US 505(b)(2) Regulatory Pathway and Strategies

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Case Study: Valacyclovir• Oral tablet for treatment of herpes– Pro-drug of acyclovir– Pro-drug in systemic circulation for about 30 min– Hepatic esterases convert pro-drug to acyclovir– Similar plasma metabolic profile to acyclovir afterconversion
Valacyclovir Regulatory Path• 505(b)(2) NDA as a new molecular entity– Acyclovir is RLD• Can rely on some acyclovir nonclinical & clinical data– Nonclinical studies for NME– Full Phase 1 PK program– Phase 2 dose-ranging– 1 adequate and well-controlled Phase 3 study• 5 Years marketing exclusivity
Page 1 and 2: US 505(b)(2) RegulatoryPathway and
Page 3 and 4: Differentiated Products Now Essenti
Page 5 and 6: 505(b)(2) RegulationPotential 505(b
Page 7 and 8: 505(b)(2) NDAReference Listed Drug
Page 9 and 10: Industry ExamplesHighlighting the B
Page 11 and 12: Corporate StrategyMr. Sims: Actuall
Page 13 and 14: Case Study: Ulesfia TM - Excipient
Page 15: Pro-Drugs• Fundamental:- Where do
Page 19 and 20: Benefits of 505(b)(2)• Get out of
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

US 505(b)(2) Regulatory Pathway and Strategies

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