Highlights from the Medivir R&D-Day currently underway


Highlights from the Medivir R&D-Day currently underway

Medivir (OME: MVIRB SS) is, this afternoon, holding an R&D-Day in Stockholm. The
objective is to provide an update on Medivir's projects, strategy and business
focus during 2008. Also being addressed are the status of two clinical phase
pharmaceutical projects which Medivir itself is managing, Lipsovir® for labial
(oral) herpes and MIV-701 for bone-related disorders.

All presentations from the Investment Market Day will be available from 6 pm
today on Medivir's website under the tab IR-Media / Latest Presentations
/Medivir R&D Day.

Phase III clinical trial program for Lipsovir® proceeding as planned 
-Final patients have now initiated treatment

The phase III program consists of five clinical trials. In the main study, the
pivotal trial, 1400 patients are to be treated with the aim of demonstrating
that timely treatment with Lipsovir® can prevent cold sores from arising.
Patients in the pivotal trial receive one of three treatment regimes: placebo,
acyclovir or Lipsovir®. The final patient has now initiated treatment in this
trial.

In the remaining trials of the phase III program, all patients in each trial
have completed treatment.

One of these trials has been carried out in immunocompromised herpes patients.
The main objective of this study was to compare lesion healing time between
Lipsovir® and acyclovir. The study included 201 patients, of which 105 were
treated with Lipsovir® or acyclovir.

Another trial included adolescents with recurrent labial herpes. The aim of the
study was to document the safety profile of Lipsovir® in this age group. The
study included 254 patients, of which 130 were in the active arm, all treated
with Lipsovir®.

During the summer, Medivir has also carried out photosensitization and
phototoxicity trials, which are standard studies for many topical
pharmaceuticals.

Medivir will have access to the results of the whole pharmaceutical development
program and its conclusions during the first quarter of 2008, as planned. These
results will be communicated. The regulatory applications will be filed in USA
and Europe during late spring/summer of 2008 and Medivir anticipates obtaining
the first marketing authorization during spring 2009.

“ It is highly pleasing that the main Lipsovir® trial is progressing to plan and
that we are meeting the timeframes communicated to the market”, comments Börje
Darpö, Medivir's VP, Pharmaceutical Development.

Proof-of-Principle attained in the phase I clinical trial with MIV-701
MIV-701 inhibits the enzyme cathepsin K which degrades bone and which probably
contributes to cartilage degradation in diseases of the joints. The efficacy of
the compound in reducing bone degradation has been demonstrated in laboratory
research and extensive preclinical trials. The interim results of the phase I
clinical trial, presented today, confirms this efficacy.

“The results of this phase I study show that we have attained Proof-of-Principle
for MIV-701 as regards the compound's activity against osteoporosis, but also
other bone-related disorders such as arthritis and bone metastasis”, comments
Medivir's VP Pharmaceutical Development Börje Darpö.

The now-completed phase I clinical trial program has enabled Medivir to
investigate how an oral dosage form of MIV-701 is taken up by the body and
tolerated. By studying biomarkers (blood components which reflect disease state)
it has also been possible to get a first impression of the compound's efficacy
on osteoporosis.

To begin with, individual doses of increasing concentration (25 mg, 75 mg, 150
mg 300 mg) were administered to the volunteers. In the next phase repeated
dosing (100 mg, 200 mg, 300 mg, QD) was administered for longer durations (7-14
days). The last phase of the study included a group of post-menopausal women (a
patient group which often suffers from osteoporosis) and the efficacy of MIV-701
on osteoporosis biomarkers was investigated.

Results indicative of 50% lower bone degradation
The group of post-menopausal women were dosed with 300 mg MIV-701, QD (once
daily) for 14 days. The efficacy of MIV-701 on particular biomarkers is an
indicator that bone degradation was reduced by 50%, which is consistent with
what Medivir was hoping to see.

Observed side effects, mainly headache and gastrointestinal disturbances, were
mild (grade 1) and transient. A more serious adverse event was also noted, but
this was probably not related to the administration of MIV-701.

“ The phase I results for MIV-701, in combination with the progress in our
broader research program, constitute a valuable platform when we now reach out
to find an industrial partner who can help us develop our cathepsin K project on
its way towards marketing authorization”, comments Lars Adlersson, Medivir's CEO& President. 

For additional information, please contact:
Rein Piir CFO & VP Investor Relations, Medivir AB +46 8 5468 3123, +46 708 537
292

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

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