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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Page 1: Medivir AB Aktiespararna i Norrköping 18 April 2007 Rein Piir, CFO / IR

Medivir AB

Aktiespararna i Norrköping 18 April 2007

Rein Piir, CFO / IR

Page 2: 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

Page 3: Medivir AB Aktiespararna i Norrköping 18 April 2007 Rein Piir, CFO / IR

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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

Page 4: Medivir AB Aktiespararna i Norrköping 18 April 2007 Rein Piir, CFO / IR

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Medivir: pipelines and partners

Page 5: Medivir AB Aktiespararna i Norrköping 18 April 2007 Rein Piir, CFO / IR

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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.

Page 6: Medivir AB Aktiespararna i Norrköping 18 April 2007 Rein Piir, CFO / IR

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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

Page 7: Medivir AB Aktiespararna i Norrköping 18 April 2007 Rein Piir, CFO / IR

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HSV-1

Immune response

Dual mechanism of action

Page 8: Medivir AB Aktiespararna i Norrköping 18 April 2007 Rein Piir, CFO / IR

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HSV-1

Immune response

Current drugs

Dual mechanism of action

Page 9: Medivir AB Aktiespararna i Norrköping 18 April 2007 Rein Piir, CFO / IR

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HSV-1

Immune response

Lipsovir®

Dual mechanism of action

Page 10: Medivir AB Aktiespararna i Norrköping 18 April 2007 Rein Piir, CFO / IR

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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

Page 11: Medivir AB Aktiespararna i Norrköping 18 April 2007 Rein Piir, CFO / IR

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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

Page 12: Medivir AB Aktiespararna i Norrköping 18 April 2007 Rein Piir, CFO / IR

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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

Page 13: Medivir AB Aktiespararna i Norrköping 18 April 2007 Rein Piir, CFO / IR

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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)

Page 14: Medivir AB Aktiespararna i Norrköping 18 April 2007 Rein Piir, CFO / IR

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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

Page 15: Medivir AB Aktiespararna i Norrköping 18 April 2007 Rein Piir, CFO / IR

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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

Page 16: Medivir AB Aktiespararna i Norrköping 18 April 2007 Rein Piir, CFO / IR

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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)

Page 17: Medivir AB Aktiespararna i Norrköping 18 April 2007 Rein Piir, CFO / IR

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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

Page 18: Medivir AB Aktiespararna i Norrköping 18 April 2007 Rein Piir, CFO / IR

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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

Page 19: Medivir AB Aktiespararna i Norrköping 18 April 2007 Rein Piir, CFO / IR

LIPSOVILIPSOVI

RR®®

A profitable pharmaceutical companywith its own research and sales

Next step in company transformation