ABCDEFGHIJKL
1Main
2Brand NameAciphex. Known as Pariet in ROW.
3Generic Namerabeprazole delayed release
4IndicationGERD, Heartburn, Peptic Ulcer
5AdministrationOral
6MechanismPPI
7EconomicsEisai co-promotion -- what are the details?
8TimelineFiled 3/31/1998, approved 8/19/1999.
9IP5/8/2013 found to be enforceable, Teva loses case. 30-Month stay expires February 2007. 20mg delay release tablet being sued by TEVA, RDY and MYL
10CompetitionNexium (AZN), Prilosec (generic OTC), Protonix (WYE), Zantac (OTC), Axid (generic), Prevacid (Takeda/Abbott).
11Rx
122001200220032004200520062007200820092010
13US
14ROW
15WW697966111611691239135711581096
16
17
18Clinical Trials
19Phase 3 GERD study vs placebo
20At week 4, 63% of 10mg were healed vs 56% for 20mg, 54% for 40mg and 0% placebo.
21Comparing across trials, Protonix label notes 46%, 58% and 75% healing rates for 10mg, 20mg and 40mg with 14% for placebo.
22At week 8, 93% of 10mg were healed vs 84% for 20mg, 85% for 40mg and 12% for placebo.
23Comparing across trials, Protonix label notes 66%, 84% and 93% cure rates for 10mg, 20mg and 40mg vs 40% placebo.
24
25Phase 3 GERD study vs ranitidine (Zantac)
26At week 4, 59% were healed vs 36% for Zantac.
27Comparing across trials, Protonix label notes 61% and 64% cure rates vs 22% for Axid.
28At week 8, 87% were healed vs 66% for Zantac.
29Comparing across trials, Protonix label notes 79% and 83% cure rates vs 41% for Axid.
30
31
32
33Rx
3410/31/2008
3510/24/2008
3610/17/2008133726
3710/10/2008137437
3810/3/2008142546
399/26/2008139554
409/19/2008136830
419/12/2008138729
429/5/2008132066
438/29/2008140859
448/22/2008135720
458/15/2008134693