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Tuesday October 27, 8:36 am Eastern Time
Company Press Release
Medeva Files Pan-European License
Application For Hepagene As A
Vaccine Against Hepatitis B
LONDON--(BUSINESS WIRE)--October 27, 1998--Medeva PLC (NYSE: MDV - news), the
international pharmaceutical company, today announced that a pan-European product license
application for its hepatitis B product HepageneO, for use as a vaccine, has been filed with The
European Agency for the Evaluation of Medicinal Products (EMEA). A second license application
for Hepagene(TM) as a vaccine is on schedule to be made to the US Food and Drug Administration
later this year.
Hepagene(TM) is a novel third generation hepatitis B vaccine. It is the first two-dose vaccine
offering the opportunity of successful vaccination to individuals who either fail to respond to other
existing vaccines, who need more rapid protection than can be provided by these same vaccines or
for whom compliance with a full dosing regimen of these vaccines presents difficulties.
Hepagene(TM) is Medeva's lead development product and this submission represents a significant
milestone in demonstrating Medeva's development capabilities, particularly in the field of
biotechnology.
Commenting on today's announcement, Medeva's Chief Executive, Dr. Bill Bogie said:
''Hepagene(TM) is a highly complex biotechnology product and Medeva has shown that it can bring
such a product successfully through the development process. This augurs well for our ability to
secure promising new products for our pipeline and our potential to generate growth for the future.'' |
