Novartis and Amgen announce expanded collaboration with Banner Alzheimer's Institute in pioneering prevention program
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Novartis International AG /
Novartis and Amgen announce expanded collaboration with Banner Alzheimer's
Institute in pioneering prevention program
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The issuer is solely responsible for the content of this announcement.
* Parties to collaborate on a new Generation Study 2, assessing whether
investigational drug CNP520 can prevent or delay the symptoms of Alzheimer's
disease (AD)
* Clinical trial is part of the Generation Program, which includes cognitively
healthy people at genetic risk of developing AD
* Generation Study 2 aims to include a broader high-risk population, as
compared to the ongoing Generation Study 1
* 44 million people globally are estimated to have AD or a related dementia,
with one new case diagnosed every three seconds[1],[2]
Basel, November 2, 2017 - Novartis, Amgen and the Banner Alzheimer's Institute
(BAI) today announced an expanded collaboration to initiate a new trial - the
Alzheimer's Prevention Initiative (API) Generation Study 2. This trial follows
the launch of the Generation Study 1, and will determine whether the BACE1
inhibitor CNP520 can prevent or delay the onset of Alzheimer's disease symptoms
in a high-risk population. BACE1 is an enzyme that plays an important role in
the production of Amyloid ß, a protein which accumulates in the brains of
individuals with AD years before clinical symptoms begin. More information on
the sites participating in Generation Study 2 can be found at Clinical
trials.gov and in the website www.GenerationProgram.com.
"Expanding our collaboration with Banner Alzheimer's Institute stands testament
to our belief that preventing amyloid buildup is one of the most promising
approaches to treating Alzheimer's disease," said Vas Narasimhan, M.D., Global
Head Drug Development and Chief Medical Officer for Novartis. "If we determine
that our BACE1 inhibitor can prevent or delay the onset of symptoms in healthy
yet high-risk populations, this would represent a tremendous breakthrough for
those that may face this debilitating disease."
The Generation Study 2 started enrolling participants in the US in August 2017,
and will eventually include more than 180 sites in more than 20 countries around
the world. This five-year study will recruit approximately 2,000 cognitively
healthy participants, aged 60 to 75, who are at high risk of developing AD based
on their age and who carry either two copies of the apolipoprotein E (APOE) 4
gene or one copy of the gene with evidence of elevated brain amyloid. This is
different from the Generation Study 1, which only targeted those who carry two
copies of the APOE4 gene. APOE4 is the major genetic risk factor for late-onset
Alzheimer's disease. Roughly one in four people carry a single copy of the APOE4
gene, but only about two percent of the world's population carries two
copies.[3] Eligible participants will be randomized to receive placebo or one of
two doses of CNP520 (15 mg or 50 mg), co-developed by Novartis and the
biotechnology company Amgen.
"This expanded collaboration builds upon the API Generation Study 1 which
launched last year, and is another step in our effort to take clinical trials to
a critical new stage," said Pierre N. Tariot, MD, co-director of API and
director of BAI, a division of Banner Health, one of the largest nonprofit
healthcare systems in the U.S. "This approach continues to shift the Alzheimer's
research paradigm from reversing disease damage to attacking its root cause
before symptoms surface. It is our hope that by targeting people earlier, we
will have a better chance of delaying or preventing the onset of the disease."
Participants will be recruited via multiple venues, including, in the US, the
Alzheimer's Prevention Registry's GeneMatch program
(www.endALZnow.org/GeneMatch). GeneMatch is a first-of-its-kind program designed
to identify a large group of people interested in volunteering for Alzheimer's
disease prevention research studies, based in part on their APOE genetic
information.
About the Generation Program
The Generation Program consists of two pivotal Phase 2/3 studies. The studies
are testing whether investigational anti-amyloid treatments might prevent or
delay the emergence of symptoms of AD in people at particularly high risk for
developing the disease at older ages because of their genetic status.
The Generation Study 2 is examining whether the BACE1 inhibitor CNP520 can
prevent or delay the onset of the symptoms of the disease in individuals who are
at high risk of developing AD because of their age and because they carry either
one or two copies of the APOE4 gene. Those with one copy will require evidence
of elevated brain amyloid.
About Alzheimer's Prevention Initiative
The Alzheimer's Prevention Initiative (API) is an international collaborative
research effort formed to launch a new era of Alzheimer's prevention research.
Led by the Banner Alzheimer's Institute, the API conducts prevention trials in
cognitively healthy people at increased genetic risk for Alzheimer's disease. It
will continue to establish the brain imaging, biological and cognitive
measurements needed to rapidly test promising prevention therapies and provide
registries to support enrollment in future prevention trials. API is intended to
provide the scientific means, accelerated approval pathway with the cooperation
of the regulatory agencies and enrollment resources needed to evaluate the range
of promising Alzheimer's prevention therapies and find ones that work. For more
information, go to www.banneralz.org.
Disclaimer
This press release contains forward-looking statements within the meaning of the
United States Private Securities Litigation Reform Act of 1995. Forward-looking
statements can generally be identified by words such as "potential," "can,"
"will," "plan," "expect," "anticipate," "look forward," "believe," "committed,"
"investigational," "pipeline," "launch," or similar terms, or by express or
implied discussions regarding potential marketing approvals for CNP520 or the
other investigational products described in this press release, or regarding
potential future revenues from such products or the collaboration with Amgen and
Banner Alzheimer's Institute. You should not place undue reliance on these
statements. Such forward-looking statements are based on our current beliefs and
expectations 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 CNP520 or the other investigational
products described in this press release will be submitted or approved for sale
in any market, or at any particular time. Neither can there be any guarantee
that the collaboration with Amgen and Banner Alzheimer's Institute will achieve
any or all of its intended goals and objectives, or be commercially successful.
Nor can there be any guarantee that CNP520 or the other investigational products
described in this press release will be commercially successful in the future.
In particular, our expectations regarding such products, and the collaboration
with Amgen and Banner Alzheimer's Institute, could be affected by, among other
things, 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; our ability to
obtain or maintain proprietary intellectual property protection; the particular
prescribing preferences of physicians and patients; global trends toward health
care cost containment, including government, payor and general public pricing
and reimbursement pressures; general economic and industry conditions, including
the effects of the persistently weak economic and financial environment in many
countries; 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
121,000 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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References
1. Alzheimer's Association 2015. Changing the Trajectory of Alzheimer's Disease:
How a Treatment by 2025 Saves Lives and Dollars
2. Policy Brief for Heads of Government: The Global Impact of Dementia
2013-205. Published by Alzheimer's Disease International (ADI), London. December
2013.
3. Genin et al 2011; Liu at al 2013; Jansen et al 2015
# # #
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Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 02.11.2017 - 21:30 Uhr
Sprache: Deutsch
News-ID 566517
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Business News
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