SGP - boceprevir
what do you guys think about boceprevir coming out from AASLD? some physicians think the additional anemia with boc isn't an issue. but this is cut and paste from a rodman analyst report:
he thinks boc is headed for 'no man's land'
Close Competitor Boceprevir Likely Headed for No Man’s Land Recall that Schering-Plough Corp. (SGP, Not
Rated) is developing its own investigational oral HCV protease inhibitor, boceprevir, which is the TVR competitor
closes in development. In data presented at EASL in April, SVR12 were surprisingly high, 57% and 55%, for the
two arms with or without a 4-week lead-in of standard therapy, respectively. Although less impressive than the
61% SVR12 demonstrated by telaprevir in PROVE 1, the data showed that boceprevir could be competitive.
Prompted by these surprising positive results, Schering-Plough (SP) began recruiting patients for two Phase III
clinical trials with boceprevir. One study, HCV SPRINT-2, will evaluate boceprevir in previously untreated (naïve)
patients, and the other, HCV RESPOND-2, in patients who failed prior treatment (relapsers and nonresponders),
however, both include a 4-week lead-in with standard therapy. In line with recent insights we gained at AASLD on
likely short duration treatment regimens that will be explored, we believe boceprevir headed down the wrong path.
Were boceprevir to be approved, the 4-week lead-in period of standard therapy, which SP believes is important for
to achieve steady state levels of P+R to reduce the selection and expansion of resistant strains after the addition of
a protease inhibitor, poses a significant problem. With the potential evaluation of RVR at week 4, we believe
hepatologists may choose instead to re-initiate therapy for RVR negative CHC patients with a TVR-based therapy
instead of risking an evaluation 12 weeks into therapy that could also show positive HCV RNA, as treatment with
boceprevir could preclude patients from subsequently being treated with TVR. Further, the viral kinetics of
boceprevir therapy at week 4 (week 8 overall) are largely unknown. Experts we consulted are in agreement that
evaluating virological response at week 8 does not provide useful decision-making information. As a result, we
believe boceprevir is headed for the “no man’s” land of future HCV treatment regimens. The likely evolution of HCV
treatment toward shorter duration therapy at best could relegate boceprevir to TVR-failures, or at worst, prompt SP
to scrap its Phase III plans and evaluate more optimal doses of boceprevir further solidifying TVR’s first-mover
entry into the market.
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