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PRO 2000: Decisions on Further Development Al Profy

PRO 2000: Decisions on Further Development Al Profy. MMCI September 30, 2009. History of PRO 2000. Synthetic antimicrobial compound Active against HIV and other STIs in laboratory Acts by preventing viral entry into human cells Invented in early 1990’s by Procept, Inc.

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PRO 2000: Decisions on Further Development Al Profy

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  1. PRO 2000:Decisions on Further DevelopmentAl Profy MMCISeptember 30, 2009

  2. History of PRO 2000 • Synthetic antimicrobial compound • Active against HIV and other STIs in laboratory • Acts by preventing viral entry into human cells • Invented in early 1990’s by Procept, Inc. • Licensed to Indevus Pharmaceuticals in 2000 • Endo Pharmaceuticals acquired Indevus in March 2009 • Endo now owns PRO 2000

  3. Endo Pharmaceuticals • Specialty pharmaceutical company basedin Chadds Ford, Pennsylvania, USA • ~1500 employees; NASDAQ:ENDP • Historical focus on pain medications; now diversifying into endocrinology, cancer areas • Focused on US market

  4. Endo Seeks to Outlicense PRO 2000 • PRO 2000 does not match Endo’s business focus • Endo plans to out-license PRO 2000 • Partner would develop, manufacture and distribute product • Seeking partners for industrialized and developing countries • Contract with MRC includes terms designed to ensure affordable access to women in developing countries, including all African countries where MDP 301 was conducted (These countries are called “The Territory”)

  5. Endo-MRC Contract: Access Provisions • Company must make product available to MRC/DfID or their agents at cost-plus for distribution in the Territory or • Company must grant MRC/DfID or its agents a license to manufacture the product (anywhere in the world) for distribution in the Territory

  6. Decisions on Further Development • When/where to pursue licensure? • Partners will decide whether/where to pursue licensure • Decisions will depend on MDP 301 results, other data • Risk-benefit assessment may differ for different regions • Additional work will be needed for licensure/introduction • Scale-up and validation of manufacturing process • Additional nonclinical and clinical studies • Preparation and submission of regulatory dossiers • Preparation for introduction in different regions

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