Transcript Competitive advantage

Company Presentation
Summer 2004
Medivir in brief
• One of the world leaders in polymerase research.
• Aiming for a similar position in protease research.
• Unique competitive advantages in all clinical projects.
• Nine partnerships with eight companies and a broad
network with academia in Europe and US.
• Total deal value amounting to > SEK 2000m
• Nordic marketing rights for all projects.
• Located in Stockholm (Sweden) and Cambridge (UK) with
approximately 100 employees in R&D.
Skilled and experienced management
Anders Vedin – M.D., Professor – Chairman of the Board
Previous positions include President of Astra Hässle
Lars Adlersson – B.Sc. (Business Adm & Econ) – CEO
Previous positions include Vice President and General Manager GlaxoSmithKline Austria,
Managing Director GlaxoWellcome Sweden.
Johan Harmenberg M.D. Associate Professor – VP Drug Development
Previous positions include Clinical Research Director, Medical Advisor and Medical
Director at Roche, Astra and Pharmacia & Upjohn.
Bertil Samuelsson – Ph.D. Professor – VP Research
Previous positions include Head of Medical Chemistry at AstraZeneca.
Rein Piir – B.Sc. (Business Adm & Finance) – CFO / IR
Previous positions include Head of Research and Health Care at Carnegie Investment Banking,
Health Care and Strategy at Alecta Asset Management
Paul Wallace - Ph.D. – VP Business Development
Previous positions include Business Development Manager at Peptide Therapeutics and Director of
Research at Eclagen.
Medivir pipeline and market
Medivir’s clinical and pre-clinical projects
Discovery
Lead
Optimisation Late preclinical
identification
phase
development
RP-606 Shingles
ME-609 Labial herpes
MIV-310 NRTI Multi-resistant HIV
MIV-210 NRTI Multi-resistant HIV
MIV-150 NNRTI HIV
IND Phase I
Phase II
Phase III NDA Market
Population Council
MV026048
Cath S
Cath K
MIV-170
HCV
HCV
Alzheimer
COPD
New proteases
Other activities
Polymerase inhibitor
Combination including polymerase inhibitor
Protease inhibitor
Polymerase and protease inhibitors
Unique Selling Propositions in all clinical projects
• Valomaciclovir (RP 606) – shingles
Expected to reduce chronic pain
• ME 609 – labial herpes
Expected to prevent ulcerative lesions
• Alovudine (MIV 310) - HIV-NRTI
Excellent activity against multi-resistant strains
Once daily dosing
•MIV 210 – HIV-NRTI
Excellent activity against multi-resistant strains
High oral bioavailability
Valomaciclovir (RP 606)
Indication:
Shingles
Competitive advantage:
IP protection:
Partner:
Status:
Expected to reduce chronic pain
Patents to 2017
Reliant (1.000 sales reps in US)
Phase II completed
Ongoing preparations for Phase III
expected to reduce chronic pain
The chronic pain (PHN),
is the major problem for shingles patients
Share of patients
Acute phase
Chronic pain
time
expected to reduce chronic pain
ME 609
Indication:
Competitive advantages:
IP protection:
Partner:
Status:
avoid your next cold sore
Labial and genital herpes
First drug to prevent labial lesions
Patents to 2016 in US and EU
No
Positive phase II data
Preparation prior to phase III ongoing
You can avoid your next cold sore
No treatment
0%
Existing drugs
0%
29%
ME 609
Avoided outbreaks
avoid your next cold sore
0%
5%
10%
15%
20%
25%
30%
Alovudine (MIV 310)
Indication:
Competitive advantages:
IP protection:
Partner:
Status:
HIV
No resistance development observed in phase IIa,
or in vitro. Unique multi-resistance profile.
Once daily oral dosing
Exceptionally low COGS
Patents to 2019 (USA)
Boehringer Ingelheim
Phase IIa data showed unique activity against
multi-drug resistant HIV
Licensed to Boehringer Ingelheim in July 2003
BI recently started phase II dose range studies
MIV 210
Indication:
Competitive advantages:
IP protection:
Partner:
Status:
* Information from GSK’s R&D-day
HIV, Hepatitis B
Unique multi-resistance profile, different from
MIV-310
Excellent oral bioavailability in humans
Low COGS
Next generations NRTI in fixed-dose-combination*
Patents to 2018
GlaxoSmithKline
Licensed to GSK in May 2003
Broad range of preparations prior to
phase II ongoing
NDA expected to be filed in H2 2007 *
Expected peak sales: USD 500 – 1.000m *
High Market Potential*
RP-606 Shingles
Sales of shingles drugs > USD 1.000m in
2003. None of the existing drugs have a
claim for PHN
ME-609 Labial herpes
MIV-310 NRTI Multi-resistant HIV
Even without any
drug preventing
labial herpes, sales
amounted to more
than USD 500m in
2003
MIV-210 NRTI Multi-resistant HIV
MIV-150 NNRTI HIV
Sales of HIV drugs amounted
MV026048
to USD 5.800m in 2003. NRTI’s
represented 60% and are
MIV-170
expected to grow their
Cath S
market share above 70% in the
Cath K
coming five years
HCV
HCV
Alzheimer
COPD
* Market data according to IMS-data
Population Council
Growing share of multiresistant HIV. MIV-310 and
210 are developed to
address this
HIV market is expected to grow rapidly,
NRTI’s having the largest share
Polymerase Inhibitors, NRTI
Combivir (GSK)
Zerit (BMS)
Epivir (GSK)
Trizivir (GSK)
Viread (Gilead) *
Rest
Total
2000
807
620
448
11
0
584
2470
2001
872
546
435
241
13
605
2712
2002
882
443
443
473
226
597
3064
2003
966
354
480
617
566
512
3495
2002
3064
763
1422
5249
2003
3495
930
1411
5836
P2004
4071
1104
1725
6900*
* High need of new Multi - resitant profiles
USD m
Polymerase Inhibitors, NRTI
Polymerase Inhibitors, NNRTI
Protease Inhibitors, PI
Total
* According to DataMonitor
2000
2470
680
1700
4850
2001
2712
705
1770
5187
P2010
7808
1952
2440
12200*
The Late Stage Preclinical Pipeline
Discovery
Lead
Optimisation Late preclinical
identification
phase
development
IND Phase I
Phase II
Phase III NDA Market
MV026048
Cath S
A new treatment paradigm for
RA, MS and asthma. Possible
improvements over TNF-alpha
blockers.
Cath K
MIV-170
HCV
HCV
COPD
Strong presence in
hepatitis C
New treatment paradigm for osteoporosis
and osteoarthritis. Present therapies like,
bisphosphonates and HRT all have
limitations
Polymerase inhibitor
Protease inhibitor
The Cathepsin S Project
(JV with Peptimmune)
Potential indications:
• Immunological disorders (e.g. rheumatism, multiple sclerosis)
• Chronic pain
Competitive advantages:
• New class of drugs for treating autoimmune and inflammatory diseases.
Project status:
• Potent and selective compounds identified.
• Oral administration results in impressive efficacy in pre-clinical disease
models.
• EU-patent granted for cathepsin S-inhibitors in immune reactions.
• A Candidate Drug was recently selected in the program, and the
project is now in preclinical development towards a IND.
• No competing projects identified in clinical development
Osteoporosis and Cathepsin K
Osteoporosis:
• The amount of treated patients is expected to grow from
7.8m (2002) to 18.3m (2015)*
• Market size 2001: USD 5.5bn (2001) is expected to grow
to USD 11bn(2008)**
Cathepsin K:
• An enzyme involved in the process of bone destruction.
• By inhibiting cathepsin K, the bone destruction process is reduced.
• This has recently been proved by Novartis in a phase IIa POC study.
• No other competing projects identified in clinical development.
*Datamonitor, Epidatabase (2003)
**IMS Data
Medivir’s Cathepsin K Project
Potential indications:
• Osteoporosis
• Osteoarthritis, Paget’s Disease, Bone metastasis, RA, Bone cancer etc.
Competitive advantages:
• A new treatment principle. By regulating cathepsin K the bone breakdown
process will be controlled. This will open up possibilities in a range of diseases.
Project status:
• Potent and selective inhibitors of cathepsin K with drug like properties identified.
• The inhibitors have shown good effect in an in vitro-model for human bone resorption.
• The project is at an advanced stage in i preclinical optimisation.
• Strong IP on NCE’s have been filed.
Balancing risk
Five individual
projects in clinical
development
RP-606 Shingles
ME-609 Labial herpes
MIV-310 NRTI Multi-resistant HIV
MIV-210 NRTI Multi-resistant HIV
Total deal value
MIV-150 NNRTI HIV
Population Council
> SEK 2.000m
MV026048
Cath S
Cath K
Five individual
Three Joint
MIV-170
projects able to
Ventures
HCV
generate royalty
HCV
Four individual projects
Alzheimer
able to generate
COPD
milestones
New proteases
Other activities
Partners in
four clinical
projects
The strategic journey
Medivir: the strategic journey
Today
Tomorrow
development and protease inhibitors in
• Polymerase and protease inhibitors in
clinical development
pre-clinical research.
• Broad range of partnerships.
• Polymerase inhibitors in clinical
• Broad range of partnerships.
• First product launch from own pipeline.
• Nordic marketing rights to all projects.
• Aim for product swaps in coming
• Approximately 120 employees.
• Research based biotech company.
partnerships.
• Research based pharmaceutical company
with a sales force focusing on specialist
products for the Nordic region.
A broader clinical portfolio creates higher value
Value
Osteoporosis
Autoimmune disorders
2004 and onwards
Infectious diseases
Infectious diseases
Time
Financial information
Key Financial Data
31th of March 2004
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•
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Result after financial items amounted to SEK -45,3 (-47,1)m.
SEK 208m in cash.
Net R&D costs for 2004 will be approximately SEK 175m, this is in line with previous years.
The Q2 report will be published on the 6th of July.
World leader in drugs inhibiting proteases and polymerases