Lupin Limited

History and evolution

Lupin was founded in 1968 by Desh Bandhu Gupta, then an Associate Professor at BITS-Pilani, Rajasthan. Named after the Lupin flower because 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 world’s 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 company’s R&D endeavours have resulted in significant progress in its new chemical entity (NCE) program. Lupin’s 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, Japan’s MHLW, TGA Australia, WHO, and the MCC South Africa.

In July 2015 the company announced its intention to acquire Gavis Pharmaceuticals and Novel Laboratories for $880 million.

Research and development

Lupin’s research program covers the entire pharma product chain. The company’s R&D program is headquartered in the Lupin Research Park located near Pune that houses over 1400 scientists. Lupin’s R&D covers:

Businesses

Lupin’s businesses encompass the entire pharmaceutical value chain, ranging from branded and generic formulations, APIs, advanced drug delivery systems to biotechnology. The company’s 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 $891 million enterprise. It 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 28 products out of the 77 products marketed in the US generics market, of which it is amongst the Top 3 by market share in 57 of these products (IMS Health, December 2014): Suprax (Cefixime), a paediatric antibiotic, is Lupin’s top-selling product here. Other products in Lupin's branded portfolio include Antara< (Fenofibrate), Locoid lotion, Alinia (Nitazoxanide) and InspiraChambers (Anti-static valved holding chamber). 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 9% of total US sales whereas the generics business contributed 91% during FY 2014-15.

India Region Formulations (IRF)
Lupin’s IRF business focuses on Lifestyle diseases and Chronic disease therapy segments, particularly in Cardiology, Central Nervous System (CNS), Diabetology, Anti-Asthma, Anti-Infective, Gastro Intestinal and Oncology. The IRF business contributed 24% of the company’s overall revenues for FY 2014-15, growing by 20% and recording revenues of ₹29,676 million (US$440 million) for FY 2014-15 as compared to ₹24,794 million (US$370 million) for FY 2013-14.

It has 10 manufacturing plants and 2 Research plants in India, as Jammu(J&K),Mandideep & Indore(Madhya pradesh), Ankaleswar & Dabasa (Gujarat), Tarapur, Aurangabad and Nagpur (Maharashtra) and Goa; where research centre at Pune and Aurangabad. Among these the baby plant is Nagpur plant which will the biggest formulation unit for Lupin in coming year.

Europe
Lupin’s 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 company’s 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). It operates in Japan through its subsidiary, Kyowa Pharmaceutical Industry Co. Ltd. (Kyowa), a company acquired in 2007, and I’rom, 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.

In 2014, Lupin entered into a strategic joint venture agreement with Toyama-based Japanese pharmaceuticals company, Yoshindo Inc. to create YL Biologics (YLB). YLB will be jointly managed by both partners and wil be responsible for conducting clinical development of certain biosimilars including regulatory fillings and obtaining marketing authorization in Japan.

South Africa
Lupin's South African subsidiary, Pharma Dynamics (PD) is the fastest growing and the 4th 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, Gastro-Intestinal and Diabetes care. FY 2012 also marked its foray into the Neurology segment when it entered into a strategic marketing partnership with Sanofi.

Mexico & Latin America
In 2014, Lupin acquired 100% equity stake in Laboratories Grin, S.A. De C.V. (Grin), Mexico, a specialty pharmaceutical company engaged in the development, manufacturing and commercialization of branded ophthalmic products. This marked their entry into Mexico and the larger Latin American pharmaceuticals market. In May 2015, Lupin entered the Brazilian market with its acquisition of 100% stake in Medquímica Indústria Farmacêutica S.A., Brazil, (Medquímica).

Anti-Tuberculosis
Lupin is a global leader in Cephalosporins, Cardiovasculars and the anti-TB space. The company is also a strategic supplier of anti-TB products to the Stop TB Partnership, with its formulations supplied to more than 50 countries through GDF procurement.

Rgwduen is also a global leader in anti-TB APIs, and is associated with the Revised National Tuberculosis Control Program of the Government of India. It supplies to various Government agencies, the Stop TB Partnership and various other international agencies like Pan American Health Organization (PAHO), Médecins Sans Frontières (MSF) and the Damien Foundation. Ethambutol, Rifampicin and Pyrazinamide are the company’s top selling TB molecules.

Biotechnology research
The Lupin Biotechnology Research Group, based out of Ghotawade & Wakad, near Pune is focussed on developing biosimilars. As of May 2013, it has a pipeline of 10 biosimilar products under development, and is close to getting marketing authorization for 2 of its oncology products for the Indian market. Lupin has competencies for the complete development and manufacture of recombinant protein therapeutic products from high yielding and proprietary microbial and mammalian cell culture platforms. The Biotech R&D infrastructure offers a range of product development capabilities ranging from clone development, process optimization, analytical method development, bioassay, formulation, stability studies, non-clinical and clinical studies backed by a sound understanding of regulatory and IP aspects. The company’s biotech development programs are in compliance of and follow IC, EMEA, and Indian Regulatory guidelines.

Corporate social responsibility

Lupin established the Lupin Human Welfare & Research Foundation on 2 October 1988. Its chief objective was to provide an alternative sustainable, replicable and ever evolving model of holistic rural development. It 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 in 3100 villages in the states of Rajasthan, Madhya Pradesh, Maharashtra and Uttarakhand.

Awards and Recognitions

Lupin topped in the India's Most Reputed Brands (Pharmaceutical) list in a study conducted by BlueBytes, a leading Media Analytics firm in association with TRA Research, a brand insights organization (both a part of the Comniscient Group).