US 505(b)(2) Regulatory Pathway and Strategies
US 505(b)(2) Regulatory Pathway and Strategies US 505(b)(2) Regulatory Pathway and Strategies
Corporate StrategyThe company applies its KME development model to identify existing drugs or‘known molecular entities’ with established safety profiles which can be developedand clinically differentiated for gastrointestinal indications. The KME developmentmodel allows the company to more quickly establish the efficacy profile of itscandidates for the target gastrointestinal indications.• 505(b)(2) provides the ability to clinically differentiate from other products• Allows for market niche• Not available for ANDA (505(j)) products10
Corporate StrategyMr. Sims: Actually, because we start with drugs already approved by the FDA, we canfile for approval using the 505b2 procedure rather than the full NDA (new drugapplication). Where clinical trials are required for a 505b2 application, the number ofpatients required and length of time needed for those clinical trials are significantly lessthan for a new chemical entity. For example, with ESTRASORB, our Phase 1 trial had14 patients and our Phase 2 and Phase 3 trials required less than 400 patients. As theefficacy and safety of the active ingredients have already been established, thecomplexity of the studies, including the duration, is generally significantly less than foran NDA application. We believe that from the starting point of developing a drug in amicellar nanoparticle to regulatory submission, it should take no more than a three orfour year time frame, which is actually quite fast for this industry. From the point offiling, we would add about another year for FDA review and approval.• Eliminate some of the studies required for a 505(b)(1)(preclinical, extensive safety and efficacy studies)• Significant financial savings• Significant time savings11http://www.novavax.com/images/TWST%200205%20Final.pdf©2005 The Wall Street Transcript, 67 Wall Street, NYC 10005Tel: (212) 952-7400 • Fax: (212) 668-9842 • Website: www.twst.com
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- Page 5 and 6: 505(b)(2) RegulationPotential 505(b
- Page 7 and 8: 505(b)(2) NDAReference Listed Drug
- Page 9: Industry ExamplesHighlighting the B
- Page 13 and 14: Case Study: Ulesfia TM - Excipient
- Page 15 and 16: Pro-Drugs• Fundamental:- Where do
- Page 17 and 18: Valacyclovir Regulatory Path• 505
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- Page 21 and 22: 505(b)(2) Risks• Uncertain market
- Page 23 and 24: 505(b)(2) Risks• Like Generics (5
- Page 25: Thank You• Regulatory Sciences Co
Corporate StrategyThe company applies its KME development model to identify existing drugs or‘known molecular entities’ with established safety profiles which can be developed<strong>and</strong> clinically differentiated for gastrointestinal indications. The KME developmentmodel allows the company to more quickly establish the efficacy profile of itsc<strong>and</strong>idates for the target gastrointestinal indications.• <strong>505</strong>(b)(2) provides the ability to clinically differentiate from other products• Allows for market niche• Not available for ANDA (<strong>505</strong>(j)) products10
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