Health Service ("NHS") has committed to purchase 3 million doses of NeisVac-C(TM) in 2000 for approximately $65 million, with shipments scheduled to begin in the second quarter of 2000, subject to UK regulatory approval.
No assurances can be given that the license for NeisVac-C(TM) will be issued by UK regulatory authorities, or that their review of the application and any requests for additional information will not involve delays that would adversely affect the Company's ability to supply the product under the NHS contract or to meet the closing condition set forth in the definitive acquisition agreement with Baxter that the Company obtain the UK regulatory approval for NeisVac-C(TM) by April 1, 2000.
The Company has had some initial problems in scaling up bulk manufacturing of NeisVac-C(TM) and believes that progress is being made to address these problems. The production of vaccines is a highly complex, biological process involving many steps from seed culture through final production. If the Company experiences substantial disruptions or failures in its production process, then the Company may not be able to meet its production requirements for NeisVac-C(TM) under the NHS contract or the definitive acquisition agreement with Baxter, which requires that the Company manufacture a two-month supply of NeisVac-C(TM) for the NHS contract by April 1, 2000.
Meningococcal infection is a common and important cause of bacterial meningitis throughout the world. The populations at risk span all age categories from infants to adults. In Europe and the Americas, group C meningococcus is a leading cause of meningococcal infection. Meningococcal infections can cause permanent brain damage and death. |
