Highlights From The Medivir R&D-Day Currently Underway

Medivir (OME: MVIRB SS) is, 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 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 oraldosage form of MIV-701 is taken up by the body and tolerated. By studying biomarkers (bloodcomponents which reflect disease state) it has also been possible to get a first impression of thecompound’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.