Transcript Medivir

Medivir AB
Carnegie Health Care Seminar
May 2007
Lars Adlersson, CEO & President
Börje Darpö, VP Development
Rein Piir, CFO / IR
Basic facts
• Listed since 1996
(OME: MVIRB SS)
18 month performance
• MCap:
~ USD 190m
• 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®)
Herpes virus
Immune defense
6
Herpes virus
Current
drugs
Immune defense
7
Herpes virus
Lipsovir®
Immune defense
8
Lipsovir®: first to show prevention
Treatment
Topical vs. placebo
Acyclovir
Penciclovir
Docosanol (Abreva)
Prevention of cold sores
Reduction in
episode duration
No
No
No
10 to 12%
17%
15%
No
No
17%
9 to 20%
Yes, 29%
19%*
Oral vs. placebo
Acyclovir
Valaciclovir
Lipsovir® vs. placebo
* In the Lipsovir study, where prevention of cold sores was demonstrated, the reduction of
episode duration refers only to those patients who developed ulcerative lesions.
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9
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)
10
A billion dollar market
Annual value
growth: 9%
Rx
(USD 450m)
Annual value
growth: 12%
Palliative
(USD 400m)
OTC
(USD 220m)
11
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
12
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
13
Hepatitis C – Opportunities to improve current
therapy
• Curing a larger proportion of patients
–
Less than 50% of patients with most common genotype G1 (>70% in the US)
respond to current therapy (peg-Interferon  + ribavirin)
• Decreasing duration of therapy
–
Currently 48 weeks for most common and difficult-to-treat genotype 1
• Improving tolerability
–
–
Standard-of-care associated with severe side effects (flu-like symptoms,
fatigue, depression, hemolytic anemia)
Contraindicated in patients with decompensated liver failure
14
Hepatitis C – Medivir/JNJ program
Process
•
Partnership with Tibotec / Johnson &
Johnson since November 2004
•
Phase I trials ongoing since February
2007
•
Strong back-up program
NS3/4A:
Key protease for
virus replication
Patents
•
Extensive and non-limiting IP
published July 2005
Collaboration agreement
•
Research funding, milestones &
royalty
•
Rights to receive pharmaceutical
product for Nordic countries from JNJ
at pre-defined point in development
•
Nordic rights retained by Medivir
Enzyme inhibiting compound
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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
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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)
Cath K
• Bone growth capability
• Once-daily oral dosing
• Strong Follow-on 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)
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“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
Business model
Structure:
Research & development
of protease inhibitors
Revenue streams:
Upfronts & milestones
Sales & marketing of
proprietary products
Royalties
Quids
Pharmaceutical
sales revenues
Own products
(e.g. HIV Franchise, HCV PI)
Acquired products
20
Key Events Going Forward
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
21
Next step in company transformation
A profitable pharmaceutical company
with its own research and sales