CAMBRIDGE, Mass., April 18, 2007 /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 11 abstracts have been accepted for presentation at the 2007 Digestive Disease Week (DDW) meeting, to be held in Washington D.C. from May 19 to 24. The abstract contents are available on the DDW web site at http://www.ddw.org .
Hepatitis C Abstracts:
Dr. Norman Gitlin, Professor of Medicine, Atlanta Gastroenterology Associations and Emory University, Atlanta, GA, will present "Valopicitabine (NM283) Plus Peg-Interferon Alfa-2a (peg-IFN) in Treatment-Naive Patients With HCV-1 Infection: Preliminary Results At Weeks 24 and 48" in a poster session beginning on Monday, May 21, 2007 at 8:00 a.m. Eastern Daylight Time (EDT).
Dr. Maribel Rodriguez-Torres, President, Fundacion de Investigacion de Diego, Santurce, Puerto Rico, will present "Final Results from a Phase IIA Pharmacokinetic Study of Valopicitabine (NM283) and Peg-IFNa-2b in Patients with Genotype 1 Chronic Hepatitis C" in a poster session beginning on Monday, May 21, 2007 at 8:00 a.m. EDT.
About Valopicitabine (NM283)
Valopicitabine is an investigational HCV RNA polymerase inhibitor being evaluated in ongoing clinical trials for the treatment of hepatitis C.
Hepatitis B Abstracts
Dr. Maria Seifer, Director, Biology at Idenix Pharmaceuticals, will present "Genotypic Analysis of Patients with Evaluable HBV DNA After 1 Year of Telbivudine Therapy in the GLOBE Registration Trial" in a meeting session on Sunday, May 20, 2007 at 11:15 a.m. EDT.
Dr. Steven Han, Associate Clinical Professor in the Division of Digestive Diseases and the Division of Liver and Pancreas Transplantation and Directo r of the UCLA Hepatology Clinical Research Center, will present "Telbivudine Globe Trial at Year Two: Efficacy, Safety, and Predictors of Outcome in Patients with Chronic Hepatitis B" in a poster session beginning on Sunday, May 20, 2007 at 8:00 a.m. EDT.
Dr. Steven Han will also present "Hepatitis B Patient Survey: Disease Understanding and Compliance in the United States" in a poster session beginning on Sunday, May 20, 2007 at 8:00 a.m. EDT.
Dr. Natalie Bzowej, Director of Clinical Hepatology Research at California Pacific Medical Center, will present "A Randomized Trial of Telbivudine vs. Adefovir for HBeAg-Positive Chronic Hepatitis B: Efficacy Through Week 76, Predictors of Response and Effects of Switching to Telbivudine" in a poster session beginning on Sunday, May 20, 2007 at 8:00 a.m. EDT.
Dr. Elizabeth J. Heathcote, Professor of Medicine at the University of Toronto Western Hospital, will present "Salvage Therapy with Adefovir for Virologic Breakthrough in Telbivudine-Treated Patients from the GLOBE Study" in a poster session beginning on Sunday, May 20, 2007 at 8:00 a.m. EDT.
Dr. Yuming Wang, Professor of Infectious Disease, Southwest Hospital, Chongqing, China, will present "A Phase III Comparative Trial of Telbivudine vs Lamivudine in Chinese Patients with Chronic Hepatitis B: Two- Year Results" in a poster session beginning on Sunday, May 20, 2007 at 8:00 a.m. EDT.
Dr. Vinod Rustgi, Co-Director of the Transplant Institute at Georgetown University School of Medicine and Clinical Professor of Medicine at the Medical College of Virginia, will present "A Survey of Hepatitis B Patient Demographics, Disease Characteristics and Management Practice in the United States" in a poster session beginning on Sunday, May 20, 2007 at 8:00 a.m. EDT.
Dr. Xiao-Jian Zhou, Director, Clinical Pharmacology at Idenix Pharmaceuticals, will present "Absence of Pharmacokinetic Drug-Drug Interaction Between Telbivudine and Tenofovir" in a poster session beginning on Sunday, May 20, 2007 at 8:00 a.m. EDT.
Dr. David Standring, Senior Vice President, Biology at Idenix Pharmaceuticals, will present "Resistance Determination in Patients Experiencing Virologic Breakthrough Following Telbivudine or Lamivudine Therapy in the International GLOBE Trial" in a poster session beginning on Sunday, May 20, 2007 at 8:00 a.m. EDT.
Important Information About TYZEKA(R) (telbivudine)
TYZEKA is indicated for the treatment of chronic hepatitis B in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. This indication is based on virologic, serologic, biochemical and histologic responses after one year of treatment in nucleoside-treatment-naive adult patients with HBeAg-positive and HbeAg-negative chronic hepatitis B with compensated liver disease. For full prescribing information please visit http://www.tyzeka.com .
Important Safety Information about TYZEKA (telbivudine) -- Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti- hepatitis B therapy, including TYZEKA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, resumption of antihepatitis B therapy may be warranted. -- Cases of myopathy have been reported with TYZEKA use several weeks to months after starting therapy. Myopathy has also been reported with some other drugs in this class. Physicians considering concomitan t treatment with these or other agents associated with myopathy should weigh carefully the potential benefits and risks and should monitor and advise patients to report any signs or symptoms of unexplained muscle pain, tenderness or weakness, particularly during periods of upward dosage titration. TYZEKA therapy should be interrupted if myopathy is suspected, and discontinued if myopathy is diagnosed. -- Because TYZEKA is eliminated primarily by renal excretion, co- administration of TYZEKA with drugs that affect renal function may alter plasma concentrations of TYZEKA and/or the coadministered drug. Dose interval adjustment is required in patients with creatinine clearance <50mL/min including those with end stage renal disease on hemodialysis. For patients on hemodialysis, telbivudine should be administered after hemodialysis. -- The safety and efficacy of TYZEKA in liver transplant recipients are unknown. If TYZEKA treatment is determined to be necessary for a liver transplant recipient who has received or is receiving an immunosuppressant that may affect renal function, such as cyclosporine or tacrolimus, renal function should be monitored both before and during treatment with TYZEKA. -- Patients should be advised that treatment with TYZEKA has not been shown to reduce the risk of transmission of HBV to others through sexual contact or blood contamination. -- Safety and effectiveness of TYZEKA in pediatric patients under the age of 16 years have not been established. -- Most common adverse events (>5%) in clinical studies, regardless of attributability to telbivudine, were upper respiratory tract infection (14%), fatigue and malaise (12%), abdominal pain (12%), nasopharyngitis (11%), headache (11%), blood CPK increased (9%), cough (7%), nausea and vo miting (7%), influenza and influenza-like symptoms (7%), post-procedural pain (7%), diarrhea and loose stools (7%), and pharyngolaryngeal pain (5%). -- Grade 3-4 creatine kinase (CK) elevations occurred in 9% of TYZEKA- treated patients. -- The optimal duration of treatment with TYZEKA has not been established. The relationship of initial treatment response to outcomes such as hepatocellular carcinoma and decompensated cirrhosis are unknown.
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, MA, 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). For further information about Idenix, please refer to http://www.idenix.com .
This press release may contain "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 forward-looking terminology such as "will," or similar expressions, or by express or implied statements with respect to clinical trial development of telbivudine and valopicitabine. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantees that Idenix will successfully commercialize telbivudine, that TYZEKA(R) will ultimately be approved for sale by the European Commission, or in any additional markets, or that revenues from TYZEKA or any potential product will reach any particular level or that Idenix will advance any other clinic product candidate or other component of our potential pipeline in the clinic or in the regulatory process. In particular, management's expectations could be affected by unsuccessful efforts to commercialize TYZEKA or any other product candidate; unexpected regulatory actions or delays; uncertainties relating to results of clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; the company's ability to obtain additional funding required to conduct its research, development and commercialization activities; the company's dependence on its collaboration with Novartis Pharma AG; 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 its other product candidates and its discoveries. These and other risks which may impact management's expectations 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, 2006 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)
CONTACT: Investors, Amy Sullivan, +1-617-995-9838, or Media, Teri Dahlman,+1-617-995-9905, both of Idenix Pharmaceuticals, Inc.
Ticker Symbol: (NASDAQ-NMS:IDIX)
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