Biocon

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Biocon Limited
Public
Traded as BSE532523
NSEBIOCON
Industry Biotechnology
Founded 1978
Founder Kiran Mazumdar-Shaw
Headquarters Bangalore, Karnataka, India
Key people

Kiran Mazumdar-Shaw
(Chairperson & MD)

Arun Chandavarkar
(CEO & Joint Managing Director)

Products Biologics
Small Molecules
Branded Formulations
Research Services
Revenue Increase 4,079 crore (US$570 million) (2016–17) [1]
Number of employees
9,234 (Mar 2017)[1]
Subsidiaries Syngene
Website www.biocon.com

Biocon Limited (BSE532523) is an Indian biopharmaceutical company based in Bangalore, India.[2] The Company manufactures generic active pharmaceutical ingredients (APIs) that are sold in over 120 countries across the globe, including the developed markets of the United States and Europe.[2] It also manufactures novel biologics, as well as, biosimilar insulins and antibodies, which are sold in India as branded formulations. Biocon's biosimilar products are also sold in both bulk and formulation forms in several emerging markets. In research services, Syngene International Limited (Syngene), a publicly listed subsidiary of Biocon, is engaged in the business of integrated end-to-end drug discovery and development services.

Biocon’s formulations for the Indian market straddles Metabolics, Oncology, Immunotherapy, Nephrology and Specialty. Some of Biocon’s key brands in India include INSUGEN (rh-insulin), BASALOG (Glargine), BIOMAb EGFR (Nimotuzumab), BLISTO (Glimepiride + Metformin), CANMAb (Trastuzumab), Evertor (Everolimus), TACROGRAF (Tacrolimus), ALZUMAb(Itolizumab) and KRABEVA (Bevacizumab), which are claimed to be considerably less expensive than other leading brands.[2] 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 T1h, a novel humanised monoclonal antibody (MAb), the only first-in-class novel MAb being tested in India for rheumatoid arthritis and psoriasis.[citation needed]

Biocon and Syngene together employ about 9200 personnel including biologists, chemists, medical practitioners, pharmacologists, engineers, finance/legal/marketing analysts, HR generalists and general administrators.[2]

History[edit]

Biocon was founded in 1978 with 10,000 (US$140) as the initial capital, failing to find any financial institution for investment.[3] The operations began out of the garage of a rented house with two employees.

Biocon’s first product to go to market was papain, an enzyme found in papaya which is used to prevent beer from turning hazy.[4] Until 1983, the company blended enzymes and supplied them to brewing, textiles, biofuels, animal feed and other such industries across the world.

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.[5]

Biocon’s milestone events in each year are as follows:[6]

  • 29 November 1978 - Biocon India is incorporated as a joint venture between Biocon Biochemicals Ltd. of Ireland and Kiran Mazumdar-Shaw.[7]
  • 1979 - Becomes the first Indian company to manufacture and export enzymes to USA and Europe.[8]
  • 1989 - Unilever acquires Biocon Biochemicals Ltd. in Ireland and merges it with its subsidiary, Quest International; Biocon receives US funding for proprietary technologies.[4]
  • 1994 - Establishes Syngene International Pvt. Ltd. as a Custom Research Company (CRC).[4]
  • 1998 - Unilever agrees to sell its shareholding in Biocon to the Indian promoters. Biocon becomes an independent entity.[9]
  • 2001 - Becomes the first Indian company to be approved by USFDA for the manufacture of lovastatin; PlaFractor is granted a US 2001 and worldwide patent.[10]
  • 2003 - Biocon becomes the first company worldwide to develop human insulin on a Pichia expression system.[11]
  • 2006 - BIOMAb EGFR, first indigenously developed humanised monoclonal antibody for head-and-neck cancer is launched and Dr. APJ Abdul Kalam inaugurates India's Largest Biotech-Hub "Biocon Park".[12]
  • 2007- Biocon and Neopharma sign an MOU to establish a JV to manufacture and market a range of biopharmaceuticals for the GCC countries.
  • 2008 - Biocon acquires a 70% stake in German pharmaceutical company, AxiCorp GmbH.[13]
  • 2009 - Syngene-Bristol Myers Squibb research facility is established in Bengaluru.[14]
  • 2009 - Mylan announces strategic collaboration with Biocon to Enter the Global Generic Biologics Market.[15]
  • 2010 - Biocon expands to Malaysia, biopharmaceutical manufacturing and R&D facility established in Iskandar Malaysia, Johor.[16]
  • 2011 - Biocon launches INSUPen®, a convenient and affordable reusable insulin delivery device.[17]
  • 2012 - Abbott announces collaboration with Syngene to Open First Nutrition R&D Center in India.[18]
  • 2013 - Biocon launches biologic drug ALZUMAb to treat psoriasis.[19]
  • 2014 - Biocon launches world's first biosimilar drug CANMAb to treat breast cancer.[20]
  • 2015 - Biocon launches hepatitis-C drug in India under brand name CIMIVIR-L.[21]
  • 2016 - Becomes the first Indian company to launch a biosimilar Insulin Glargine pen in Japan.[22]
  • 2016 - Syngene sets up Amgen R&D center in Bangalore.[23]
  • 2017 - Biocon's Insugen is the first locally manufactured biosimilar product to be approved for sale by the Malaysian drug regulator.[24]
  • 2017 - USFDA approves Mylan-Biocon’s biosimilar for cancer drug Herceptin.[25]
  • 2018 - Novartis and Biocon announce partnership on ‘next wave’ of biosimilars.[26]
  • 2018 - Biocon, Mylan get European Commission approval to market biosimilar insulin glargine.[27]

Corporate Governance[edit]

Kiran Mazumdar-Shaw is an Indian entrepreneur. She founded Biocon in 1978.

Biocon’s technocrat CMD Kiran Mazumdar–Shaw has nurtured Biocon since its inception in 1978.[6][28][29]

Her efforts in biotechnology have drawn global recognition both for the industry in India and for Biocon and she has been termed India’s Biotech Queen by The Economist[30] and India’s mother of invention by The New York Times.[31] She was recently named among TIME magazine’s 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.[32] Ms Shaw features on the Forbes list of ‘The World’s 100 Most Powerful Women’[33] and in Financial Times’ ‘Top 50 Women in Business’ list[34]

Ms Shaw chairs Karnataka’s Vision Group on Biotechnology and also served on the Board of Science Foundation, Ireland. She serves on the Advisory Council of the Government’s Department of Biotechnology and is part of the prime minister’s 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.[6]

Ms. Shaw is the recipient of several awards including the Nikkei Asia Prize, 2009 for Regional Growth,[35] Express Pharmaceutical Leadership Summit Award 2009 for Dynamic Entrepreneur, The Economic Times ‘Businesswoman of the Year’, the ‘Veuve Clicquot Initiative For Economic Development For Asia, Ernst & Young’s 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.[6]

Born on 23 March 1953 in Bangalore, Ms. Shaw received a graduate honours 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.[6]

Active on the corporate social responsibility front, Ms. Shaw set up the Biocon Foundation in 2004. Recently, she contributed Rs 400 million to help establish the presently 500-bed Mazumdar–Shaw Cancer Center in Bangalore.[36] In an interview, she stated: “The way I have looked at it is that business is very mercenary and you’ve 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.” [37]

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 to 1998 as Chairman and Managing Director.[4]

The members of the Board of Directors are:[38]

  • Ms. Kiran Mazumdar-Shaw – Chairperson & Managing Director, First generation entrepreneur with more than 42 years of experience in biotechnology and industrial enzymes.
  • Mr. John Shaw – Vice-chairman and Whole Time Director, Served in senior corporate positions around the world; and Former chairman, Madura Coats Ltd.
  • Dr. Arun Chandavarkar – Chief Executive Officer & Joint Managing Director, Core Member of Biocon's Leadership team, Played a pivotal role in the evolution of Biocon over the last 27 years.
  • Prof. Ravi Mazumdar – Non-Executive Director, University Research Chair Professor, Department of Electrical and Computer Engineering, University of Waterloo.
  • Russell Walls – Independent Director, Chairman, Aviva Life Holdings Ltd. Experience of more than 47 years in the field of Finance.
  • Dr. Vijay Kuchroo- Independent Director, Samuel L. Wasserstrom Professor of Neurology & Director of Evergrande Center for Immunologic Diseases at Harvard Medical School, USA.
  • Dr. Jeremy Levin, Independent Director, Former President and CEO of Teva Pharmaceuticals.
  • Mary Harney- Independent Director, Deputy Prime Minister of the Irish Republic from 1997-2006.
  • Daniel M. Bradbury- Independent Director, On the board of trustees of the Keck Graduate Institute, California, USA
  • M. Damodaran- Independent Director, Founder & Chairman, IIM Trichy.

Subsidiaries, Acquisitions and Strategic Global Alliances[edit]

Syngene International Pvt Ltd[edit]

Established in 1994, Syngene International Limited is Biocon’s custom research organisation offering pharmaceutical and biotechnology majors customised 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 India’s first CRO to receive special export status by the Government of India. Recently it has collaborated with Abbott Nutrition.[6]

Clinigene[edit]

Clinigene International Limited is a subsidiary on Syngene offering international pharmaceutical majors Phase I-IV clinical trials and studies for novel/generic molecules.[6]

BBPL[edit]

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.[6]

Biocon-AxiCorp[edit]

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 Biocon’s entry into the generics market as well as enabling it to market biosimilar insulin and analogues in the German market. AxiCorp is now an autonomous subsidiary of Biocon and the most successful Indian owned German pharmaceutical company.[6]

NeoBiocon[edit]

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/in-licensed products, targeted therapeutics, research-based differentiated formulations and innovative drug delivery systems. It also launched Abraxane in the UAE.[6]

Biocon and Amylin[edit]

In 2009, Biocon and Amylin Pharmaceuticals of the United States entered into an agreement to develop, commercialise 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 utilise its expertise in recombinant microbial expression and experience in preclinical and clinical development of diabetes products to manufacture the compound.[6]

Biocon and IATRICa[edit]

In 2008, Biocon and IATRICa of the United States announced a strategic partnership to co-develop immunoconjugates for targeted immunotherapy of cancers and infectious diseases. The companies are co-developing candidate products based upon IATRICa’s technology platform and Biocon’s 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, characterising and scaling up of conjugated monoclonal antibody production are being currently studied.[6]

Biocon and Mylan[edit]

In 2009, Biocon signed a collaboration agreement with Mylan to develop and commercialise multiple, high-value generic biologics. Mylan and Biocon will share development, capital and other costs to bring products to market. Mylan will have exclusive commercialisation rights in USA, Canada, Japan, Australia, New Zealand, EU and European Free Trade Association countries through a profit sharing arrangement with Biocon.[6]

Biocon and Optimer[edit]

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.,[2][6]

Biocon and Vaccinex[edit]

Biocon is also developing fully human antibodies BVX 10 and BVX-20 with a US antibody technology partner, Vaccinex. The partnership was initiated in 2004. BVX 10 targets TNF (Tumor Necrosis Factor) which is expressed at high levels in patients suffering from rheumatoid arthritis. Biocon’s strategic partnership with Vaccinex allows access to their proprietary human antibody platform technology, thereby providing a strong IP protection to Biocon’s antibody pipeline.,[2][6]

Biocon and Abraxis[edit]

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 Biocon’s 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.[6]

Biocon and Sandoz[edit]

In January 2018, Sandoz (a Novartis division) announced a global partnership with Biocon to develop, manufacture and commercialize multiple biosimilars in immunology and oncology for patients worldwide. Under the terms of the agreement, both companies will share responsibility for end-to-end development, manufacturing and global regulatory approvals for a number of products, and will have a cost and profit share arrangement globally.[39]

Biocon Technology[edit]

Biocon’s manufacturing facilities are located at two sites in Bangalore.[6]

Research & Development Capabilities[edit]

Inside Biocon Park - India's largest integrated biotechnology hub, comprising an integrated cluster of research laboratories and manufacturing facilities spread across 90 acres.

Biocon’s discovery-led R&D focuses on the entire drug development pathway – from process development, to non-clinical and clinical research.[6]

Process sciences[edit]

Biocon 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.

Non-clinical research[edit]

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.

Clinical research[edit]

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. Till date Biocon has filed nearly 1,300 patent applications and hold over 1,050 patents and 555 trademark registrations globally, covering technology areas of fermentation, protein purification, drug delivery systems and bio-therapeutic molecules.[40]

Products[edit]

Biocon’s portfolio consists of 36 brands across the four therapeutic divisions of Diabetology, Nephrology, Oncology and Cardiology.[2]

Diabetology[edit]

This is the oldest of Biocon’s 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 analogue, 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 Biocon’s oral anti-diabetic formulations while OLISATTM is an oral anti-obesity formulation.[41]

Nephrology[edit]

ERYPRO safe (erythropoietin) is among the top brands in the EPO market. RENODAPT, Biocon’s premium immunosuppressant, mycophenolatemofetil ranks 4th among 25 brands, while the newly introduced immunosuppressant, tac brands. Biocon has newly launched dosage forms like TACROGRAF 0.25 mg, RENODAPT 750 mg, to suit Indian patient needs through ideal dosage and enhanced compliance. In 2009, Biocon launched a specially formulated protein supplement, NARITA+ in the renal nutrition segment, for dialysis patients suffering from malnutrition.[42]

Oncology[edit]

This division’s BIOMAb EGFR, approved in 22 countries, is a successful formulation for indications like head-and-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.[43]

Cardiology[edit]

With major brands like STATIX (anti-cholesterol) and TELMISAT (anti-hypertensive), Biocon’s cardiology division is now ranked number 22nd in its representative market. Biocon’s CLOTIDETM is the leading eptifibatide brand in India and MYOKINASE (met-free streptokinase) is a life-saving injectable. Other brands like ACTIBLOK-IPR (metoprolol) and the newly launched BESTOR (rosuvastatin) and BRADIA (ivabradine) are also from this division.

Other conditions[edit]

Chronic plaque psoriasis: itolizumab, a humanized monoclonal antibody targeting the CD6 protein, became available to physicians in India in August 2013.[44]

Growth drivers[edit]

Today, biologics, with revenues of $125 billion in 2008, are outperforming the global pharma market.[45] The growth rate of biologics—which include biosimilar MAbs, biosimilar insulin and novel biotherapeutics, among others—is projected to increase at double-digit levels.[46] Moreover, even as mature markets have a single-digit growth rate of 4.3%, the growth essential to the industry’s 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.[47] In such a scenario, Biocon has the structures to engage these growth drivers.[2]

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.[48] 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 characterisation as well as manufacturing and clinical development. Biocon has entered into sales and marketing agreements with Mylan to develop and commercialise molecules globally.[49]

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 analog space.[2]

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.[50] IN-105 is currently undergoing Phase 3 clinical studies in India. An investigational new drug application (IND) with the US Food and Drug Administration was filed in December.[51] 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.[52]

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 Biocon’s sales.[53] Biocon has entered into partnerships with companies around the world to gain access in emerging markets.

Firsts

Set up in 1978, Biocon is India's first biotech company.

  • First Indian biotech company to receive US funding for proprietary technologies (1989) [54]
  • Sets up India's first clinical research organisation, Clinigene (2000) [55]
  • First Indian company to be approved by USFDA for the manufacture of lovastatin, a cholesterol-lowering molecule (2001) [56]
  • First company worldwide to develop human insulin on a Pichia expression system (2003) [57]
  • Launches India’s first cancer drug, BIOMAb EGFR (2006) [58]
  • First Indian company to manufacture and export enzymes to USA and Europe.[54]
  • India’s largest producer and exporter of enzymes.[54]
  • Releases country’s first 24-hour diabetes drug, Glargine (2009) [59]
  • First biotech company to receive ISO 9001 certification in India.[54]
  • Syngene is country’s first custom research company in drug discovery.[60]
  • First Indian Company to get a USFDA approval for a biosimilar (2017) [61]

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