Idenix
Pharmaceuticals, Inc. (Nasdaq: IDIX) today announced the adoption of a
positive opinion by the European Medicines Agency's (EMEA) Committee for
Medicinal Products for Human Use (CHMP), recommending granting of marketing
authorization of SEBIVO(R) (telbivudine), a once-a-day tablet taken with or
without food, for the treatment of chronic hepatitis B infection in adult
patients. The CHMP's recommendations are advisory but the European
Commission has historically followed them and the company expects a final
decision to be issued within three months.
"Chronic hepatitis B is a very serious disease affecting more than 350
million people worldwide and a growing public health problem in Europe,"
said Jean-Pierre Sommadossi, Idenix's chairman and chief executive officer.
"We are assembling a strong commercial team in Europe and look forward to
working with Novartis to make SEBIVO available to European patients as soon
as possible after it is formally approved."
The positive opinion from CHMP follows earlier approvals in the United
States, where the drug is being marketed as TYZEKA(R) (telbivudine) 600 mg
tablets; Canada; Switzerland and various other countries in Asia and Latin
America. An application for marketing approval is pending with the Chinese
health authority. Regulatory submissions have been based primarily on one-
year data from the GLOBE study, the largest worldwide registration trial
including both HBeAg-positive and HBeAg-negative patients with chronic
hepatitis B ever conducted.
Data from the pivotal phase III clinical trial, known as the GLOBE
study, compared telbivudine to lamivudine in 1,367 patients. The primary
efficacy endpoint of the GLOBE study was therapeutic response at one year,
a composite endpoint coupling viral suppression (serum HBV DNA suppression
below 100,000 copies/mL) with either improved liver disease markers (ALT
normalization) or loss of detectable hepatitis B e-antigen (HBeAg). In
HBeAg-positive patients, therapeutic response was 75 percent (n=345/458)
among patients treated with SEBIVO and 67 percent (n=310/463) for those
patients treated with lamivudine, while the response for HBeAg-negative
patients after one year was 75 percent (n=167/222) vs. 77 percent
(n=173/224), respectively. In the GLOBE study, patients who achieved
non-detectable HBV DNA levels at 24 weeks were more likely to undergo
e-antigen seroconversion, achieve undetectable levels of HBV DNA, normalize
ALT, and minimize resistance at one year.
In clinical studies SEBIVO was generally well tolerated with most
adverse experiences classified as mild or moderate in severity. Common
(greater than or equal to 1/100,
Idenix is co-promoting the product as TYZEKA(R) (telbivudine) in the
United States, and as SEBIVO(R) (telbivudine) in France, Germany, Italy,
Spain and the United Kingdom in collaboration with Novartis Pharma AG under
a development and commercialization agreement established in May 2003.
Important Information About Telbivudine
The following information about telbivudine is adapted from the U.S.
Food and Drug Administration's approved product label. It is anticipated
that similar language related to the product's indication and important
safety information will pertain for the product once approved by the
European Commission.
Telbivudine 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.
Important Safety Information
-- 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
telbivudine. 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 anti-hepatitis B therapy may be warranted.
-- Cases of myopathy have been reported with telbivudine 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. Telbivudine therapy should be interrupted if myopathy
is suspected, and discontinued if myopathy is diagnosed.
-- Because telbivudine is eliminated primarily by renal excretion, co-
administration of telbivudine with drugs that affect renal function may
alter plasma concentrations of telbivudine and/or the co-administered
drug. Dose interval adjustment is recommended in patients with
creatinine clearance < 50mL/min including those with ESRD on
hemodialysis. For patients on hemodialyis, telbivudine should be
administered after hemodialysis.
-- The safety and efficacy of telbivudine in liver transplant recipients
are unknown. If telbivudine treatment is determined to be necessary for
a liver transplant recipient who has received or is receiving an
immunosuppressant that may affect renal function, such as cyclosporine
or tacrolimus, renal function should be monitored both before and
during treatment with telbivudine.
-- Patients should be advised that treatment with telbivudine has not been
shown to reduce the risk of transmission of HBV to others through
sexual contact or blood contamination.
-- Safety and effectiveness of telbivudine in pediatric patients under the
age of 16 years have not been established.
-- Creatine kinase (CK) elevations were more frequent among subjects on
telbivudine treatment. Grade 3/4 CK elevations occurred in 9% of
telbivudine-treated patients and 3% of lamivudine-treated patients.
-- The optimal duration of treatment with telbivudine has not been
established. The relationship of initial treatment response to
outcomes such as hepatocellular carcinoma and decompensated cirrhosis
are unknown.
About Hepatitis B
Chronic hepatitis B is a significant public health issue in Europe.
Caused by the hepatitis B virus (HBV), which attacks liver cells, chronic
hepatitis B can lead to liver scarring (cirrhosis), liver cancer and liver
failure.(1) In Europe, there are an estimated one million new HBV
infections every year,(2), with an incidence ranging from 29 cases for
every 100,000 people in western Europe to 523 per 100,000 in eastern
Europe.(2) Of these, 90,000 will become chronic carriers and 24,000 will
die from cirrhosis or liver cancer.(2)
About Idenix
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, MA, 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). For
further information about Idenix, please refer to idenix.
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 "expected," "will," "goal," "treatment option," "look
forward to," or similar expressions, or by express or implied discussions
regarding potential approvals of SEBIVO by the European Commission or in
additional markets, or potential future revenues from SEBIVO. 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. Even though the CHMP has made a positive opinion regarding
SEBIVO, there can be no guarantees that SEBIVO will ultimately be approved
for sale by the European Commission, or in any additional markets, or that
revenues from the sale of SEBIVO will reach any particular level. In
particular, management's expectations could be affected by unexpected
regulatory actions or delays, or government regulation generally;
unexpected clinical trial results, including additional analysis of
existing clinical data and new clinical data; 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; government, industry, and general public
pricing pressures; competition in general; and the company's ability to
obtain, maintain and enforce patent and other intellectual property
protection for SEBIVO. These and other risks which may impact management's
expectations regarding SEBIVO are described in greater detail under the
caption "Risk Factors" in the company's latest quarterly results for the
third quarter of 2006 on Form 10-Q 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. CDC Frequently Asked Questions. Available at:
cdc/ncidod/diseases/hepatitis/b/faqb.htm
2. Van Damme P, et al. Hepatitis B prevention in Europe: a preliminary
economic evaluation. Vaccine, Vol. 13, Supplement 1, pp. S54-S57, 1995
International Journal of Epidemiology; V.32; 2003; p118
Idenix Pharmaceuticals, Inc.
idenix