Expanding opportunities. Our purpose Providing affordable and innovative medicines for healthier...

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Expanding opportunit ies

Transcript of Expanding opportunities. Our purpose Providing affordable and innovative medicines for healthier...

Page 1: Expanding opportunities. Our purpose Providing affordable and innovative medicines for healthier lives.

Expandingopportunities

Page 2: Expanding opportunities. Our purpose Providing affordable and innovative medicines for healthier lives.

Our purpose

Providing affordable and innovative medicines for healthier lives.

Page 3: Expanding opportunities. Our purpose Providing affordable and innovative medicines for healthier lives.

An emerging global pharmaceutical company

Established in 1984, we are a fully integrated global pharmaceutical company through three core businesses:

• Pharmaceutical Services and Active Ingredients - comprising of our Active Pharmaceutical Ingredients and Custom Pharmaceutical Services business

• Global Generics - which includes Branded and Unbranded generics

• Proprietary Products - which includes New Chemical Entities (NCEs), Differentiated Formulations, TM Generic Biopharmaceuticals and a Dermatology focused Specialty company - Promius Pharma

Our products are marketed globally, with a strong focus on India, Russia, Europe and US. Dr. Reddy's conducts NCE research in the areas of metabolic disorders, cardiovascular diseases, anti-infectives and pain/ inflammation

Page 4: Expanding opportunities. Our purpose Providing affordable and innovative medicines for healthier lives.

Indian Pharma Firsts

• New York Stock Exchange listing

• Sarbanes-Oxley (SOX) certification

• 180-days exclusive marketing rights forageneric drug in the US

• Authorized Generic

• Commencement of Discovery Research

• NCE out-licensed for development

• NCE into Phase III development

• Fastest to reach $1 billion in revenues

• HDMA Diana Award winner (2006, 2007 and 2008)

• United States Custom and Border Protection Agency certification

Page 5: Expanding opportunities. Our purpose Providing affordable and innovative medicines for healthier lives.

Global Pharma Firsts

• USP certification under the Pharmaceutical Ingredient Verification Program

• Launch of generic monoclonal antibody

• Polypill (Cardiovascular) Trial

Page 6: Expanding opportunities. Our purpose Providing affordable and innovative medicines for healthier lives.

Driving value through collaborationThe foundation of our partnership philosophy:

• Diversified business model; multiple product and service offerings

• A simple, transparent and streamlined process to progress partnering discussions

• Centralized Business Development Council to facilitate thorough diligence of multiple partnership opportunities and coordination between the different business units

• Flat organizational structure to facilitate swift decision making

• Effective alliance management processes

• Adherence to highest global regulatory standards

Page 7: Expanding opportunities. Our purpose Providing affordable and innovative medicines for healthier lives.

Deal Execution,Alliance Managementand Value Realization

Evaluation, Negotiation

and Due-Diligence

Preliminary Contact &Opportunity Screening T

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Page 8: Expanding opportunities. Our purpose Providing affordable and innovative medicines for healthier lives.

Global Generics

Our Branded and Unbranded generic products offer

affordable alternatives to innovator brands, both directly

and through key partnerships

Page 9: Expanding opportunities. Our purpose Providing affordable and innovative medicines for healthier lives.

Manufacturing Bandwidth

• 7 Formulation plants [6 in India (1 USFDA approved), 1 in US]

Product Portfolio

• Integrated product development center

• 50+ products marketed in the US

• 130+ ANDAs filed till date. 69 ANDAs pending approval at the USFDA, of which 32 are Para IV and 19 are FTFs*

• 160+ products marketed in the EU

• 200+ branded formulations marketed in India, Russia and other emerging markets

• Among the top 10 generic companies in the US; ranks 5 in Germany; the 7th largest Generic Pharma company in Russia and among the largest pharma companies in India

* As on Q3 FY09

Global Generics

Page 10: Expanding opportunities. Our purpose Providing affordable and innovative medicines for healthier lives.

Unbranded Generics

We have a significant presence in the

regulated markets of USA, Germany

and UK where we offer high quality

medicines at affordable prices

Page 11: Expanding opportunities. Our purpose Providing affordable and innovative medicines for healthier lives.

Strengths

• World-class distribution capabilities

• Strong product portfolio and an attractive pipeline

• Proven ability to garner market share

• Credible track record of successful “Day 1” launches

• Strong relationships with key distributors, pharmacy chains

and insurance funds

Partnering Opportunities

• In-licensing, co-development and product opportunities in difficult-to-make generics

• Product portfolio expansion

• Partners with unique platform technologies for product development

Unbranded Generics

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Branded Generics

Our Branded Generics portfolio offers over 200 products in

the major therapeutic areas of gastro-intestinal,

cardiovascular, pain management, oncology, anti- infectives,

paediatrics and dermatology.

Our top brands enjoy leadership positions in our key markets

of India, Russia & the CIS, Romania and Venezuela

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Branded Generics

India• Among the largest pharmaceutical companies

• Product portfolio of over 200 brands across 13 therapeutic areas

• Market leader in gastro-intestinal, cardiovascular, pain management and oncology

• 2000+ sales and marketing team

• 300,000+ doctors and 1900+ stockist

• Near 100% coverage of KOLs and key institutes

• Stamlo, Omez, Reditux, Nise, Ketorol are market leaders in their respective category

Page 14: Expanding opportunities. Our purpose Providing affordable and innovative medicines for healthier lives.

Branded Generics (Contd.)

Russia

• Among the top 15th pharma companies. 14th in retail segment

• Fastest growing international branded generic company by volumes

• Top 5 brands occupy the 1 spot in their respective molecule space

• 4 brands [Omez, Ketorol, Nise and Ciprolet] among Top 100

• Strong presence in gastro-intestinal, cardiovascular, anti-Infective, oncology, pain and dermatology

• Building capabilities in wellness and nutraceuticals

• 300 + sales and marketing team

• Working with top 5 distributors

• Coverage of 66 town classes, 50800 doctors, 20000 retailers and 500 hospitals

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Branded Generics (Contd.)

Partnering Opportunities

• In-licensing opportunities in Differentiated Products and NCEs (phase

III, registered, marketed) in gastro- intestinal, cardiovascular, metabolic

disorders, pain, anti-infectives and dermatology

• Partnerships to build Hospital and Paediatric portfolio

• Life cycle management opportunities for big brands

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Global Oncology

Strengths

• One stop portfolio solution with a broad product basket for launches across the globe

• Established capabilities in chemistry and biology enabling strong IP positions

• Low cost development and manufacturing operations

• Strong commercial infrastructure in focus Geographies

Partnering opportunities

• Partners for commercialization of our portfolio

• In-licensing opportunities in:

- Differentiated Products and NCEs (phase III, registered, marketed)

- Complimentary basket of oncology products

• Co-development opportunities for big brands

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Pharmaceutical Services &Active Ingredients

The Pharmaceutical Services and Active Ingredients

business of Dr. Reddy's serves Generics and Innovator

companies through the Active Pharmaceutical Ingredients

(API) and Custom Pharmaceutical Services (CPS) businesses

respectively

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Pharmaceutical Services &Active Ingredients

• Manufacturing Bandwidth

– 8 USFDA approved facilities (6 in India, 1 in Mexico and 1 in UK)

– 3 Technology Development Centers (2 in India and 1 in UK)

• Among the top three API players globally

• Product Portfolio

– 150+ APIs in the market

– 20 products under development at any given point of time

• IP leveraged wide basket of assets

• Cost effective API pipeline; end-to-end services and

competitive pricing

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Active PharmaceuticalIngredients (API)

We offer an unparalleled portfolio to our

customers, who include innovators and

generic formulators worldwide. With

more than 150 products, including

cytotoxic and hormones, and our “first

in, last out” approach, we are among

the top three API players globally

Page 20: Expanding opportunities. Our purpose Providing affordable and innovative medicines for healthier lives.

Active PharmaceuticalIngredients (API)

Strengths

• Broad Global Portfolio: Portfolio of 140+ USDMFs, 80+ EDMFs and several filings in the Rest-of-the-World markets

• Global Presence: Sales in over 85 countries

• Large scale of operations: 8 USFDA approved facilities; serving 300+ SKUs across the globe; unmatched scale-up facilities

• Strong product lifecycle management

• Cost and technology leadership

Partnering Opportunities

• Sourcing opportunities for products globally

• Technology platforms to achieve breakthrough costs for better life cycle management

• Partnerships to build capabilities and strengthen the overall value chain

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Custom PharmaceuticalServices (CPS)

The CPS business today is a partner of choice for the strategic outsourcing needs of 'Innovators', both big pharma and emerging biotech companies worldwide.

Partners will benefit from our years of experience in developing and extending product life cycles and enhancing intellectual property. Our services and capabilities go beyond the boundaries of contract services and enable value creation through different stages of pharmaceutical development.

Page 22: Expanding opportunities. Our purpose Providing affordable and innovative medicines for healthier lives.

Custom PharmaceuticalServices (CPS)

Strengths:

• Cost effectiveness, speed and flexibility in project execution

• Broad service offerings

– Process development and scale up to commercial manufacturing of drug substance and drug products

– Customized solutions with a range of products (APIs and dosage forms)

– Technology leveraged manufacturing services including chiral technology (asymmetric hydrogenation, hydroformulation and bio catalysis)

– Activated mPEGs/ Pegylation

– Steroidal API manufacturing

• IP advantaged basket of assets

Partnering Opportunities: • Life cycle management solutions

• End-to-End services in development and manufacturing

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Proprietary Products

Our Proprietary Products business comprises of New Chemical Entities (NCEs), Generic Biopharmaceuticals, Differentiated Formulations and a Dermatology focused Specialty company - Promius Pharma.

We are building world-class capabilities and partnerships to accelerate the discovery and development of new and improved therapies in select diseases

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Proprietary Products

Development and Manufacturing Bandwidth

• Discovery Research centers in India and US

• cGMP E.Coli and Mammalian cell-culture manufacturing facilities with

filling and finishing

• Dedicated product development teams for differentiated products and

Promius Pharma

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Discovery Research

Strengths

• Discovery and development efforts in metabolic disorders (type 2 diabetes, obesity, dyslipidemia),anti- bacterials and pain/inflammation

• History of successful R&D collaborations with external partners

• Creative risk-sharing partnerships that leverage strengths in therapeutic areas of focus

• Systematic project management principles and processes for timely execution and monitoring of development programs

Partnering opportunities

• Co-development and commercialization partners for internal programs

• In-licensing of drug delivery technology platforms in metabolic disorders, anti- bacterials and pain/inflammation

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Biologics

We view generic biopharmaceuticals as an

integral part of our mid to long term growth

strategy and believe that building depth in

development and manufacturing capabilities

will be critical in accessing this opportunity.

We have made significant efforts in this

direction and have over the years succeeded

in creating world class infrastructure and a

highly capable team.

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BiologicsStrengths

• Proven generic biopharmaceutical development capabilities with two marketed products - GrafeelTM (filgrastim) and RedituxTM (rituximab), in emerging markets

• Developed and launched RedituxTM (rituximab) - the world's first generic monoclonal antibody

• Pipeline of eight generic biopharmaceuticals in various stages of development with two in clinical development

• The product portfolio spans multiple therapeutic areas - oncology, auto-immune diseases and CNS

• cGMP facilities to manufacture Biologics, in adherence with global regulatory requirements at a significant cost advantage

Partnering opportunities

• Partners with intent and capabilities to commercialize generic biopharmaceuticals in specific geographies

• Partners developing generic biopharmaceuticals as differentiated product or for new indications and want to source product

Page 28: Expanding opportunities. Our purpose Providing affordable and innovative medicines for healthier lives.

Promius Pharma

Promius Pharma is a branded

Specialty company with a portfolio

of in-licensed dermatology

products and an internal pipeline in

different stages of development.

Promius Pharma's current portfolio

contains innovative products for

the treatment of psoriasis, atopic

dermatitis and seborrheic

dermatitis

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Promius Pharma

Strengths

• 2 products in the market: EpiCeram Skin Barrier Emulsion and Scytera Foam, 7 products in pipeline

• Track record of successful partnerships with Ceragenix, Foamix, Sinclair and Antares

• Strong portfolio of in-licensed and co-developed dermatological products and an internal pipeline under development

• Strong and committed sales force

• State-of-the-art integrated product development center in Hyderabad, India

Partnering opportunities

• In-licensing and product opportunities in branded dermatology space

• Interested in late stage (phase II, Phase III, ready-to-market, or in-market) opportunities for development and commercialization

• Out-licensing, co-development and commercialization partners for internal programs for market outside of the US

Page 30: Expanding opportunities. Our purpose Providing affordable and innovative medicines for healthier lives.

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