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Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President. Basic facts. 18 month performance. Listed since 1996 (OME: MVIRB SS) MCap: ~ USD 180m

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medivir ab acumen biofin 4th annual global healthcare conference lars adlersson ceo president

Medivir ABAcumen BioFin 4th Annual Global Healthcare ConferenceLars Adlersson, CEO & President

basic facts
Basic facts

18 month performance

  • Listed since 1996 (OME: MVIRB SS)
  • MCap: ~ USD 180m
  • Major shareholders: Staffan Rasjö Founders Handelsbanken Den Norske Bank Skandia
  • Cash position: SEK 370m (end-Q1)
  • Revenues: SEK 129m (FY 2006)
  • Burn rate: SEK 155m (FY 2006)
the strategic journey
The strategic journey

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

key projects
Key projects

Lipsovir®,Phase III data late 2007. Market approval by end of 2008.

LABIAL HERPES

Collaboration with Tibotec / Johnson & Johnson. Phase I trials ongoing.

HEPATITIS C

MIV-701, Phase I trials ongoing.

Further indications such as OA, RA and bone metastases explored.

OSTEOPOROSIS

labial herpes lipsovir
Labial herpes (Lipsovir®)
  • 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
slide7

Herpes virus

Immune defense

slide8

Herpes virus

Current

drugs

Immune defense

slide9

Herpes virus

Lipsovir®

Immune defense

a billion dollar market
A billion dollar market

Annual value growth: 9%

Rx

(USD 450m)

Palliative

(USD 400m)

OTC

(USD 220m)

Annual value growth: 12%

development process
Development process

60%

treated

Phase III

data

Approval

July 06 Jan 07 Mar 07 H2 07 H1 08 end-08 2009

Start

Phase III

75%

treated

Genital

Herpes?

Filing

Marketing

Partner(s)

slide13

Three of four 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

slide14

Physician prescribing habits post- launch of 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

hepatitis c hcv pi
Hepatitis C – HCV PI

Key enzyme for

virus replication

Market

  • 170-200 million infected
  • Over 50% non-responders to current treatments
  • 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

Enzyme inhibiting compound

medivir tibotec hcv pi series
Medivir/Tibotec HCV PI Series
  • Several series of highly promising NS3/4A inhibitors have been developed
  • Further optimization of these inhibitors in collaboration with Tibotec Pharmaceuticals Ltd, J&J, has resulted in the selection of a Clinical Candidate

Data on Compound “A”

(an example from the lead series)

From presentations at the 1st International Workshop on Hepatitis C Resistance and New Compounds, Boston 25-26 October 2006

and the 3rd Anglo-Swedish Medicinal Chemistry Meeting, 11-14 March 2007, Åre, Sweden

bone disorders miv 701
Bone disorders (MIV-701)

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
    • Once-dailyoral dosing
  • Strong Back-up program in place with pre-CD’s selected

Cath K

Osteoclast

slide18

Bone disorders (MIV-701)

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)
slide19

“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
the journey ahead
The journey ahead
  • Phase III data, autumn 2007
  • Partnership agreement(s)
  • Market registration, end-2008

LIPSOVIR

  • Phase I data during 2007
  • Possibility to receive “approved drug”
  • from Johnson & Johnson

HEPATITIS C

  • Phase I data during 2007
  • Partnership post phase I

MIV-701

  • 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

HIV FRANCHISE