Replies to post #35952 on Biotech Values

[DewDiligence]

A few observations:

1. SGP has not put anywhere near the same money into its PI program as VRTX has put into 950. This tells me that SGP itself does not view its PI as a top-flight prospect.

2. Until there is evidence to the contrary, IDIX’s NM283 should rank ahead of Roche’s R1626 as the lead candidate in the polymerase space. NM283 is further along in development and it’s a once-daily pill vs BID for R1626.

3. If ribavirin continues to have a place, it will probably have a place in various cocktails, not merely in an all-SGP regimen.

4. The idea that companies like Roche and SGP will attempt to market an all-inclusive cocktail of solely in-house agents is just speculation at this point. I doubt that things will shake out exactly like that.

[DewDiligence]

SGP Says Direct Thrombin Inhibitor Has Big Potential

[The comment came on today’s CC in reply to a question about what is interesting in SGP’s mid-stage pipeline. The answer was notable in that Hassan did not mention the HCV PI until prompted to comment on it.]

http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20061020:MTFH85338_2...

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Fri Oct 20, 2006 9:05 AM ET

NEW YORK, Oct 20 (Reuters) - Fred Hassan, the chief executive of Schering-Plough Corp. <SGP>, on Friday said he has high hopes an experimental company drug to prevent blood clots will be launched in 2010 or 2011 and become a big seller.

The once-a-day oral drug, which blocks receptors to a protein called thrombin involved in blood clotting, is now in mid-stage studies.

Hassan told analysts in a conference call the so-called thrombin receptor antagonist (TRA) could achieve annual sales "past the $1 billion" mark, if approved, which would qualify it for blockbuster status.
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[DewDiligence]

InterMune to Present Research on ITMN-191 in Hepatitis C at Two Liver Disease Conferences

[grmm, gofish et al: Comments on abstract #1134?]

http://biz.yahoo.com/prnews/061024/sftu031.html?.v=68

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Tuesday October 24, 8:00 am ET

BOSTON, Oct. 24 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN ) announced today that InterMune scientists will be presenting at the American Association for the Study of Liver Diseases (AASLD) 57th annual meeting in Boston and at the 1st International Workshop on Hepatitis C -- Resistance and New Compounds hosted by Virology Education.

InterMune scientists will make the following presentation at Virology Education:

Wednesday, October 25, 2006 -- 3:00 p.m. Eastern Session: Resistance and New Compounds

-- Slide Presentation: Sequence variation of NS3 and NS4A in hepatitis C virus (HCV) replicons following exposure to ITMN-191 concentrations likely to encompass those achieved in human liver following clinical dosing

InterMune scientists will make the following presentations at AASLD:

Monday, October 30, 2006 -- 8:00 a.m. Eastern Session: HCV Therapy: Pre-clinical and Early Clinical Development

-- Poster Presentation (#933): In Vitro Synergistic Antiviral Activity of ITMN-191, an Orally Active Inhibitor of the Hepatitis C Virus (HCV) NS3/4A Protease, in Combination with PEG-Interferon Alfa-2a

Tuesday, October 31, 2006 -- 8:00 a.m. Eastern Session: Clinical Trials and Therapeutic Developments

-- Poster Presentation (#1134): Final Results of pilot study evaluating safety, viral clearance and antifibrotic efficacy of treatment with Interferon Gamma-1b plus an Interferon alpha plus Ribavirin in HCV patients who failed prior Pegylated Interferon Plus Ribavirin therapy

About ITMN-191

InterMune has successfully completed preclinical toxicology and pharmacokinetic studies in multiple species in support of initiating Phase I clinical studies of ITMN-191 for the treatment of chronic HCV. The European Clinical Trial Authorization (CTA) application, which InterMune filed in the third quarter of 2006, includes results of 28-day preclinical toxicology studies utilizing doses many-fold higher than those expected to be given to humans. These studies demonstrate that ITMN-191 has a favorable toxicology profile, allowing the compound to be studied in clinical trials over a range of doses predicted to have antiviral efficacy. ITMN-191 has also demonstrated high in vitro potency and specificity in biochemical assays and in assays utilizing the HCV replicon system. Moreover, ITMN-191 displays a favorable cross-resistance profile, including significant potency against variants of the NS3/4A protease that are resistant to other HCV protease inhibitors currently in development. The preclinical pharmacokinetic results support the exploration of twice-daily oral dosing in HCV patients. On October 16, 2006, InterMune signed a collaboration agreement with Roche for the research, development and commercialization of ITMN-191 and potential second-generation HCV protease inhibitor compounds.
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