Transcript Medivir

Medivir AB
Aktiespararna i Norrköping
18 April 2007
Rein Piir, CFO / IR
2006 – Delivery according to Strategy
Progress protease
projects
Q2
• Outlicensing of HIV PI
• Prolonged agreement
on HCV PI
Q1
Secure Lipsovir
approval in
2008
• Outlicensing of MIV-210
• Outlicensing of MIV-606
• Outlicensing of MIV-170
Q3
Q4
Finding new
harbours for
polymerase projects
• HCV PI: Tibotec files CTA
• Milestone (EUR 2.5m)
• Outlicensing of MIV-310
• Outlicensing of MIV-410
• HCV PI: Start of phase I
• Milestone (EUR 2.5m)
• MIV-701: Start of phase I
• Outlicensing of MIV 160
• MIV-606: Shares in Epiphany
and milestone (USD 0.5m)
• Lipsovir enters Phase III
• Enrollment update: 60%
of patients treated in
pivotal trial
2
Next phase in Medivir transformation A focused pharmaceutical company
Nordic marketing rights
for all projects and
possible product from
J&J
Successful outlicensing of 6
polymerase projects. Strong
partnerships with deal value in
excess of 400 MUSD plus royalties
3
Medivir: pipelines and partners
4
Key Projects
LABIAL HERPES
Lipsovir®, Phase III studies completed late 2007.
Market approval by end of 2008.
HEPATITIS C
Collaboration with Tibotec / Johnson & Johnson.
Phase I trials ongoing.
OSTEOPOROSIS
MIV-701, Phase I trials ongoing.
Further indications such as OA, RA and bone
metastases explored.
5
Labial Herpes (Lipsovir®, ME-609)
• First drug to treat and prevent cold sores
• Low-risk — based on safe, well-documented and already marketed
compounds
• Goal: Marketing permission from regulatory authorities by 2008
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Dual mechanism of action
HSV-1
Immune response
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Dual mechanism of action
HSV-1
Current drugs
Immune response
8
Dual mechanism of action
HSV-1
Lipsovir®
Immune response
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Lipsovir®: first product to show prevention
Prevention of cold sores
Reduction in
lesion healing time
Acyclovir
No
10 - 12%
Penciclovir
No
13 - 15%
Docosanol (Abreva)
No
(15%)
Acyclovir
No
9 - 13%
Valaciclovir
No
10 – 11%
Yes, 29%
11% (19%*)
Treatment
Topical vs placebo
Oral vs placebo
Lipsovir® vs placebo
*
Episode duration
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Labial Herpes (Lipsovir®)
Market
• Global market $666M; split 33% OTC, 67% Rx
• Additional $400M palliative OTC market (estimate)
• Strong annual growth: OTC +$11.6% and Rx +$9%
• Cold sore treatments second fastest growing OTC category
Process
• Phase III ahead of schedule, more than 60% of patients treated by January 2006
• Data from pivotal trial during autumn 2007
• Estimated approval by end of 2008
• Potential upside in genital herpes
Patent/generic competition
• Patents protect Lipsovir from generic competition until 2016-2021
• Uncommonly difficult and time-consuming for competitors to register a copy of a
topical drug as all clinical trials must be repeated
Partner strategy
• Finalize phase III on our own - partnerships for market launches
11
Lipsovir® consumer interest
Strong interest in the concept: 1 in 4 in the UK and 1 in 3 in the USA claim they ‘would definitely buy’
Around three quarters of sufferers express an interest in Lipsovir®
Definitely would buy
Probably would buy
Might or might not buy
Probably would not buy
Definitely would not buy
Primary market research 403 (UK) 411 (US) respondents
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Physician prescribing habits post Lipsovir®
• Physicians are willing to prescribe a new
cold sore remedy
• When asked what they would prescribe
on the next 10 occasions, Lipsovir
claims a 45% share of prescriptions,
making it the leading product and
drawing users from all 3 principal Rx
brands (Zovirax, Valtrex, Denavir)
Primary market research
Base: 225 physicians who have prescribed
cold sore remedies 10+ times in the last 12 months
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Hepatitis C - HCV PI
Market
•
170-200 million infected globally
•
Over 50% non-responders to current
treatments, growing medical need
•
Estimated market value in 2010: 7.8
billion USD
Key enzyme for
virus replication
Process
•
Partnership with Tibotec / Johnson &
Johnson since November 2004
•
Candidate drug selected 2005
•
CTA submitted December 2006
•
Phase I trials started February 2007
Patents
•
Extensive and non-limiting IP
published July 2005
Enzyme inhibiting compound
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MIV-701 (Bone Disorders)
• MIV-701 selectively inhibits the
bone and cartilage degrading
enzyme cathepsin K
• Osteoporosis, osteoarthritis and
bone metastases
Bone surface
• Target profile:
• Improved bone quality (c/f
bisphosphonates)
• Bone growth capability
Cath K
• Once-daily oral dosing
• Strong Back-up program in place
with pre-CD’s selected
Osteoclast
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MIV-701 (Bone Disorders)
Market
• Approx 100 million patients in major growing
markets (osteoporosis only)
• Global osteoporosis market 11 billion USD by
2008
• Strong interest in cathepsin K inhibition from
major pharma companies
Process
• Clinical phase Ia trials commenced March 2007
• Phase Ib trials planned for late 2007
Patent/generic competition
• Patent applications being processed
• Expected patent protection until 2025
Partner strategy
• Establish industrial partnership after completion
of phase Ib (2008)
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“The Protease Discovery Engine” – A reliable
repeat innovator
HIV – PI
–Collaboration project with Tibotec / Johnson & Johnson
MMP- COPD
–Collaboration with Hengrui
–Extensive IP, excellent results in pre-clinical disease model
–Next step: selection of Candidate Drug
Renin - Hypertension
–IP compiled for three distinct and potent inhibitor series
–Next step: studies in a pre-clinical efficacy model
Cathepsin S – RA, MS and pain
–Potent and selective inhibitors
–Efficacious in preclinical disease models
–Fine-tuning of PK properties
Several early protease programs, e.g. Alzheimer's (BACE inhibitors) and novel
cholesterol lowering MOA
Large inhibitor libraries and proprietary technologies
–facilitate CD generation against any new protease target
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The journey ahead
LIPSOVIR
HEPATITIS C
MIV-701
HIV FRANCHISE
• Phase III data, autumn 2007
• Partnership agreement(s)
• Market registration, end-2008
• Phase I data during 2007
• Possibility to receive “approved drug”
from Johnson & Johnson
• Phase I data during 2007
• Partnership post phase I
• MIV-170: Entry into phase I by late 2007
• MIV-606 start of phase IIb trials
• New clinical trials and new data in other outlicensed projects
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Next step in company transformation
A profitable pharmaceutical company
with its own research and sales