Biotech Values

[DewDiligence]

Here’s SGP’s update on the Boceprevir SPRINT-1 trial
for archival purposes. These data are essentially the
same as what SGP reported a few weeks ago at AASLD
(#msg-33283156); however, there is a minor anomaly
(#msg-33792479).

IMO: i) Boceprevir is a full-fledged competitor to
Telaprevir based on the 28-week data from SPRINT-1;
and ii) the 48-week data from SPRINT-1, though
impressive from a medical standpoint, are probably
inconsequential from a business standpoint because
the emerging standard based on the Telaprevir results
to date is that first-line patients will be treated for only
24-28 weeks if they achieve an RVR (undetectable virus
at week 4) and don’t have a viral breakthrough.

http://biz.yahoo.com/prnews/081124/ny48214.html

› Schering-Plough Provides Update on Boceprevir Clinical Development and Introduces Potent Next-Generation Oral HCV Protease Inhibitor for Treating Patients With Chronic Hepatitis C

Monday November 24, 11:21 am ET

KENILWORTH, N.J., Nov. 24 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP ) today provided a clinical update on boceprevir, its lead investigational oral hepatitis C protease inhibitor currently in Phase III development. The company believes boceprevir has the potential to be a first-in-class and best-in-class protease inhibitor for treating chronic hepatitis C. The company also announced that it is developing a highly potent next-generation oral hepatitis C protease inhibitor that has future best-in-class potential. The compound, known as SCH 900518 is currently in Phase IIa clinical development. The update was presented today as part of the company's 2008 R&D Update meeting at its headquarters in Kenilworth, N.J.

"As pioneers in the hepatitis field, our vision is to apply our experience and innovation, as we have in the past, to continue to redefine and improve treatments for chronic hepatitis C, in the near term and in the future," said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute.

The company reported for the first time that in a Phase II study, a 48-week boceprevir regimen achieved an unprecedented 75 percent sustained virologic response (SVR) rate at 24 weeks after the end of treatment (SVR 24) in patients who received 4 weeks of PEGINTRON(TM) (peginterferon alfa-2b) and REBETOL® (ribavirin, USP) prior to the addition of boceprevir (800 mg TID) (P/R lead-in). This represents a near doubling of the 38 percent SVR 24 rate for patients in the control group receiving 48-weeks of PEGINTRON and REBETOL alone (ITT).(1,2)

In a 28-week boceprevir P/R lead-in regimen, the SVR 24 rate was 56 percent. Importantly, for patients who received the boceprevir P/R lead-in regimen and had rapid virologic response (RVR), defined as undetectable virus (HCV-RNA) in plasma after 4 weeks of boceprevir treatment, SVR was 94 percent in the 48 week regimen and 82 percent in the 28-week regimen. RVR has been shown to be a reliable predictor for achieving SVR. These final results are from the HCV SPRINT-1 study in 595 treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1.

"We are very encouraged by the strong boceprevir results to date. We look forward to our ongoing Phase III studies, which are designed to demonstrate that boceprevir has the potential to benefit a broad range of patients by significantly increasing sustained response rates with a potentially shorter course of treatment," Koestler said.

He noted that the company has now completed patient enrollment in the HCV RESPOND-2 study, a pivotal Phase III study in patients who failed prior treatment, and has screened more than 1,200 patients in the HCV SPRINT-2 study, a pivotal Phase III study in treatment-naive patients.

Next-Generation HCV Protease Inhibitor SCH 900518

As part of its long-term commitment to hepatitis C therapy, Schering-Plough also is developing SCH 900518 ("518"), a next-generation HCV protease inhibitor. A Phase IIa study with 518, known as the NEXT-1 study, is currently ongoing. The company said that 518 has been shown to be 10 times more potent in-vitro than other protease inhibitors currently in Phase III development and has the potential for once daily dosing. 518 also has shown decreased emergence of resistance in vitro. Given its pharmacokinetic (PK) profile, the company anticipates that 518 may be active against some HCV strains that are resistant to other protease inhibitors. Phase I proof of concept studies with 518 in treatment-naive patients and those who failed prior treatment, both as monotherapy and in combination with peginterferon (without ribavirin), demonstrated enhanced antiviral activity, with up to 4 log10 and 5 log10 decreases in circulating HCV, respectively.

Full results of the boceprevir HCV SPRINT-1 study and early phase clinical results with SCH 900518 are being submitted for presentation at a future medical meeting.

About the Boceprevir HCV SPRINT-1 Study

In this Phase II study, known as HCV SPRINT-1 (HCV Serine Protease Inhibitor Therapy-1), boceprevir (800 mg TID) was evaluated in three treatment regimens: 4 weeks of PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (800-1400 mg daily based on patient weight) therapy followed by the addition of boceprevir to the combination for 24 or 44 weeks (totaling 28 or 48 weeks of treatment), boceprevir in combination with PEGINTRON and REBETOL at the doses described above for 28 or 48 weeks, and, in Part II of the study, boceprevir in combination with PEGINTRON and low-dose REBETOL (400-1000 mg daily based on patient weight) for 48 weeks, compared to a control of PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (800-1400 mg daily based on patient weight) alone for 48 weeks (an approved treatment regimen). The primary endpoint of the study is SVR after 24 weeks of follow up (SVR 24). SVR rates are not yet available for Part II of this study evaluating boceprevir with low-dose REBETOL (n=59) compared to contemporaneous control (n=16) as described above.

About Boceprevir Phase III Studies

Schering-Plough is conducting two large ongoing pivotal Phase III studies of boceprevir in patients chronically infected with HCV genotype 1. One study is in treatment-naive patients and the other in patients who failed prior treatment (relapsers and nonresponders). The two randomized, double-blind, placebo-controlled studies evaluate the efficacy of boceprevir in combination with PEGINTRON and REBETOL compared to standard of care with PEGINTRON and REBETOL alone.

The study in treatment-naive patients is known as HCV SPRINT-2 and the study in patients who failed prior treatment is known as HCV RESPOND-2. The two studies are expected to enroll a total of more than 1,400 patients at U.S. and international sites.‹