Idenix Announces Thirteen Data Presentations at the 2007 European Association For the Study of the Liver
March 01 2007 - 11:00AM
PR Newswire (US)
CAMBRIDGE, Mass., March 1 /PRNewswire-FirstCall/ -- Idenix
Pharmaceuticals, Inc. (NASDAQ:IDIX), 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 13 abstracts have been accepted for
presentation at the 42nd annual meeting of the European Association
for the Study of the Liver (EASL), to be held in Barcelona, Spain,
April 11-15, 2007. Full abstracts are available on the EASL web
site (http://www.easl.ch/liver-meeting/). 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 (Peg-IFN/RBV) Retreatment in
Patients With HCV-1 Infection and Prior Non-Response to
Peg-IFN/RBV: One-Year Results" in a general session on Thursday
April 12, 2007 between 3:00 p.m. and 4:30 p.m. Central European
Time (CET). Dr. Eric Lawitz of Alamo Medical Research in San
Antonio will present "Clearance of HCV RNA With Valopicitabine
(NM283) Plus Peg-Interferon in Treatment-Na�ve Patients With HCV-1
Infection: Results at 24 and 48 Weeks" in a parallel session on
Thursday, April 12, 2007 between 5:00 p.m. and 7:00 p.m. (CET).
Vadim Bichko, Director, Biology at Idenix Pharmaceuticals, Inc.,
will present "Valopicitabine (NM283) Is Fully Active Against Known
HCV Protease Resistance Mutations In Vitro" in a poster session
beginning on Thursday, April 12, 2007 at 7:00 p.m. CET. Dr. Robert
Ralston, Senior Director, Virology, Schering-Plough Corporation,
will present "Combination of Two Hepatitis C Virus Inhibitors, SCH
503034 and NM107, Provides Enhanced Anti-Replicon Activity and
Suppresses Emergence of Resistant Replicons" in a poster session
beginning on Thursday, April 12, 2007 at 7:00 p.m. CET. 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. Thierry
Poynard, Professor of Medicine at the University of Paris, Hopital
Pitie-Salpetriere in Paris France, will present "Sustained Off-
Treatment HBeAg Response in Telbivudine and Lamivudine Treated
HBeAg-Positive Patients From The GLOBE Study" in a parallel session
on Friday, April 13, 2007 between 4:00 p.m. and 6:00 p.m. CET. Dr.
Antonio Riva of the UCL Institute of Hepatology, University College
London, UK, will present "Effector/Memory Subsets and Functionality
of CD4/CD8+ T-Cells During Potent Antiviral Therapy in Chronic
Hepatitis B (CHB)" in a parallel session on Saturday, April 14
between 4:00 p.m. and 6:00 p.m. CET. Dr. Patrick Marcellin,
Professor of Medicine and Head of the Viral Hepatitis Research
Center at the University of Paris, Hopital Beaujon in Clichy,
France, will present "76 Week Follow-up of HBeAg-Positive Chronic
Hepatitis B Patients Treated with Telbivudine, Adefovir or Switched
from Adefovir to Telbivudine" in a general session on Sunday, April
15, 2007 between 12:00 p.m. and 1:30 p.m. CET. Dr. Marcellin will
also present "In Hepatitis B Patients Treated with Either Adefovir
or Telbivudine, Maximal Early HBV Suppression at 24 Weeks Predicts
Optimal One-Year Efficacy" in a poster session beginning on
Thursday, April 12, 2007 at 7:00 p.m. CET. Dr. Rifaat Safadi of the
Division of Medicine at The Hebrew University in Jerusalem, Israel,
will present "A Randomized Trial of Switching to Telbivudine Versus
Continued Lamivudine In Adults With Chronic Hepatitis B: Results of
the Primary Analysis at Week 24" in a poster session beginning on
Thursday, April 12 at 7:00 p.m. CET. Dr. Jens Rasenack, Professor
of Internal Medicine at Albert Ludwigs University, Freiburg,
Germany, will present "Efficacy of Telbivudine vs Lamivudine at 2
Years In Patients With HBeAg-Positive Chronic Hepatitis B Who Are
Eligible for Treatment Based on Guidelines" in a poster session
beginning on Thursday, April 12, 2007 at 7:00 p.m. CET. Dr. Ji-Dong
Jia, Professor of Medicine and Director of the Hepatitis Research
Center at Beijing Friendship Hospital, Beijing, China, will present
"Two-Year Results of a Phase III Comparative Trial of Telbivudine
vs Lamivudine in Chinese Patients" in a poster session beginning on
Thursday, April 12, 2007 at 7:00 p.m. CET. Dr. Edward Gane,
Professor of Gastroenterology and Hepatology, Middlemore Hospital
in Auckland, New Zealand, will present "Adefovir Salvage Therapy
for Virologic Breakthrough in Telbivudine-Treated Patients from the
GLOBE Study" in a poster session beginning on Thursday, April 12,
2007 at 7:00 p.m. CET. Dr. John Wong, Professor of Medicine at
Tufts University School of Medicine, Boston, will present
"Cost-effectiveness of Telbivudine Versus Lamivudine for Chronic
Hepatitis B" in a poster session beginning on Thursday, April 12,
2007 at 7:00 p.m. CET. Important Information About Telbivudine
Telbivudine 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. Important Safety Information about
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 telbivudine. 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 anti-hepatitis B therapy
may be warranted. - Cases of myopathy have been reported with
telbivudine use several weeks to months after starting therapy.
Myopathy has also been reported with some other drugs in this
class. Physicians considering concomitant 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. Telbivudine therapy should be interrupted if
myopathy is suspected, and discontinued if myopathy is diagnosed. -
Because telbivudine is eliminated primarily by renal excretion,
co-administration of telbivudine with drugs that affect renal
function may alter plasma concentrations of telbivudine and/or the
coadministered drug. Dose interval adjustment is recommended in
patients with reatinine clearance 5%) in clinical studies 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 vomiting (7%), influenza
and influenza-like symptoms (7%), post-procedural pain (7%),
diarrhea and loose stools (7%), and pharyngolaryngeal pain (5%). -
Creatine kinase (CK) elevations were more frequent among subjects
on telbivudine treatment. Grade 3/4 CK elevations occurred in 9% of
telbivudine-treated patients and 3% of lamivudine-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. About Idenix Idenix Pharmaceuticals, Inc.,
headquartered in Cambridge, Massachusetts, 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/. 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 may be identified by implied
discussions regarding clinical trial development of telbivudine or
valopicitabine, any potential therapeutic benefits of telbivudine
or valopicitabine or our clinical development programs in hepatitis
B or C, or any potential pipeline candidates. 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 advance any clinical product candidate or other
component of our potential pipeline. In particular, management's
expectations could be affected by the 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 quarterly report
on Form 10-Q for the quarter ended September 30, 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' Contacts: Media: Teri Dahlman (617) 995-9905
Investors: Amy Sullivan (617) 995-9838 DATASOURCE: Idenix
Pharmaceuticals, Inc. CONTACT: Media, Teri Dahlman,
+1-617-995-9905; Investors, Amy Sullivan +1-617-995-9838, both of
Idenix Pharmaceuticals Web site: http://www.idenix.com/
http://www.easl.ch/liver-meeting
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