MIV701 Cath K inhibitor for bone disorders Phase I interim data Next step

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MIV-701 Cath K inhibitor for bone disordersPhase
I interim data - Next step
Börje Darpö, VP Development
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Bone disorders (MIV-701) Multiple indications
Bone surface

• MIV-701 selectively inhibits the bone and
  cartilage degrading enzyme cathepsin K
• Osteoporosis, osteoarthritis and bone metastases
• Target profile
• Improved bone quality (c/f bisphosphonates)
• Bone growth capability
• Excellent long term tolerability
• Follow-on program with CD selection near term

Cath K
Osteoclast
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Bone disorders (MIV-701) Growing market

• Market
• Approx 100 million patients in major growing
  markets (osteoporosis only)
• Strong interest in cathepsin K inhibition from
  major pharma companies for various indications as
  osteoporosis, osteoarthritis and bone metastasis
• Patent/generic competition
• Patent applications being processed
• Expected patent protection until 2025
• Partner strategy
• Establish broad industrial partnership on program
  including MIV-701 and follow up compounds (2008)
• Status
• Clinical phase I trials interim data available

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CTX suppression translates into clinical effect
Odanacatib Phase IIb results 12-month study in
postmenopausal women
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MIV-701 Phase I set up Biomarkers,
pharmacokinetics and tolerability - with Proof
of Concept in post-menopausal women
Study initiated March 2007. To be completed Q4,
2007. Interim data
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MIV-701 decreases bone resorptionSustained
reduction of CTX by 40-50
Placebo n4
Treated n8
CTX-I in 14 day dosing with 300 mg in
postmenopausal women Efficacy maintained over 14
days
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Safety and tolerability (interim data)

• No significant changes in hematology or clinical
  chemistry
• No rash or skin-related AEs
• Most common adverse event
• Day 1 Mild/moderate adverse event, mainly GI
  related
• One Grade 4 event
• Day 2-14 Only mild and the majority classified
  as not substance related

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Summary Phase I interim data

• Proof-of-concept in terms of expected
  pharmacodynamic response (sCTX-1), with a 50
  sustained reduction during 14 days

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Next steps

• Our aim is to enter a collaboration agreement
  with big pharma to develop the MIV-701
  program/Cathepsin K for different indications
• There is an interest in cathepsin K as a target
  for different indications, which will be
  evaluated in collaboration with a partner
• The phase I study with MIV-701 has confirmed
  proof-of-concept for the Cath K program, which is
  a key step before initiating discussions with
  potential partners
• Broad preclinical program follow-on candidate
  drug likely to be selected shortly
•