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2016-12-19

Novartis International AG: Novartis announces exclusive option, collaboration and license agreement with Conatus to develop new oral treatments for chronic live

Novartis International AG / Novartis announces exclusive option, collaboration
and license agreement withConatus to develop new oral treatments for chronic
liver diseases . Processed and transmitted by Nasdaq Corporate Solutions.The
issuer is solely responsible for the content of this announcement.
* Novartis to broaden liver portfolio to deliver best-in-class single and
combination therapies for non-alcoholic steatohepatitis (NASH) with
advanced fibrosis and cirrhosis through an option, collaboration and
license agreement with Conatus
* There are currently no approved treatments for NASH patients in all stages
of the disease, which is expected to be the leading cause of liver
transplants in the US by 2020[1]
* Novartis has FXR agonists in clinical development for NASH, the most
advanced of which is in a Phase 2 clinical trial and has been granted Fast
Track designation from the US FDA

Basel, December 19, 2016
-
Novartis announced today the signing of an exclusive option, collaboration and
license agreement with Conatus Pharmaceuticals Inc., a biotechnology company
focused on the development of novel medicines to treat liver disease. This
agreement will enable Novartis and Conatus to jointly develop 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. This collaboration has the potential to
expand treatment options for people in various stages of fatty liver disease,
where no approved medicines currently exist.

Under the terms of this agreement, Novartis will make an upfront payment to
Conatus of USD 50 million. Any additional exercise fee will be paid to
Conatus following achievement of certain criteria as defined in the option,
collaboration and license agreement, including required anti-trust approvals.

"Our collaboration with Conatus is a major step forward to delivering
innovative oral treatments for NASH patients, who are in urgent need of new
approved options," said Vasant Narasimhan, Global Head, Drug Development and
Chief Medical Officer, Novartis. "Emricasan shows great promise as a single
agent and in potential combination with our internal FXR agonists as a
treatment for NASH patients".

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 2b clinical trials with emricasan in NASH. If
concluded positively, Novartis would then conduct Phase 3 studies of
emricasan as a single treatment and start 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 compound, a potent, non-bile acid FXR
agonist, has recently received Fast Track designation from the US Food and
Drug Administration (FDA) for NASH with liver fibrosis and is in a Phase 2
clinical trial.

NASH is a common, often silent liver disease; the major feature of which is
fat in the liver, along with inflammation and scarring. Around 3-5% of the US
population is affected with NASH[2], which is set to become the leading cause
of liver transplants in the US by 2020[1].

About emricasan

Emricasan is a first-in-class, oral, pan-caspase inhibitor for the treatment
of NASH fibrosis 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 2 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. The FDA has granted Fast Track
designation for the development of emricasan in patients with NASH cirrhosis.

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. 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 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]. Currently, there are no approved
treatment options for people living with the varying stages of NASH.

Disclaimer

The foregoing release contains forward-looking statements that can be
identified by words such as "option," "to broaden," "to develop," "expected,"
"by 2020," "Fast Track designation," "investigational," "potential," "will,"
"option," "step forward," "promise," "would," "set to become," 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 regarding potential
future revenues from emricasan and the FXR agonists being developed
internally by Novartis, either as single agents or in combination, or
regarding the possible exercise of the option for the collaboration with
Conatus and license for emricasan, or regarding the intended goals and
objectives of the collaboration with Conatus and license for emricasan. 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
transaction or 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 transaction or option exercise will be met in any
particular time frame, or at all. Nor can there be any guarantee that the
option for the collaboration with Conatus and license for emricasan will be
exercised within the expected time frame, or at all. Neither can there be any
guarantee that the collaboration with Conatus and license for emricasan will
achieve any of their intended goals and objectives, or in any particular time
frame. Nor can there be any guarantee that emricasan or the FXR agonists
being developed internally by Novartis, either as single agents or in
combination, will be submitted or approved for sale in any market, or at any
particular time. Neither can there be any guarantee that emricasan or the FXR
agonists being developed internally by Novartis, either as single agents or
in combination, 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,
and the option for the collaboration with Conatus and license for emricasan,
could be affected by, among other things, the potential that the intended
goals and objectives of the collaboration with Conatus and license for
emricasan may not be achieved or may take longer to achieve than expected;
the uncertainties inherent in research and development, including unexpected
clinical trial results and additional analysis of existing clinical data;
unexpected regulatory actions or delays or government regulation generally,
including an unexpected failure to obtain necessary government approvals for
the transaction or option exercise, or unexpected delays in obtaining such
approvals; the potential that any other closing conditions for the
transaction or 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 pressures; unexpected 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, eye care and cost-saving generic pharmaceuticals. Novartis is the
only global company with leading positions in these areas. In 2015, the Group
achieved net sales of USD 49.4 billion, while R&D throughout the Group
amounted to approximately USD 8.9 billion (USD 8.7 billion excluding
impairment and amortization charges). Novartis Group companies employ
approximately 118,000 full-time-equivalent associates. Novartis products are
available in more than 180 countries around the world. For more information,
please visithttp://www.novartis.com.

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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.

# # #

Novartis Media Relations

Central media line: +41 61 324 2200
E-mail:media.relations@novartis.com

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