New Drug Application (NDA) for Lipsovir® submitted to US FDA

New Drug Application (NDA) for Lipsovir® submitted to US FDA

Medivir has today submitted an NDA to the US Food & Drug Administration (FDA)
for Lipsovir®, a topical product for prevention and treatment of cold sores.
Lipsovir® is a patented combination of hydrocortisone (an anti-inflammatory
agent) and aciclovir (an antiviral agent) in a proprietary cream base developed
by Medivir.

“We had a pre-NDA meeting with the FDA in May 2008, at which the final results
from the program were presented and discussed, as well as the format and
time-lines of the submission. We have since then worked hard to finalize all
documentation and we are very happy to announce that the NDA now has been
submitted in accordance with our previously communicated time schedule. This was
made possible by a very dedicated team and through collaboration with external
experts and key opinion leaders”, says Börje Darpö, MD, Vice President and Head
of the development group at Medivir.

The clinical phase III program demonstrated that the development of cold sores
can be prevented with early treatment initiation, an effect that available
products for this indication lack. Lipsovir® thereby provides subjects with
recurrent cold sores with a clinically important benefit compared to currently
available products. 


The results from the phase III program have been presented during the
spring/summer of 2008 and showed that:

•  42% of subjects treated with Lipsovir® did not develop cold sores with
blisters, ulcers and crusting, compared to 26% in the placebo group

•  Lipsovir® reduced the healing time of cold sores by 1.5 days as compared to
placebo

•  Lipsovir® was well tolerated in all studied populations, including
adolescents.

“It is a huge step forward for Medivir to file our first registration
application. The partnership process continues, with the intention to liaise
with one or several companies to help us commercializing the product globally”,
says Lars Adlersson CEO & President Medivir AB.


For additional information, please contact
Rein Piir, CFO & Vice President, Investor Relations, +46 708 53 72 92.

For further information on Medivir, please see our website: www.medivir.se