Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President
Dec 28, 2015
Medivir AB
Acumen BioFin 4th Annual Global Healthcare Conference
Lars Adlersson, CEO & President
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Basic facts
• 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)
18 month performance
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The strategic journey
Successful outlicensing of 6 polymerase projects. Strong partnerships with deal value in excess of 400 MUSD plus royalties
Nordic marketing rights for all projects and possible product from J&J
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OSTEOPOROSIS
HEPATITIS C
LABIAL HERPES
Key projects
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.
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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
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Treatment Prevention of cold soresReduction in
lesion healing time
Topical vs placebo
Acyclovir
Penciclovir
Docosanol (Abreva)
No
No
No
10 - 12%
13 - 15%
(15%)
Oral vs placebo
Acyclovir
Valaciclovir
No
No
9 - 13%
10 – 11%
Lipsovir® vs placebo Yes, 29% 11% (19%*)
* Episode duration
Lipsovir®: first to show prevention
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A billion dollar market
Annual value growth: 12%
Annual value growth: 9%
OTC(USD 220m)
Rx(USD 450m) Palliative
(USD 400m)
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Development process
July 06 Jan 07 Mar 07 H2 07 H1 08 end-08 2009
StartPhase III
75%treated
60%treated
Phase IIIdata
Filing
Approval
GenitalHerpes?
MarketingPartner(s)
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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
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Physician prescribing habits post- launch of Lipsovir®
Primary market researchBase: 225 physicians who have prescribed cold sore remedies 10+ times in the last 12 months
• 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)
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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
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
Key enzyme for virus replication
Enzyme inhibiting compound
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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
Enzymatic activity on genotype 1b (Ki, nM) <1nM
Replicon activity on genotype 1b[IC50, nM] <10nM
In vivo PK, Oral dose: 10 mg/kg
Cmax (µM)
T 1/2 (h)
F (%)
0.955.420
Data on Compound “A” (an example from the lead series)
LO
M O
NH
R3
O
R2
R1
( )n
From presentations at the 1st International Workshop on Hepatitis C Resistance and New Compounds, Boston 25-26 October 2006and the 3rd Anglo-Swedish Medicinal Chemistry Meeting, 11-14 March 2007, Åre, Sweden
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Bone disorders (MIV-701)• 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-daily oral dosing
• Strong Back-up program in place with pre-CD’s selected
Bone surface
Osteoclast
Cath K
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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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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 Protease Discovery Engine”: A reliable repeat innovator
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MIV-701
HEPATITIS C
LIPSOVIR
The journey ahead• 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
HIV FRANCHISE
• 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
LIPSOVILIPSOVI
RR®®
A profitable pharmaceutical companywith its own research and sales
Next step in company transformation