Pharma Licensing –Case Studies Pointers.pptVIP

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2018-06-16 发布于北京
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Pharma Licensing –Case Studies Pointers.ppt

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PRIVILEGED AND CONFIDENTIAL ATTORNEY WORK PRODUCT Pharma Licensing – Case Studies Pointers IP Summit Ireland 2008, February 2008 Major Products are Losing Patent Protection with Reformulation Opportunities for Both Innovator and Specialty Pharma It is Becoming Increasingly Difficult and Expensive to Develop New Drugs … Reformulations are Cost Effective Technology Providers can a Play Role in Both Enabling NCE-based Products and Lifecycle Management Case Studies Based on Different Technologies Developed at Elan Case Study 1. ProStepTM - nicotine transdermal patch Case Study 2. Avinza? - once-a-day morphine Case Study 2. Avinza? - once-a-day morphineBenefits to patients Case Study 2. Avinza? - once-a-day morphine Benefits to Commercial Partner Case Study 2. Avinza? - once-a-day morphine Case Study 3. Emend? (aprepitant) - NCE Case Study 3. Emend? (aprepitant) - NCE Case Study 4: Megace? - Lifecycle Management NanoCrystal? Technology Platform IP Summit Ireland 2008 ? EPIL, 2008 – * – Dr. Richie Paul Director, Intellectual Property Elan Drug Technologies Estimated Annual Sales of Major Brands Losing Patent Protection 1. ~$96B worth of pharmaceutical products will go off patent from 2007-2012 and by 2016 it will be $140B in sales.2 Sources: Merrill Lynch Industry Report, Jan 06. Datamonitor Report, 2007. 100-200 40 4-5 Optimization / Reformulation2. 300-500 900 9-12 NCE / Discovery compound1. Average Peak Sales ($MM) Development Costs ($MM) Years to develop Sources: 1. TUFTS Centre for Study of Drug Development website 2. Defending brand revenue - Pharmaceutical Lifecycle management planning, June 2005 - Cutting Edge Information Report 3. FDA website Year Reformulations* NCEs 2003 49 21 2004 69 31 2005 49 18 2006 63 18 Total 230 8 8 * New ester, salt or non-covalent derivative, new formulation, OTC switch and/or new combination. Over two-thirds of FDA product approvals are for reformulations (note