Estimates of Expected R&D Costs
`
`Metric
`
`Source
`
`Expected R&D Costs, Clinical Costs Only
`
`Total Expected R&D Costs
`
`Published estimate (2013 $)
`
`Adjustment for genitourinary R&D costs
`
`Adjustment for development time profile
`
`Adjustment for inflation
`
`Toviaz approval
`
`Years from approval
`
`Adjustment for present value
`
`Expected R&D costs
`
`1998
`
`2008
`
`1998
`
`2008
`
`[A]
`
`[B]
`
`[C]
`
`[D]
`
`[E]
`
`[F]
`
`[G]
`
`[H]
`
`
`
`1,460.0$
`
`
`
`1,460.0$
`
`
`
`2,558.0$
`
`
`
`2,558.0$
`
`
`
`0.732
`
`
`
`0.732
`
`
`
`0.732
`
`
`
`0.732
`
`
`
`0.672
`
`
`
`0.672
`
`
`
`0.938
`
`
`
`0.938
`
`
`
`0.700
`
`
`
`0.924
`
`
`
`0.700
`
`
`
`0.924
`
`10/31/2008
`
`10/31/2008
`
`10/31/2008
`
`10/31/2008
`
`
`
`10.5
`
`
`
`-
`
`
`
`10.5
`
`
`
`-
`
`
`
`0.352
`
`
`
`1.000
`
`
`
`0.352
`
`
`
`1.000
`
`
`
`176.6$
`
`
`
`663.5$
`
`
`
`431.6$
`
`
`
`1,621.4$
`
`Notes and sources:
`Monetary values are in millions of $U.S.
`[A] Grabowski, Henry and Ronald Hansen, "Briefing Cost of Developing a New Drug," Tufts Center for the Study of Drug Development, 11/18/2014, at 21.
`Estimates based on drugs first tested in humans between 1995 and 2007.
`Toviaz was authorized to test in humans 6.7 years before product approval in October 2008. See:
`Moore, Thomas and Curt Furberg (2014), "Development Times, Clinical Testing, Postmarket Follow-up, and Safety Risks for the New Drugs
`Approved by the US Food and Drug Administration: The Class of 2008," JAMA Intern Med. 174(1): 90–95, at Table 1.
`[B] Adjustment based on cost differences between average drug development and genitourinary drug development in:
`Adams, Christopher P. and Van V. Brantner (2006), "Estimating the Cost of New Drug Development: Is It Really Worth $802 Million?," Health Affairs 25(2): 420–428, at 424, 426.
`I note, however, that Adams and Brantner (2009) state that overall drug development costs for genitourinary drugs "may not be too different form the 'average drug.'" See:
`Adams, Christopher Paul and Van Vu Brantner (2009), "Spending on New Drug Development," Health Economics 19(2): 130–141, at 140.
`[C] Adjustment based on differences between the representative development time profile for products in the study and the development time profile for Toviaz.
`The representative development time profile for products in the study is 96.8 months from clinical start to approval, and 128 months from synthesis to approval. See:
`Grabowski, Henry and Ronald Hansen, "Briefing Cost of Developing a New Drug," Tufts Center for the Study of Drug Development, 11/18/2014, at 18.
`The first patent application pertaining to Toviaz was filed in 1998, and Toviaz clinical trials started in June 2003. See:
`Novel Derivatives of 3,3-Diphenylpropylamines, European Patent No. 0,957,073 (filed 5/12/1998, issued 11/17/1999).
`ClinicalTrials.gov, Two Phase Extension Trial of SP668 to Investigate the Safety and Tolerability of Sustained Release Fesoterodine in Subjects with Overactive Bladder:
`A Double-Blind Phase Folowed by an Open-Label Extension Phase, https://www.clinicaltrials.gov/ct2/show/NCT00220389?term=fesoterodine&rank=50 (accessed 1/21/2016).
`[D] = 1 / (CPI for 2013 / CPI for specified year (column)) from Exhibit 1049.
`[E] FDA Approval Letter, NDA 22-030, 10/31/2008.
`[F] = Date of [E] – (5/12/1998 or 10/31/2008).
`[G] = 1 / (1 + 10.5%)^[F]. See notes and sources in Exhibit 1045 and Exhibit 1046.
`[H] = [A] × [B] × [C] × [D] × [G].
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1047 - Page 1
`
`Petitioner Torrent Pharmaceuticals Limited - Exhibit 1047 - Page 1