Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX) and Novartis (NYSE: NVS) today
announced new data that demonstrate telbivudine, an investigational oral,
once-daily nucleoside analogue, provided significantly greater antiviral and
clinical efficacy in Chinese patients with chronic hepatitis B (CHB) after
one-year of treatment when compared with a current standard of care,
lamivudine. The one-year results from a phase III registration trial
conducted in China were presented today at the biennial meeting of the
International Liver Congress in Shanghai.
These data, together with one-year data from the international phase III
GLOBE study, the largest registration trial ever conducted for a CHB
treatment, were included in a recent regulatory submission to Chinese health
authorities for marketing approval of telbivudine.
"The results from this study are very promising," said Dr. Jinlin Hou,
Director and Professor of Hepatology Unit and Department of Infectious
Diseases at Nanfang Hospital, Southern Medical University, Guangzhou, China
and a principal investigator in the study. "Telbivudine displayed increased
efficacy compared to lamivudine on the key viral and clinical markers
including significantly greater viral suppression, a higher percentage of
patients with normalization of liver enzymes and a higher proportion of
patients with HBeAg loss at one year. These data suggest that telbivudine, if
approved in China, may become an important new treatment option for the
millions of Chinese patients with this potentially life-threatening disease."
"Chronic hepatitis B is a major public health threat worldwide and is a
particularly serious problem in China, where nearly 1 out of 10 people are
infected. We are pleased that telbivudine has now been submitted for
regulatory approval in China and could provide a new treatment option for
those patients," said Jean-Pierre Sommadossi, chairman and chief executive
officer of Idenix. "The positive results achieved in this trial are similar
to the one-year results seen in the GLOBE study and demonstrated that
telbivudine provided rapid and profound viral suppression in patients with
chronic hepatitis B."
About One-Year Results of Chinese Phase III Trial(1)
This trial is an ongoing, randomized, double-blind trial comparing 2 years
of treatment with telbivudine or lamivudine in 332 Chinese adults with chronic
hepatitis B. The majority of patients in this trial were HBeAg-positive
(n=290) although HBeAg-negative patients also participated (n=42).
After one year of treatment, telbivudine displayed significantly greater
antiviral and clinical efficacy compared with lamivudine. Telbivudine
significantly reduced virus levels (HBV DNA) by 6.22 log10, or more than 1
million-fold, compared with 5.4 log10 for lamivudine (p
Significantly more telbivudine-treated patients achieved normalization of
liver enzymes (ALT) compared with lamivudine-treated patients (89 and 76
percent, respectively; p=0.003). In addition, HBeAg loss (in HBeAg positive
patients only and an indicator of a potential durable response to treatment)
occurred in a significantly higher percent of telbivudine-treated patients
compared with lamivudine-treated patients (31 and 20 percent, respectively;
p=0.047).
Seroconversion rates (in HBeAg positive patients only) were 25 percent for
telbivudine and 18 percent for lamivudine. Resistance rates were 4.5 percent
for telbivudine and 10.1 percent for lamivudine.
The overall safety profiles for telbivudine and lamivudine in this study
closely resembled the recently-reported results from the GLOBE study. The
rate of clinical adverse events was similar between the telbivudine and
lamivudine treatment groups, with nasopharyngitis, (25 and 21 percent
respectively) upper respiratory tract infection, (3.0 and 4.8 percent
respectively) and fatigue, (3.6 percent for both treatment groups) occurring
most commonly. As in the GLOBE study, serum ALT elevations were more common
in lamivudine-treated patients compared to telbivudine and creatine kinase
elevations, not requiring treatment modification, were more common with
telbivudine compared to lamivudine.
About Chronic Hepatitis B
Chronic hepatitis B is the tenth leading cause of death worldwide(2) with
approximately 350 million people chronically infected (lifelong infection).(3)
Additionally, chronic hepatitis B is responsible for up to 80 percent of the
world's primary liver cancer(4), and annually an estimated 1.2 million
individuals die from hepatitis B-related chronic liver disease.(2) Mainland
China has the largest population affected by the hepatitis B virus of any
nation with 120 million infected (nearly one out of every ten people in China)
and 30 million chronic sufferers.(5)
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 idenix.
About Novartis
Novartis Pharmaceuticals Corporation researches, develops, manufactures
and markets leading innovative prescription drugs used to treat a number of
diseases and conditions, including central nervous system disorders, organ
transplantation, cardiovascular diseases, dermatological diseases, respiratory
disorders, cancer and arthritis. The company's mission is to improve people's
lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation
is an affiliate of Novartis AG (NYSE: NVS) -- a world leader in offering
medicines to protect health, treat disease and improve well-being. Our 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. We are strengthening our 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 novartis.
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 "very promising," "may become," "could," "will," "if" or
similar expressions or by express or implied discussions regarding regulatory
submissions, potential market approval and clinical trial development of
telbivudine. 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 telbivudine will
be approved for sale in any market or that if approved, revenues from the sale
of such product will reach any specific level. In particular, management's
expectations could be affected by the acceptance for filing and approval, if
any, of the regulatory filings seeking authorization to market telbivudine;
results of clinical trials, including additional data relating to the ongoing
phase III and IIIb clinical trial evaluating telbivudine; the decision by
Novartis regarding the possible exercise of the option it holds to license
valopicitabine; the ability to advance valopicitabine into phase III clinical
trials, 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, valopicitabine, its other
product candidates and its discoveries. These and other risks which may impact
management's expectations regarding telbivudine and Idenix's other product
candidates 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, 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. Hou JL, Yin YK, Xu DZ, et. al. A phase III comparative trial of
telbivudine and lamivudine for treatment of chronic hepatitis B in
Chinese patients: first-year results. Abstract presented at
International Liver Congress March 27, 2006
2. Lavanchy D. J Viral Hepat. 2004 Mar 11 (2): 97-107
3. WHO Hepatitis B Fact Sheet #204
4. World Health Organization. Expanded programme on immunization hepatitis
B vaccine -- making global progress
5. Lai CL, Ratziu V, Yuen M, Poynard T. Viral hepatitis B. Lancet. 2003;
362: 2089
Idenix Pharmaceuticals, Inc.
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