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Medivir AB
Acumen BioFin 4th Annual Global Healthcare
Conference
Lars Adlersson, CEO & President
Basic facts
• Listed since 1996
(OME: MVIRB SS)
18 month performance
• 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)
2
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
3
Pipelines and partners
4
Key projects
LABIAL HERPES
HEPATITIS C
OSTEOPOROSIS
Lipsovir®, Phase III data 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.
5
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
6
Herpes virus
Immune defense
7
Herpes virus
Current
drugs
Immune defense
8
Herpes virus
Lipsovir®
Immune defense
9
®
Lipsovir : first 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
10
A billion dollar market
Annual value
growth: 9%
Rx
(USD 450m)
Annual value
growth: 12%
Palliative
(USD 400m)
OTC
(USD 220m)
11
Development process
60%
treated
July 06
Jan 07
Start
Phase III
Mar 07
Phase III
data
H2 07
H1 08
75%
treated
Approval
end-08
Filing
2009
Genital
Herpes?
Marketing
Partner(s)
12
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
13
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
14
Hepatitis C – HCV PI
Market
•
170-200 million infected
•
Over 50% non-responders to current
treatments
•
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
15
Medivir/Tibotec HCV PI Series
•
Several series of highly promising NS3/4A
inhibitors have been developed
Data on Compound “A”
(an example from the lead series)
1
R
2
R
L
H
N
O
M
O
O
<1nM
Replicon activity on genotype 1b
[IC50, nM]
<10nM
3
R
( )n
•
Enzymatic activity on genotype 1b (Ki, nM)
Further optimization of these inhibitors in
collaboration with Tibotec Pharmaceuticals
Ltd, J&J, has resulted in the selection of a
Clinical Candidate
In vivo PK, Oral dose: 10 mg/kg
Cmax (µM)
T 1/2 (h)
F (%)
0.95
5.4
20
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
16
Bone disorders (MIV-701)
• 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
17
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)
18
“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
19
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
20
Next step in company transformation
A profitable pharmaceutical company
with its own research and sales