Académique Documents
Professionnel Documents
Culture Documents
November 2008
Disclaimer
Except for the historical information contained herein, statements in
this presentation and the subsequent discussions, which include
words or phrases such as will, aim, will likely result, would,
believe, may, expect, will continue, anticipate, estimate,
intend, plan, contemplate, seek to, future, objective,
goal, likely, project, should, potential, will pursue and
similar expressions or variations of such expressions may constitute
"forward-looking statements". These forward-looking statements
involve a number of risks, uncertainties and other factors that could
cause actual results to differ materially from those suggested by the
forward-looking statements. These risks and uncertainties include,
but are not limited to our ability to successfully implement our
strategy, our growth and expansion plans, obtain regulatory
approvals, our provisioning policies, technological changes,
investment and business income, cash flow projections, our exposure
to market risks as well as other risks. Sun Pharma Advanced
Research Company Limited does not undertake any obligation to
update forward-looking statements to reflect events or circumstances
after the date thereof.
Investor Presentation / 2
BOARD OF DIRECTORS
Mr. Dilip S. Shanghvi, Chairman & Managing Director
Dr. T. Rajamannar, Director & Executive VP (R&D)
Mr. Sudhir V. Valia, Director
Independent Directors
Prof. Dr. Andrea Vasella
Prof. Dr. Goverdhan Mehta
Mr. S. Mohanchand Dadha
Investor Presentation / 3
NCE Pipeline
Sun-1334H : An anti-allergic
Sun-461 : An anti-inflammatory molecule for use in the
treatment of asthma and COPD
Sun-44 : A prodrug of gabapentin
Sun-09 : A prodrug of marketed muscle relaxant
SUN-1334H
Route of administration : Oral
Broad therapeutic area : Anti-allergic disorder
Treatment of
Seasonal allergic rhinitis
Perennial allergic rhinitis
Urticaria
Current status
Phase I completed in India and Europe
127 human exposure
Phase II ongoing in US
Chronic toxicity studies ongoing
Investor Presentation / 5
SUN-1334H
Mechanism of action
Selective histamine H-1 receptor antagonist
Poor or no affinity for other relevant receptors
Investor Presentation / 6
SUN-1334H
Current global market size : USD 5.5 billion
Opportunity : Patents expiring on competing products
Challenge : Justify premium on competing generic
products
Will need significant investment in studies to prove
superiority
Investor Presentation / 7
SUN-461
Route of administration : Inhaler
Broad therapeutic area : Anti-inflammatory
Indications
Asthma
COPD
Mechanism of action
Glucocorticoid receptor agonist
Suppresses inflammatory response with significantly
reduced systemic side effects
Current status
Pre-clinical studies ongoing
Acute toxicity studies ongoing
Phase I human studies exposure likely to begin in 2008
Investor Presentation / 8
SUN-461
Inactive Metabolite Approach
Classical
Corticosteroid
Anti-inflammatory
Activity
Systemic
Side Effects
Inactive
Metabolite
& Excretion
Investor Presentation / 9
Local
Anti-inflammatory
Activity
Soft
Corticosteroid
Anti-inflammatory
Activity
Systemic
Inactivation
Reduced Systemic
Side Effects
Inactive
Metabolite
& Excretion
SUN-461
Summary findings / data from studies completed *
Anti-inflammatory activity comparable to marketed
corticosteriods
Side-effect profile superior
In Sephadex-induced lung edema model, therapeutic index
significantly superior to marketed corticosteroid including
budesonide, fluticasone and ciclesonide
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Investor Presentation / 10
SUN-461
Metabolic side effect profile superior to marketed
corticosteroid *
In liver glycogen deposition screen, deposition of glycogen in
liver significantly lower compared to fluticasone and
budesonide
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Investor Presentation / 11
SUN-44
Prodrug of Gabapentin
Route of administration : Oral
Broad therapeutic area : Anti-convulsant / Neuropathy
Indications : Seizure / CNS related disorders
Development rationale
SUN-44 developed to offer higher bioavailability, enhanced
absorption and reduced dosing frequency
Current status
Studies ongoing
Pre-clinical
Acute toxicity
Investor Presentation / 12
SUN-44
Summary findings from animal studies completed *
On equivalent dosage, drug concentration 2-3 times higher
compared to existing product in the market
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Investor Presentation / 13
SUN-44
Clinical advantages
Possible to achieve higher blood level
Once-a-day dosing
Investor Presentation / 14
SUN-09
Pro-drug of a marketed drug
Route of administration : Oral / Injectable
Broad therapeutic area : Skeletal muscle relaxants
Indications : Muscle spasticity
Development rationale
SUN-09 offers quick and improved absorption during entire
gastro-intestinal tract
Current status
Studies ongoing
Pre-clinical
Acute toxicity
Investor Presentation / 15
SUN-09
Summary findings from animal studies completed *
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Investor Presentation / 17
DPI
Inhalers used for Asthma and COPD
Device can be modified for systemic delivery of drugs to
lungs
Easy to use
Simple operating sequence of 3 steps : Open-inhale-close
Investor Presentation / 18
DPI
Device engineered to
Give visual, audible and tactile feedback
Deliver uniform dose over a range of patient effort (flow
rates/patient inhalation effort)
Eliminate double dosing and dose wastages
Deliver multiple doses in one device with fail-safe dose
counter
Deliver consistently higher drug to lungs
Easy use by children, adults and elderly
Investor Presentation / 19
Regulated markets
Expected NDA filing : 2011
Investor Presentation / 20
GRID
Key features of GRID
Coated multilayered dosage form
Floats instantaneously
Swells upto 8 times its initial volume
Maintains physical integrity
Flexible and soft
Clinical advantages
Once-a-day dosing improves patient compliance
Reduced side effects
Different types of release profiles possible (IR + SR)
Investor Presentation / 22
Investor Presentation / 23
Investor Presentation / 24
IR + SR (useful in pain
management)
IR + SR + IR (for
eg in asthma)
SR + IR (for eg in
Heart diseases)
Investor Presentation / 26
Investor Presentation / 27
Nanoemulsion
Key features of technology for cytotoxic substances
Avoids toxic excipients
Better safety index as proven in animal model
Increases circulation half life and improved efficacy
More drugs can be delivered at target site
Avoids hypersensitivity reaction to toxic excipients
Uses all approved excipients in injectable products
Investor Presentation / 28
Investor Presentation / 29
Current status
Preclinical studies ongoing
Clinical studies planned in India : 2008
Somatostatin analogue
Comparable to marketed products
Achieved comparable profile in animals
Easy to use
Current status
Clinical studies in India ongoing
Investor Presentation / 30
Investor Presentation / 31
Regulated markets
Expected NDA filing : 2011
Baclofen GRS
Approved in India
IND filing 2008
Investor Presentation / 32
Financial Summary
(in Rs Lakhs)
P&L Summary
Total Income
Q2 FY09
Q2 FY08
FY 08
100
112
3,753
Total Expenditure
1,098
1,279
4,082
(1,470)
(1,199)
(488)
Investor Presentation / 33
Thank you