Transcript Medivir

Medivir AB
Rights Issue in January 2007
Next phase in Medivir transformation A focused pharmaceutical company
Nordic marketing rights
for all projects and
possible product from
J&J
2005
Focus on
protease
projects;
larger range
of disease
targets than
polymerases
2006
First phase III
project. Three
projects in
preclinical
development.
2007
Phase III
project
completed.
Three
projects in
Phase II
Three
projects in
Phase I
2008
First
market
approval
(late
2008)
2009
Stable revenue
flow
Successful outlicensing of 5
polymerase projects. Strong
partnerships with deal value in
excess of 400 MUSD plus royalties
2
Key Projects
LABIAL HERPES
Lipsovir®, Phase III studies completed late 2007.
Market approval by end of 2008.
HEPATITIS C
Collaboration with Tibotec / Johnson & Johnson.
Start of clinical phase I trials, Q1 2007.
OSTEOPOROSIS
Start of clinical phase I studies early 2007.
Further indications such as OA, RA and bone
metastases explored.
HIV/AIDS
Collaboration with Bristol-Myers Squibb.
MIV-170 expected to reach phase I late 2007.
3
2006 – Delivery according to Strategy
2005
2006
December
June
July
September
December
Decision to;
•Focus on
proteases
•License out
polymerases
•Take Lipsovir
through phase III
on our own
•Outlicensing of
HIV PI
•Outlicensing of
MIV-210
•Prolonged
agreement on
HCV PI
•Lipsovir
enters
Phase III
• Outlicensing
of MIV-606
• Outlicensing
of MIV-170
(NNRTI) to
Bristol-Myers
Squibb
• Consolidation of
research, net savings
of 50 MSEK annually
• Outlicensing of MIV310 & MIV-410
• Tibotec files a CTA for
HCV PI
4
Medivir 2007 Rights Issue to fuel next step in transformation
• Continued financing of clinical development and
registration of Lipsovir®
• Resources for phase Ia/Ib-studies of MIV 701
• Strengthened financial position for better deal terms
• More advanced projects for outlicensing
• Search for inlicensing niche products
5
The Medivir Pipeline – January 2007
Partners/Date
of agreement
Project
Indication(s)
Lipsovir ®
(ME-609)
Labial Herpes
HCV-PI
Hepatitis C
CAT-K
(MIV-701)
Osteoporosis,
Osteoarthritis
CAT-S
MS, RA, Pain
HIV-PI
HIV
Tibotec /2006
MMP
KOL
Hengrui /2003
Renin
High bloodpressure
Explorative phase
Lead identification
Optimization
IND
Phase
I
Phase
II
Phase
III
NDA
Tibotec /2004
Polymerase inhibitor/hydrocortisone
Protease inhibitor
6
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
7
Ow!
IMMUNE RESPONSE
Ow!
Current drugs
IMMUNE RESPONSE
Ow!
Lipsovir
IMMUNE RESPONSE
Labial Herpes (Lipsovir®, ME-609), cont’d
Process
•
Avoid your next cold sore
Phase III ahead of schedule, more than 50% of patients treated December 2006
Market
•
60 million with labial herpes worldwide
•
No other treatment prevents sores
•
Strong market growth possible with Lipsovir
Patent/generic competition
•
Patents protect Lipsovir from generic competition until 2016
•
Formulation technology (cream) patented to 2019 (2020 in the USA)
•
Uncommonly difficult and time-consuming for competitors to register a copy of a
topical drug as all clinical trails must be repeated
Partner strategy
•
Finalize phase III on our own - partnerships for market launches
•
Unique selling point: prevention of sores
11
Lipsovir® - Less Than 2 Years to Market Launch
• Phase III clinical trials began
July 2006
• More than 50% of patients treated
December 2006
• Clinical trials completed
Autumn 2007
• Partnership for marketing
2007/2008
• NDA
Spring 2008
• Marketing approval anticipated
End of 2008
Potential for line extension for genital herpes
12
Hepatitis C - HCV PI
• Treatment of Hepatitis-C virus infection
• Extensive patent portfolio and several series of highly
potent and efficacious inhibitors
• CTA submitted December 2006, phase I expected to start
Q1 2007
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HCV PI
Process
• Candidate drug selected 2005
• CTA submitted December 2006 and phase I trials to start Q1 2007
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 (2005, 4.5 billion USD)
•
Combination treatment to prevent resistance
Patent/generic competition
•
Extensive and non-limiting IP published July 2005
Partner strategy
• Partnership with Tibotec/J&J
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HIV PI
• Protease inhibitors for the treatment of HIV 1
•
R&D collaboration with Tibotec/J&J
•
Extensive non-limiting patent portfolio
•
Potent inhibitors with highly attractive resistance profile
•
Next milestone, selection of candidate drug
15
MIV-701 (Bone Disorders)
• Osteoporosis, osteoarthritis and bone
metastases
• Based on selective inhibition of cathepsin K
• Excellent cell-based efficacy in a human bone
resorption model
• Highly efficacious in a preclinical bone
resorption model
• Anticipated once-daily oral dosing with no
restrictions
• Improved bone quality (c/f bisphosphonates)
• Bone growth capability
• Strong Back-up program in place with pre-CD’s
selected
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MIV-701 (Bone Disorders)
Process
• Start of clinical phase Ia trials, Q1 2007,
• Phase Ib trials late 2007
Market
• Approx 100 million patients in major growing markets
• Global osteoporosis market 11 billion USD by 2008
• Novartis, GSK and Merck are marketing “block busters”
bisphosphonates and their clinical focus now includes cat K
inhibitors
Patent/generic competition
• Patent applications being processed in the EU, North America, and
other major markets. 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
• HCV-PI – HIV-PI, cathepsin K
–The major programs
• 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
18
Medivir HIV Franchise AB, polymerase inhibitors
Indication(s)
Partners/Date
of agreement
Valomacidovir
(MIV-606)
Shingles,
Herpes
viruses, HIV
Epiphany Biosciences /2006
Alovudine
(MIV-310)
HIV
Presidio
Pharma
2006
MIV-210
HIV,
Hepatitis B
Tibotec /2006
MIV-150
HIV
Population
Council /2003
MIV-160
HIV
MIV-410
HIV, CMV
Presidio
Pharma
2006
MIV-170
HIV
Bristol-Myers
Squibb /2006
Project
Explorative phase
Lead identification
Optimization
IND
Phase
I
Phase
II
Phase
III
NDA
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HIV 1 (MIV-170)
• An NNRTI for treatment of HIV-1 infection
• Highly potent and active on the key clinical resistant
strains
• Higher generic barrier than present NNRTI’s provides
less risk for resistance
• Anticipated once-daily dosing
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HIV 1 (MIV-170)
Process
• Preclinical documentation and safety evaluation of the CD selected in
February 2006
• Start of clinical phase I trials next development stage
Market
• 40 million worldwide are living with HIV/AIDS
• Increasing resistance to present NNRTI’s
• CNS side effects common with Sustiva, the leading NNRTI
Patent/generic competition
• Patent applications being processed in the EU, North America, and other
major markets. Expected patent protection until 2025
Partner strategy
• Collaboration with Bristol-Myers Squibb Company — today’s leader in the
NNRTI field (Sustiva)
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Collaborations and Partnerships
Partner
Project
Up-front
Milestones, total
Tibotec
HCV protease
6.5 MEUR
62 MEUR, of which 5 MEUR
paid when CD was selected
Royalties
Comments
Yes
2.5 MEUR when IND
submitted
FTE funding
Tibotec
HIV PI
2 MEUR
62 MEUR
Yes
FTE funding
Tibotec
MIV-210
0.5 MUSD
29.5 MUSD
Yes
Bristol-Myers
Squibb
MIV-701
7.5 MUSD
97 MUSD
Yes
Epiphany
Biosciences
MIV-606
Shares in
Epiphany
24.5 MUSD
Yes
Presidio
MIV 310
75.2 MUSD
Yes
Pharmaceuticals
MIV 410
Shares in
Presidio
Medivir keeps marketing rights in the
Nordic countries and UK, option to EU
Hengrui
COPD
___
___
Yes
Market rights outside China
Roche
HCV pol
___
___
Yes
Medivir keeps marketing
rights in the Nordic countries
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The Medivir Share
Ten largest shareholders, before rights issue
Descending order of vote
% of votes
% of capital
Öberg, Bo
16.7
4.5
Johansson, Nils Gunnar
16.0
3.6
Rasjö, Staffan
8.4
12.2
DNB Nor Bank ASA
5.8
8.5
Sahlberg, Christer
5.1
1.0
Livförsäkringsaktiebolaget Skandia
2.5
3.7
Awake Swedish Equity Fund
2.4
3.6
SIS Segaintersettle AG
2.4
3.4
Nordea Bank Finland ABP
2.2
3.2
Handelsbankens Småbolagsfond
1.9
2.8
Market cap. approx. 600 MSEK
Number of shares, Class A: 660 000
Class B: 12 242 611
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The Share Issue At a Glance
» Preferential rights for existing shareholders
• Shares issued at 29 SEK per share
• Every five class A and/or class B shares entitle holder to
subscription for three new class B shares
• Share issue brings a maximum of 225 MSEK
• Share number grows from 12 902 611 to max 20 644 178
– Of which 660 000 A-shares and max 19 984 178 B-shares
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Preliminary Share Issue Time Plan
• Distribution prospectus,
11 Jan 2007
registration bill
• Trading in subscription rights
15 Jan – 30 Jan 2007
• Subscription period
15 Jan – 2 Feb 2007
Carnegie financial advisor to Medivir
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The Journey Ahead
•
•
•
•
•
•
•
•
Lipsovir® phase III data during H2 2007
Market registration of Lipsovir® towards end 2008
Hepatitis-C project in phase I Q1 2007
Possibility receive “approved drug” from Johnson & Johnson
MIV-701 in phase I in Q1 2007
MIV-170 progressing towards Phase I during 2007
Medivir HIV Franchise outlicense last polymerase project
Capacity to acquire niche products
2008
2009
First market Stable
revenue
approval
(late 2008) flow
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Next step in company transformation
A profitable pharmaceutical company
with its own research and sales
Lipsovir® - Convincing Phase II Data
• In the phase II trial1 (n=380) the number of cold sores
in the Lipsovir-group were 29% lower than the placebo
group
• Healing time reduced by 43%
• Independent phase II cold sore trial confirms effect of
combination treatment
• Results with antivirals in this type of clinical trial are
predictive of efficacy in phase III
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Medivir January 2007
An exceptionally strong pipeline and an exceptionally efficient
generation of CDs
• CD generation (proteas targets) 1-2/y (many times more
cost efficient than Big Pharma)
• CDs
3
• INDs submitted
2
• Phase I projects
1
• Phase II projects
3
• Phase III projects
1
Nine new NCEs!
Nine collaboration agreements!
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Improved potential of polymerase inhibitors during 2006
MIV-606
•
Added indications
– HIV (HHV-6?)
– MS? (HHV-6?)
– Mononucleosis (EBV)
MIV-310
•
Combination with AZT gives antagonistic toxicity and synergistic effect against HIV
•
New patent application
MIV-410
•
New mechanism of action against HIV
MIV-210
•
Active against HBV mutants resistant to all present drugs
MIV-160
•
Added indication – Condom coating for increased protection against HIV
MIV-170
•
High genetic barrier, active against common types of resistant HIV and good
pharmacokinetics
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