Medivir has initiated a phase I clinical trial with its cathepsin K inhibitor MIV-711

Stockholm – Medivir AB (OMX: MVIR), a research-based pharmaceutical company focused on infectious diseases, announced today that a phase I clinical trial has been initiated with its investigational drug, MIV-711, a cathepsin K inhibitor for the treatment of bone disorders characterized by excessive bone resorption such as osteoporosis, osteoarthritis and bone metastases.

Maris Hartmanis, CEO of Medivir commented, “This first in man study of Medivir's MIV-711 is an important step in our effort to develop new treatment options for patients with bone related diseases. The study will provide us with crucial biomarker information reflecting both bone and cartilage turnover. Based on this data we will be able to make a fast and informed decision regarding the continued development of MIV-711 to the market.”

MIV-711 is a potent and selective reversible inhibitor of cathepsin K, a protease essential for bone destruction. MIV-711 is being developed as a new therapy in disease states where a reduction in cathepsin K activity would be advantageous.

In this first in human study, MIV-711 will be administered as single ascending oral doses to healthy volunteers, followed by repeated once daily doses for 7 days, with the aim to explore the safety, tolerability and pharmacokinetics. In addition effect on biomarkers relevant for bone and cartilage degradation will be followed. MIV-711 will also be studied in postmenopausal women following once daily oral dosing for 14 days.

The design of the study will allow Medivir to explore how MIV-711 affects biomarkers known to be relevant for measuring bone and cartilage turnover. It will also provide the company with valuable information regarding potential therapeutic dose levels to be used in future studies. The results from this study are expected in the first quarter of 2013.

               

For more information about Medivir, please contact:

Medivir
Rein Piir, EVP Corporate Affairs & IR
 
Office line +46 8 440 6550 or
Mobile +46 708 537292 
M:Communications
Europe: Mary-Jane Elliott,
Amber Bielecka, Hollie Vile
medivir@mcomgroup.com
+44(0)20 7920 2330


About Medivir
Medivir is an emerging research-based 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 which has resulted in a strong infectious disease R&D portfolio. The Company’s key pipeline asset is TMC435, a novel protease inhibitor in phase III clinical development for hepatitis C that is being developed in collaboration with Janssen Pharmaceuticals.

In June 2011, Medivir acquired the specialty pharmaceutical company BioPhausia to ensure timely commercialisation of TMC435 in the Nordic markets, once approved.

Medivir’s first product, the unique cold sore product Xerese®/Xerclear®, was launched on the US market in 2011. Xerese®/Xerclear®, which has been approved in both the US and Europe, is being launched in collaboration with GlaxoSmithKline to be sold OTC in Europe, Japan and Russia. Rights in North America, Canada and Mexico were sold to Meda AB in June 2011. 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.com

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About Us

Medivir develops innovative pharmaceuticals for the treatment of cancer. The company specializes within protease inhibitor research and nucleotide/nucleoside science.The research is conducted in all phases of pharmaceutical development, from idea to clinical phase III studies. The development work is conducted both in-house and through partnerships.Medivir is listed on the Nasdaq Stockholm Mid Cap List.

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