Idenix Announces Data Presentations at the 2007 Digestive Disease Week Meeting
April 18 2007 - 4:05PM
PR Newswire (US)
CAMBRIDGE, Mass., April 18 /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 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 Director 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 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.
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 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
vomiting (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.
About Idenix 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/ . 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 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) DATASOURCE: 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/
http://www.ddw.org/ http://www.tyzeka.com/
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