Biotech Values

[RockRat]

Speaking of the HCV space . . . today Vertex unveiled some PROVE-1 data at ICAAC. Here's the abstract:

>>Background: The VX05-950-104 study (PROVE1) is a randomized, placebo-controlled Phase 2 study of telaprevir (TVR, VX-950), an HCV protease inhibitor, with Peg-IFN-2a and RBV, in naive subjects with genotype 1 hepatitis C. We report the results of a planned interim analysis and preliminary viral sequencing. Methods: Subjects were randomized into 4 groups; 3 groups received TVR 750 mg q8h, Peg-IFN-2a 180 mg/week, and RBV 1000-1200 mg/day for 12 weeks followed by 0 (n=20), 12 (n=80) or 36 (n=82) weeks of Peg-IFN-2a and RBV (TVR/PR groups). The control group (n=81) received up to 48 weeks of Peg-IFN-2a/RBV. This analysis was performed when all treated subjects had completed 12 weeks of dosing. Samples were collected for viral sequencing at baseline and at each HCV RNA assessment. Results: The proportion of subjects with undetectable HCV RNA (LOD 10 IU/mL) at Week 4 was 79% (TVR/PR group), and 11% (control group) (p<0.001), and at Week 12 was 70% (TVR/PR group), and 39% (control group) (p<0.001). In the TVR/PR groups, 12 of 175 subjects had a breakthrough (increase of > 1-log above HCV RNA nadir) with previously described TVR resistant variants. In the group receiving 12 weeks of treatment, 6 of 9 subjects with RVR and completing 12 weeks of treatment, had undetectable HCV RNA 20 weeks after end of treatment. Three subjects have relapsed with resistant variants. Discontinuations due to adverse events were more frequent in the TVR/PR group (11% vs. 3%). Rashes, gastrointestinal (GI) events and anemia were more common, and rashes more severe in the TVR/PR groups. Conclusions: Significantly more subjects receiving a TVR-based regimen achieved undetectable HCV RNA at Weeks 4 and 12. Viral breakthrough and relapse are associated with the selection of TVR resistant variants. Shorter treatment durations appear feasible for genotype 1 HCV in a subset of patients achieving RVR.<<

And here are Cowen's alleged comments, shortly after the presentation:

>>12:08 EDT VRTX theflyonthewall.com: Vertex Pharm-VRTX telaprvir data at ICAAC shows more drop outs than expected@COWN
Cowen notes that SVR achieved 59%-61%, below their expectations of high 60's. Cowen sees limited share upside in the near-term. :theflyonthewall.com <<

This doesn't quite gibe with the abstract, wrt to SVR, at least. Dropouts may have been higher than what they were expecting; they were slightly higher than I was expecting (which was 9 - 10%, FWIW). The stock was subsequently under pressure for the day. Vertex has yet to issue a PR. Why the discrepancy between Cowen's SVR numbers and the abstract? If late data presented orally yielded the numbers Cowen cites, that would explain it. But where's the PR? Anyone got insight here? A copy of the Cowen note, if it exists?

TIA & Regards, RockRat