Lupin Limited

Lupin Limited is a transnational pharmaceutical company based in Mumbai. It is the 2nd largest Indian pharma company by market capitalization, the 14th largest generic pharmaceutical company globally and; the 5th largest generic pharmaceutical company in the US by prescription-led market share. It has the distinction of being the fastest growing generic pharmaceutical player in the two largest pharmaceutical markets of the world the US and Japan; and is the 5th largest and the fastest growing generic pharmaceutical player in South Africa.

History and Evolution

Lupin was founded in 1968 by Dr. Desh Bandhu Gupta, then an Associate Professor at BITS-Pilani, Rajasthan. Named after the Lupin flowerbecause of its inherent qualities and what it personifies and stands for, the company was created with a vision to fight life threatening infectious diseases and to manufacture drugs of the highest social priority. Lupin first gained recognition when it became one of the worlds largest manufacturers of tuberculosis drugs. The company today has a significant market share in key markets in the Cardiovascular (prils and statins), Diabetology, Asthma, Pediatrics, CNS, GI, Anti-Infectives and NSAIDs therapy segments. It also has a global leadership position in the Anti-TB and Cephalosporin segments. The companys R&D endeavours have resulted in significant progress in its NCE program. Lupins foray into Advanced Drug Delivery Systems has resulted in the development of platform technologies that are being used to develop value-added generic pharmaceuticals. Its manufacturing facilities, spread across India and Japan, have played a critical role in enabling the company realize its global aspirations. Benchmarked to International standards, these facilities are approved by international regulatory agencies including the US FDA, UK MHRA, Japans MHLW, TGA Australia, WHO, and the MCC South Africa.

Research and Development

Research and Development is at the core and is the most critical part of any pharmaceutical company. At Lupin we see R&D differently. It is fundamentally about creativity, originality and being aware of what is really required. At Lupin, our Research & Development program has been the key to our sustained growth over the past ten years; growth that has made us one of the most exciting research driven pharmaceutical companies globally; a hotbed of differentiation and innovation. Today we are building the future by strengthening our research foundation through prudent investments that position us at the cutting-edge of technology, helping us deliver complex products that very few in the world can.

Headquartered at the state-of-the-art Lupin Research Park in Pune, India, the Company's research program is home to over 1,400 scientists. The Company's global research operations are spread over multiple research facilities in India and Japan. During FY 2013, the Company invested 7.5% of its net sales in Research & Development and related spends, amounting to 7,098 million. FY 2013 was a record year in terms of progress made all around, be it our pace of filing DMFs (Drug Master Files) and ANDAs (Abbreviated New Drug Applications), progress in our drug discovery and development program, milestones in our drug delivery program and approvals in our biotechnology program.

Research and Development

Lupins Research Program covers the entire pharma value chain. The companys global R&D program is headquartered out of the Lupin Research Park located near Pune that houses over 1200 scientists. Lupins R&D covers:

Generics Research Process Research Pharmaceutical Research Advanced Drug Delivery Systems (ADDS) Research Intellectual Property Management Novel Drug Discovery and Development (NDDD) Biotechnology Research

Process Research
API Process research capabilities are a vital component of the business strategy that provides a sustainable, long-term competitive advantage. The program supports the company's generic research program by developing non-infringing and cost competitive APIs. Highlights, FY 2013 In FY 2013, the Company filed 15 US DMFs taking the cumulative total to 138 DMF filings. The Company also filed 5 EDMFs, 3 COSs, 2 Australia DMFs and 1 Japan DMF during the year Development of specialised and complex APIs like Prostaglandins and a new class of Anti-Retro Virals meant for the US, EU, Japan and other advanced markets

Intellectual Property Management

At the very core of Lupins Research is the Companys Intellectual Property Management Group (IPMG) which is not only responsible for its global product pipeline but also creates and manages a high-value patent portfolio that protects our business, research and technology assets. Lupins IPMG has built one of the best track records within the global generic pharmaceutical industry for wins when it comes to successfully litigating and protecting Lupins filings in key markets.The IP group played a pivotal role in the US launch of the generic version

Spending Pattern Differentiation is the heart of our research efforts at Lupin. We have created a truly unique world-class research program, designed to ensure a sustainable pipeline of high-value opportunities to maximise growth. 27,775million cumulative R&D spend in the last 6 years. 7.5% R&D expenditure as a percentage of Net Sales ie Development and related spends, amounting to Rs 7,098 million 29 first-to-file products 1,181 cumulative patents filed as on March 31, 2013 10 pipeline of NDDD / NCE programs in various phases of drug discovery & development.

Pharmaceutical Research
FY 2013 was a landmark year for the Pharmaceutical Research Group as it continued in its single-minded focus to create a meaningful pipeline of differentiated products for both advanced and emerging markets. The group focuses on working on difficult to develop products, first to file products and differentiated therapy areas. In the past five years, the group has added therapy areas like Oral Contraceptives, Ophthalmics, Inhalation (MDIs, DPIs and Nasal Sprays) and Dermatology. The Group ensures that its filings are in line with all global regulatory requirements and one of the key initiatives in FY 2013 was adopting processes and procedures in line with the US FDA's Quality By Design (QBD) requirements.

Highlights, FY 2013
Filed 21 ANDAs with the US FDA and 10 European Union applications The cumulative number of ANDA filings with the US FDA now stands at 176, with 78 approvals received to date. This is in spite of the fact that the Company withdrew 16 ANDA's during the year after re-evaluating their business potential Cumulative first-to-files opportunities now stand at 29 Total cumulative filings within the European Union stands at 53, with 38 approvals received so far Ramped up filings for key markets like Japan, Australia, India, South Africa and other emerging markets

Businesses
Lupins businesses encompass the entire pharmaceutical value chain, ranging from branded and generic formulations, APIs, advanced drug deliverysystems to biotechnology. The companys drugs reach 70 countries with a footprint that covers Advanced Markets such as USA, Europe, Japan, Australia as well as Emerging Markets including India, the Philippines and South Africa to name a few.

KEY MARKETS AND BUSINESSES

USA
Headquartered in Baltimore, Maryland, Lupin Pharmaceuticals, Inc. (LPI), the company's US subsidiary is a $ 706 million enterprise. LPI has a presence in the branded and generics markets of the US. In the branded business, Lupin operates in the CVS and Pediatric segments. The company is the market leader in 24 products out of the 46 products marketed in the US generics market, of which it is amongst the Top 3 by market share in 37 of these products (IMS Health, March 2013): Suprax (Cefixime), a paediatric antibiotic, is Lupins topselling product here. The company is also the 5th largest and fastest growing generics player in the US (5.3% market share by prescriptions, IMS Health). Lupin's US brands business contributed 21% of total US sales whereas the generics business contributed 79% during FY 2012-13. Lupins IRF business focuses on lifestyle and chronic therapy segments. The company has emerged as one of the fastest growing players in therapies like Cardiology, Central Nervous System(CNS), Diabetology, Anti-Asthma, AntiInfective, Gastro Intestinal and Oncology. The IRF business contributed 25% of the companys overall revenues for FY 2012-13, growing by 24% and recording revenues of 2364 crore (US$360 million) for FY 2012-13 as compared to 1905 crore (US$290 million) for FY 2011-12.

Europe
Lupins focus in the European Union encompasses Anti-Infectives, Cardiovascular, and CNS therapy areas, along with niche opportunities in segments like Oral Contraceptives, Dermatology and Ophthalmics. The companys presence in France is by way of a trade partnership; in Germany, it operates through its acquired entity Hormosan Pharma GmbH (Hormosan); while the UK business is a direct-to-market initiative.

Japan
Lupin is the fastest-growing Top 10 generic pharmaceuticals player in Japan (IMS). Lupin operates in Japan through its subsidiary, Kyowa Pharmaceutical Industry Co. Ltd. (Kyowa), a company Lupin acquired in 2007, and Irom, Pharmaceutical Co. Ltd (IP), acquired in 2011. Kyowa has an active presence in Neurology, Cardiovascular, Gastroenterology and the Respiratory therapy segments. I'rom is a niche injectables company with significant presence in the DPC hospital segment.

SouthAfrica
Lupin's South African subsidiary, Pharma Dynamics (PD) is the fastest growing and the 5th largest generic company in the South African market (IMS). The company is a market leader in the Cardiovascular segment and has a growing presence in Neurology, Gastroenterology and the Over the Counter (OTC) segments.

Australia
Lupin entered the Australian market through its subsidiary, Generic Health Pte. Ltd. (GH). It subsequently acquired the worldwide marketing rights to the over 100 year old Australian brand Goanna, used for pain management.

Philippines
Lupin's Philippines subsidiary Multicare Pharmaceuticals (Multicare), is a branded generic company focused on Women's Health, Pediatrics, GastroIntestinal and Diabetes care. FY 2012 also marked its foray into the Neurology segment when it entered into a strategic marketing partnership with Sanofi.

Corporate Social Responsibility

To further its social responsibility objectives, Lupin established the Lupin Human Welfare & Research Foundation (LHWRF) on 2 October 1988. Its chief objective was to provide an alternative sustainable, replicable and ever evolving model of holistic rural development. LHWRF started with a few small rural development projects covering around 35 villages in Bharatpur District,Rajasthan. Its efforts have touched the lives of over a million people across 2,200 villages in the states of Rajasthan, Madhya Pradesh, Maharashtra and Uttarakhand.

Key highlights Highlights, FY 2013 Filed 15 DMFs and 21 ANDAs in the US; received approvals for 16 ANDAs including 2 NDAs (New Drug Applications) during FY 2013. The Company also filed 10 MAAs (Marketing Authorisation Applications) with European Authorities, including nine DCPs (Decentralised Procedure Applications) Filed two exclusive first-to-files for the generic version of Apriso and Viread 150mg, 200mg & 250mg strengths Received initial project milestones payments aggregating over USD 6.5 million for two drug delivery products Completed Phase-I studies in Europe for a program in the CNS area, which is being advanced to Phase II clinical trial now Lupin's biotechnology group received its first marketing authorisation for an oncology product following the successful completion of a Phase III clinical trial in India.

BUSINESS DEVELOPMENT AND PARTNERSHIPS

At Lupin, we strive to help people lead healthier lives through delivering affordable and accessible medication to patients across the world. We are engaged in discovering, developing and commercializing innovative medicines that satisfy unmet medical needs. We recognize the contributions made by our partners in achieving this objective and believe in leveraging successful partnerships in the areas of discovery, technology, products and commercial operations. Over the years we have executed several business development transactions including product in/out-licensing, co-development agreements, technology licenses, joint ventures, and acquisitions that are collectively enabling Lupin to make medical treatment accessible to a larger patient population across the globe.

Our Strengths are:

Fully Integrated pharmaceutical company Strong Research Base in the areas of Generics, New Chemical Entity, Novel Drug Delivery Systems, New Biological Entity, research World Class GMP Compliant Manufacturing Facilities approved by international regulatory agencies Sound Technology Base and expertise to scale up technology to deliver innovative products Strong Global Footprint : USA, India, Japan, Australia, UK, Germany, CIS Large Dynamic Sales Force Robust Distribution Network