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Idenix Pharmaceuticals

SEBIVO(R) Demonstrated Better Antiviral Activity Compared to Adefovir in Patients With Chronic Hepatitis B; New Data Presented

Barcelona, Spain (ots/PRNewswire)

  • SEBIVO Suppressed Virus More Rapidly and Profoundly Than Adefovir(1)
  • Rapid and Powerful Viral Suppression Led to Better Treatment Outcomes(2)
  • SEBIVO Has Been Recommended for Approval by European Medicines Agency, Pending Final Approval by the European Commission
In a comparative study, SEBIVO(R) (telbivudine) provided more
rapid and  profound viral suppression than adefovir both in newly
diagnosed HBeAg- positive patients and in those who switched from
adefovir to SEBIVO.(1)  Additionally, regardless of treatment, a
substantial early reduction in virus  level correlated with better
outcomes such as maintained undetectable levels  of virus
(PCR-negativity), HbeAg seroconversion and ALT normalization, at one
year.(2) A significantly greater percentage of SEBIVO patients
achieved PCR- negativity (38 percent; n=17/45) compared to
adefovir-treated patients (12  percent; n=11/90) by six months. These
findings were presented at the Annual  Meeting of the European
Association for the Study of the Liver (EASL).
"These new data demonstrated that SEBIVO provided therapeutic
benefit not only for previously untreated patients but also for
treated patients who had not achieved sufficient viral suppression,"
said Professor Patrick Marcellin, M.D., Head of the Viral Hepatitis
Research Unit, Hopital Beaujon, University of Paris and presenter of
the study. "Suppressing the hepatitis B virus as fast and effectively
as possible is emerging as an important measure of HBV treatment
response. It is associated with better treatment outcomes at one
year, and SEBIVO achieved this goal better than adefovir."
These new findings come from a trial comparing the efficacy of
SEBIVO and adefovir in 135 HBeAg-positive patients with CHB over one
year. After six months of treatment, more than twice the number of
SEBIVO patients reached target levels of hepatitis B virus (HBV),
defined as <3 log(10) copies/mL (49 percent with SEBIVO vs. 22
percent with adefovir). Among the 78 percent of patients in the
adefovir group with suboptimal response after six months, those who
switched to SEBIVO achieved a two times greater log reduction at one
year compared to those who had remained on adefovir treatment (2.1
log(10) versus 0.8 log(10), respectively).
At one year, patients had the option of continuing on or switching
to SEBIVO treatment in an ongoing follow-on study. Preliminary data
on these patients demonstrated that patients who had a suboptimal
response to adefovir (HBV DNA >3 log(10) copies/mL) at one year and
then switched to SEBIVO also achieved additional viral suppression
(1.95 log(10)) between one and one and a half years. Moreover, 74
percent of patients continually taking SEBIVO through one and a half
years achieved PCR-negativity.(1)
Both treatments were well tolerated with no drug-attributed
serious adverse events. Adverse events for both agents were similar
and primarily those associated with viral respiratory infections and
gastrointestinal complaints. Two patients experienced grade 3 or 4
neutropenia - one SEBIVO recipient and one patient in the switch
group; both events resolved at follow-up six days later, with
continued treatment.
"We are excited by the continued success of SEBIVO in clinical
trials, as it further demonstrates SEBIVO's potential to fill an
unmet need in chronic hepatitis B treatment and provide rapid,
profound and sustained viral suppression," said Douglas Mayers, M.D.,
Idenix's executive vice president and chief medical officer. "We are
committed to providing patients with new treatment options for
serious viral diseases and eagerly anticipate a decision about the
approval of SEBIVO by the European Commission in the next few
months."
On February 23, 2007, SEBIVO was recommended for approval by the
European Medicines Agency's (EMEA) Committee for Medicinal Products
for Human Use (CHMP), which reviews drug applications for all 27
countries in the European Union as well as Iceland and Norway. The
European Commission is expected to issue a final decision within two
to three months. SEBIVO is already approved in 15 countries,
including China, Switzerland and the United States. It is marketed as
TYZEKA(R) in the U.S.
Chronic hepatitis B is becoming a major public health issue in
Europe. An estimated one million people are infected with HBV every
year in Europe, of whom 90,000 will become chronic carriers.
Annually, 24,000 will die from cirrhosis or liver cancer.(3) The
incidence of hepatitis B ranges from 29 cases for every 100,000
people in Western Europe to 523 per 100,000 in Eastern Europe.(3) HBV
is 50 to 100 times more infectious than human immunodeficiency virus
(HIV).(4)
Telbivudine Presentations at EASL
Additional studies pertaining to telbivudine were presented at
EASL. Key presentations included:
    -- Professor Thierry Poynard, Hopital Pitie-Salpetriere, University of
       Paris VI, France, presented findings from a study that examined the
       post-treatment response in HBeAg-positive patients from the GLOBE
       study who were treated with telbivudine and lamivudine. After one
       year, HBeAg-positive patients were eligible to discontinue treatment
       for efficacy provided they had exhibited HBeAg loss and maintained HBV
       DNA <5 log(10) copies/mL for at least six months; 39 out of the 134
       eligible patients discontinued telbivudine treatment for efficacy. A
       preliminary analysis of these patients showed that 80 percent or more
       of the 39 patients who discontinued telbivudine treatment for efficacy
       exhibited sustained HBeAg responses, demonstrating durability of
       response when patients have come off treatment due to successful
       treatment with telbivudine.(5)
    -- Professor Jens Rasenack, Albert Ludwigs University, Freiburg, Germany
       presented a preliminary analysis of the two-year GLOBE data, which
       showed that telbivudine provided better treatment outcomes in those
       patients who are eligible for treatment according to international
       liver association treatment guidelines such as the Asian Pacific
       Association for the Study of Liver (APASL) and American Association
       for the Study of Liver Diseases (AASLD) guidelines. Those guidelines
       recommend patients with elevated levels of HBV DNA and liver enzyme
       levels (called ALT) that are two times higher than normal undergo
       antiviral treatment to reduce viral levels in their bodies. In these
       patients (n=588), telbivudine provided significantly greater HBeAg
       seroconversion than lamivudine at two years (36 percent vs. 27
       percent, respectively) as well as significantly better antiviral
       efficacy (61 percent vs. 43 percent achieved undetectable virus
       levels, respectively) and ALT normalization (72 percent vs. 63
       percent, respectively) than lamivudine.(6)
    -- Dr. Rifaat Safadi, Holy Family Hospital, Nazareth, Israel, presented
       study findings that show that switching patients with inadequate
       response to lamivudine (residual HBV DNA >3 log) to telbivudine
       provided significantly improved viral suppression. Patients switched
       from lamivudine to telbivudine at six months(n=122) experienced an
       additional reduction of 1.90 log10 copies/mL compared to 0.90 log(10)
       copies/mL for patients who continued lamivudine (n=124).(7)
    -- Dr. Jia JiDong, Beijing Friendship Hospital, Beijing, discussed
       findings from a study of 332 Chinese hepatitis B patients showing that
       after two years of therapy, telbivudine achieved more profound,
       sustained viral suppression than lamivudine (HBV DNA reduction of 5.48
       vs. 4.00 mean log(10) copies/mL, respectively). In addition, more
       patients treated with telbivudine achieved HBeAg seroconversion and
       HBeAg loss at two years compared to patients taking lamivudine, (29
       percent (40/138) vs. 20 percent (28/138) and 40 percent (55/138) vs.
       28 percent (39/138), respectively).(8)
In clinical studies telbivudine was generally well tolerated with
most adverse experiences classified as mild or moderate in severity.
Common (>1/100, <1/10) adverse reactions in telbivudine-treated
patients reported by one year in the GLOBE study were dizziness,
headache, cough, diarrhea, nausea, abdominal pain, skin rash, fatigue
and blood testing showing higher levels of liver enzymes, amylase,
lipase or creatine kinase. Uncommon (>1/1,000, <1/100) adverse
reactions included joint pain, persistent muscle weakness or muscle
pain and malaise.
About Idenix/Novartis collaboration
Idenix and Novartis Pharma AG are co-promoting SEBIVO
(telbivudine), for the treatment of 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, valtorcitabine and
valopicitabine in the US, France, Germany, Italy, Spain and the UK.
Novartis has the exclusive right to commercialize SEBIVO,
valtorcitabine and valopicitabine in the rest of the world.
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
http://www.idenix.com.
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 "potential," "committed,"
"anticipate," "expected," "will," or similar expressions, or by
express or implied statements with respect to potential approvals of
SEBIVO or other development product candidates by the European
Commission or in additional markets, or potential future revenues
from SEBIVO or other development product candidates. 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 approved for sale by the European Commission or in any other
markets, or that SEBIVO will achieve any particular levels 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 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. Marcellin P et al. 76 week follow-up of HBeAG-positive chronic
       hepatitis B patients treated with telbivudine, adefovir or switched
       from adefovir to telbivudine. Study abstract. EASL 2007.
    2. Marcellin P et al. In hepatitis B patients treated with either
       adefovir or telbivudine, maximal early HBV suppression at 24 weeks
       predicts optimal one-year efficacy. Study abstract. EASL 2007
    3. 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
    4. World Health Organization. Hepatitis B fact sheet number 204.
       Available at http://www.who.int/mediacentre/factsheets/fs204/en/
       Accessed 2/5/07
    5. Poynard T. et al. Sustained off-treatment HBeAG response in
       telbivudine and lamivudine treated HBeAG-positive patients from the
       GLOBE study. Study abstract. EASL 2007.
    6. Rasenack J. et al. Efficacy of telbivudine vs lamivudine at 2 years in
       patients with HBeAG-positive chronic hepatitis B who are eligible for
       treatment on guidelines. Study abstracts. EASL 2007.
    7. Safadi R. et al. A randomized trial of switching to telbivudine versus
       continued lamivudine in adults with chronic hepatitis B: results of
       the primary analysis at week 24. Study abstracts. EASL 2007.
    8. Jia JD. et al. Two-year results of a phase III comparative trial of
       telbivudine vs lamivudine in Chinese patients. Study abstract. EASL
       2007.
    Idenix Pharmaceuticals' Contacts:
    Media: Teri Dahlman +1-617-995-9905
    Investors: Amy Sullivan +1-617-995-9838
Web site: http://www.idenix.com

Contact:

Teri Dahlman, +1-617-995-9905; or Amy Sullivan, +1-617-995-9838, both
of Idenix Pharmaceuticals