CAMBRIDGE, Mass., March 17 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. , a biopharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of human viral and other infectious diseases, announced today that thirteen abstracts have been accepted for presentation at the 41st annual meeting of the European Association for the Study of the Liver (EASL), to be held in Vienna, Austria from April 26-30, 2006. The abstract contents are available on the EASL web site (http://www.easl.ch/easl2006/).
Hepatitis C Abstracts:
Dr. Nezam Afdhal, Chief of Hepatology at Beth Israel Deaconess Medical Center in Boston and Associate Professor at Harvard Medical School, will present "Valopicitabine (NM283), Alone or with Peg-Interferon, Compared to Peg-Interferon/Ribavirin (PegIFN/RBV) Retreatment in Hepatitis C Patients with Prior Non-Response to PegIFN/RBV: Week 24 Results" in a meeting session on Friday, April 28 at 10:30 a.m. Central European Time (CET). Dr. Afdhal will present full interim 24-week results from the ongoing phase IIb trial evaluating valopicitabine combined with pegylated interferon in 190 treatment- refractory patients.
Dr. Douglas Dieterich, Professor of Medicine at the Mt. Sinai School of Medicine, New York, will present "Early Clearance of HCV RNA with Valopicitabine (NM283) plus Peg-Interferon in Treatment-Naive Patients with HCV-1 Infection: First Results from a Phase IIb Trial" in a late-breaking oral presentation session on Saturday, April 29, at 5:15 p.m. CET. Complete 8-week and available 12-week data from this ongoing trial evaluating 174 treatment- naive patients will be presented.
Dr. Xiao-Jian Zhou, Idenix's Associate Director, Clinical Pharmacology, will present "Absence of Effect of Pegylated Interferon Alfa-2b on the Pharmacokinetics of Valopicitabine (NM283) in Patients with Chronic Hepatitis C" in the poster session beginning on Thursday, April 27, 2006 at 7:00 p.m. CET.
Dr. Zhou will also present "Safety and Pharmacokinetics of NM107 Following Intravenous Infusion of Escalating Doses in Healthy Volunteers: Determination of Absolute Oral Bioavailability of Valopicitabine (NM283)" in the poster session beginning on Thursday, April 27, 2006 at 7:00 p.m. CET.
Dr. Vadim Bichko, Idenix's Director, Research, will present "Long-Term Study of NM283 (Valopicitabine) Resistance Using Bovine Viral Diarrhea Virus" in the poster session beginning on Thursday, April 27, 2006 at 7:00 p.m. CET.
Valopicitabine is an investigational compound for the treatment of hepatitis C that is currently being evaluated in ongoing clinical trials. In a majority of patients who have received valopicitabine, adverse events, most notably gastrointestinal side effects, have occurred. For most of these patients, the side effects are mild-moderate, transient and resolve while remaining on treatment. However, in a minority of patients, the side effects persist resulting in treatment discontinuation.
Hepatitis B Abstracts:
Dr. Stefan Zeuzem, Professor of Medicine at Saarland University, in Homburg, Germany, will present "Optimal Virologic and Clinical Efficacy at One Year is Associated with Maximal Early HBV Suppression in Nucleoside-Treated Hepatitis B Patients" in a meeting session on Friday, April 28 at 5:15 p.m. CET.
Dr. Henry Chan, Associate Professor of Medicine at the Chinese University of Hong Kong, will present "A Randomized Trial of Telbivudine (LdT) vs. Adefovir for HBeAg-Positive Chronic Hepatitis B: Results of the Primary Week 24 Analysis" in a meeting session on Friday, April 28 at 5:30 p.m. CET.
Dr. Satawat Thongsawat, Professor of Medicine at Chiang Mai University in Thailand, will present "Telbivudine Displays Consistent Antiviral Efficacy Across Patient Subgroups for the Treatment of Chronic Hepatitis B: Results from the GLOBE Study" in a meeting session on Sunday, April 30 at 1:15 p.m. CET.
Dr. Nikolai Naoumov, Consultant Physician at the Institute of Hepatology, University College London, England, will present "Effect of Core Promoter/Precore Mutation Pattern and Early Virologic Response on Efficacy Outcomes with Telbivudine in HBeAg-negative Chronic Hepatitis B" in the poster session beginning on Thursday April 27, 2006 at 7:00 p.m. CET.
Dr. Edward Gane, Associate Professor of Gastroenterology and Hepatology at Middlemore Hospital in Auckland, New Zealand, will present "Phase III Comparison of Telbivudine vs. Lamivudine in HBeAg-Positive Patients with Chronic Hepatitis B: Efficacy, Safety, and Predictors of Response at 1 Year" in the poster session beginning on Thursday, April 27, 2006 at 7:00 p.m. CET.
Dr. Zhou will present "Absence of Pharmacokinetic Drug-Drug Interaction Between Telbivudine and Peginterferon alfa-2a or Cyclosporine in Healthy Subjects" in the poster session beginning on Thursday, April 27, 2006 at 7:00 p.m. CET.
Dr. David Standring, Idenix's Senior Vice President, Biology, will present "HBV Resistance Determination from the Telbivudine GLOBE Registration Trial" in the poster session beginning on Thursday, April 27, 2006 at 7:00 p.m. CET.
Dr. Edward Bridges, Idenix's Vice President, Preclinical Pharmacology and Toxicology, will present "Telbivudine Preclinical Safety Studies Suggest Minimal Risk of Chronic Toxicity, Reproductive Toxicity or Carcinogenicity" in the poster session beginning on Thursday, April 27, 2006 at 7:00 p.m. CET.
Telbivudine is an investigational compound for the treatment of hepatitis B. Idenix is currently evaluating telbivudine in an ongoing two-year international phase III clinical trial referred to as the GLOBE study. The GLOBE study, in which 1,367 patients are enrolled, is comparing 600 mg dose of telbivudine orally administered once a day to treatment once a day with 100 mg of lamivudine. The most frequently reported adverse events in the GLOBE study were upper respiratory tract infection, nasopharyngitis, fatigue and headache. Creatine kinase (CK) elevations, not requiring treatment modification, were more common among patients treated with telbivudine compared to lamivudine.
Idenix is developing its hepatitis B product candidates in collaboration with Novartis Pharma AG under a license granted by Idenix and a development and commercialization arrangement established in May 2003.
About Idenix
Idenix Pharmaceuticals, Inc. is a biopharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of human viral and other infectious diseases. Idenix's current focus is on the treatment of infections caused by hepatitis B virus, hepatitis C virus and human immunodeficiency virus (HIV). Idenix's headquarters are located in Cambridge, Massachusetts and it has drug discovery and development operations in Montpellier, France and drug discovery operations in Cagliari, Italy. For further information about Idenix, please refer to http://www.idenix.com.
Forward-looking Statement
This press release may contain "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward- looking statements may be identified by implied discussions regarding regulatory submissions and clinical trial development of telbivudine and valopicitabine. Such forward-looking statements are subject to numerous factors, risks and uncertainties that may cause actual events or results to differ materially from the company's current expectations. There can be no guarantee that any product Idenix is developing will be approved for sale in any market or that, if approved, revenues from sales of such product will reach any specific level. In particular, management's expectations could be affected by risks and uncertainties relating to the submission and approval, if any, of regulatory filings seeking marketing authorization by the FDA, EMEA, or other regulatory authorities in other jurisdictions; results of clinical trials, including subsequent analysis of existing data and new data received from ongoing and future studies; the company's dependence on its collaboration with Novartis Pharma AG; the company's ability to obtain additional funding required to conduct its research, development and commercialization activities; the ability of the company to attract and retain qualified personnel; competition in general and the company's ability to obtain, maintain and enforce patent and other intellectual property protection for any products we are developing. These and other risks which may impact management's expectations regarding any product we are developing are described in greater detail under the caption "Risk Factors" in the company's annual report on Form 10-K for the year ended December 31, 2005 and filed with the Securities and Exchange Commission and other filings that the company makes with the Securities and Exchange Commission.
All forward-looking statements reflect the company's expectations only as of the date of this release and should not be relied upon as reflecting the company's views, expectations or beliefs at any date subsequent to the date of this release. Idenix anticipates that subsequent events and developments may cause these views, expectations and beliefs to change. However, while Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.
Idenix Pharmaceuticals' Contact:
Teri Dahlman (617-995-9905)
Idenix Pharmaceuticals, Inc.CONTACT: Media: Teri Dahlman of Idenix Pharmaceuticals, Inc.,+1-617-995-9905
Web site: http://www.idenix.com//
