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North America Dr. Reddy's Laboratories Inc. 3600 Arco Corporate Drive, Suite 310 Charlotte, NC 28273, USA Tel: +1 866 733 3952 Europe Dr. Reddy's Laboratories UK Ltd. 258 Bath Road, Slough, Berkshine, SL14DX, UK Tel: +44 1753 5125 00 Fax: +44 1753 6966 77 India Dr. Reddy's Laboratories Ltd. Block-III, Level V, White House, Kundanbagh, Begumpet, Hyderabad 500 016 Tel: +91 40 6602 2500 Fax: +91 40 6602 2595 Russia Dr. Reddy's Laboratories Ltd. Representative Office, 115035, 20, Build. 1, Ovchinnikovskaya emb., Business Centre Central City Tower, 6th floor, Moscow Tel: +7 495 783 29 01 / +7 495 795 39 39 Fax: +7 495 795 39 08
Active Pharmaceutical Ingredients (API) email@example.com Dr. Reddy's Laboratories Ltd., Ashoka Hitech Chambers, B-2/120/76/1/B, Road No. 2, Banjara Hills, Hyderabad 500034, India Tel: +91 40 664 709 60 Fax: +91 40 2355 8941 Custom Pharmaceutical Services (CPS) firstname.lastname@example.org USA Dr. Reddy's Laboratories Inc. 200 Somerset Corporate Blvd., Bridgewater, NJ 08807 Tel: +1 908 203 4900 Fax: +1 908 203 4914 Europe Dr. Reddy's Laboratories (UK) Ltd. 258 Bath Road, Slough, Berkshire, SL1 4DX, UK Tel: +44 1753 5125 00 Fax: +44 1753 6966 77 Asia Pacific Dr. Reddy's Laboratories Ltd. Bollaram Road, Miyapur, Hyderabad 500 049, India Tel: +91 40 2304 5737 Fax: +91 40 2304 6600
NCE and Differentiated Products Dr. Reddy's Laboratories Inc. 200 Somerset Corp. Blvd., Building II, Floor 7, Bridgewater, NJ 08807 Tel: +1 908 203 4900 Fax: +1 908 203 4970 Biologics Dr. Reddy's Laboratories Ltd. Biologics Development Center, Survey No. 47, Bachupally, Qutubullapur, R R District 500 123, Andhra Pradesh, India Tel: +91 40 2304 2003/4/5 Fax: +91 40 2304 1418 PromiusTM Pharma 200 Somerset Corporate Blvd., Building II, 7th floor, Bridgewater, NJ 08807, USA Tel: +1 908 203 4917 Fax: +1 908 203 4597 email@example.com
Corporate Development Dr. Reddy's Laboratories Ltd., Corporate Headquarters, Greenlands, Ameerpet, Hyderabad 500 016, India Tel: +91 40 2373 1036, Fax: +91 40 2373 1955 firstname.lastname@example.org
Global Oncology Dr. Reddy's Laboratories Ltd. Survey No. 42, Bachupally, Qutubullapur Mandal, R R District 500 123, AP, India Tel: +91 40 4434 6200 Fax: +91 40 4434 6285
Chirotech Technology Limited, UK Unit 162, Cambridge Science Park, Milton Road, Cambridge CB4 0GH, UK Tel: +44 1223 728010 email@example.com
We are committed to providing affordable and innovative medicines for healthier lives.
An emerging global pharmaceutical company
Established in 1984, Dr. Reddy's Laboratories (NYSE: RDY) is an emerging, fully integrated global pharmaceutical company. We strive to achieve our goals 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, Generic Biopharmaceuticals and a Dermatology focused Speciallty 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.
Indian Pharma Firsts:
• New York Stock Exchange listing • Sarbanes-Oxley (SOX) certification • 180-days exclusive marketing rights for a generic 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
Global Pharma Firsts:
• USP certification under the Pharmaceutical Ingredient Verification Program • Launch of generic monoclonal antibody • Polypill (Cardiovascular) Trial
1984: Dr Anji Reddy establishes Dr. Reddy's Laboratories with an initial capital outlay of Rs.25 lakhs 1987: Obtains its first USFDA approval for Ibuprofen API. Starts its formulations operations
Driving value through collaboration
Our partnership philosophy is defined by a relationship based on trust and mutual respect. The negotiation, transaction and alliance process result in a shared vision to create long term value for both partners. The foundation of our partnership philosophy is based on the following elements: • 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 Dr. Reddy's Alliance Management principles and practices facilitate successful execution of joint initiatives. While deal execution is the final stage in the transaction process, we believe that it is only the first step in building a lasting relationship. Following deal execution, an alliance management team is established with the objective of driving collaborative programs and championing the interest of both parties in the collaboration.
Evaluation, Negotiation and Due-Diligence
The Partnership Process
Deal Execution, Alliance Management and Value Realization
1993: Dr. Reddy's Research Foundation established. The company's drug discovery programme starts 1997: Becomes the first Indian pharmaceutical company to out-license an original molecule. First ANDA filed with the USFDA for Ranitidine
Preliminary Contact and Opportunity Screening
Our Branded and Unbranded generic products offer affordable alternatives to innovator brands, both directly and through key partnerships.
We have a significant presence in the regulated markets of USA, Germany and UK where we offer high quality medicines at affordable prices.
• 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
• 7 Formulation plants [6 in India (1 USFDA approved), 1 in US]
• 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 5th in Germany; the 7th largest Generic Pharma company in Russia and among the largest pharma companies in India
• In-licensing, co-development and product opportunities in difficult-to-make generics • Product portfolio expansion • Partners with unique platform technologies for product development
* As on Q3 FY09
2001: Becomes the first Asia Pacific pharma company, outside Japan, to list on NYSE Launches its first generic product, Ranitidine, in the US market
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.
• Working with top 5 distributors • Coverage of 66 town classes, 50800 doctors, 20000 retailers and 500 hospitals
• 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
• 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
• 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
• Among the top 15 pharma companies. 14th in retail segment • Fastest growing international branded generic company by volumes • Top 5 brands occupy the 1st 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
• 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 and joint commercialization of molecules
2001: Becomes the first Indian pharmaceutical company to obtain 180-day exclusive marketing rights for a generic drug in the US market with the launch of Fluoxetine 40 mg capsules on August 3, 2001
Pharmaceutical Services and 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.
Active Pharmaceutical Ingredients (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.
• 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 • 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
• Sourcing opportunities for products globally • Technology platforms to achieve breakthrough costs for better lifecycle management • Partnerships to build capabilities and strengthen the overall value chain
2005: Acquires Roche's API Business at the state-of-the-art manufacturing site in Mexico with a total investment of USD 59 million 2006: Acquires betapharm- the fourth-largest generics company in Germany. The largest overseas acquisition ever by an Indian company. Becomes the fastest Indian Pharma company to cross $1 billion in revenues
Custom Pharmaceutical Services (CPS)
Challenge, Lifeline, Value Enabling
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. 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: We offer • Life cycle management solutions • End-to-End services in development and manufacturing
Our Proprietary Products business comprises of New Chemical Entities (NCEs), Generic Biopharmaceuticals, Differentiated Formulations and a Dermatology focused Specialty company PromiusTM Pharma. We are building world-class capabilities and partnerships to accelerate the discovery and development of new and improved therapies in select diseases.
Development and Manufacturing Bandwidth
• cGMP E.Coli and Mammalian cell-culture manufacturing facilities with filling and finishing • Dedicated product development teams for differentiated products and PromiusTM Pharma
• 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
• Co-development and commercialization partners for internal programs. • In-licensing of drug delivery technology platforms in metabolic disorders, anti-bacterials and pain/inflammation
2007: Becomes #1 pharmaceutical company in India in turnover and profitability Launches Reditux™ (rituximab) the world's first generic monoclonal antibody
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.
PromiusTM Pharma is a branded Specialty company with a portfolio of in-licensed dermatology products and an internal pipeline in different stages of development. PromiusTM Pharma's current portfolio contains innovative products for the treatment of psoriasis, atopic dermatitis and seborrheic dermatitis.
• 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
• Proven generic biopharmaceutical development capabilities with two marketed products - Grafeel (filgrastim) and Reditux (rituximab), in emerging markets • Developed and launched Reditux (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
• 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
• 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
2008: Acquires BASF's manufacturing facility at Shreveport, Louisiana and Dowpharma's small molecule business at its Mirfield and Cambridge facilities, UK. Launches its US Specialty Business, PromiusTM Pharma,
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