Novartis exercises exclusive option agreement with Conatus for the treatment of NASH
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Novartis International AG /
Novartis exercises exclusive option agreement with Conatus for the treatment of
NASH
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The issuer is solely responsible for the content of this announcement.
* Exclusive license for emricasan supports rapidly growing development
portfolio in chronic liver diseases, including NASH
* Conatus has initiated the Phase IIb ENCORE-LF clinical trial with emricasan
in NASH. If positive, Novartis would conduct Phase III studies of emricasan
as a single and combination treatment with a Novartis FXR agonist
* NASH, a progressive form of non-alcoholic fatty liver disease is expected to
be the leading cause of liver transplants in the US by 2020[1]
The digital press release with multimedia content can be accessed here:
Basel, May 4, 2017 - Novartis announced today that it has notified Conatus
Pharmaceuticals Inc., of its exercise of the option to an exclusive license for
the global development and commercialization of emricasan, under the option,
collaboration and license agreement signed with Conatus on December 19, 2016.
The exercise of the option with Conatus, a biotechnology company focused on the
development of novel medicines to treat liver disease, and grant of exclusive
license to Novartis will be effective upon receipt of all required anti-trust
approvals and payment of USD 7 million option exercise fee to Conatus.
This follows the initiation of the Phase IIb ENCORE-LF trial by Conatus
evaluating emricasan in patients with decompensated liver cirrhosis caused by
nonalcoholic steatohepatitis (NASH). This collaboration has the potential to
expand treatment options for people in various stages of fatty liver disease,
where no approved medicines currently exist.
"We are pleased to add another important medicine to our liver portfolio with
emricasan, which has shown potential in patients with advanced fibrosis and
cirrhosis," said Vas Narasimhan, Global Head, Drug Development and Chief Medical
Officer, Novartis. "We look forward to advancing our broad portfolio of NASH and
chronic liver disease programs to address this growing unmet need."
Novartis is developing Farnesoid X receptor (FXR) agonists for the treatment of
chronic liver diseases. As part of this collaboration, Conatus will conduct
multiple Phase IIb clinical trials with emricasan in NASH. If results are
positive, Novartis would then conduct Phase III studies of emricasan as a single
treatment as well as development of combination therapies with an FXR agonist.
FXR agonists have been shown to address three of the most important aspects of
NASH progression by reducing fat, inflammation and fibrosis in the liver. The
most advanced Novartis investigational compounds, both non-bile acid FXR
agonists, are in Phase II clinical trials. Both of these FXR agonists have
received Fast Track designation from the US Food and Drug Administration (FDA)
for NASH with liver fibrosis. In addition, the FDA has granted Fast Track
designation for the development of emricasan in patients with NASH cirrhosis.
Recently, Novartis announced a clinical collaboration with Allergan to conduct a
Phase IIb study, involving the combination of a Novartis FXR agonist and
Allergan's cenicriviroc (CVC) for the treatment of NASH with liver fibrosis.
Both collaborations with Conatus and Allergan continue to support the growing
Novartis portfolio to develop new therapies in chronic liver diseases, including
NASH.
About emricasan
Emricasan is an investigational, first-in-class, oral, pan-caspase inhibitor for
the treatment of non-alcoholic steatohepatitis (NASH) with advanced fibrosis
(scarring) and cirrhosis.
To date, emricasan has been studied in over 650 patients in sixteen clinical
trials across a broad range of liver diseases. In multiple clinical Phase II
trials conducted by Conatus, emricasan has demonstrated significant, rapid and
sustained reductions in elevated levels of key biomarkers of inflammation and
cell death, which play a role in the severity and progression of liver disease.
About Novartis FXR agonists
Novartis scientists began to develop leads for the FXR agonism program in 2007.
Through this effort, several non-bile acid FXR agonists have been identified and
pre-clinical data demonstrates that these compounds are very selective with
differentiated biological profiles. In animal models, FXR agonists have been
shown to address three of the most important aspects of NASH progression by
reducing fat, inflammation and fibrosis in the liver. First-in-human studies
have continued to support their differentiated profiles and their potential for
further development. Two Novartis FXR agonists are now in worldwide clinical
studies in NASH patients.
About Non-Alcoholic Steatohepatitis (NASH)
NASH is a chronic, progressive form of non-alcoholic fatty liver disease. It is
a leading cause of liver disease worldwide and it is estimated to affect 3% to
5% of the US population alone[2]. As fat builds up in the liver, it triggers a
vicious cycle of chronic inflammation and liver scarring called fibrosis. Over
time, liver inflammation and fibrosis may progress to cirrhosis, which can lead
to liver failure and, barring a transplant, death. NASH is expected to be the
principal cause of liver transplantation in the US by 2020[1] and is currently
the leading cause of liver transplants for people under 50 in the US[3].
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "option," "growing," "portfolio," "initiated," "would,"
"expected," "by 2020," "will," "potential," "look forward," "investigational,"
"Fast Track designation," "to develop," "may," "can," or similar terms, or by
express or implied discussions regarding potential marketing approvals for
emricasan and the FXR agonists being developed internally by Novartis, either as
single agents or in combination, or for cenicriviroc in combination with the FXR
agonists being developed internally by Novartis, or regarding potential future
revenues from emricasan and the FXR agonists being developed internally by
Novartis, either as single agents or in combination, or from cenicriviroc in
combination with the FXR agonists being developed internally by Novartis, or
regarding the exercise of the option for the license for emricasan, or regarding
the intended goals and objectives of the collaboration with Conatus and license
for emricasan, and the clinical collaboration with Allergan. You should not
place undue reliance on these statements. Such forward-looking statements are
based on the current beliefs and expectations of management regarding future
events, and are subject to significant known and unknown risks and
uncertainties. Should one or more of these risks or uncertainties materialize,
or should underlying assumptions prove incorrect, actual results may vary
materially from those set forth in the forward-looking statements. There can be
no guarantee that the necessary government approvals for the option exercise
will be obtained in any particular time frame, or at all. Neither can there be
any guarantee that any other closing conditions for the option exercise will be
met in any particular time frame, or at all. Nor can there be any guarantee that
the collaboration with Conatus and license for emricasan, or the clinical
collaboration with Allergan, will achieve any of their intended goals and
objectives, or in any particular time frame. Neither can there be any guarantee
that emricasan or the FXR agonists being developed internally by Novartis,
either as single agents or in combination, or cenicriviroc in combination with
the FXR agonists being developed internally by Novartis, will be submitted or
approved for sale in any market, or at any particular time. Nor can there be any
guarantee that emricasan or the FXR agonists being developed internally by
Novartis, either as single agents or in combination, or cenicriviroc in
combination with the FXR agonists being developed internally by Novartis, will
be commercially successful in the future. In particular, management's
expectations regarding emricasan and the FXR agonists being developed internally
by Novartis, either as single agents or in combination, cenicriviroc in
combination with the FXR agonists being developed internally by Novartis, the
option for the license for emricasan, and the clinical collaboration with
Allergan, could be affected by, among other things, the potential that the
intended goals and objectives of the collaboration with Conatus and license for
emricasan, or the clinical collaboration with Allergan, may not be achieved or
may take longer to achieve than expected; the uncertainties inherent in research
and development, including clinical trial results and additional analysis of
existing clinical data; regulatory actions or delays or government regulation
generally, including a failure to obtain necessary government approvals for the
option exercise, or delays in obtaining such approvals; the potential that any
other closing conditions for the option exercise may not be met; the company's
ability to obtain or maintain proprietary intellectual property protection;
general economic and industry conditions; global trends toward health care cost
containment, including ongoing pricing and reimbursement pressures; safety,
quality or manufacturing issues, and other risks and factors referred to in
Novartis AG's current Form 20-F on file with the US Securities and Exchange
Commission. 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 innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has
leading positions globally in each of these areas. In 2016, the Group achieved
net sales of USD 48.5 billion, while R&D throughout the Group amounted to
approximately USD 9.0 billion. Novartis Group companies employ approximately
118,000 full-time-equivalent associates. Novartis products are sold in
approximately 155 countries around the world. For more information, please visit
http://www.novartis.com.
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For Novartis multimedia content, please visit www.novartis.com/news/media-
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References
[1] Charlton MR, Burns JM, Pedersen RA, Watt KD, Heimbach JK, Dierkhising RA.
Frequency and Outcomes of Liver Transplantation for Nonalcoholic Steatohepatitis
in the United States. Gastroenterology; 2011:141 (4):e22-e23.
[2] Vernon G, Baranova A, Younossi ZM. Systematic review: the epidemiology and
natural history of non-alcoholic fatty liver disease and non-alcoholic
steatohepatitis in adults. Aliment Pharmacol Ther. 2011;34(3):274-85.
[3] Banini BA, et al. Abstract #46. Presented at: American College of
Gastroenterology Annual Scientific Meeting; Oct. 14-19, 2016; Las Vegas, NV.
# # #
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Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 04.05.2017 - 07:15 Uhr
Sprache: Deutsch
News-ID 540172
Anzahl Zeichen: 14046
contact information:
Town:
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Kategorie:
Business News
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