Medivir designates MIV-710 a Candidate Drug (CD) for Osteoporosis and Osteoarthritis

Medivir designates MIV-710 a Candidate Drug (CD) for Osteoporosis and
Osteoarthritis

Medivir is developing selective cathepsin K inhibitors for the treatment of
osteoporosis and osteoarthritis. Medivir has now designated a highly active and
selective small molecule inhibitor of cathepsin K, MIV-710, as Candidate Drug
(CD). 

MIV-710 shows very pronounced efficacy, based on biomarkers for osteoporosis in
preclinical models, with a long duration of effect after once daily oral dosing.


MIV-710 dose-dependently attenuates the break down of bone, the hallmark of
osteoporosis, whilst maintaining the beneficial bone formation. MIV-710 is
expected to be dosed conveniently only once daily as a tablet and at low doses,
due it's favorable potency and pharmacokinetic properties. 

Scientific background
A selective inhibitor of the cathepsin K enzyme is believed to play a central
role in osteoclastic bone resorption, particularly in the degradation of the
protein component of bone. Inhibition of cathepsin K is a novel approach to the
treatment of osteoporosis that differs from those of currently approved
treatments. By developing a drug that attenuates this activity, excessive bone
degradation, as occurs in e.g. patients with osteoporosis, can be normalized and
the imbalance in bone turnover can be restored. In disease models Medivir has
shown that the pathological resorption (break down) of bone can be dose
dependently suppressed by blocking cathepsin K activity. MIV-710 also
demonstrates potent effects in a human cell-based model of bone resorption. 

Therapeutic opportunities
The main clinical indication for MIV-710 is osteoporosis but included are also
RA (rheumatoid arthritis), OA (osteoarthritis) and bone metastasis. Osteoporosis
(brittle bones) arises from an imbalance between skeletal formation and
resorption where the equilibrium is skewed towards excessive bone loss. There is
a large unmet medical need for new and improved treatments that can regulate and
suppress the progression of pathological bone erosion. Osteoporosis is the
second largest health problem in the world and a major cause of death,
disability and medical expenditure. The presently dominating treatment
principels are bisphosphonates and oestrogen receptor modulators.

“We are extremely pleased to have developed a new CD in the cathepsin K program
showing these highly competitive and advantageous properties. Medivir has
previously shown proof-of-principle in a phase I clinical trial with it's
earlier cathepsin K inhibitor MIV-701. The very favorable efficacy and expected
convenient low dosing makes MIV-710 a strong complement to the broad Medivir
cathepsin K program. This is yet another clear sign of Medivir's productivity
and competence in the development of efficacious orally active protease
inhibiting drugs”, comments Medivir VP Discovery Research, Professor Bertil
Samuelsson.

Next step
Medivir is now in a strong position to move into outlicensing discussions for
the cathepsin K program including MIV-710 and MIV-701 which both have the
potential to become a first-in-class treatment option in this important disease
area. 

About osteoporosis
Osteoporosis is a big public health problem affecting more than 75 million
people in the U.S., Europe, South America and Japan alone.  It is a disease in
which the bone mineral density and strength of bone are reduced increasing the
risk of bone fracture as bones become more porous and fragile. The most common
fractures associated with osteoporosis occur at the hip, spine and wrist and the
risk of having an osteoporosis-related fracture increases with age.  One in
three women over age 50 will experience an osteoporotic fracture, as will one in
five men.  According to the International Osteoporosis Foundation (IOF), the
worldwide incidence of hip fracture is approximately 1.6 million each year, and
by 2050 this number could reach between 4.5 million and 6.3 million. 

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

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