Académique Documents
Professionnel Documents
Culture Documents
Leveraging the India advantage to deliver high value, licensable R&D assets
After 1947
Patent Act of 1970 Drug price Capped Local Companies impact Process Development Product Infrastructure Creation Export Initiatives
19701990s
Growth Phase
Biocon History
Biocon India ---joint venture between Biocon Biochemicals Ltd. of Ireland and an Indian entrepreneur, Kiran Mazumdar-Shaw first Indian company to manufacture and export enzymes to USA and Europe Introduced Insugen creates a buzz in the stock market divested its enzyme business to Danish firm and set up a wholly owned subsidiary in Swizerland,Biocon SA ,which acquires a 71% stake in German pharmaceutical company, AxiCorp GmbH
1978-1988
1988-1999
1999-2009
2009-2013
Unilever Plc. acquires Biocon Biochemicals Ltd. in Ireland & merges it with its subsidiary, Quest International, later divested the ownership Biocon establishes Syngene International Pvt. Ltd. as a Custom research Company (CRC)
Enhances Partnership with Mylan through Strategic Collaboration for Insulin Products Partnered with CytoSorbents to Market CytoSorb - A 'First-in-Class' Therapy for Sepsis Management Entered into an option agreement with Bristol-Myers Squibb for Biocon's IN105,
IN-105 Program
IN-105 Oral Insulin: a conjugated insulin molecule that is orally delivered and targeted towards liver which is a central organ in glucose metabolism.
2012
2009
2005
Got positive data from Phase II studies in India, Decide to move to phase III or not Acquired Nobexs intellectual property and start in-house research, IN-105 was borned
2003
2002
Organic design
( Low formalization, Low standardization, Flat organization, cross function team, Free flow of information)
Title in here
Organization Culture Entrepreneurial culture
Open communication, informal atmosphere, agility in decision making, synergy amongst functions
Platform Innovation
Radical Innovation
Incremental Innovation
Architecture Innovation
Collaboration or Alone
Positive data from Phase II studies. High Risk Involved Most Expensive Phase of the clinical trials
Substantial cost of administrations, hospitals & doctor. India $2.2-$2.7 million U.S dollars for 500 patients.
Need for faster clinical trials as IN-105 patent expires in 2025. Guidance through regulatory processes and commercialization of the drug Bridging capability gap
Integrated Platforms
o State-of-the-art manufacturing capabilities o Indias largest Contact Research Organization (CRO) with 1,500 + scientists.
Niche Offerings
Evolving Services
Customized models
Strategic Alliance
Go Alone
Advantages o Positive Phase III results will elevate the valuation of the molecule o Valuation increases exponentially along the development curve
Go with a partner
Advantages o Global Partner with capital infusion o Dedicated R & D Infrastructure o Guidance and speed during critical stages of trials o Increased probability of success Disadvantages o Lower deal value at trial phases o Risks to IP protection o Differing operational structures may strain ability to deal with operational, or competitive issues
Disadvantages
o Significant risk of failure o Insufficient funds o Uncertainty over manufacturing at a lower cost o Delay to market erodes peak sales value
Strategic Alliance
IN-105 Option Agreement: BMS (First-in-Class Oral Prandial Insulin)
Combines Biocon's novel asset and development experience with BMS novel drug development, regulatory & commercialization capabilities.
Biocon will continue global development of the molecule through Phase II via redesigned trials.
Partnership encompasses Financial, Strategic and Clinical Support throughout the development phase
BMS will have an exclusive option post phase II to further develop & commercialise the asset worldwide (excl. India) Biocon will receive licensing fee in addition to potential regulatory & commercialization milestones, when BMS exercises its option
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