Biocon

From Wikipedia, the free encyclopedia

Biocon Limited

Type

Public company

Traded as

BSE: 532523 NSE: BIOCON

Industry

Biotechnology

Founded

1978

Founder(s)

Kiran Mazumdar-Shaw

Headquarters

Bangalore, India

Key people

Kiran Mazumdar-Shaw, Chairman& MD

Products

Pharmaceuticals Enzymes

Revenue

28.14 billion (US$619.08 million)(2010-11)[1]

Net income

3.68 billion (US$80.96 million)(2010-11)

Employees

5,585 (Mar 2011)[1]

Subsidiaries

Syngene Clinigene

Website

www.biocon.com

Biocon Limited (BSE: 532523) is a global biopharmaceutical company with products and research services ranging from pre-clinical to clinical development through to commercialization.[ref 1] Within biopharmaceuticals, the Company manufactures generic active pharmaceutical ingredients (APIs) like Statins and Immunosuppressants that are sold in the developed markets of the United States and Europe. It also manufactures biosimilar Insulins, which are sold in India as branded formulations and in both bulk and formulation forms. In research services, Syngene International Limited (Syngene) is engaged in the business of custom research in drug discovery while the other fully owned subsidiary Clinigene International Limited (Clinigene) is in the clinical development space. In December 2009, Biocon acquired the Active Pharma Ingredients (API) undertaking from IDL Speciality Chemicals Ltd., a subsidiary of Gulf Oil Corporation Limited. Located in Bangalore, India, Biocon has two subsidiaries, Syngene, a custom research organization, and Clinigene, a clinical research organization. Biocons presence straddles four main therapeutic areas Diabetology, Cardiology, Nephrology and Oncology even as it plans to introduce two new divisions, Comprehensive Care, and Immunotherapy, this year. Biocons cardiology, nephrology, diabetology and oncology products including BESTOR, BASALOGTM, BioMAb EGFR, STATIX, NUFIL safeTM, INSUGEN, TACROGRAFTM, ERYPRO safeTM, and MYOKINASETM are considerably less expensive than other leading brands.[ref 1] Two of its novel programs on the verge of proof-of-concept stage are IN-105, which is the only oral insulin in the world to be in long duration clinical trials, and the T1h, a novel humanized monoclonal antibody (MAb), the only first-in-class novel MAb being tested in India for rheumatoid arthritis and psoriasis.[ref 1][ref 2] Between 2005 and 2010, Biocon entered into more than 2,200 high-value R&D licensing and other deals within the pharmaceuticals and bio-pharmaceutical space.[ref 1] It has also expanded its global footprint to emerging and developed markets through acquisitions, partnerships and in-licensing. Biocons Corporate Social Responsibility wing, the Biocon Foundation, is involved in numerous health and education outreach programs targeting the underprivileged sections of India. In 2009-10, Biocons net income increased 44% to Rs. 24,048 million, crossing the half-billion-dollar mark and profits grew 215% to Rs. 2,933 million. The pharmaceutical business exceeded Rs. 200,871 million in revenue and the net R&D expenditure increased to Rs. 917 million, growing 42% over 2008 and up 282% over 2005, while its research services business crossed Rs. 2,807 million.[ref 1]

Biocon, Syngene and Clinigene together employ approximately 4,500 personnel including biologists, chemists, medical practitioners, pharmacologists, engineers, finance/legal/marketing analysts, HR generalists and general administrators. Around 6% of its employees have PhD degrees, 45% have a masters degree, and 33% are graduates. Biocon also collaborates with educational institutes to make courses more industry oriented.[ref 1]
Contents
[hide]

1 History 2 Corporate Governance 3 Subsidiaries, Acquisitions and Strategic Global Alliances

o o o o o o o o o o o

3.1 Syngene 3.2 Clinigene 3.3 BBPL 3.4 Biocon-AxiCorp 3.5 NeoBiocon 3.6 Biocon and Amylin 3.7 Biocon and IATRICa 3.8 Biocon and Mylan 3.9 Biocon and Optimer 3.10 Biocon and Vaccinex 3.11 Biocon and Abraxis

4 Biocon Technology 5 Biocon R&D

o o o

5.1 Process Sciences 5.2 Non-clinical Research 5.3 Clinical Research

6 Affordable Healthcare 7 Products

o o o o

7.1 Diabetology 7.2 Nephrology 7.3 Oncology 7.4 Cardiology

8 Growth Drivers

9 Awards and Achievements 10 Corporate Social Responsibility

o o o o

10.1 Health 10.2 Education 10.3 Infrastructure 10.4 Flood Relief

11 References 12 External links

[edit]History
Having decided to become a brewer like her father, Kiran Mazumdar-Shaw qualified as a master brewer from Australias Ballarat University. However, in India she was unable to find a job because of her gender. [ref 3] It was when she was planning to go abroad to start a brewing career, that she had a chance meeting with Les Auchincloss, who had started a biotechnology company in Ireland called Biocon. He asked her to be his business partner and start Biocon in India. Having no entrepreneurial background, she refused the offer at first. However, when Les Auchincloss, persuaded her to give it a try with a buy-back clause if the business failed, she finally conceded and spent six months in Ireland, training for the job. Back in Bangalore in 1978 she started Biocon with Rs. 10,000 as the initial capital, failing to find any financial institution to back her.[ref 4] She began operations out of the garage of a rented house with two employees. She faced several hurdles the company was operating in an environment with sub-optimal infrastructure and personally, she had credibility issues to overcome: she was a 25-year-old first-generation woman entrepreneur without business experience. There was the risk of the business of biotechnology itself an unknown business in 1978. Biocons first product to go to market was peptinpapain, an enzyme found in papaya which is used to prevent beer from turning hazy.[ref 5] Until 1983, the company blended enzymes and supplied them to brewing, textiles, biofuels, animal feed and other such industries across the world. In the mid-1980s with a loan of US $250,000 from ICICI Bank, Biocon was able to build a solid-state fermentation plant which helped in the growth of its R&D. In 1989, the Irish Biocon was acquired by Unilever. In the mid-1990s, Kiran Mazumdar-Shaw decided to focus on biopharmaceuticals rather than enzymes. But Unilever, a major shareholder, did not want to be in the biopharmaceuticals business. At that time, John Shaw, the Scotsman whom Kiran Mazumdar-Shaw had married in 1998, used his savings to reclaim the entire Biocon stake from Unilever.[ref 6]

Deciding to follow an aggressive growth chart, Biocon soon ventured into the lucrative biopharmaceutical segment. Foreseeing a great opportunity when branded drugs went off patent, they began to develop lovastatin, a cholesterol-lowering drug whose patent expired in 2001. Biocon eventually began making other forms of statins. The companys revenue went up from Rs. 70 crore in 1998, to Rs. 500 crore in 2004 when it went public.[ref 7] In 2007, Biocon made a strategic decision to divest its historic enzymes business to Novozymes A/S of Denmark. Today, Biocon has evolved from an enzyme company to a fully integrated biopharmaceutical company. It now focuses its activities on its bio-pharma business verticals that include APIs, biologicals and proprietary molecules both commercialized and under development.[ref 8] It is the first company globally to manufacture human insulin, Insugen using a Pichia expression system. In 2006, Biocon launched BIOMAb EGFR [ref 9] the first indigenously developed humanized monoclonal antibody for head-and-neck cancer. Biocons milestone events in each year are as follows
[ref 10]

November 29, 1978 - Biocon India is incorporated as a joint venture between Biocon Biochemicals Ltd. of Ireland and Kiran Mazumdar-Shaw.

1979 - Becomes the first Indian company to manufacture and export enzymes to USA and Europe. 1989 - Unilever plc. acquires Biocon Biochemicals Ltd. in Ireland and merges it with its subsidiary, Quest International; Biocon receives US funding for proprietary technologies.

1990 - Scales up its in-house research program, based on a proprietary solid substrate fermentation technology, from pilot to plant level.

1993 - Biocon's R&D and manufacturing facilities receive ISO 9001 certification from RWTUV, Germany. 1994 - Establishes Syngene International Pvt. Ltd. as a Custom Research Company (CRC). 1996 - The commercial success of Biocon's proprietary fermentation plant leads to a 3-fold expansion; enters biopharmaceuticals and statins.

1997 - Spearheads initiatives in human healthcare through a dedicated manufacturing facility. 1998 - Unilever agrees to sell its shareholding in Biocon to the Indian promoters. Biocon becomes an independent entity

2000 - Commissions its first fully automated submerged fermentation plant to produce specialty pharmaceuticals; establishes Clinigene, India's first Clinical Research Organisation (CRO).

2001 - Becomes the first Indian company to be approved by US FDA for the manufacture of lovastatin; PlaFractorTM is granted a US 2001 and world-wide patent.

2002 - Clinigene's clinical laboratory receives CAP accreditation.

2003 Biocon becomes the first company worldwide to develop human insulin on a Pichia expression system.

2004 Day 1 on the bourses closes with a market value of $1.11 billion, making Biocon only the second Indian company to cross the $1 billion mark on the first day of listing; Syngene establishes new research centre; Biocon launches INSUGEN; Biocon partners with Vaccinex to discover and co-develop at least four therapeutic antibody products.

2005 - Signs a commercial agreement for supply of insulin API to Asia, Africa and the Middle East. 2006 - Inaugurates Biocon Biopharmaceuticals, India's largest multi-product Biologics facility at Biocon Park; Inaugurates Biocon Park, India's largest integrated biotechnology hub; Licensing agreement with Bayer HealthCare (BHC) for the exclusive marketing and trademark rights for INSUGEN for the Chinese market; Syngene signs a cooperation agreement with Innate Pharmaceuticals to jointly develop, manufacture and market virulence blockers to counteract bacterial diarrhoeal disease; Biocon launches India's first anti-cancer drug, BIOMAb EGFR.

2007 - Biocon and Neopharma sign an MOU to establish a JV to manufacture and market a range of biopharmaceuticals for the GCC countries; Grants exclusive license to Ferozsons Laboratories Limited for marketing BIOMAb EGFR in Pakistan; Announces the launch of its Nephrology Division and a comprehensive portfolio of renal therapy products; Syngene enters into a research partnership with BristolMyers Squibb; Biocon signs MoU with Deakin University, Australia to establish Deakin Research Institute in Bangalore; Divests enzymes division for USD 115 million to Novozymes; Biocon and Abraxis BioScience, announce an agreement wherein Abraxis will license the right to develop a biosimilar version of G-CSF (Granulocyte-Colony Stimulating Factor) in North America and the European Union; Biocon and Neopharma sign an MoU to establish Neobiocon, a JV company in Dubai; Biocon and Abraxis BioScience Inc., announce a licensing agreement for the commercialization of Abraxane in India; Biocon presents the results of Phase 1 studies on its oral insulin product, IN-105 at the European Association for Study of Diabetes (EASD) meeting held at Amsterdam.

2008 - Biocon acquires a 70% stake in German pharmaceutical company, AxiCorp GmbH for a consideration of 30 Million; Launches a Safety Device in the form of pre-filled syringes for two of its life saving products, GCSF and EPO in collaboration with Safety Syringes Inc.; Biocon and Abraxis Bioscience launch Abraxane in India for treatment of breast cancer; Biocon ranked among the top 20 global biotechnology companies (Med Ad News); Biocon is the 7th largest biotech employer in the world (Med Ad News); NeoBiocon and Abraxis Bioscience launch Abraxane in The UAE.

2009 - Syngene partners with Sapient Discovery to expand integrated drug discovery offerings; Syngene and DuPont Crop Protection Forge Alliance Partnership; Bristol-Myers Squibb and Syngene open new R&D facility at Biocon Park; Biocon launches BASALOGTM - long lasting basal insulin for Type 1 & Type 2 Diabetics; Biocon inks partnership with ISB to launch the Biocon Cell for Innovation Management;

Announces strategic collaboration with Mylan to enter the global generic biologics market; Biocon and Amylin Pharmaceuticals enter into a global development and commercialization agreement for a novel peptide hybrid.

[edit]Corporate

Governance

Biocons technocrat CMD Kiran Mazumdar-Shaw has nurtured Biocon since its inception in 1978, steering its evolution from a maker of industrial enzymes to a fully integrated biopharmaceutical enterprise with world-class capabilities.,,[ref 10][ref 11][ref 12] Her efforts in biotechnology have drawn global recognition both for the industry in India and for Biocon and she has been termed Indias Biotech Queen by The Economist York Times.
[ref 14] [ref 13]

and Indias mother of invention by The New

She was recently named among Time magazines 100 most influential people in the world

based not only on her contribution to the biotech industry but also because she gives back to the community. [ref
15]

Ms Shaw features on the Forbes list of The Worlds 100 Most Powerful Women

[ref 16]

and in Financial

Times Top 50 Women in Business list [ref 17] A pioneer of the Indian biotech sector, Ms Shaw wants to create a global leadership profile for Indias biotech industry. Hence, she engages with the government to shape policies for the sector. Her determination to create a research ethos in India has seen her getting involved with academia.[ref 18] Ms Shaw chairs Karnatakas Vision Group on Biotechnology and also served on the Board of Science Foundation, Ireland. She serves on the Advisory Council of the Governments Department of Biotechnology and is part of the Prime Ministers Council on Trade & Industry in India and the US-India CEO Forum. She serves as Member, Governing Body and General Body of the Indian Pharmacopoeia Commission, an Autonomous Body of the Government of India. She is a founder member of the Society for the formation of Institute for Stem Cell Biology and Regenerative Medicine. She has been nominated as Member of the Board of Trade, Directorate General of Foreign Trade, Ministry of Commerce & Industry.[ref 10] Ms. Shaw is the recipient of several prestigious awards including the Nikkei Asia Prize, 2009 for Regional Growth,[ref 19] Express Pharmaceutical Leadership Summit Award 2009 for Dynamic Entrepreneur, the Economic Times Businesswoman of the Year, the VeuveClicquot Initiative For Economic Development For Asia, Ernst & Youngs Entrepreneur of the Year Award for Life Sciences & Healthcare, Technology Pioneer recognition by World Economic Forum and The Indian Chamber of Commerce Lifetime Achievement Award. She has received two Indian national awards Padma Shri (1989) and Padma Bhushan (2005) for her pioneering efforts in Industrial Biotechnology.[ref 10] Born on 23 March 1953 in Bangalore, Ms. Shaw received a graduate honors degree in Zoology from Bangalore University (1973) and qualified as a Master Brewer from Ballarat University, Australia (1975). She received an honorary Doctorate of Science in 2004 from Ballarat University in recognition of her contributions to biotechnology.[ref 10]

Active on the corporate social responsibility front, Ms. Shaw set up the Biocon Foundation in 2004. Recently, she contributed Rs 40 crore to help establish the presently 500-bed Mazumdar-Shaw Cancer Center in Bangalore.[ref 20] In an interview, she stated: The way I have looked at it is that business is very mercenary and youve got to balance it with some missionary aspect. To me corporate social responsibility is getting that balance right that you got to make sure that you invest in the community that supports your business. [ref 21] Apart from her interested in the civic well-being of Bangalore, she is an avid art collector. She is married to John Shaw who headed leading textiles MNC Madura Coats from 1991-1998 as Chairman and Managing Director.[ref 5] The members of the Board of Directors are [ref 1]

Dr. Neville Bain Chairman, Institute of Directors, UK; Board Member, Scottish & Newcastle Plc., Provexis Ltd

Prof. Charles L. Cooney Professor, Chemical & Biochemical Engineering, Massachusetts Institute of Technology, USA; Director, Genzyme Inc

Dr.Bala S. Manian Chairman and Founder, Reametrix Inc.; Co-founder, Quantum Dot Corporation and Surromed Corporation, USA; and Expert in the design of electro-optical systems

Mr. Suresh Talwar Partner, Talwar Thakore & Associates; Director, Cadbury India Ltd., Blue Star Ltd., L&T Ltd. and other leading companies

Ms.Kiran Mazumdar-Shaw Chairman & Managing Director, Biocon; First generation entrepreneur with more than 32 years of experience in biotechnology and industrial enzymes

Mr. John Shaw Vice Chairman, Biocon; Served in senior corporate positions at various locations around the world; and Former Chairman, Madura Coats Ltd.

Prof. Ravi Mazumdar University Research Chair Professor, Department of Electrical and Computer Engineering, University of Waterloo, Canada

Prof. Catherine Rosenberg Alternate Director, Biocon; University Research Chair Professor and Chairman, Department of Electrical and Computer Engineering, University of Waterloo, Canada

[edit]Subsidiaries, [edit]Syngene

Acquisitions and Strategic Global Alliances

Established in 1994, Syngene International Limited is Biocons custom research organization offering pharmaceutical and biotechnology majors customized solutions in synthetic chemistry and molecular biology for early-stage drug discovery and development. It offers high-value services from target identification and validation to small molecule and library synthesis, on a strong platform of confidentiality and intellectual property protection. It was Indias first CRO to receive special export status by the Government of India. [ref 10]

[edit]Clinigene
Clinigene International Limited is Biocons full-service clinical research organization offering international pharmaceutical majors Phase I-IV clinical trials and studies for novel/generic molecules. Clinigene achieves its main objective of Accelerating Clinical Research by leveraging a high-quality mix of technology, experience and personal traits. It has extensive clinical trial and project management expertise and has conducted complex clinical programs.[ref 10]

[edit]BBPL
Anticipating the increasing importance of immunotherapy medicines of the future, Biocon established Biocon Biopharmaceuticals Pvt. Ltd. (BBPL) in 2003 as a joint venture with the Cuban institute CIMAB to develop and market a range of MAbs and cancer vaccines. BBPL leverages CIMABs expertise in developing and manufacturing immunotherapy products and Biocon's R&D and state-of-the-art manufacturing capabilities.[ref 10]

[edit]Biocon-AxiCorp
In 2008, Biocon acquired a majority stake of 70% in AxiCorp GmbH, a German pharmaceutical marketing company and amongst the fastest growing in Europe. AxiCorp also won the German AOK (a leading public health insurer) tender for Metformin, marking an important milestone for Biocons entry into the generics market as well as enabling it to market biosimilar insulin and analogs in the German market. AxiCorp is now an autonomous subsidiary of Biocon and the most successful Indian owned German pharmaceutical company.,[ref
1][ref 10]

[edit]NeoBiocon
Incorporated in January, 2008 NeoBiocon FZ LLC is a research and marketing pharmaceutical company based in Abu Dhabi. It is a 50:50 joint venture established with the Abu Dhabi-based pharmaceutical manufacturing company NeoPharma, in order to manufacture and market a range of biopharmaceuticals for the GCC countries (Gulf Cooperation Council) The new company's product offering includes biologicals, proprietary/inlicensed products, targeted therapeutics, research-based differentiated formulations and innovative drug delivery systems. It also launched Abraxane in the UAE.,[ref 1][ref 10]

[edit]Biocon

and Amylin

In 2009, Biocon and Amylin Pharmaceuticals of the United States entered into an agreement to develop, commercialize and manufacture a novel peptide therapeutic for the potential treatment of diabetes. Amylin provides expertise in peptide hormone development, particularly in the area of phybrid technology and metabolic disease therapeutics. Biocon will utilize its expertise in recombinant microbial expression and experience in preclinical and clinical development of diabetes products to manufacture the compound.,[ref 1][ref 10]

[edit]Biocon

and IATRICa

In 2008, Biocon and IATRICa of the United States announced a strategic partnership to co-develop an exclusive new class of immunoconjugates for targeted immunotherapy of cancers and infectious diseases. The companies are co-developing candidate products based upon IATRICas technology platform and Biocons expertise in drug development, biologics manufacturing, and clinical research. The goal of this collaboration is to develop a therapeutic vaccine where the T cell mediated immunity is enhanced and maintained against a tumor which otherwise evades immune responses. Methods of developing, characterizing and scaling up of conjugated monoclonal antibody production are being currently studied.,[ref 1][ref 10]

[edit]Biocon

and Mylan

In 2009, Biocon signed a collaboration agreement with Mylan to develop and commercialize multiple, highvalue generic biologics. The partnership combines Biocons scientific expertise and state-of-the-art, costefficient, and scalable biologics manufacturing with Mylans global commercial footprint and regulatory expertise around the world. Mylan and Biocon will share development, capital and other costs to bring products to market. Mylan will have exclusive commercialization rights in USA, Canada, Japan, Australia, New Zealand, EU and European Free Trade Association countries through a profit sharing arrangement with Biocon.,[ref 1][ref 10]

[edit]Biocon

and Optimer

Biocon and Optimer Pharmaceuticals, a biopharmaceutical company focused on the treatment of serious infections such as Clostridium Difficile Infection (CDI), have entered into a long-term supply agreement for the commercial manufacturing of the active pharmaceutical ingredient, fidaxomicin., [ref 1][ref 10]

[edit]Biocon

and Vaccinex

Biocon is also developing fully human antibodies BVX 10 and BVX-20 with a US antibody technology partner, Vaccinex. The partnership was initiated in 204. BVX 10 targets TNF (Tumor Necrosis Factor) which is expressed at high levels in patients suffering from rheumatoid arthritis. Biocons strategic partnership with Vaccinex allows access to their proprietary human antibody platform technology, thereby providing a strong IP protection to Biocons antibody pipeline.,[ref 1][ref 10]

[edit]Biocon

and Abraxis

In 2007, Biocon and Abraxis BioScience, Inc. entered into an agreement which helped Biocon out-license the rights to develop and market a biosimilar version of GCSF (Granulocyte Colony-Stimulating Factor) to North American and European markets. Biocon receives an upfront licensing fee and, following approval in the licensed territories, royalties from Abraxis BioScience. The partnership has also helped Biocons Oncotherapeutics division add another frontline anti-cancer drug Abraxane to its portfolio. In-licensed from Abraxis BioScience, Biocon has obtained the rights to market Abraxane in India for the treatment of breast cancer.[ref 10]

[edit]Biocon

Technology

Biocons manufacturing technologies have helped it transform from a specialty enzymes player to a global provider of biopharmaceuticals spanning small molecules, recombinant proteins, peptides and monoclonal antibodies. These technologies range from large-scale microbial fermentation, chemical synthesis, mammalian cell culture, protein and antibody purification, aseptic formulation to fill-finish.[ref 10] Biocons manufacturing facilities are designed to cGMP standards and are supported by state-of-the-art process development and quality control laboratories and an efficient service infrastructure. They are located at two sites in Bangalore, both of which have been certified by local and international regulatory agencies, including US FDA and EDQM.[ref 10] Biocons human insulin facility has several sophisticated technologies and equipment used for the first time in India. Its biosimilars, such as granulocyte colony stimulating factor (GCSF), streptokinase, reteplase, human growth hormone, etc. are manufactured in a facility equipped to handle both intracellular and extracellular products. Through its subsidiary Biocon Biopharmaceuticals Private Limited, it has established a large-scale, multi-product, cell culture facility.[ref 10]

[edit]Biocon

R&D

Biocon Corporate Presentation

Biocons discovery-led R&D focuses on the entire drug development pathway - from process development, to non-clinical and clinical research.[ref 10]

[edit]Process

Sciences

Biocons has developed processes for multiple products, including Insulin, Streptokinase, GCSF and BIOMAb EGFR. In this department, it also develops cell lines, fermentation/purification/scale-up/ formulation processes and analytical methods to meet global regulatory standards. It also researches and develops a range of microbial-derived pharmaceutical products for diseases spanning the cardiovascular, diabetes, nephrology, inflammatory and oncology areas.

[edit]Non-clinical

Research

Biocon scientists take up toxicology and pharmacology studies to establish proof-of-concept and provide assurance of safety in molecules under investigation. They plan, develop and execute studies that meet global regulatory requirements.

[edit]Clinical

Research

Biocon develops clinical protocols for several novel drugs. It conducts studies like assessment of novel biomarkers to understand the safety and efficacy of molecules in clinical trials. Biocons patent portfolio totals close to 942 applications worldwide with over 182 granted patents, covering technology areas of fermentation, protein purification, drug delivery systems and biotherapeutic molecules.[ref 10]

[edit]Affordable

Healthcare

Biocon believes that affordable innovation is critical to meeting the healthcare needs of the world. [ref 10] The global healthcare industry is facing an affordability and accessibility crisis. In the face of the drying drug pipeline and declining research productivity and costly nature of drug discovery,[ref 22] India offers a huge cost advantage pharmaceutical research can be carried out at roughly one-fourth the cost in the US. Moreover, the country has a large, qualified English-speaking workforce, a network of research laboratories and traditional pharmaceutical capabilities. These factors combine to endow new drug discovery and development in India with high capital efficiency. On the other hand, the biotechnology industry has opportunities opening up. The pharmerging markets of India, Brazil, Russia, China, South Korea, Mexico, and Turkey are expected to account for 51 per cent of the industrys growth.[ref 23] To ensure affordable medicines and grow profits in such a scenario, Biocon has made four paradigm-changing shifts [ref 1]:

Reduce the risk and cost of drug development by experimenting with new risk-sharing models such as codevelopment of molecules and offshoring development to contract research organizations and conducting clinical trials in lower-cost locations. Biocons Syngene and Clinigene aim to offer a huge range of costcompetitive, quality research to partners across the world.[ref 1]

Expand into emerging markets not only for their extensive market but also to develop new products and establish manufacturing, R&D and other facilities. Biocon has partnered with the Centre for Molecular Immunology (CIM) in Cuba to develop and commercialize a monoclonal antibody for the treatment of head-and-neck cancers in India. Biocon has forged marketing tie-ups in emerging markets like Latin America, Mexico, Middle East, North Africa, Asia, China, and Turkey with strong regional players.[ref 1]

Acquire advanced R&D assets through mergers, alliances, and licensing deals to refresh the product pipeline, gain a strategic time-to-market edge, and ensure a competitive advantage. Biocon has partnered

with Mylan to jointly develop biosimilars, with Amylin for a novel anti-diabetic hybrid peptide, and with Johns Hopkins start-up, IatriCa [ref 24] for a novel therapeutic cancer vaccine. It has also developed collaborations with several highly innovative US biotech companies with unique platform technologies that did not have the capabilities to take their innovations to the market.

Diversify its portfolio by choosing products with shorter regulatory timelines like diagnostics, devices, new drug delivery systems, and vaccines, and turning to generics and biosimilars. Biocon started with generics and statins and moved to recombinant proteins like insulin and insulin analogs and then worked on complex biosimilar monoclonal antibodies. Two novel biologics oral insulin and anti-CD6 are in latestage clinical trials. Biocons strategy is to maximize development in India to take advantage of the lower R&D costs and faster clinical development timelines.

[edit]Products
Biocons portfolio consists of 36 key brands across the four therapeutic divisions of Diabetology, Nephrology, Oncology and Cardiology.[ref 1]

[edit]Diabetology
This is the oldest of Biocons four divisions and has acquired 50% of the market share in the Indian insulin segment through its flagship product INSUGEN which has since been introduced into several overseas markets. In 2009, the division launched its first insulin analog, BASALOGTM, in the Indian market. It can be used just once a day and is effective for 24 hours. Both INSUGEN and BASALOGTM are being developed for registration in Europe and USA between 2012 and 2016. BLISTO-MFTM and METADOZE-IPR are Biocons oral anti-diabetic formulations while OLISATTM is an oral anti-obesity formulation.

[edit]Nephrology
ERYPRO safeTM (erythropoietin) is among the top 5 brands in the 30-brand EPO market. RENODAPT, Biocons premium immunosuppressant, mycophenolatemofetil ranks 4th among 25 brands, while the newly introduced immunosuppressant, tacrolimus branded TACROGRAFTM is 3rd among 20 brands. Biocon has newly launched dosage forms like TACROGRAFTM 3 mg, RENODAPT750 mg, RENODAPT-S 540 mg and RAPACANTM 2 mg to suit Indian patient needs through ideal dosage, enhanced compliance and reduced pill burden. In 2009, Biocon launched a specially formulated protein supplement, NARITA+TM in the renal nutrition segment, for dialysis patients suffering from malnutrition.

[edit]Oncology
This divisions BIOMAb EGFR, approved in 22 countries, is a successful formulation for indications like headand-neck cancers, both adult and paediatric glioma, and nasopharyngeal carcinoma. Abraxane, launched in July 2008, is being used to treat metastatic breast cancer and also other tumors such as pancreatic cancer,

non-small cell lung cancer and ovarian cancer. It is a first-in-class, innovative treatment regimen designed to address unmet needs associated with solvent-based paclitaxel such as hypersensitivity reactions, increased myelosuppression and axonal degeneration. NUFIL safeTM for the treatment of chemotherapy-induced neutropenia is among the top 10 brands in the filgrastim segment.

[edit]Cardiology
With major brands like STATIX (anti-cholesterol) and TELMISAT (anti-hypertensive), Biocons cardiology division is now ranked number 22nd in its representative market. Biocons CLOTIDETM is the leading eptifibatide brand in India and MYOKINASETM (met-free streptokinase) is a life-saving injectable. Other brands like ACTIBLOKTM-IPR (metoprolol) and the newly launched BESTOR(rosuvastatin) and BRADIATM (ivabradine) are also from this division.

Apart from these oral insulin, anti-CD6, targeted immune-conjugates, anti-CD20, peptide hybrid, biosimilarMAbs and insulin analogs are under various stages of development. The complete list of Biocons products is as follows: STATIX (controls elevated cholesterol levels), STATIX-F (corrects cholesterol levels in diabetic dyslipidemics), STATIX -EZ (controls extremely high levels of cholesterol), TELMISATTM(offers 24-hour blood pressure control), TELMISATTM-H (for uncontrolled hypertension), TELMISAT AM (for diabetic hypertensives), ACTIBLOKTM-IPR (for patients of hypertension, angina, IHD and heart failure), ACTIBLOKTM AM (for uncontrolled hypertension), BESTOR (for the management of dyslipidemia and atherosclerosis), BRADIATM (for the management of stable angina), THINRINTM (for early and long-term risk reduction in high risk ACS patients), CLASPRIN (for early and longterm risk reduction in high risk ACS patients), ZARGO(reduces high blood pressure), ZARGO - H (reduces high blood pressure), ZIGPRIL (for patients with risk of CVD), MYOKINASETM (for patients of acute myocardial infarction), DYNALIX (for patients of acute coronary syndrome and prophylaxis of deep vein thrombosis), CLOTIDETM (for patients of acute coronary syndrome, undergoing percutaneous coronary interventions), INSUGEN -R (Regular), INSUGEN -N(NPH) and INSUGEN -30/70 & 50/50 (for diabetes, useful when oral agents fail to control blood glucose levels), BASALOGTM (for diabetes mellitus, for 24-hour basal insulin action), BLISTOTM (increases Insulin secretion in Type 2 diabetes by stimulating pancreas), BLISTOTM- 1MF/2MF/4MF (for type 2 diabetes, when blood glucose is not controlled with a single medication), METADOZE -IPR (improves action of insulin in type 2 diabetes), TriGPMTM-1/2 (a triple drug combination for uncontrolled type 2 diabetes), ZUKERTM-MF (comprehensively controls hyperglycemia in Type 2 Diabetes), PIODART (helps insulin work better in Type 2 Diabetes), PIODART-MF (improves blood sugar control when not controlled by monotherapy), OLISATTM (weight reducer), GABILTM(for diabetic neuropathy), GMABTM Plus (nutritional supplement), ERYPRO safeTM (for the treatment of patients with anemia due to chronic renal failure, either on dialysis or non-dialysis), ERYPROTM(for the treatment of patients with anemia due to chronic renal failure,

either on dialysis or non-dialysis), TACROGRAFTM (for prophylaxis of transplant rejection in organ transplantation and as a rescue therapy in patients with rejection episodes), RENODAPT-S (for prophylaxis of transplant rejection in organ transplantation and as a rescue therapy in patients with rejection episodes), RENODAPT(in prophylaxis of transplant rejection in organ transplantation and as a rescue therapy in patients with rejection episodes), CYCLOPHIL METM (in prophylaxis of allograft rejection in kidney transplantation and as a rescue therapy in patients with rejection episodes), CYCLOPHIL METM (ORAL SOLUTION) (in prophylaxis of transplant rejection in organ transplantation and as a rescue therapy in patients with rejection episodes), NaritaTM+ (for patients who need high protein supplementation), RAPACANTM (prevention of rejection and rescue therapy for rejection in renal transplantation), biOSEVTM (for the management of hyperphosphatemia in CKD patients), CeRACaLTM (for the treatment of secondary hyperparathyroidism in dialysis patients), BIOMAb EGFR(humanized monoclonal antibody targeting epidermal growth factor receptor indicated for its use in head-and-neck cancer), Abraxane (for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy), ERYPRO safeTM (for the treatment of chemotherapy induced anaemia), NUFIL safeTM (for the treatment of chemotherapy induced neutropenia), NUFILTM (for the treatment of chemotherapy induced neutropenia) [ref 1]

[edit]Growth

Drivers

Today, biologics, with revenues of $125 billion in 2008, are outperforming the global pharma market. [ref 25] The growth rate of biologics which include biosimilar MAbs, biosimilar insulin and novel biotherapeutics, among others is projected to increase at double-digit levels.[ref 26] Moreover, even as mature markets have a singledigit growth rate of 4.3%, the growth essential to the industrys survival is coming from emerging markets that are expected to expand by $90 billion during 2009-13 and contribute 48% of annual market growth in 2013.[ref
27]

In such a scenario, Biocon has the structures to engage these growth drivers.[ref 1]

Monoclonal Antibodies (MAbs): These are one of the fastest growing categories of the biopharmaceuticals industry with sales expected to reach $67.6 billion by 2015, a CAGR of 13.8% between 2008 and 2015. [ref
28]

Biocon has the expertise required to develop MAbs as seen with its product, BIOMAb-EGFR it has the

manufacturing facilities required for MAb research and has developed expertise in process development, formulation development and characterization as well as manufacturing and clinical development.[ref 1] Biocon has entered into sales and marketing agreements with Mylan to develop and commercialize molecules globally.[ref 29] Biosimilar insulin: With the worldwide insulin market expected to be worth over $11 billion by 2011 and an estimated 246 million people affected by diabetes worldwide, according to The World Health Organization, the demand for insulin in expected to increase greatly over the next decade. Biocon has expertise in developing cost-effective Pichia-derived insulin. It has a rich insulin portfolio comprising recombinant human insulin,

insulin glargine (a long-acting basal insulin analogue), insulin aspart (short-acting, in pre-clinical), and insulin lispro (another short-acting analogue, in pre-clinical) covering the analogue space.[ref 1] Novel licensing program: Biocon has programs to out-license two molecules IN-105 and T1h. With a positive safety and clearance profile, IN-105 is an orally delivered conjugated insulin drug that is expected in the market soon.[ref 30] IN-105 is currently undergoing Phase 3 clinical studies in India.[ref 1] An investigational new drug application (IND) with the US Food and Drug Administration was filed in December.[ref 31] T1h is a novel humanized monoclonal antibody that blocks CD6. In clinical trials in the autoimmune segment, T1h is the only Class I novel biological being tested in India for rheumatoid arthritis (RA) and psoriasis. Two Phase II clinical trials have been started one in RA and one in psoriasis, and are expected to be completed this year. [ref 32] Emerging markets: With the dynamics of the pharma world shifting, emerging markets the 17 high-growth pharmaceutical markets, including the 7 primary pharmerging markets of India, Brazil, Russia, China, Mexico, Turkey and South Korea present an important opportunity for biotechnology firms. Emerging markets including India already contribute about 40% of Biocons sales.[ref 33]Biocon has entered into partnerships with companies around the world to gain access in emerging markets.[ref 1]

[edit]Awards

and Achievements

Biocon has the following awards and achievements to its credit,[ref 1][ref 10]: 2010: Bio-Excellence Award for Outstanding Achievement in the Healthcare Sector at Bangalore Bio 2009: - Among Top 20 Indian companies in Forbes Best Under A Billion list - Bio-Excellence Award for Outstanding Achievement in the Healthcare Sector at Bangalore Bio - Bio-Excellence Award for outstanding achievement in the Biotech Service Sector at Bangalore Bio for Syngene IDMA Best Patent of the year award - BIOMAb EGFR voted Bio-Spectrum Asia-Pacific Product of the year, 2008 - BioSingapore Asia Pacific Biotechnology Award for Best Listed Company 2008: - Ranked among the top 20 global biotechnology companies (Source: Med Ad News, June 2008) - 7th largest biotech employer in the world (Source: Med Ad News, June 2008) 2007: BioServices Company of the Year for Syngene, BIOMAb EGFR wins Product of the Year, BioSpectrum Awards

2006: Best IT User Award in the Pharmaceutical Sector, NASSCOM 2004: - India's first and No. 1 biotech company with a global ranking of 16 (Source: Biospectrum, July 2004) - India's top 5 Life Sciences companies (at close of trade as on July 30, 2004) - Best Reinvention of HR Function Award, Indira Group, Mumbai - Best Employer of India Award, Hewitt 2003: - Bio-Business Award for bio-entrepreneurship, Rabo India - Express Pharma Pulse Award for excellence in the pharmaceutical industry 2001: - Biotech Product, Process Development and Commercialisation Award, Department of Biotechnology, Ministry of Science and Technology, Government of India 2000: - Technology Pioneer Recognition, World Economic Forum 1985: - Export Performance Award, Karnataka State Financial Corporation (KSFC) - National Award for Best Small Industry, Government of India Firsts Set up in 1978, Biocon is India's first biotech company

First Indian biotech company to receive US funding for proprietary technologies (1989) Sets up India's first clinical research organization, Clinigene (2000) First Indian company to be approved by US FDA for the manufacture of lovastatin, a cholesterol-lowering molecule (2001)

First company worldwide to develop human insulin on a Pichia expression system (2003) Biocon enters the stock market with its IPO and becomes only the second Indian company to cross the $1billion mark on the day of listing (2004)

Launches Indias first cancer drug, BIOMAb EGFR (2006) First Indian company to manufacture and export enzymes to USA and Europe Indias largest producer and exporter of enzymes Releases countrys first 24-hour diabetes drug, Glargine (2009) First biotech company to receive ISO 9001 certification in India Syngene is countrys first custom research company in drug discovery

[edit]Corporate

Social Responsibility

While Biocon was involved in community programs from inception, it started a corporate social responsibility wing the Biocon Foundation in 2004 [ref 21] through which it works in the areas of health, education and infrastructure, especially in rural areas.[ref 1]

[edit]Health
Through the Arogya Raksha Yogana (ARY) clinics, Biocon helps meet the primary, tertiary and secondary healthcare needs of various communities. Its 7 ARY clinics located where healthcare facilities are poor offer clinical care, generic medicines and basic tests. Each of the clinics located in Austin Town and Krishnarajpuram in Bangalore City, Huskur and Hennagara in Anekal taluk, and in the districts of Mandya, Chickballapur and Bagalkote serves a population of 50,000 people living within a radius of 10 km.[ref 1] The clinics organize health camps in remote villages. A mobile diabetic foot van from the Jain Institute of Vascular Sciences, Bangalore, visits each clinic once a month to treat diabetics.[ref 1] The Foundation employs community health workers to educate communities on health, disease prevention and early detection. CHWs are equipped with mobile phones to facilitate flow of information to the clinic. Through an integrated outreach strategy, ARY clinics promote linkage with the ARY Health Insurance scheme that helps the poor access good quality healthcare. Scheme members use the services such as free surgeries, subsidised hospitalisation, free consultation, medicines and tests at ARY clinics and other hospitals by paying an annual premium of Rs.120 per head.[ref 9] The scheme has enrolled more than 1,00,000 members in Karnataka and, in five years, has facilitated more than 1,000 surgeries.[ref 1] With a 100% renewal rate in most villages, this plan has benefited almost 2,50,000 people.[ref 21] Since many health problems arise due to lack of awareness and poor hygiene, the Foundation spreads awareness on hygiene and sanitation and has built more than 800 toilets in Phase 1 of its sanitation program. [ref
1]

[edit]Education
In a scheme aimed at popularising mathematics among Karnatakas rural children, Biocon has started the Chinnara Ganitha program. Mathematics workbooks were distributed to 70,000 children in 800 schools in three districts of the state.[ref 1] Biocon initiated the Aata Pata Wadi Project in 2009. This after-school resource center, the first of which was set up in Thithimati in Kodagu district, aims to provide an enabling and learning environment for underprivileged children. Among other things, it offers access to computer-aided learning and boosts their English language skills.[ref 1]

[edit]Infrastructure

The Biocon Foundation has helped build infrastructure in several communities by constructing school buildings, crches, sanitary facilities, and water supply connections. It has built a primary school and toilet blocks in Hebbagodi village, sponsored the construction of two primary schools, a compound wall, school stage, and toilet block in Hennagara gram panchayat and has facilitated a water scheme at Srirampura and Hebbagodi village.[ref 1]

[edit]Flood

Relief

When floods devastated North Karnataka in September/October 2009, the Biocon Foundation dispatched doctors and nurses and helped treat more than 5,000 patients. The Foundation is also helping rebuild 1,000 homes destroyed in the floods in three affected villages of Bagalkot district.[ref 1]