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Biocon : ウィキペディア英語版
Biocon

Biocon Limited () is an Indian biopharmaceutical company based in Bangalore, India.〔 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.
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.〔 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 humanised monoclonal antibody (MAb), the only first-in-class novel MAb being tested in India for rheumatoid arthritis and psoriasis.〔〔
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.〔 It has also expanded its global footprint to emerging and developed markets through acquisitions, partnerships and in-licensing. Biocon’s 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, Biocon’s net income increased 44% to 24,048 million, crossing the half-billion-dollar mark and profits grew 215% to 2,933 million. The pharmaceutical business exceeded 200,871 million in revenue and the net R&D expenditure increased to 917 million, growing 42% over 2008 and up 282% over 2005, while its research services business crossed 2,807 million.〔
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 master's degree, and 33% are graduates. Biocon also collaborates with educational institutes to make courses more industry oriented.〔
==History==
Biocon was founded in 1978 with 10,000 as the initial capital, failing to find any financial institution for investment.〔 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.〔 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 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.〔
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 in 1998, to 5 billion in 2004 when it went public.〔
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.〔
In 2006, Biocon launched BIOMAb EGFR〔 the first indigenously developed humanised monoclonal antibody for head-and-neck cancer.
Biocon’s milestone events in each year are as follows:〔
* 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 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 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
* 2013-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.

抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)
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