Novartis International AG / Novartis gains exclusive rights to Debio 025, an antiviral agent in Phase IIb development as potential first-in-class hepatitis C therapy processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
* Phase II results demonstrate efficacy of Debio 025, a cyclophilin inhibitor,
against hepatitis C virus when used alone or in combination with current
standard therapy(1)
* Cyclophilin inhibitors evolving as new class of medicines with potential to
become part of future standard of care for treating hepatitis C
* Hepatitis C is one of the world's most common liver diseases, current
therapies may only be effective in around 50% of patients(2)
* Novartis to make upfront payment to Debiopharm Group(TM), with Debiopharm
eligible for milestones and royalties on future sales
Basel, February 9, 2010 - Novartis has gained exclusive rights to develop and
market Debio 025 (alisporivir), a potential first-in-class antiviral agent
currently in Phase IIb development for the treatment of hepatitis C. Debio 025
is the first in a new class of drugs called cyclophilin inhibitors which could
become part of the future standard of care for the disease.
Debio 025 has been in-licensed from Debiopharm Group(TM), an independent
biopharmaceuticals company based in Switzerland, under an agreement which gives
Novartis exclusive worldwide development and marketing rights (excluding Japan).
Under the terms of the agreement, Novartis will make an upfront payment to
Debiopharm, and Debiopharm will be eligible for milestone payments, and for
royalties on future sales of Debio 025, if it is approved. The transaction is
subject to customary regulatory approvals.
"Hepatitis C is sometimes referred to as a 'silent epidemic' because the virus
can lie dormant in the body for years or even decades before the symptoms become
apparent," said David Epstein, CEO of the Novartis Pharmaceuticals Division.
"Novartis is dedicated to developing medicines that will reduce the impact of
this disease on patients, and we believe that Debio 025 could prove an important
step forward by significantly enhancing the efficacy of existing therapy that
forms the standard of care for hepatitis C."
More than 170 million people worldwide are infected with hepatitis C virus
(HCV)(3), and this can cause serious liver disease leading to cirrhosis or liver
cancer which may result in death. There is an urgent need for more effective
medications, often used in combination, as current therapy is only effective in
around 50% of patients with the most prevalent form of the virus, called
genotype 1(2).
Cyclophilin inhibitors such as Debio 025 provide a novel approach to treatment
by targeting host proteins that are involved in the growth of the hepatitis C
virus. Results of a Phase II study show that Debio 025 significantly reduced HCV
replication when used alone, and had an important additive anti-HCV effect (4.6
log(10) reduction) in combination with pegylated interferon alfa-2a in
treatment-naïve patients(1). No significant safety issues have been identified
so far.
A double-blind, placebo-controlled Phase IIb study is now under way to assess
the efficacy and safety of Debio 025 in combination with the current standard of
care for hepatitis C - peginterferon alfa-2a plus ribavirin - in treatment-naïve
patients. The study is being conducted in patients with the most common genotype
1. Debio 025 is also effective against other genotypes of the virus(1,4).
The in-licensing of Debio 025 represents a further expansion of the Novartis
hepatitis C portfolio following the filing of Joulferon(®)/Zalbin(®)
(albinterferon alfa-2b) for European and US regulatory approval at the end of
2009. In Phase III studies, Joulferon dosed every two weeks showed similar
efficacy to peginterferon alfa-2a dosed weekly while requiring half the number
of injections. Albinterferon alfa-2b is being developed and will be
co-commercialized in the US together with Human Genome Sciences, who filed for
US approval under the brand name Zalbin(®) .
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "potential," "eligible," "could," "will," "can,"
"dedicated," "believe," "may," or similar expressions, or by express or implied
discussions regarding potential regulatory approval of Novartis' acquisition of
rights to Debio 025, potential marketing approvals for Debio 025, or for
Joulferon/Zalbin, or regarding potential future revenues from such products. You
should not place undue reliance on these statements. Such forward-looking
statements reflect the current views of management regarding future events, and
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 Novartis will receive the necessary regulatory approvals to
complete its acquisition of the rights to Debio 025. Nor can there be any
guarantee that Debio 025 or Joulferon/Zalbin will be approved for sale in any
market. Nor can there be any guarantee that these products will achieve any
particular levels of revenue in the future. In particular, management's
expectations regarding these products could be affected by, among other things,
unexpected regulatory actions or delays or government regulation generally;
unexpected clinical trial results, including unexpected new clinical data and
unexpected additional analysis of existing clinical data; the company's ability
to obtain or maintain patent or other proprietary intellectual property
protection; competition in general; government, industry and general public
pricing pressures; the impact that the foregoing factors could have on the
values attributed to the Novartis Group's assets and liabilities as recorded in
the Group's consolidated balance sheet, 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 provides healthcare solutions that address the evolving needs of
patients and societies. Focused solely on healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines,
cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and
consumer health products. Novartis is the only company with leading positions in
these areas. In 2009, the Group's continuing operations achieved net sales of
USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D
activities throughout the Group. Headquartered in Basel, Switzerland, Novartis
Group companies employ approximately 100,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visit http://www.novartis.com.
References
1. Flisiak R, et al. The cyclophilin inhibitor Debio 025 combined with PEG
IFNalpha2a significantly reduces viral load in treatment-naïve hepatitis C
patients. Hepatology 2009;49 (5):1460-8.
2. Hoofnagle JH. A step forward in therapy for hepatitis C. N Engl J Med.
2009;360 (18):1899-901.
3. Lauer GM, Walker BD. Hepatitis C virus infection. N Engl J Med. 2001;345
(1):41-52.
4. Flisiak R, et al. The cyclophilin inhibitor Debio-025 shows potent
anti-hepatitis C effect in patients coinfected with hepatitis C and human
immunodeficiency virus. Hepatology. 2008;47(3):817-26.
# # #
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