Medivir AB Aktiespararna i Norrköping 18 April 2007 Rein Piir, CFO / IR.
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Medivir AB
Aktiespararna i Norrköping 18 April 2007
Rein Piir, CFO / IR
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2006 – Delivery according to Strategy
Progress protease projects
Secure Lipsovirapproval in
2008
Finding new harbours for
polymerase projects
• Outlicensing of HIV PI• Prolonged agreement on HCV PI
Q2
Q3
Q4
Q1
• Outlicensing of MIV-210
• Lipsovir enters Phase III• Outlicensing of MIV-606• Outlicensing of MIV-170
• HCV PI: Tibotec files CTA • Milestone (EUR 2.5m)
• Outlicensing of MIV-310• Outlicensing of MIV-410
• Enrollment update: 60% of patients treated in pivotal trial
• Outlicensing of MIV 160• MIV-606: Shares in Epiphany and milestone (USD 0.5m)
• HCV PI: Start of phase I • Milestone (EUR 2.5m)• MIV-701: Start of phase I
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Next phase in Medivir transformation -A focused pharmaceutical company
Successful outlicensing of 6 polymerase projects. Strong partnerships with deal value in excess of 400 MUSD plus royalties
Nordic marketing rights for all projects and possible product from J&J
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OSTEOPOROSIS
HEPATITIS C
LABIAL HERPES
Key Projects
Lipsovir®, Phase III studies completed late 2007. Market approval by end of 2008.
Collaboration with Tibotec / Johnson & Johnson. Phase I trials ongoing.
MIV-701, Phase I trials ongoing.Further indications such as OA, RA and bone metastases explored.
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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
10
Treatment Prevention of cold soresReduction in
lesion healing time
Topical vs placebo
Acyclovir
Penciclovir
Docosanol (Abreva)
No
No
No
10 - 12%
13 - 15%
(15%)
Oral vs placebo
Acyclovir
Valaciclovir
No
No
9 - 13%
10 – 11%
Lipsovir® vs placebo Yes, 29% 11% (19%*)
* Episode duration
Lipsovir®: first product to show prevention
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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
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Lipsovir® consumer interest
Definitely would buy Probably would buy Might or might not buy Probably would not buy Definitely would not buy
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®
Primary market research 403 (UK) 411 (US) respondents
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Physician prescribing habits post Lipsovir®
Primary market researchBase: 225 physicians who have prescribed cold sore remedies 10+ times in the last 12 months
• 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)
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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
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
Key enzyme for virus replication
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
• Target profile:
• Improved bone quality (c/f bisphosphonates)
• Bone growth capability
• Once-daily oral dosing
• Strong Back-up program in place with pre-CD’s selected
Bone surface
Osteoclast
Cath K
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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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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
“The Protease Discovery Engine” – A reliable repeat innovator
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MIV-701
HEPATITIS C
LIPSOVIR
The journey ahead
• 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
HIV FRANCHISE
• MIV-170: Entry into phase I by late 2007• MIV-606 start of phase IIb trials • New clinical trials and new data in other out- licensed projects
LIPSOVILIPSOVI
RR®®
A profitable pharmaceutical companywith its own research and sales
Next step in company transformation
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