Medivir Signs Research & Development Collaboration on Dengue Virus


Medivir Signs Research & Development Collaboration on Dengue Virus

Highlights of the Collaboration:

  · Collaboration with Janssen Pharmaceutica N.V. focused on dengue
virus
  · Both parties to contribute 50:50 resources to the research program
  · Strengthens Medivir's presence in infectious diseases and utilises
strong know-how in the discovery of protease inhibitor drugs

Huddinge, Sweden - Medivir AB (OMX: MVIR), the emerging research-based
specialty pharmaceutical company focused on infectious diseases,
announces today that it has signed a collaboration agreement with
Janssen Pharmaceutica N.V. (Janssen) for the discovery and development
of drugs for the prophylaxis and treatment of dengue virus infection.
Utilising both companies' core competences in the discovery and
development of protease inhibitors, Medivir and Janssen will initiate an
R&D program to co-develop drugs based on the inhibition of the dengue
NS3 protease activity. Both parties will contribute equal resources to
the research program and Medivir has an option to continue to contribute
equal funding for the non-clinical and clinical development stages.
Terms
The terms of the agreement govern the discovery, clinical development
and commercialisation of any drugs developed under the agreement.
Depending on the level of funding through pre-specified decision points,
each party has the option to take products discovered through the
research program forward through development and on to
commercialisation. If both parties remain in the collaboration until
product approval, Janssen will be responsible for commercialization.
Medivir will receive pre-agreed royalties on net sales of future
products that reflect its contribution to the development of products. 

Dengue Virus and Disease
Dengue fever is a mosquito-borne viral infection, causing a severe
debilitating fever, rash, and muscle and joint pain. In an unpredictable
subset of cases, Dengue haemorrhagic fever occurs, which may lead to
vascular leakage and Dengue shock syndrome, a potentially lethal
condition. Dengue virus infection is a major problem in subtropical
regions where the incidence has increased 30-fold over the last 50
years. Up to 50 million infections are now estimated to occur annually
in more than 100 endemic countries and as the disease continues to
spread, approximately one third of the world's population is at risk.
Dengue hemorrhagic fever and Dengue shock syndrome contribute
significantly to hospitalization costs in endemic regions. This growing
prevalence has not been met by any significant advances in treatment1
and the annual death rate from dengue infection is approximately 30,000.

Development approach
Inhibition of the dengue NS3 protease is considered to be an attractive
target in developing novel efficacious drugs against dengue infection,
due to the critical role that the NS3 protease plays in viral
replication. Drug candidates that inhibit the dengue NS3 protease thus
offer the prospect of disease prevention and the control of outbreaks in
endemic areas. In addition, an NS3 protease inhibitor with therapeutic
benefit could be used to treat ongoing viral infections.

Medivir has extensive expertise and knowledge in the discovery of
protease inhibitors and the Company's lead drug TMC435, for the
treatment of hepatitis C, which is partnered with Tibotec (an affiliate
of Janssen) has recently reported positive interim data in three Phase
2b studies. Medivir has further partnerships with Tibotec that utilise
Medivir's unparalleled knowledge in the discovery and development of
treatments for infectious diseases, including partnerships on hepatitis
C polymerase and HIV protease inhibitor drugs.

Ron Long, CEO and President of Medivir commenting on the announcement
said, “Medivir has strong experience in the discovery of protease
inhibitors for the treatment of infectious diseases and we are delighted
to be collaborating with Janssen in this important disease area. This
strategic collaboration represents a significant step forward in our
ambition to retain more value in products by taking them further into
development and securing a much more active role in our collaborations
with partners. We believe that dengue NS3 protease inhibitors offer the
best prospect for effective treatment of dengue fever and we look
forward to working closely with our partner to take this project
forward.”

Notes
1 World Health Organisation, Fact sheet N°117, March 2009.

For more information about Medivir, please contact:
Medivir (www.medivir.se) Rein Piir, CFO & VP Investor Relations         
  Mobile: +46 708 537 292 
M:CommunicationsEurope: Mary-Jane Elliott / Amber Bielecka / Nick
Francis  Medivir@mcomgroup.com (Medivir@mcomgroup.com)+44(0)20 7920 2330
USA: Jason Marshall                                                     
  +1 212 897 5497

About Medivir
Medivir is an emerging research-based specialty pharmaceutical company
focused on the development of high-value treatments for infectious
diseases. Medivir has world class expertise in polymerase and protease
drug targets and drug development. Medivir has a strong R&D portfolio
and has recently launched its first product Xerese™/Xerclear®. Medivir's
key pipeline asset, TMC435, a protease inhibitor, is in phase 2b
clinical development for Hepatitis C and is partnered with Tibotec
Pharmaceuticals. 

Xerese™/Xerclear® is an innovative treatment for cold sores, which has
been approved in both the US and Europe. It is partnered with
GlaxoSmithKline to be sold OTC in Europe and Russia and with Meda AB in
North America. Medivir has retained the Rx rights for Xerclear® in
Sweden and Finland.

For more information about Medivir, please visit the Company's website:
www.medivir.se.

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