Medivir September 2007Lunch presentation at SHB

CEO Lars AdlerssonVP Research Bertil SamuelssonCFO / IR Rein Piir

2

Business model

Research & developmentof protease inhibitors

Sales & marketing of proprietary products

Structure: Revenue streams:

Upfronts & milestones

Royalties

Pharmaceutical sales revenues

Quids (e.g. JNJ)

Own products(e.g. HIV Franchise, HCV PI)

Acquired products

Co marketing

3

OSTEOPOROSIS

HEPATITIS C(TMC-435350)

LABIAL HERPES

Key projects and recent events

Lipsovir®, all patients enrolled in the phase III programme

Phase I trials ongoingPre-clinical data presented on TMC-435350

MIV-701, Phase Ib trial ongoing

Sales & marketing

VP Sales and Marketing starts in October

4

Pivotal Immuno Children/study compromised Adolescents

Number of patients enrolled 2400 (2400) 200 (200) 240 (240)

Started treatment 1316 (1400) 105 (105) 130 (130)

Treatment arms Lipsovir Lipsovir LipsovirAcyclovir AcyclovirPlacebo

Endpoint Prevention Safety/Healing time Safety

Results Q1 2008 Q1 2008 Q1 2008

All patients now enrolled in phase III program

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Partner strategy - Sign partner/s after completion of phase III

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Time line

Q3 06 Q3 06 Q4 06 Q1 07 Q2 07 Q3 07 Q4 07 Q1 08 Q2 08 Q3 08 Q4 08 Q1 09

Start of pivotal trial (PS)

All patients included in the phase III program

Start of 2 supportive phase III trials (IC & AC)

Results in PS

ResultsIC & AC

94% treated in PS

Timeline and prognosis at program start (July 2006)

Timeline and new prognosis September 2007

MarketingPartner(s)

Filing

Results fromall studies

Approval

Approval

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Hepatitis C –opportunities to improve current therapy• Efficacy – SVR superior to Pegasus/RBV

– G1 treatment naïve: currently achieves ~45% SVR (of HCV infected in the US >70% has G1)

– Non-responders– Genotype 2-6

• Decrease treatment duration – Currently 48 weeks for most common and difficult-to-treat

genotype 1 (G1)

• Safety – no added AE’s compared with Pegasus/RBV – Standard-of-care associated with severe side effects (flu-like

symptoms, fatigue, depression, hemolytic anemia)– Contraindicated in patients with decompensated liver failure

• Dosing – once daily (q.d.)

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Hepatitis C – Medivir/J&J program

Process • Partnership with Tibotec / Johnson &

Johnson since November 2004• Phase I trials initiated February 2007• Pre-clinical data on TMC435350

presented in Glasgow at “14th International Symposium on Hepatitis C Virus and Related Viruses” September 9-13

• Clinical phase Ia data on safety, tolerability and pharmacokinetics will be presented at the AASLD Liver Meeting in Boston 2-6th November.

Patents• Extensive and non-limiting IP

published July 2005Licensing agreement• Rights to receive pharmaceutical

product for Nordic countries from JNJ at pre-defined point in development

• Nordic rights retained by Medivir

NS3/4A:Key protease for virus replication

Enzyme inhibiting compound

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HCV Direct Antivirals in Development

J&J/Vertex VX-950

SGP Sch503034Medivir/Tibotec

Pre-clin Ph I Ph IIa Ph IIb

PR

OT

EA

SE

INH

IBIT

OR

S

HCV-796 VPHM/Wyeth

BILB-1941

PO

LY

ME

RA

SE

INH

IBIT

OR

S

NovartisIdenix NM-283

Ph III

Gilead GS9132ITMN-191Roche/ITMN

Tibotec

Multiple

Combination with PEG-IFN

BMS?Abbott/Enanta

Roche R-1626

XTL-2125

Roche/Pharmasset R-7128 (RO5024048)

Boehringer

NS

5AIN

HIB

ITO

RS

Arrow A-831

Phenomix

GSK pyrrolidine

Gilead GS9190

GNLB

Biocryst

Biota/BI

Merck MK-0608

nucleoside

Non-nucleoside

?

?

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Medivir/Tibotec HCV PI Series

• Several series of highly potent NS3/4A inhibitors with strong IP developed

• Fine tuning of these inhibitors in collaboration with Tibotec Pharmaceuticals Ltd, J&J, has resulted in the selection of a Clinical Candidate, TMC435350

Enzymatic activity on genotype 1b/1b (Ki, nM) 0.3 nM

Replicon activity on genotype 1b[IC50, nM] 7.8 nM

In vivo rat PK, Oral dose: 40 mg/kg

T 1/2 (h)

F (%)

2.645

Data on TMC435350

LO

M O

NH

R3

O

R2

R1

( )n

From presentations at the 1st International Workshop on Hepatitis C Resistance and New Compounds, Boston 25-26 October 2006and the 3rd Anglo-Swedish Medicinal Chemistry Meeting, 11-14 March 2007, Åre, Sweden

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Rat exposure of TMC435350

Contains CONFIDENTIAL data on TMC435.

Fig 6. Exposure of TMC435350

1

10

100

1000

10000

100000

1000000

0 4 8 12 16 20 24

time (h)

TMC

4353

50 (n

M)

EC50

EC90

EC99

Plasma

Liver

1

10

100

1000

10000

100000

1000000

0 4 8 12 16 20 24

time (h)

TMC

4353

50 (n

M)

EC50

EC90

EC99

Plasma

Liver

Good systemic oral bioavailability Plasma exposure : C8h-plasma>EC99; liver exposure C24h-liver >EC99

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TMC435350

Safety pharmacology

• Agar Ames assay: negative

• Mouse lymphoma assay: negative

• Mouse micronucleus screening assay: negative

• No effect on autonomic and behavioral parameters in mice up to 300 mg/kg (oral) and in rats up to 10 mg/kg in a Pharmascreen®

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TMC435350 - Combination with IFNα in vitro Displays additive to synergistic effects with IFNa in cells combination with IFNa suppresses generation of TMC435350 resistance combination leads to >4 log10 reduction in HCV RNA (9 days) in cells

-5

-4.5

-4

-3.5

-3

-2.5

-2

-1.5

-1

-0.5

0

0 3 6 9

days

Lo

g H

CV

RN

A c

han

ge

vs n

on

tre

ate

d

con

tro

l (n

orm

ali

zed

to

RP

L13

A)

TMC435350(0.6xEC50) + IFNα (1xEC50)

TMC435350 (6xEC50) + IFNα (1xEC50)

TMC435350 (0.6x EC50)

TMC435350 (6xEC50)

IFNα (10xEC50)

IFNα (1XEC50)

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Bone disorders (MIV-701)• 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 Follow-on program in place with CD selection as next step

Bone surface

Osteoclast

Cath K

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Bone disorders (MIV-701)

Market • Approx 100 million patients in major

growing markets (osteoporosis only)• Strong interest in cathepsin K

inhibition from major pharma companies

Process • Clinical phase Ia trials commenced

March 2007• Phase Ib trials ongoing • Results from the phase I trial late

2007Patent/generic competition• Patent applications being processed • Expected patent protection until

2025Partner strategy• Establish industrial partnership after

completion of phase I (2008)

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Part 1 Groups A and B Single dose male

Fed and fasted

Group C Single dose female (PMW)

Part 2 Group D and E Multiple dosing male 7 days

Group F Multiple dose male 14 days

Part 3 Group G Multiple dose PMW 14 days

MIV-701 Phase I

Study initiated March 2007 Completion during Q4 2007Objective: Safety, tolerability, PK and biomarkers for efficacy

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HIV – PI–Collaboration project with Tibotec / Johnson & Johnson

MMP- COPD–Excellent results in pre-clinical disease model–Next step: selection of Candidate Drug

Renin - Hypertension–IP compiled for three distinct and highly potent inhibitor series–Next step: studies in a pre-clinical hypertensive efficacy model

Cathepsin S – RA, MS and pain–Potent and selective inhibitors–Efficacious in preclinical disease models–Fine-tuning of PK properties

BACE – Alzheimer’s disease –High potency and selective inhibitor series identified–Optimization ongoing–IP filed

“The Protease Discovery Engine” -A reliable repeat innovator

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MIV-701

HEPATITIS C(TMS-435350)

LIPSOVIR

Key Events Going Forward

• Phase III data, Q1 2008• Partnership agreement(s)• Market approval, 2008/09

• Phase Ia data in November 2007 • Start phase II trials• Possibility to receive “approved drug”from Johnson & Johnson

• Phase I data late 2007• Partnership post phase I

HIV FRANCHISE

• MIV-606 start of phase IIb trials • New clinical trials and new data in other out- licensed projects

Sales & marketing

• Product acquisitions, quids and co marketing 2008/09

LIPSOVILIPSOVI

RR®®

A profitable pharmaceutical companywith its own research and sales

Next step in company transformation