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New HCV Drug NM283 HBV Drug LdT at AASLD
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"IDENIX ANNOUNCES DATA PRESENTATIONS AT THE 2005 56th ANNUAL MEETING OF THE AMERICAN ASSOCIATION FOR THE STUDY OF LIVER DISEASES (AASLD)'
-Idenix to Webcast Conference Call Regarding the Accepted Abstracts at 2:00 p.m. ET on October 3, 2005-
Idenix issued this press announcement today.
Idenix Pharmaceuticals' Contact:
Amy Sullivan 617-995-9838
Cambridge, MA; October 3, 2005 - Idenix Pharmaceuticals, Inc. (NASDAQ: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases, announced today that five abstracts have been accepted for presentation at the 56th annual meeting of the American Association for the Study of Liver Diseases
(AASLD), to be held in San Francisco, CA, from November 11-15, 2005. Full abstracts can now be viewed on the AASLD website at www.aasld.org.
Hepatitis B treatment abstracts:
Dr. Ching-Lung Lai, Professor of Medicine and Hepatology, Department of Medicine, University of Hong Kong will present, "Telbivudine (LdT) vs. Lamivudine for Chronic Hepatitis B: First-Year Results from the International Phase III GLOBE Trial" in the late-breaker session on Monday, November 14 at 3:00 p.m. Pacific Standard Time (PST). Dr. Lai, a principal investigator in the trial, will present first-year efficacy and safety results from the ongoing two-year phase III GLOBE trial of the investigational agent telbivudine in HBeAg-positive and HBeAg-negative chronic hepatitis B patients. After 1 year of treatment, telbivudine, compared with lamivudine, demonstrated statistically significantly greater efficacy on all virologic endpoints in both HBeAg-positive and HBeAg-negative patients. Telbivudine met superiority criteria for the primary clinical efficacy endpoint of Therapeutic Response in HBeAg-positive patients and met non-inferiority criteria on the Therapeutic Response endpoint in HBeAg-negative
patients.
Both treatments were well tolerated, however telbivudine showed significantly less resistance and fewer ALT flares as compared to lamivudine. Transient creatine kinase (CK) elevations, not requiring treatment modification, were more common with telbivudine compared to lamivudine. In the GLOBE trial, the
most frequently reported adverse events, regardless of attributability to study treatment, were upper respiratory infection and fatigue, which were equally common for telbivudine and lamivudine.
Additionally, Dr. Lai will present, "Maximal Early HBV Suppression is Predictive of Optimal Virologic and Clinical Efficacy in Nucleoside-Treated Hepatitis B Patients: Scientific Observations from A Large Multinational Trial" in a Presidential Plenary session on Monday, November 14 at 8:15 a.m. (PST). Dr. Lai will present an analysis of the results from the 1,367 patients from the ongoing phase III GLOBE trial of telbivudine that evaluates the potential link between rapid and profound viral suppression and subsequent clinical benefits in patients with chronic hepatitis B. This analysis suggests that after 1 year of
treatment with anti-HBV nucleosides, the highest rates of clinical efficacy outcomes are associated with maximal reduction of HBV DNA levels early in the course of therapy (at six months).
Idenix is developing its hepatitis B clinical drug candidates in collaboration with Novartis Pharma AG under a license granted by Idenix and a development and commercialization arrangement established in May 2003. Idenix and Novartis are currently evaluating telbivudine in the largest hepatitis B registration trial to date (the GLOBE study). Idenix and Novartis anticipate using one-year data from the GLOBE study as the basis for regulatory filings expected to be submitted beginning in late 2005.
Hepatitis C treatment abstracts:
Dr. Christopher O'Brien, Clinical Associate Professor of Medicine at the University of Miami, will present "Randomized Trial of Valopicitabine (NM283), Alone or with Peg-interferon, vs. Retreatment with Peg-interferon Plus Ribavirin (PegIFN/RBV) in Hepatitis C Patients with Previous Non-response to PegIFN/RBV: First Interim Results" in a Presidential Plenary session on Monday, November 14 at 9:00 a.m. (PST). Dr. O'Brien, a principal investigator in the trial, will present 12-week interim findings from this phase IIb clinical trial, which is evaluating the therapeutic potential of valopicitabine (NM283), a novel investigational treatment for chronic hepatitis C, in patients who previously failed treatment with pegylated interferon plus ribavirin. Both 4-week and 12-week data demonstrate that valopicitabine combined with Pegasys produces statistically significantly greater suppression of HCV replication, resulting in a statistically significantly greater proportion of patients achieving early viral response, defined as greater than or equal to a 2 log reduction from baseline, as compared to retreatment with Pegasys and ribavirin. In this trial, valopicitabine has demonstrated satisfactory safety and tolerance overall, to date. A low percentage of patients have discontinued due to adverse events (approx. 6% by week 12). Two discontinuations due to serious adverse events were considered attributable to study treatment (anemia and dehydration) and both resolved. To date, there is no predominant treatmentlimiting adverse event or laboratory abnormality.
Two posters will be presented during the hepatitis C session on Monday, November 14 from 1:45-3:00 p.m. PST:
- Dr. Vadim Bichko, Idenix's Associate Director, Research, will present "Characterization of NM283 (valopicitabine) Resistance Profile Using Bovine Viral Diarrhea Virus." The study evaluated the potential for the development of resistance to valopicitabine in an in vitro infection model that uses bovine viral diarrhea virus (BVDV), a pestivirus related to the hepatitis C virus. In this study, an NM283-related resistant mutation in BVDV was identified. However BVDV containing this mutation demonstrated a reduced capacity to replicate and increased sensitivity to inhibition by interferon alpha.
- 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." Dr Zhou will present pharmacokinetic findings from an ongoing phase IIb trial of valopicitabine in patients with chronic hepatitis C. The results of this analysis suggest that the pharmacokinetics of valopicitabine and pegylated interferon _-2b are not altered when these two agents are administered in combination.
Conference Call Information
Idenix will hold a conference call at 2:00 p.m. ET. Company management will review one-year data from the ongoing phase III GLOBE trial of telbivudine as well as preliminary 12-week data from the phase IIb trial of valopicitabine in patients who have previously failed treatment with pegylated interferon plus
ribavirin. Please log in approximately 10 minutes before the call to ensure a timely connection.
An archived webcast will be available on the Idenix website for two weeks after the call. A replay of the call will also be available from 8:00 p.m. ET on October 3, 2005 until 8:00 p.m. ET on October 17, 2005. To access the replay, please dial (800) 642-1687 or (706) 645-9291 (international), and provide the access
code 1132843.
About Idenix
Idenix Pharmaceuticals, Inc. is a biopharmaceutical company engaged in the discovery and development 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 Statements
This press release contains "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements can be identified by the use of forwardlooking terminology such as "anticipate" or similar expressions or by express or implied discussions regarding potential therapeutic benefits and successful development of telbivudine and valopicitabine and the anticipated regulatory filings required for the registration of telbivudine. 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. These risks and uncertainties relate to the results of clinical trials and other studies with respect to telbivudine, valopicitabine and the other product candidates that the company has under development; the timing and success of submission, acceptance and approval of regulatory filings; 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; and the company's ability to obtain, maintain and enforce patent and other intellectual property protection for telbivudine and valopicitabine. These and other risks are described in greater detail under the caption "Factors That May Affect Future Results" in the company's quarterly report on Form 10-Q for the quarter ended June 30, 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.
Pegasys is a registered trademark of Hoffmann-La Roche.
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