Replies to post #68951 on Biotech Values

[ghmm]

SGP:

FYI the portion of the talk on their PI's starts at about 2:14. They don't go into too much detail. They review development of Boceprevir. Currently treatment experienced trial fully enrolled, naive screened 1200 patients. Will be studying with Pegasys. Rash similar to placebo.

SGH-900518 just said QD dosing, favorable resistance profile, phase 2, referenced slides but I only had the audio.

EDIT:
Link for slide presentation http://media.corporate-ir.net/media_files/irol/89/89839/SP_RandD_WEB_Archive_11_24_08.pdf

[DewDiligence]

ghmm et al: An anomaly in the Boceprevir SPRINT-1 data:

The SVR rate in the “4+44” arm as reported in yesterday’s PR was 75%.

The SVR12 rate in this same trial arm as reported at AASLD was 74% (#msg-33283156).

Something’s wrong here because SVR, by definition, cannot be higher than SVR12!

I presume that the discrepancy stems from the re-inclusion in the SVR data set of one responder who was excluded from the SVR12 data set.

Did any analysts pick up on this anomaly during the webcast?

[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.‹

[DewDiligence]

More on SGP’s R&D presentation:

http://www.reuters.com/article/marketsNews/idINN2452738320081124

› Schering-Plough Touts Pipeline Stars

Mon Nov 24, 2008 2:31pm EST
By Ransdell Pierson and Lewis Krauskopf

KENILWORTH, N.J., Nov 24 (Reuters) - Schering-Plough Corp (SGP) touted five "stars" of its product pipeline nearing the market on Monday and highlighted a series of earlier-stage medicines that it said could be first and best in new classes of treatment.

All told, the drugmaker predicted that seven drugs in its pipeline could reach at least $1 billion in annual sales, with four more that could achieve $500 million.

Schering-Plough claimed its robust research pipeline and its relatively low exposure to patent expirations and generic competition set it apart in the pharmaceutical industry.

"We believe we're hitting the sweet spot on product flow and expected exclusivity at a time so many of our competitors will be facing product droughts and patent cliffs," CEO Fred Hassan told analysts at a meeting at its New Jersey headquarters to review its research pipeline.

"Because the company has a lack of generic exposure in the near term, even modest opportunities can have a meaningful impact on their bottom line," BMO Capital Markets analyst Bert Hazlett said. "They have a collection of solid opportunities."

The company highlighted five medicines in late-stage development or under review by regulators, the foremost being its TRA blood-clot treatment.

Schering-Plough said it was in its interest to maintain full control of the TRA program, after previously indicating it might seek a partner to share development risks and costs. It hopes to seek approval for the drug in 2010-2011 for TRA, which it said has multibillion-dollar sales potential.

Two other drugs with potential for sales exceeding $1 billion were Simponi, also known as golimumab, which is under review by regulators as a rheumatoid arthritis treatment; and its hepatitis C drug, boceprevir, which the company hopes to file for approval for in 2011-2012 and said has proven sustained effectiveness without rash problems tied to rival medicines.

But analysts cautioned at the meeting that two "stars" have been held up by the U.S. Food and Drug Administration.

One, a schizophrenia treatment, now known by the brand name Saphris, and also called asenapine, has seen its approval delayed. The FDA earlier this year unexpectedly rejected Bridion, which reverses the effects of anesthesia.

Citigroup analyst John Boris said Saphris and Bridion are "critical for revitalizing the U.S. franchise" and was concerned about them. Bridion is likely to require a safety study on allergic reactions, Boris said.

Of the promising earlier-stage products, one has the potential to treat psoriasis and Crohn's disease without infections seen in standard treatments. Another is a fertility drug, known as an LH agonist, which can be taken orally.

A third is beta secretase inhibitor for Alzheimer's disease that addresses a certain type of brain plaque. A drug for Parkinson's disease, known as preladenant, met the main goal of a mid-stage trial, Schering-Plough announced on Monday.

It also revealed it would start human research next year for a flu vaccine made from living cells rather than chicken eggs.

Monday's meeting was the first update for investors on Schering-Plough's research pipeline since its purchase of Organon Biosciences a year ago.

It comes as its prospects have been overshadowed this year by controversy over the safety and effectiveness of its cholesterol drugs, Vytorin and Zetia. Total sales of the drugs, which the company markets with Merck & Co (MRK), fell 15 percent in the third quarter.

Shares of Schering-Plough had fallen 46 percent this year through Friday, compared to a 28 percent drop for the American Stock Exchange Pharmaceutical index.‹