Acyclovir

Regulatory News:

Medivir (STO:MVIRB):

For the first time, a clinical phase III program has demonstrated
that it is possible to prevent cold sores by early treatment
initiation. The entire phase III program comprised almost 3000
patients in five studies, the pivotal trial being the largest ever
conducted with 1443 patients treated out of 2437 recruited. Treatment
with Lipsovir(R) prevented the development of cold sores in 42% of
patients. In those patients who nevertheless developed a cold sore,
the healing time and severity were significantly reduced.

Lipsovir(R) is a patented combination of hydrocortisone (an
anti-inflammatory agent) and aciclovir (an antiviral agent) in a
proprietary cream base developed by Medivir. Lipsovir(R) prevented
cold sores significantly better than placebo (p less than 0.0001).
Even though Medivir’s proprietary cream base seemed to have increased
the effect of aciclovir, Lipsovir(R)’s preventive effect was superior
(p=0.014). The healing time of ulcerative recurrences was reduced by
1.5 days in comparison to placebo, which is a clinically highly
meaningful reduction. Lipsovir(R) was well tolerated in all phase III
studies.

“The phase III clinical program shows that Lipsovir(R) has clear
advantages compared with the current standard treatment for cold
sores. The results are remarkably good and it is very positive for
patients with recurrent cold sores that over 40% of episodes could be
prevented by Lipsovir(R). No product on the market has been able to
show a preventive effect. We therefore consider it important that
patients with recurrent cold sores are given access to Lipsovir(R),”
says Assoc. Professor Borje Darpo, Medivir’s Vice President for
Clinical Development.

The result of the comparison between Lipsovir(R) and placebo
widely exceeded FDA’s requirement. Before the start of the trial, a
preventive effect of acyclovir had not been demonstrated. FDA
therefore asked for a somewhat higher level of significance (p=0.001)
for the comparison between Lipsovir(R) and aciclovir than was
achieved. In addition to the strong preventive effect of Lipsovir(R),
analysis of all the available data from the entire development program
will provide basis for a constructive dialogue with regulatory
authorities. After this dialogue, the time for regulatory submissions
can be more accurately specified.

“We have proven that the Lipsovir(R) concept works. The
combination of an antiviral and an anti- inflammatory agent in our
cream base prevents cold sores. We will now continue our contacts with
potential marketing partners,” says CEO Lars Adlersson.

Press Conference Invitation

Medivir will hold a press conference today at 11 am at the IVA
Conference Centre, Grev Turegatan 16, Stockholm (a light lunch will be
served). The phase III clinical trial results will be presented in
detail with opportunities for discussion and questions. Medivir will
be represented by its CEO Lars Adlersson, VP Clinical Development
Assoc Prof Borje Darpo, the Lipsovir(R) Project Director Eva Arlander
and Medivir’s CFO/VP IR Rein Piir.

For more information on Medivir, please see the company website:
www.medivir.se

This information was brought to you by Cision
http://newsroom.cision.com

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