Biogenerics 2007: How far have we come?
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John Tucker is a medicinal chemist with 16 years experience conducting industrial drug discovery projects in diabetes, multi-drug resistant bacterial infections, central nervous system disorders, cancer, and HIV infection. His expertise includes biomedical technology assessment, drug discovery research strategy and risk evaluation, research collaboration management, and the design and implementation of effective research outsourcing strategies. His scientific endeavours have led to 11 US patents, over 30 US patent applications, and 18 papers published in peer-reviewed scientific journals. He joined Katan Associates in 2007. Seth Yakatan has over 15 years of experience as a corporate finance professional in North America. In the past five years as a Co-Founder of Katan, Seth has led numerous sell-side M&A engagements in the Life Science space, generating aggregate transaction value in excess of $75.0m. Additionally, Seth has been responsible for closing three early-stage pharmaceutical partnering assignments with aggregate value generated for clients in excess of $250.0m. Seth holds an MBA in Finance and Statistics from the University of California, Irvine and a Bachelor of Arts degree in History and Public Affairs from the University of Denver. Stan Yakatan has dedicated the last 12 years of his career to sharing his experiences with management teams interested in building technology based companies, after 30 years as a successful CEO, entrepreneur, and operational manager. His experience as a ‘A’ level executive is far reaching, he has served in such a capacity with New England Nuclear, EI Dupont, ICN Pharma, New Brunswick Scientific and Biosearch. These experiences have provided him with management skills and corporate finance acumen that he enjoys sharing with others.
Abstract The recent approval of a follow-on version of Pfizer’s Genotropin (recombinant human growth hormone) signalled the beginning of the end of an era in which biopharmaceuticals enjoyed immunity from competition even after expiration of their patent protection. This paper describes many of the key scientific challenges facing the nascent ‘biogenerics’ industry and the evolving regulatory framework that will shape its competition with innovator companies. We describe key differences between the biogeneric and traditional generic drug business models and the M&A activity that been undertaken in pursuit of the expertise and resources needed to be competitive in this commercial space. We conclude with a discussion of the commercial opportunity presented by recent and upcoming European patent expirations and the challenges presented by competition from second-generation innovator products.
Journal of Commercial Biotechnology (2008) 14, 56–64. doi:10.1057/palgrave.jcb.3050080 Keywords: biogeneric , biosimilar, generic , biopharmaceutical
INTRODUCTION Correspondence: Seth Yakatan, Katan Associates, 245 33rd Street, Hermosa Beach, CA 90254, USA Tel: + 1 310 374 0808 Fax: + 1 310 374 0803 E-mail: [email protected] Web: www.katanassociates.com
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