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)
Products Pharmaceuticals
Enzymes
Revenue 3,569.90 crore (US$560 million) (2015–16)[1]
Increase 970.50 crore (US$150 million) (2015–16)
Number of employees
8,234 (Mar 2016)[1]
Subsidiaries Syngene
Clinigene
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 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 with R&D in Bangalore and API unit in Hyderabad, India, Biocon has two subsidiaries— Syngene, a custom research organisation, and Clinigene, a clinical research organisation. Biocon’s presence straddles four main therapeutic areas—Diabetology, Cardiology, Nephrology and Oncology— and plans to introduce two new divisions, Comprehensive Care, and Immunotherapy, this year[when?].

Biocon’s cardiology, nephrology, diabetology and oncology products including BESTOR, BASALOGTM, BioMAb EGFR, STATIX, NUFIL safe, INSUGEN, TACROGRAF, ERYPRO safe, and MYOKINASE 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.[2][3]

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.[2]

In 2009–10, Biocon’s net income increased 44% to 24.048 billion (US$370 million), crossing the half-billion-dollar mark and profits grew 215% to 2.933 billion (US$46 million). The pharmaceutical business exceeded 200.871 billion (US$3.1 billion) in revenue and the net R&D expenditure increased to 917 million (US$14 million), growing 42% over 2008 and up 282% over 2005, while its research services business crossed 2.807 billion (US$44 million).[2]

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.[2]

History[edit]

Biocon was founded in 1978 with 10,000 (US$160) as the initial capital, failing to find any financial institution for investment.[4] The operations began out of the garage of a rented house with two employees.

Biocon’s first product to go to market was peptinpapain, an enzyme found in papaya which is used to prevent beer from turning hazy.[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.[6]

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 company’s revenue went up from 700 million (US$11 million) in 1998, to 5 billion (US$78 million) in 2004 when it went public.[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 commercialised and under development.[8]

In 2006, Biocon launched BIOMAb EGFR[9] the first indigenously developed humanised monoclonal antibody for head-and-neck cancer.

Biocon’s milestone events in each year are as follows:[10]

  • 29 November 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 speciality pharmaceuticals; establishes Clinigene, India's first Clinical Research Organisation (CRO).
  • 2001—Becomes the first Indian company to be approved by USFDA for the manufacture of lovastatin; PlaFractor 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 Bristol-Myers Squibb; Biocon signs MoU with Deakin University, Australia to establish Deakin Research Institute in Bangalore; Divests enzymes division for US$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 commercialisation 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 commercialisation agreement for a novel peptide hybrid.
  • 2010 - Biocon explores investment in Malaysia in partnership with BiotechCorp

Biocon and Bayer join hands to create awareness for self-monitoring for diabetics Syngene and Endo Pharmaceuticals, USA to jointly discover and develop novel biological drug molecules to fight cancer Biocon acquires stake of its Cuban partner CIMAB S.A. in their seven-year-old JV, Biocon Biopharmaceuticals Pvt. Ltd Biocon and Optimer Pharmaceuticals announce manufacturing and supply agreement for a novel API, first-in-class anti-infective (C. difficile) Biocon and the Center of Molecular Immunology (CIM), based in Havana, Cuba strengthen their existing research partnership by joining forces for an integrated antibody program in immunology Biocon announces a strategic foreign direct investment in Malaysia with the Malaysian Biotechnology Corporation SdnBhd (BiotechCorp)

  • 2011 - Biocon divests its stake in its German subsidiary, AxiCorp GmbH, to the existing group of promoter shareholders, AxiCorp was the licensee for Biocon's biosimilar Insulin and Glargine in Germany and had the sole responsibility for commercializing these products. As a consequence of this divestment, these rights revert to Biocon.

Biocon launches INSUPen®, a convenient and affordable reusable insulin delivery device

  • 2012 - Biocon announced Positive Results from its Global Phase 3 study with Recombinant Human Insulin

GE Capital invests in Syngene, Biocon's Research Services Subsidiary Biocon announced Positive Efficacy Data from Phase 3 clinical study with its Novel Monoclonal Antibody, Itolizumab for Psoriasis Syngene - a subsidiary of Biocon Group, in collaboration with Abbott, set up a dedicated Nutrition Research and Development Center at Biocon Park Biocon announced positive results from its Phase 1 Comparative PK-PD Study with Biosimilar Insulin Glargine Biocon: the only Asian Company to Feature in the Global Top 20 BioPharma Employers, by Science Magazine Biocon enters into an agreement with Bristol-Myers Squibb for its IN-105, an Oral Insulin drug

  • 2014 - Biocon received Marketing Authorization from the Drugs Controller General of India (DCGI) for its Novel Biologic Itolizumab, anti CD6 molecule, for the treatment of chronic plaque Psoriasis

Biocon enhances Partnership with Mylan through Strategic Collaboration for Insulin Products Biocon Delivers a Healthy Growth of 22% driven by strong traction in Biopharma Biocon Launched ALZUMAb™- a 'First in Class' Novel Biologic Treatment for Psoriasis Patients in India

  • 2014 - Biocon launched CANMAb, a new injectable drug for the treatment of a highly prevalent HER2-positive breast cancer. The drug has been jointly developed by Biocon and US-based generic pharmaceutical major Mylan and will be manufactured in Biocon's facility in Bangalore.[11]
  • 2015 - Biocon Limited on 24 December 2015 launched the generic version of hepatitis – C drug in the Indian market. The generic version of the drug named Harvoni will be sold under the brand name CIMIVIR-L.

Corporate governance[edit]

Kiran Mazumdar–Shaw, 2013. Chemical Heritage Foundation

Biocon’s 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.[10][12][13]

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[14] and India’s mother of invention by The New York Times.[15] 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.[16] Ms Shaw features on the Forbes list of ‘The World’s 100 Most Powerful Women’[17] and in Financial Times’ ‘Top 50 Women in Business’ list[18]

A pioneer of the Indian biotech sector, Ms Shaw wants to create a global leadership profile for India’s 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.[19] 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.[10]

Ms. Shaw is the recipient of several prestigious awards including the Nikkei Asia Prize, 2009 for Regional Growth,[20] 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 & 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.[10]

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.[10]

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.[21] 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.” [22]

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.[5]

The members of the Board of Directors are [2]

  • 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. Vijay Kuchroo, as of 2015[23]
  • Dr. Jeremy Levin, as of 2015[23]
  • 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

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.[10]

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.[10]

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.[10]

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.,[2][10]

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.,[2][10]

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.,[2][10]

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.,[2][10]

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.,[2][10]

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][10]

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][10]

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.[10]

Biocon technology[edit]

Biocon’s manufacturing facilities are located at two sites in Bangalore.[10]


Biocon R&D[edit]

Biocon Corporate Presentation

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

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. Biocon’s 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.[10]

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.[citation needed]

Nephrology[edit]

ERYPRO safe (erythropoietin) is among the top 5 brands in the 30-brand EPO market.[citation needed] 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.[citation needed]

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.[citation needed]

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.[24]

Growth drivers[edit]

Today, biologics, with revenues of $125 billion in 2008, are outperforming the global pharma market.[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.[26] 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.[27] 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.[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 characterisation as well as manufacturing and clinical development.[2] Biocon has entered into sales and marketing agreements with Mylan to develop and commercialise molecules globally.[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 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.[30] IN-105 is currently undergoing Phase 3 clinical studies in India.[2] An investigational new drug application (IND) with the US Food and Drug Administration was filed in December.[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.[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 Biocon’s sales.[33] Biocon has entered into partnerships with companies around the world to gain access in emerging markets.[2]

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 organisation, 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 $1-billion mark on the day of listing (2004)
  • Launches India’s first cancer drug, BIOMAb EGFR (2006)
  • First Indian company to manufacture and export enzymes to USA and Europe
  • India’s largest producer and exporter of enzymes
  • Releases country’s first 24-hour diabetes drug, Glargine (2009)
  • First biotech company to receive ISO 9001 certification in India
  • Syngene is country’s first custom research company in drug discovery[citation needed]

References[edit]

  1. ^ a b "Biocon Ltd Results". Retrieved 21 July 2016. 
  2. ^ a b c d e f g h i j k l m n o p q r s t Biocon Annual Report, 2010
  3. ^ "Biocon Biopharmaceuticals becomes wholly owned subsidiary", Moneycontrol.com, 6 April 2010
  4. ^ [1], The Hindu, Metro Plus, 27 April 2010[dead link]
  5. ^ a b Kiran Mazumdar-Shaw, CMD, Biocon Ltd, ‘Biotech Is Not for Punters’, Outlook Money, 15 July 2004
  6. ^ ‘Big Shot in Bangalore’, Forbes.com, 18 October 2004
  7. ^ Economic Times, 18 September 2006
  8. ^ "Biocon Injects Innovation Gene", Technology Review, October 2009
  9. ^ Financial Express, Bangalore, 25 September 2009
  10. ^ a b c d e f g h i j k l m n o p q r s Biocon Website ("Archived copy". Archived from the original on 7 August 2014. Retrieved 2014-08-03. )
  11. ^ "Kiran Mazumdar-Shaw's Biocon develops new breast cancer drug". indiatimes.com. 2014-01-18. Retrieved 2014-01-19. 
  12. ^ Nature Reviews Drug Discovery, July 2010
  13. ^ Biospectrum India Friday, 11 July 2008
  14. ^ Kiran Mazumdar Shaw, India's fermentation queen, 30 August 2001
  15. ^ "How India's Mother of Invention Built an Industry", 16 August 2003
  16. ^ Time, 29 April 2010
  17. ^ The World's 100 Most Powerful Women, Forbes, 19 August 2009
  18. ^ FT top 50 women in world business, Financial Times, 25 September 2009
  19. ^ India’s biotech future, Kiran Mazumdar-Shaw, The Hindu, 15 August 2007
  20. ^ The Hindu, 12 May 2009
  21. ^ Quality Cancer Care is Now Affordable, The Times of India, Bangalore, 18 July 2009
  22. ^ Biocon Foundation: Mending social, eco state of the nation, Moneycontrol.com, 30 May 2010
  23. ^ a b "People". Genetic Engineering & Biotechnology News. 35 (5). 1 March 2015. p. 37. 
  24. ^ Jayaramun, Killugudi (December 2013). "Biocon's first-in-class anti-CD6 mAb reaches the market". Nat. Biotechnol. 31 (12). pp. 1062–3. closed access publication – behind paywall
  25. ^ Biosimilars and Follow-on Biologics, VisionGain
  26. ^ The Big Fix, Outlook Business, June 2010
  27. ^ 'Big Pharma' Turns to Biologics for Growth to 2010, Datamonitor, May 2006
  28. ^ The Future of Monoclonal Antibodies – Market Forecasts to 2015, Competitive Benchmarking, Product Pipeline and Deals Analysis, Research and Markets, 2009
  29. ^ Biocon, Mylan ink generics biologics deal, Financial Chronicle, Bangalore, 30 June 2009
  30. ^ Biocon banks on biosimilars, novel drugs, DNA, 23 October 2009
  31. ^ Biocon Seeks U.S. OK for Human Trials of Oral Insulin, Wall Street Journal, 14 January 2010
  32. ^ Biocon Biopharmaceuticals becomes wholly owned subsidiary, Moneycontrol.com, 6 April 2010
  33. ^ Emerging markets drive Q3 revenue growth for Biocon, Mint, 21 January 2010

External links[edit]