Cathepsin K Discovery Program Designates Candidate Drug (CD)

Medivir announces today that an orally active, small molecule inhibitor of Cathepsin K has been selected as a Candidate Drug (CD). The designation of a CD in the Cathepsin K program is an important milestone for the project and paves the way towards clinical trials. Cathepsin K is a key protease (protein processing enzyme) whose activity regulates skeletal break down. The project goal is to develop a drug that reduces excessive bone degradation. In disease models, Medivir has shown that the pathological resorption (break down) of bone can be dose dependently suppressed if cathepsin K activity is attenuated. Medivir’s inhibitors of Cathepsin K also demonstrate powerful efficacy in a human cell-based model of bone resorption. The clinical applications of these inhibitors are likely to include disorders such as osteoporosis, RA (rheumatoid arthritis), OA (osteoarthritis) and bone metastasis among others. Osteoporosis (brittle bones) arises from an imbalance between skeletal formation and resorption where the equilibrium is skewed towards excessive bone loss. There is a major unmet medical need in several diseases for new treatment paradigms that can regulate or suppress the progression of bone resorption. Osteoporosis is the second largest health problem in the world and a major cause of death, disability and medical expenditure. The presently dominating treatment principals are bisphosphonates and oestrogen receptor modulators. “We are very pleased to have selected a candidate drug in the Cathepsin K program, which entered the lead optimization stage only 18 months ago. This is yet another clear sign of Medivir’s productivity and competence in the development of protease inhibiting drugs. The Cathepsin K program is one out of three advanced protease projects in late preclinical optimization phase, all of which have the possibility to become first-in-class treatment options in major chronic disease areas” comments Medivir VP Discovery Research, Professor Bertil Samuelsson. The project now enters the authority-regulated phase of pre-clinical development with the aim to file an Investigational New Drug application (IND) and to enter clinical phase I trials as the next Milestone. The IND stage includes many different tasks including synthesis of larger amounts of drug compound and safety studies which takes approximately 12-18 months (according to the industry average). The up-scaling (synthesis) of the drug candidate is currently ongoing. For further information please contact: Rein Piir CFO / IR Office: +46 8 546 831 23 or Mobile: +46 708 53 72 92 For additional information, please see Medivir’s website www.medivir.com