Idenix and Novartis Announce New Drug Application Submitted to the U.S. Food and Drug Administration for Telbivudine for The Tre
04 January 2006 - 12:00AM
PR Newswire (US)
- Submission Based on Positive Data from GLOBE Study - CAMBRIDGE,
Mass., Jan. 3 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals,
Inc. (NASDAQ:IDIX) and Novartis Pharmaceuticals Corporation
(NYSE:NVS) announced today that a New Drug Application (NDA) was
submitted to the United States Food and Drug Administration (FDA)
seeking marketing approval for the 600 mg dose of telbivudine for
the treatment of chronic hepatitis B. This NDA is the first
marketing approval submission for telbivudine, an oral, once-daily
nucleoside analog. Additional applications for marketing
authorization in the European Union (EU) and key Asian markets are
expected to be submitted by Novartis Pharma AG (an affiliate of
Novartis Pharmaceuticals Corporation) in 1Q2006. "Idenix is pleased
to be submitting its first NDA for an agent that has the potential
to provide a new treatment option for the millions of chronic
hepatitis B patients around the world," said Jean-Pierre
Sommadossi, chairman and chief executive officer of Idenix. "The
submission of this application in just 7 years from discovery of
the use of telbivudine for the treatment of hepatitis B highlights
the expertise and execution capabilities of our team and the impact
of our alliance with Novartis. This marks a significant step in our
company's growth and in the pursuit of our goal of building a
leading antiviral franchise." The NDA submission is primarily based
on one-year data from the GLOBE study, the largest registration
trial for a chronic hepatitis B treatment and the first global
trial to include clinical sites and patients in mainland China. The
GLOBE study is an ongoing two-year phase III clinical trial
comparing telbivudine with a standard therapy, lamivudine, in 1,367
adults with chronic hepatitis B from 112 clinical centers in 20
countries worldwide. The FDA has up to 60 days to review an NDA
submission prior to accepting it for filing. The Centers for
Disease Control and Prevention (CDC) estimates that 1.25 million
Americans are chronically infected with hepatitis B(1), the most
common serious liver infection in the world that can cause liver
failure, cirrhosis (scarring), liver cancer and death.(2) Chronic
hepatitis B is caused by the hepatitis B virus (HBV), which infects
the liver.(2) HBV is 50-to-100 times more infectious than HIV (the
virus that causes AIDS).(3) Chronic hepatitis B is the tenth
leading cause of death worldwide.(4) It affects approximately 350
million people worldwide and is responsible for up to 80 percent of
the world's primary liver cancer.(5) Each year approximately 1.2
million people die worldwide from hepatitis B-related chronic liver
disease.(4) 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 Located in East Hanover, New Jersey, Novartis
Pharmaceuticals Corporation is an affiliate of Novartis AG
(NYSE:NVS), a world leader in pharmaceuticals and consumer health.
In 2004, the Group's businesses achieved net sales of USD 28.2
billion and pro forma net income of USD 5.6 billion. The Group
invested approximately USD 4.1 billion in R&D. Headquartered in
Basel, Switzerland, Novartis Group companies employ about 91,700
people and operate in over 140 countries around the world.
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 "seeking," "expected," "will", "if successfully
developed," "option" or similar expressions or by express or
implied discussions regarding the potential approval of telbivudine
by the FDA or by regulatory authorities in other countries, or
regarding 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, if approved, revenues from sales of such product will
reach any specific level. Management's expectations regarding
telbivudine could be affected by, among other things, risks and
uncertainties relating to the acceptance for filing and approval,
if any, of regulatory filings seeking marketing authorization by
the FDA or other regulatory authorities in other jurisdictions;
unexpected regulatory actions or delay; results of clinical trials,
including new clinical data and additional analysis of existing
clinical 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. Viral
Hepatitis B Fact Sheet. Available at
http://www.cdc.gov/ncidod/diseases/hepatitis/b/fact.htm Accessed
12/8/05 (2) 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 (3) 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 (4) Lavanchy D. J Viral Hepat. 2004 Mar 11 (2):
97-107 (5) 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 DATASOURCE: Idenix Pharmaceuticals, Inc. CONTACT: Teri
Dahlman of Idenix Pharmaceuticals, +1-617-995-9905 Web site:
http://www.idenix.com/
http://www.cdc.gov/ncidod/diseases/hepatitis/b/fact.htm
http://www.who.int/mediacentre/factsheets/fs204/en/print.html
http://www.childrensvaccine.org/files/WHO_hep_B_update.pdf
Copyright
(MM) (NASDAQ:IDIX)
Historical Stock Chart
From Jun 2024 to Jul 2024
(MM) (NASDAQ:IDIX)
Historical Stock Chart
From Jul 2023 to Jul 2024