Telbivudine Achieves Primary Endpoint in Phase III GLOBE Trial, Largest Ever Registration Trial in Hepatitis B
29 July 2005 - 7:02AM
PR Newswire (US)
Telbivudine Achieves Primary Endpoint in Phase III GLOBE Trial,
Largest Ever Registration Trial in Hepatitis B * Idenix and
Novartis anticipate first regulatory filing by the end of 2005 *
Complete GLOBE results to be submitted for presentation at American
Association for the Study of Liver Diseases meeting in November
2005 CAMBRIDGE, Mass., July 28 /PRNewswire-FirstCall/ -- Idenix
Pharmaceuticals, Inc. (NASDAQ:IDIX) and Novartis Pharma AG
announced today that the phase III GLOBE registration trial for
telbivudine successfully reached its primary, composite efficacy
endpoint of therapeutic response at one year in chronic hepatitis B
patients. This endpoint, which was designed to assess if
telbivudine was at least as effective as lamivudine, evaluated the
combination of viral suppression (serum HBV DNA suppression below
100,000 copies/mL) coupled with either improved liver function (ALT
normalization) or loss of detectable hepatitis B e-antigen (HBeAg).
The largest hepatitis B registration trial to date, GLOBE enrolled
more than 1,350 patients in over 130 medical centers worldwide. The
ongoing trial is evaluating the safety and efficacy of telbivudine
compared to lamivudine in patients with HBeAg-positive and
HBeAg-negative compensated chronic hepatitis B for two years of
treatment in two daily treatment regimens: telbivudine 600 mg or
lamivudine 100 mg. The one-year analysis of this trial will be the
primary data used for preparing the marketing registration
applications. Idenix and Novartis plan to file with the U.S. Food
and Drug Administration (FDA) by the end of 2005 for marketing
approval of telbivudine for the treatment of chronic hepatitis B.
Worldwide marketing filings, including the filing that will be
submitted to the European Medicines Agency (EMEA), are expected in
the first quarter of 2006. Idenix and Novartis are co-developing
telbivudine. The World Health Organization (WHO) has estimated that
approximately 350 million people, or 5% of the world's population,
are chronically infected with hepatitis B virus (HBV). Current
treatment options are often associated with limited efficacy, poor
tolerability or resistance concerns, and new therapeutic options
are needed to respond to the significant unmet need in treating
chronic hepatitis B. "We are very pleased that telbivudine met the
primary endpoint in the phase III GLOBE study and may provide an
important new therapeutic option for patients with chronic
hepatitis B," commented Nathaniel Brown, M.D., executive vice
president of clinical development and chief medical officer of
Idenix. "Bringing our first clinical candidate through this stage
of development is a major milestone for Idenix, particularly given
the large international scope of the GLOBE study." The companies
anticipate that complete data from the GLOBE study will be
submitted for presentation to the American Association for the
Study of Liver Diseases (AASLD) meeting in San Francisco,
California, November 11-15, 2005. More About Telbivudine
Telbivudine is a specific and selective, oral, once-daily
nucleoside that is unique in its preferential inhibition of 2nd
strand HBV DNA synthesis. This distinct mechanism of action may be
responsible for the rapid and profound viral suppression associated
with telbivudine treatment. The GLOBE study results continue to
support a favorable overall safety profile for telbivudine with no
substantial safety issues being identified to date through the
combined two years of treatment in the phase IIb clinical trial and
in the phase III clinical program to date. The most frequently
reported adverse events, regardless of attributability to study
treatment, were upper respiratory infection and fatigue, which were
equally common for telbivudine (14% and 12 %, respectively) and
lamivudine (13% and 10% respectively). An additional phase III
trial is evaluating the safety and efficacy of telbivudine compared
to lamivudine in HBeAg-positive and HBeAg-negative patients with
decompensated chronic hepatitis B. This ongoing trial has enrolled
87 patients to date. About Hepatitis B Chronic Hepatitis B is
caused by a virus that attacks the liver. The virus, which is
called hepatitis B virus (HBV), can cause lifelong infection,
cirrhosis (scarring) of the liver, liver cancer, liver failure, and
death. The WHO estimates that annually over 50 million people
become infected with HBV and that more than one million individuals
die from HBV-related chronic liver disease. Idenix/Novartis
Collaboration Idenix is developing its hepatitis B clinical product
candidates, telbivudine and valtorcitabine, in collaboration with
Novartis Pharma AG under a development and commercialization
arrangement established in May 2003. The collaboration arrangement
further provides that Novartis and Idenix will co- promote in the
United States, France, Germany, Italy, Spain and the UK those
product candidates Novartis has licensed, including telbivudine and
valtorcitabine, that are approved for marketing. Novartis holds the
exclusive license to telbivudine and valtorcitabine in the rest of
the world. The collaboration also provides Novartis with an
exclusive option to license and collaborate with Idenix in the
development and commercialization of other product candidates in
Idenix's portfolio, including valopicitabine (NM283), a direct
antiviral hepatitis C product candidate. 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. The
company also 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 forward-looking
terminology such as "will be," "plan to," "expected,"
"anticipates," or similar expressions, or by express or implied
discussions regarding the potential therapeutic benefits, the
potential development or the potential future sales 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. There
can be no guarantee that telbivudine will be approved for sale in
any market, or that telbivudine will achieve any particular level
of sales. Any such commercialization can be affected by, among
other things, uncertainties relating to clinical trials; new
clinical data with respect to telbivudine, or additional analysis
of existing clinical data; uncertainties regarding 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; competition in general; government,
industry, and general public pricing pressures; the company's
ability to obtain, maintain and enforce patent and other
intellectual property protection for telbivudine and its related
discoveries; as well as other factors discussed under the caption
"Factors That May Affect Future Results" in the company's quarterly
report on Form 10-Q for the quarter ended March 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. Contact:
Idenix Pharmaceuticals, Inc. Media: Teri Dahlman (617) 995-9905
Investors: Amy Sullivan (617) 995-9838 DATASOURCE: Idenix
Pharmaceuticals, Inc. CONTACT: Teri Dahlman, Media Contact,
+1-617-995-9905, or Amy Sullivan, Investors Contact,
+1-617-995-9838, both Idenix Pharmaceuticals, Inc. Web site:
http://www.idenix.com/
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