Idenix and Novartis Seek European Approval of Telbivudine for the Treatment of Patients with Chronic Hepatitis B
08 February 2006 - 12:00AM
PR Newswire (US)
* Application Features Positive Data from GLOBE Study * GLOBE study
results show treatment after one year with telbivudine provided
significantly greater response on all evaluated virologic markers
compared to lamivudine * US and EU submissions now completed,
submissions in key Asian markets planned to be completed in the
first quarter 2006 CAMBRIDGE, Mass., Feb. 7 /PRNewswire-FirstCall/
-- Idenix Pharmaceuticals, Inc. (NASDAQ:IDIX) and Novartis
(NYSE:NVS) announced today the submission of a Marketing
Authorization Application (MAA) to the European Medicines Agency
(EMEA) seeking marketing authorization for the 600 mg dose of
telbivudine for the treatment of chronic hepatitis B. This MAA is
the second in a series of submissions aimed at obtaining marketing
approvals for telbivudine, an orally active, once-daily nucleoside
analogue. A New Drug Application (NDA) was recently submitted with
the United States Food and Drug Administration (FDA). Novartis
expects to submit applications for marketing authorization in key
Asian markets during the first quarter of 2006. "This MAA
submission with the EMEA is another significant step in the
development of telbivudine, a drug with the potential to improve
the management of chronic hepatitis B, a disease with potentially
fatal consequences that affects millions of people around the
globe," said Jean- Pierre Sommadossi, chairman and chief executive
officer of Idenix. "The submission of the MAA in Europe and the NDA
in the U.S. within a month of each other demonstrates the strength
of our ongoing collaboration with Novartis." The MAA submission is
based primarily on one-year data from the GLOBE study, the largest
registration trial for a chronic hepatitis B treatment. The GLOBE
study is an ongoing, two-year, phase III clinical trial comparing
telbivudine with a standard therapy, lamivudine, in the treatment
of 1,367 adults with chronic hepatitis B from 112 clinical centers
in 20 countries worldwide including (in Europe) the Czech Republic,
France, Germany, Greece, Italy, Poland, Spain, Turkey and the
United Kingdom. GLOBE is the first international hepatitis B study
to include clinical sites and patients in mainland China. Chronic
hepatitis B is the most common serious liver infection in the
world. It can cause liver failure, cirrhosis (scarring), liver
cancer and death.(1) It is caused by the hepatitis B virus (HBV),
which infects the liver.(1) HBV is 50 to 100 times more infectious
than HIV (the virus that causes AIDS).(2) Chronic hepatitis B is
the tenth leading cause of death worldwide.(3) It affects
approximately 350 million people worldwide and is responsible for
up to 80 percent of the world's cases of primary liver cancer.(4)
Each year approximately 1.2 million people die worldwide from
hepatitis B-related chronic liver disease.(3) In Europe there are
considerable regional differences in the prevalence of chronic
hepatitis B, ranging from below 0.1% in Northwestern Europe to up
to 8% in Eastern and Southern Europe.(5) Despite the availability
of treatments for chronic hepatitis B, significant unmet needs
still exist, including the need for improved response rates,
better-long-term efficacy, reduced rates of drug resistance,
improved safety and tolerability, and more convenient dosing
regimens. 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
Pharma AG and Idenix will co-promote telbivudine and valtorcitabine
and other product candidates that Novartis Pharma AG has licensed,
if successfully developed and approved for marketing, in the United
States, France, Germany, Italy, Spain and the UK. Novartis Pharma
AG holds the exclusive license to commercialize telbivudine and
valtorcitabine in the rest of the world. The collaboration also
provides Novartis Pharma AG 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 for the treatment of
chronic hepatitis C. 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/. About Novartis Novartis AG (NYSE:NVS) is
a world leader in offering medicines to protect health, cure
disease and improve well-being. Novartis' goal is to discover,
develop and successfully market innovative products to treat
patients, ease suffering and enhance the quality of life. Novartis
is the only company with leadership positions in both patented and
generic pharmaceuticals. Novartis is strengthening its
medicine-based portfolio, which is focused on strategic growth
platforms in innovation-driven pharmaceuticals, high- quality and
low-cost generics and leading self-medication OTC brands. In 2005,
the Group's businesses achieved net sales of USD 32.2 billion and
net income of USD 6.1 billion. Approximately USD 4.8 billion was
invested in R&D. Headquartered in Basel, Switzerland, Novartis
Group companies employ approximately 91,000 people and operate in
over 140 countries around the world. For more information, please
visit http://www.novartis.com/. Forward-looking Statement 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", "option", "planned,"
"seeking," "expects," "with the potential to" or similar
expressions or by express or implied discussions regarding
regulatory submissions to the EMEA, FDA and other governmental
authorities in Asia relating to registration of the product and
potential therapeutic benefits and successful development and
commercialization 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, if
approved, revenues from sales of such product will reach any
specific level. In particular, management's expectations regarding
telbivudine could be affected by risks and uncertainties relating
to the acceptance for filing and approval, if any, of regulatory
filings seeking marketing authorization by the EMEA, FDA or other
regulatory authorities in other jurisdictions; results of clinical
trials, including additional data from the GLOBE study, and other
studies with respect to telbivudine; 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 and the company's ability to obtain, maintain and enforce
patent and other intellectual property protection for telbivudine.
These and other risks which may impact management's expectations
regarding telbivudine 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 September 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. References: (1) Centers for Disease Control
and Prevention. Hepatitis B Frequently Asked Questions. Available
at: http://www.cdc.gov/ncidod/diseases/hepatitis/b/faqb.htm
Accessed 12/8/05 (2) World Health Organization. Hepatitis B Fact
Sheet Number 204. Available at
http://www.who.int/mediacentre/factsheets/fs204/en/print.html
Accessed 12/8/05 (3) Lavanchy D. J Viral Hepat. 2004 Mar 11 (2):
97-107 (4) World Health Organization. Expanded programme on
immunization hepatitis B vaccine - making global progress.
Available at
http://www.childrensvaccine.org/files/WHO_hep_B_update.pdf Accessed
12/8/05 (5) Robert Koch Institut. Epidemiologisches Bulletin. 18.
November 2005 / Nr. 46 Idenix Pharmaceuticals' Contact: Investors:
Amy Sullivan (617-995-9838) Media: Teri Dahlman (617-995-9905)
First Call Analyst: FCMN Contact: DATASOURCE: Idenix
Pharmaceuticals, Inc. CONTACT: Amy Sullivan, +1-617-995-9838, or
Teri Dahlman, +1-617-995-9905, both of Idenix Pharmaceuticals Web
site: http://www.idenix.com/
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