Sebivo(R) (Telbivudine) Approved in European Union as a New Treatment for Chronic Hepatitis B Patients
30 April 2007 - 5:00PM
PR Newswire (US)
Every year in Europe an estimated one million people are infected
with the hepatitis B virus and 90,000 will become chronic carriers
and 24,000 will die(1) CAMBRIDGE, Mass., April 30
/PRNewswire-FirstCall/ -- The European Commission today approved
SEBIVO(R) (telbivudine), a new once-a-day oral treatment for adult
patients with chronic hepatitis B (CHB) and evidence of viral
replication and active liver disease. The European Commission
decision applies to all 27 countries in the European Union as well
as Iceland and Norway. Launches are expected to start in the second
quarter of 2007 beginning with the United Kingdom and Germany. The
approval of SEBIVO in Europe triggers a milestone payment from
Novartis Pharma AG to Idenix. In addition to the European Union,
SEBIVO is currently approved in more than 15 major markets,
including the United States [where it is marketed as TYZEKA(R)
(telbivudine)], Canada, Switzerland and China. "The approval of
SEBIVO now offers Europeans infected with chronic hepatitis B a new
treatment option," said Professor Thierry Poynard of Hopital
Pitie-Salpetriere, University of Paris VI, France and an
investigator in the phase III GLOBE study. "There is no cure for
chronic hepatitis B. High hepatitis B viral load increases the risk
of serious complications. To reduce this risk, the goal of therapy
is to suppress the hepatitis B virus as much as possible, and to
maintain that decrease over time." Worldwide regulatory submissions
have been based primarily on one-year data from the GLOBE study,
the largest worldwide registration trial including hepatitis B
e-antigen (HBeAg)-positive and HBeAg-negative patients with CHB.
The worldwide phase III GLOBE study compared telbivudine to
lamivudine, a commonly used antiviral therapy for the treatment of
CHB, in 1,367 patients. In the European Union, participating
countries included the Czech Republic, France, Germany, Greece,
Italy, Poland, Spain and the UK. "The European approval of SEBIVO
is another significant achievement for Idenix," said Jean-Pierre
Sommadossi, chief executive officer and chairman of Idenix.
"Working with our alliance partner, Novartis, we have gained
approval of SEBIVO in more than 40 countries in less than 18
months. The speed with which we have gained these approvals is a
testament to our strength and focus on developing new antiviral
agents." About Idenix Idenix Pharmaceuticals, Inc., (NASDAQ:IDIX)
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
http://www.idenix.com/. About Idenix/Novartis Collaboration Idenix
and Novartis Pharma AG are co-promoting SEBIVO/TYZEKA for the
treatment of chronic hepatitis B, and co-developing valtorcitabine,
a second hepatitis B compound, and valopicitabine, a hepatitis C
compound, under a development and commercialization arrangement
established in May 2003. Under this agreement, Novartis and Idenix
will co-promote SEBIVO/TYZEKA and, if approved, valtorcitabine and
valopicitabine in the United States, France, Germany, Italy, Spain
and the United Kingdom. Novartis has the exclusive right to
commercialize SEBIVO, valtorcitabine and valopicitabine in the rest
of the world. Information about TYZEKA/SEBIVO (telbivudine) In the
European Union, SEBIVO is indicated for the treatment of chronic
hepatitis B in adult patients with compensated liver disease and
evidence of viral replication, persistently elevated serum alanine
aminotransferase (ALT) levels and histological evidence of active
inflammation and/or fibrosis. This indication is based on
virologic, serologic, biochemical, and histologic responses after
one year of treatment in nucleoside treatment-na�ve adult patients
with HBeAg-positive and HBeAg-negative CHB with compensated liver
disease. The following information about telbivudine is adapted
from the U.S. Food and Drug Administration approved product label.
Similar language related to the product's important safety
information will pertain to the product in the European Union.
Important Safety Information about Telbivudine 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 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 coadministered drug. Dose interval adjustment is
required in patients with creatinine clearance /=5%) in the GLOBE
trial, regardless of attributability to telbivudine, were upper
respiratory tract infection (14%), fatigue and malaise (12%),
abdominal pain (12%), nasopharyngitis (11%), headache (11%), blood
CPK increased (9%), cough (7%), nausea and vomiting (7%), influenza
and influenza-like symptoms (7%), post- procedural pain (7%),
diarrhea and loose stools (7%), and pharyngolaryngeal pain (5%). --
Creatine kinase (CK) elevations were more frequent among subjects
on telbivudine treatment. Grade 3/4 CK elevations occurred in 9% of
telbivudine-treated patients. -- The relationship of initial
treatment response to outcomes such as hepatocellular carcinoma and
decompensated cirrhosis are unknown. 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 "goal," "estimate,"
"anticipate," "expected," "believe," "will," or similar
expressions, or by express or implied statements with respect to
potential approvals of TYZEKA/SEBIVO for other indications or other
development product candidates by the European Commission or in
additional markets, potential future revenues from TYZEKA/SEBIVO or
other development product candidates, or expectations with respect
to additional milestone payments. 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 SEBIVO or other
development product candidates will be brought to market in the
European Union or in any other markets, or that TYZEKA/SEBIVO will
achieve any particular level of sales, or that our development
product candidates will ever achieve any sales. In particular,
management's expectations could be affected by unexpectedly
unsuccessful efforts to commercialize TYZEKA/SEBIVO; unexpected
regulatory actions or delays; uncertainties relating to results of
clinical trials, including additional data relating to the ongoing
clinical trials evaluating its product candidates; the company's
ability to obtain additional funding required to conduct its
research, development and commercialization activities; the
company's dependence on its collaboration with Novartis Pharma AG;
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 its other product candidates and its discoveries.
These and other risks which may impact management's expectations
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, 2006 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) 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' Contact: Investors: Amy Sullivan (+1-617-995-9838)
Media: Teri Dahlman (+1-617-995-9905) DATASOURCE: Idenix
Pharmaceuticals, Inc. CONTACT: Investors, Amy Sullivan,
+1-617-995-9838, or Media, Teri Dahlman, +1-617-995-9905, both of
Idenix Pharmaceuticals, Inc. Web site: http://www.idenix.com/
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