Sebivo® approved in China for treatment of chronic hepatitis B, thenation's second leading cause of death

Donnerstag, 01.03.2007 19:36 von Hugin - Aufrufe: 117

* China is the country worst impacted by hepatitis B, with more
than half a million deaths each year [1],[2]
* Data show Sebivo gives better viral suppression than lamivudine,
the most widely prescribed treatment for chronic hepatitis B
* Sebivo recently recommended for European approval, and already
available in US under brand name Tyzeka®
 
Basel, March 2, 2007 - Novartis announced today the Chinese
regulatory approval of Sebivo® (telbivudine) as a treatment for
chronic hepatitis B, a disease estimated to affect more than 100
million people in China[1-3] and considered the second leading cause
of death in the country[1]. The decision comes shortly after Sebivo
was recommended for approval in the European Union.
 
Sebivo meets an urgent demand for effective therapies that can
provide profound and sustained suppression of the hepatitis B virus,
reducing the risk of liver disease and improving long-term outcomes
for patients[4]. Sebivo will be available in China in April.
 
The need for new therapies is especially pressing in China, where an
estimated 10% of the population suffer from chronic hepatitis
B[2],[5]. The number of infected people in China represents about
one-third of those with the disease worldwide[2]. Despite existing
treatments, nearly half a million people in mainland China die each
year from liver damage and liver cancer caused by chronic hepatitis
B[1],[2].
 
"Chronic hepatitis B is a major health problem in China, and through
treatment, we aim to prevent the progression of the disease by
getting the viral load to as low a level as possible," said Prof.
Jidong Jia, Director of the Liver Research Center, Beijing Friendship
Hospital, Capital Medical University, China. "Sebivo's demonstrated
ability to rapidly and profoundly drive down virus levels within the
first 24 weeks of treatment, in addition to its favorable safety
profile, make it a promising treatment option for patients with
chronic hepatitis B."
 
Worldwide regulatory submissions have been based primarily on
one-year data from the GLOBE study, the largest worldwide
registration trial ever conducted in patients with chronic hepatitis
B and the first to include patients from mainland China. The study
results demonstrated that Sebivo provided greater viral suppression
and significantly greater response on all virologic markers after one
year compared to lamivudine, the most widely prescribed treatment. An
additional Chinese Phase III trial corroborated these findings and
supplemented the filing in China.
 
"The approval of Sebivo in China represents a milestone in treatment
for the millions of patients suffering from chronic hepatitis B,"
said James Shannon, MD, Global Head of Development at Novartis Pharma
AG. "We now look forward to receiving final European Commission
approval, and to providing chronic hepatitis B patients in Europe
with access to this promising new treatment."
 
The positive opinion in Europe was issued on February 22 by the
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 generally follows the
CHMP's advice and is expected to issue a final decision within two to
three months.
 
Sebivo, a once-daily oral treatment, is already approved in 12
countries including Switzerland and the US, where it is marketed as
Tyzeka®.
 
Novartis in China
Novartis and its predecessor companies have been active in China
since 1938 when Ciba opened its office in Shanghai, initially as a
provider of dyestuffs and later expanding into the pharmaceutical
arena.
 
The Chinese name for Novartis (pronounced Nuo Hua) means Commitment
to China, which reflects the company's long-term strategy in the
region. The total investment in China now totals over USD 400
million, with two major developments announced in 2006: a
manufacturing and development center in Changshu, to be fully
operational by the end of 2007, and an integrated biomedical research
and development center in Shanghai expected to open in May.
 
Novartis currently ranks as the fourth largest pharmaceutical company
in the Chinese hospital market with a compound annual sales growth
rate of over 30% during the last five years, and currently has around
2,400 full-time employees in China.
 
About Idenix/Novartis collaboration
Novartis Pharma AG and Idenix are co-promoting Sebivo, 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, 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.
 
Novartis is committed to infectious diseases and is developing a
portfolio of complementary mechanisms of action in the treatment of
hepatitis B and C, while working to bring innovation for serious
hospital infections.
 
Disclaimer
The foregoing release contains forward-looking statements which can
be identified by the use of terminology such as "will," "aim to,"
"promising," "look forward to," "expected," "to be," "committed,"
"developing," "working to bring," or similar expressions, or by
express or implied discussions regarding the potential marketing
approvals of Sebivo in the EU or in additional countries, or
potential future revenue 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. There can be no guarantee that Sebivo will be approved
for any indications in the EU or any other market, or that Sebivo
will reach any particular sales levels. In particular, management's
expectations regarding the approval and commercialization of Sebivo
could be affected by, among other things, unexpected regulatory
actions or delays or government regulation generally; competition in
general; increased government, industry, and general public pricing
pressures; unexpected clinical trial results, including additional
analysis of clinical data, or new clinical data; our ability to
obtain or maintain patent or other proprietary intellectual property
protection; and other risks and factors referred to in Novartis AG's
current Form 20-F on file with the US Securities and Exchange
Commission. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect, actual
results may vary materially from those anticipated, believed,
estimated or expected. Novartis is providing the information in this
press release as of this date and does not undertake any obligation
to update any forward-looking statements contained in this press
release as a result of new information, future events or otherwise.
 
About Novartis
Novartis AG (NYSE: NVS) is a world leader in offering medicines to
protect health, cure 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. We
are strengthening our medicine-based portfolio, which is focused on
strategic growth platforms in innovation-driven pharmaceuticals,
high-quality and low-cost generics, human vaccines and leading
self-medication OTC brands. Novartis is the only company with
leadership positions in these areas. In 2006, the Group's businesses
achieved net sales of USD 37.0 billion and net income of USD 7.2
billion. Approximately USD 5.4 billion was invested in R&D.
Headquartered in Basel, Switzerland, Novartis Group companies employ
approximately 101,000 associates and operate in over 140 countries
around the world. For more information, please visit
http://www.novartis.com.
 
References
[1] Sun Z, et. al. Prevention and control of hepatitis B in China. J
Med Virol 2002, 67:447-450.
[2] Lesmana LA, Leung NW, Mahachai V, et al. Hepatitis B: overview of
the burden of disease in the Asia-Pacific region. Liver Int 2006 Dec;
26 Suppl 2: 3-10.
[3] Guan Z, Dong Z, Wang Q, et al. Cost of chronic hepatitis B
infection in China. J Clin Gastroenterol 2004 Nov; 38(10 Suppl):
S175-S178.
[4] 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. Presented at: Shanghai-Hong
Kong International Liver Congress; March 25-28, 2006. Poster 180.
[5] You GB. Treatment of chronic hepatitis B in China. J
Gastroenterol Hepatol 2000 May; 15 Suppl: E61-E66.
 
# # #
 
Media contacts
 
Corinne Hoff
Novartis Global Media Relations
+41 61 324 9577 (direct)
+41 79 248 5717 (mobile)
corinne.hoff@novartis.com
 
Birgit Gronkowski
Novartis Pharma Communications
+41 61 324 8790 (direct)
+41 79 820 1719 (mobile)
birgit.gronkowski@novartis.com
 
e-mail: media.relations@novartis.com
 
Novartis Global Investor Relations
 
International:
 
Ruth Metzler-Arnold +41 61 324 99 80
Katharina Ambühl +41 61 324 53 16
Nafida Bendali +41 61 324 35 14
Jason Hannon +41 61 324 21 52
Richard Jarvis +41 61 324 43 53
 
North America:
Ronen Tamir +1 212 830 24 33
Arun Nadiga +1 212 830 24 44
Jill Pozarek +1 212 830 24 45
Edwin Valeriano +1 212 830 24 56
 
e-mail: investor.relations@novartis.com
 
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