CAMBRIDGE, Mass., April 21 /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 four abstracts have been accepted for presentation at 2006 Digestive Disease Week (DDW) meeting, to be held in Los Angeles, California from May 20 to 25, 2006. The abstract contents are available on the DDW web site at http://www.ddw.org.
Hepatitis C Abstracts:
Dr. Paul Pockros, Division Head of the Gastroenterology/Hepatology Division at the Scripps Clinic, California, 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 Sunday, May 21, 2006 at 9:15 a.m. Pacific Daylight Time (PDT).
Valopicitabine is an investigational nucleoside polymerase inhibitor that is being developed for the treatment of patients with chronic hepatitis C. Idenix is currently evaluating valopicitabine in combination with pegylated interferon in two phase IIb clinical trials, one in treatment-refractory patients and one in treatment-naive patients, to determine the optimal dosing regimen of valopicitabine to advance in clinical development. Due to the occurrence of gastrointestinal (GI) side effects, more common at higher dosing levels (e.g., 800 mg/day), we have modified the ongoing phase IIb trials and are currently evaluating the 200 mg/day and 400 mg/day dose levels of valopicitabine in these studies.
Hepatitis B Abstracts
Dr. Elizabeth J. Heathcote, Hepatologist and Professor of Medicine at the University of Toronto Western Hospital 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 Tuesday, May 23, 2006 at 9:00 a.m. PDT.
Dr. Natalie Bzowej, Director of Clinical Hepatology Research at California Pacific Medical Center will present “Phase III Comparison of Telbivudine vs. Lamivudine in Patients with Chronic Hepatitis B: Efficacy, Safety, and Predictors of Response at 1 Year” in a meeting session on Tuesday, May 23, 2006 at 9:45 a.m. PDT.
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 a poster session on Tuesday, May 23, 2006.
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 were more common among patients treated with telbivudine compared to lamivudine.
Idenix is developing its hepatitis B product candidates and valopicitabine, its hepatitis C clinical product candidate, in collaboration with Novartis Pharma AG.
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 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; government, industry and general public pricing pressures 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:
Investors: Amy Sullivan (617-995-9838)
Media: Teri Dahlman (617-995-9905)
Idenix Pharmaceuticals, Inc.
CONTACT: Investors: Amy Sullivan, +1-617-995-9838, or Media: Teri Dahlman,+1-617-995-9905, both of Idenix Pharmaceuticals, Inc.
Web site: http://www.idenix.com//
