Replies to post #92502 on Biotech Values

[ghmm]

ITMN/EASL:

Thanks Dewophile for the link! Here is the 191 Boosted abstract

http://www.kenes.com/easl2010/Orals/144.htm

Session Title: Parallel Session: HEPATITIS C: DRUG DEVELOPMENT
Presentation Date: Apr 15, 2010
RITONAVIR BOOSTING OF LOW DOSE RG7227/ITMN-191, HCV NS3/4A PROTEASE INHIBITOR, RESULTS IN ROBUST REDUCTION IN HCV RNA AT LOWER EXPOSURES THAN PROVIDED BY UNBOOSTED REGIMENS


E. Gane1, R. Rouzier2, C. Stedman3, A. Wiercinska-Drapalo4, A. Horban4, L. Chang5, Y. Zhang5, P. Sampeur6, I. Najera7, N. Shulman7, P. Smith5, J. Tran5
1Auckland Clinical Studies, Auckland, New Zealand, 2Centre CAP, Montpellier, France, 3Christchurch Clinical Studies Trust, Christchurch, New Zealand, 4Department of Hepatology and Immunodeficiencies, Warsaw Medical University, 5Warsaw Medical University & Hospital of Infectious Diseases, Warsaw, Poland, 6Roche, South San Francisco, CA, 7Roche, Nutley, NJ, 8Roche, Palo Alto, CA, USA. *[e-mail]

Background: Co-administration of low dose ritonavir resulted in larger increases in RG7227 trough concentration than area under the curve (AUC) and marginal increase in maximum concentration (Cmax), offering the opportunity to reduce the dose and/or dosing frequency of RG7227 in future Phase 2 studies. The present study evaluated the safety, tolerability, antiviral activity and pharmacokinetics (PK) of once-daily (QD) and twice-daily (BID) ritonavir boosted RG7227 (RG7227/r) in combination with standard of care (SOC) in treatment-naïve HCV genotype 1 patients.
Material & methods: In a double-blind, placebo-controlled, Phase 1b multiple-ascending dose (MAD) study, treatment-naïve HCV genotype 1 patients were randomized to receive RG7227/r or placebo/r plus SOC for 15 days. RG7227/r regimens were 100/100mg BID (Cohort 1), 200/100mg QD (Cohort 2), and 200/100mg BID (Cohort 3). Blood samples for HCV RNA, PK, and resistance monitoring were collected at baseline and throughout the study.
Results: Cohort 1 and 2 provided blinded data for this abstract. The following table summarizes virologic response of RG7227/r compared to un-boosted 900 mg BID, the highest dose evaluated in a previous MAD study (placebo/r data are not shown due to small N of 2):


[Summary of Virologic Response]

RG7227/r AUC and Cmax were approximately 6- to 9-fold and 4- to 10-fold lower, respectively, than previously observed for 900 mg BID un-boosted. Inter-patient PK variability for RG7227/r was also lower than historical un-boosted RG7227. RG7227/r and placebo/r plus SOC were generally well tolerated. Complete data for all 3 cohorts will be presented.
Conclusion: Relative to un-boosted 900 mg BID, ritonavir boosting of low dose RG7227 provides robust and sustained virologic response at significantly lower AUC and Cmax, parameters which are often correlated with safety. These results indicate that further exploration of ritonavir boosting on the safety and efficacy of RG7227 is warranted.

[genisi]

EASL

abstracts for posters presentations at EASL are available for viewing:

http://www.kenes.com/easl2010/posters/

[DewDiligence]

Thanks to everyone who posted abstracts from EASL. Will update #msg-47309917 soon to include the new material.

[DewDiligence]

IDIX Announces EASL Presentations for IDX184, IDX320

[The most intriguing of the four presentations, IMO, is the one in the fourth bullet below, which pertains to a combination of three direct antivirals, presumably IDX184 + IDX375 + IDX320. It’s only in-vitro data, but it could nevertheless give an early read as to whether a cocktail of drugs from the three main classes will provide additive or even synergistic activity.]

http://finance.yahoo.com/news/Idenix-Announces-Data-prnews-837772920.html?x=0&.v=1

›Idenix Announces Data Presentations at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL)

Tuesday March 16, 2010, 9:44 am EDT

CAMBRIDGE, Mass., March 16 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that four abstracts have been accepted for presentation at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL, April 14-18, 2010 in Vienna, Austria). Full abstracts can now be viewed at the EASL website at www.easl.eu.

The accepted abstracts are as follows:

• Lalezari, et al, “Antiviral Activity, Pharmacokinetics and Safety of IDX184 in Combination with Pegylated Interferon (PegIFN) and Ribavirin (RBV) in Treatment-Naïve HCV Genotype 1-Infected Subjects”, will be presented in a poster session beginning on Thursday, April 15.

• Good, et al, “Preclinical Pharmacokinetic Profile of IDX320, a Novel and Potent HCV Protease Inhibitor”, will be presented in a poster session on Friday, April 16.

• Lallos, et al, “In Vitro Antiviral Activity of IDX320, a Novel and Potent Macrocyclic HCV Protease Inhibitor”, will be presented in a poster session on Friday, April 16.

• La Colla, et al, “A Triple Combination of Direct-Acting Antiviral Agents Demonstrates Robust Anti-HCV Activity In Vitro” will be presented in a poster session on Friday, April 16.‹

[DewDiligence]

VRTX Announces Telaprevir, VX-222 Presentations at EASL

[Most of these studies have already been vetted via press releases and conference calls, and hence the presentations below probably won’t have much if any effect on VRTX’s share price. Although not specific to VRTX, poster presentations #4 and #5 pertaining to subgroup definitions and QALYs, respectively, ought to be good reads for all investors who follow the HCV arena.]

http://finance.yahoo.com/news/Vertex-Pharmaceuticals-bw-2448617881.html?x=0&.v=1

›Tuesday March 16, 2010, 4:01 pm EDT

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that multiple abstracts related to the hepatitis C virus (HCV) protease inhibitor telaprevir and the HCV polymerase inhibitor VX-222 were accepted for presentation at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria, April 14-18, 2010. The accepted abstracts include an oral presentation of results from Study 107, which evaluated telaprevir in HCV patients with well-characterized prior response to HCV therapy, including those with prior null response, partial response, viral breakthrough or relapse. Additionally, an abstract related to results from a Phase 1b/2a clinical trial of VX-222 in treatment-naïve genotype 1 HCV patients was accepted for oral presentation. The abstracts can be accessed through the EASL website, www.easl.ch. In accordance with the EASL embargo policy, the accepted abstract titles are provided below:

Telaprevir Oral Presentations:

1. Study 107: “SVR with Telaprevir, Peginterferon Alfa-2a and Ribavirin in HCV Patients with Well-Characterized Prior Null Response, Partial Response, Viral Breakthrough or Relapse After PR”; April 15, 2010, 3:45 - 4:00 p.m. CET.

2. Study C208: “On-treatment Response-guided Therapy with Telaprevir Q8h or Q12h Combined with Peginterferon Alfa-2a or Peginterferon Alfa-2b and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C (STUDY C208)”; April 16, 2010, 4:45 - 5:00 p.m. CET.

3. Study C209: “Activity of Telaprevir Alone or in Combination with Peginterferon Alfa-2a and Ribavirin in Treatment-naïve Genotype 2 and 3 Hepatitis-C Patients: Final Results of Study C209”; April 16, 2010. 5:00 - 5:15 p.m. CET.

VX-222 Oral Presentation:

1. “Safety and Antiviral Activity of the HCV Non-Nucleoside Polymerase Inhibitor VX-222 in Treatment-Naïve Genotype 1 HCV-Infected Patients”; April 15 2010, 5:00 – 5:15 p.m. CET.

Poster Presentations:

1. “Improved Sustained Virologic Response (SVR) Rates in “Difficult-to-Cure” Patients Treated with Telaprevir in Combination with Peginterferon Alfa-2a and Ribavirin: an Analysis From the PROVE-3 Study”; April 15, 2010.

2. “Early Virological Response Profiles with Telaprevir (T) in Combination with Peginterferon-Alfa-2a (P) and ribavirin (R) in Genotype 1 HCV Treatment-Naïve and Treatment-Experienced Patients are Similar”; April 15, 2010.

3. “Genotypic and Phenotypic Characterization of Genotype 2/3 HCV Variants in Patients Treated with Telaprevir Alone or in Combination with Peginterferon Alfa-2a/Ribavirin in Study C209”; April 15, 2010.

4. “Discrepancies Between Definitions of Null Response to Treatment with Peginterferon Alfa-2a and Ribavirin: Implications for New HCV Drug Development”; April 15, 2010.

5. “Impact of Sustained Virological Response (SVR) on Life Expectancy and Quality-adjusted Life-years (QALYs) in Chronic Hepatitis C (CHC) Patients”; April 17, 2010.‹

[DewDiligence]

ACHN Announces ACH-1625 Presentations at EASL

[ACH-0141625, which is mentioned in the first presentation below, is evidently another name for ACH-1625.]

http://finance.yahoo.com/news/Achillion-to-Present-ACH1625-pz-3326431561.html?x=0

›Tuesday March 16, 2010, 7:00 am EDT

NEW HAVEN, Conn., March 16, 2010 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN), a leader in the discovery and development of treatments for the most challenging infectious diseases, today announced that its abstract titled "Virological Response, Safety, and Pharmacokinetic Profile Following Single- and Multiple-Dose Administration of ACH-0141625 Protease Inhibitor to Healthy Volunteers and HCV Genotype-1 Patients" has been accepted as a late breaking poster presentation at the International Liver Congress 2010 being held April 14-18 in Vienna, Austria.

Two additional abstracts on the compound's virology and hepatoselectivity titled “Preclinical Antiviral Activity, Combination and Resistance of ACH-1625, A Potent HCV NS3 Protease Inhibitor,” and “Characterization of the Hepatoselective Distribution of ACH-1625, a Potent, Clinical Stage HCV NS3 Protease Inhibitor” had previously been accepted for poster presentation.

Achillion's posters will be displayed from Thursday, April 15 at 8:00 a.m. through Saturday, April 17 at the end of the day's sessions.‹