Company Completes Acellular Pertussis Production Expansion Efforts; 300% Capacity Increase Paves Way for Group C Meningoccocal Production
COLUMBIA, Md., June 16 /PRNewswire/ -- North American Vaccine announced today that it has now completed its production enhancements for the manufacture of its acellular pertussis (aP). These improvements are projected to increase manufacturing capacity of aP by over 300% thereby lowering unit costs and enhancing profitability. The Company is now preparing the documentation necessary to obtain approval from the United States Food and Drug Administration (FDA). The Company anticipates obtaining FDA approval of its modifications during the third or fourth quarter of this year. The financial benefits of this change are expected to begin to be realized toward the end of the fourth quarter of 1999.
This production capacity increase is also expected to allow the Company to allocate manufacturing capacity to the production of its group C meningococcal vaccine. The Company expects to file for approval of its group C meningococcal vaccine in the United Kingdom during the fourth quarter of 1999, with approval anticipated during the first quarter and sales beginning in the second quarter of 2000. The market potential for the group C meningococcal vaccine is projected at $300 million per year in the US and Europe.
Dr. Randal Chase, Chief Executive Officer and President of North American Vaccine, stated "We are very pleased to have completed this upgrade to our manufacturing capabilities. The test data is very good, giving us confidence in planning for the production of both the aP and group C meningococcal products."
The expansion of the aP production capacity is a result of increases in the water supply and enhanced conditions for increases in pertussis yields. An inventory of aP vaccine for Certiva(TM) and European formulations of the Company's aP based products has been made with the new process, pending appropriate regulatory approval. Inventory manufactured using these enhancements is expected to support sales of these products into 2000.
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.
For further information contact: Tom Newberry, Director, Investor Relations, North American Vaccine, Inc., 10150 Old Columbia Road, Columbia, Maryland 21046 (410) 309-7121. |
