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2015-09-01

Novartis International AG: Novartis announces global partnership with Amgen to develop and commercialize pioneering neuroscience treatments

Novartis International AG / Novartis announces global partnership with Amgen
to develop and commercializepioneering neuroscience treatments . Processed
and transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely
responsible for the content of this announcement.
* The companies plan to co-develop and co-commercialize a BACE inhibitor
program in Alzheimer's Disease (AD); Novartis' oral therapy CNP520 will be
the lead molecule
* Novartis and Amgen also plan to co-develop and co-commercialize Amgen's
migraine portfolio, including fully human monoclonal antibody AMG 334 with
first phase III data expected in 2017
* Partnership reinforces Novartis' continued commitment to developing and
bringing innovative neuroscience treatment options to patients

Basel, September 1, 2015
-
Novartis announced today that it has entered into a global collaboration with
Amgen to commercialize and develop pioneering neuroscience treatments. The
companies will partner in the development and commercialization of a BACE
inhibitor program in Alzheimer's Disease (AD). Novartis' oral therapy CNP520
will be the lead molecule and further compounds from both company's
pre-clinical BACE inhibitor programs may be considered as follow-on
molecules. The collaboration will also focus on new Amgen drugs in the
migraine field, including phase III AMG 334 and phase I AMG 301. For the
migraine program, Novartis will have global co-development rights and
commercial rights outside the U.S., Canada, and Japan.

"This Novartis collaboration with Amgen highlights our clear commitment to
neuroscience and to bring multiple, new targeted therapies to patients living
with Alzheimer's disease and migraine, where the unmet medical need remains
high." said David Epstein, Head of Novartis Pharmaceuticals.

Alzheimer's Disease is an irreversible, progressive brain disease
characterized by loss of memory and other cognitive abilities. Amyloid
build-up is considered a key driver of the progressive damage of the nervous
system in AD. CNP520 is an oral drug designed to prevent the production of
different forms of amyloid and has the potential to prevent, slow or delay
the symptoms associated with AD. It is currently in phase I/IIa trials.
CNP520 is planned to be included in a pioneering prevention study in people
with a genetic risk of developing AD, in collaboration with the Banner
Alzheimer's Institute.

Migraine is a severe headache condition affecting more than 10% of the
population[1] worldwide and a leading cause of disability. AMG 334 is a fully
human monoclonal antibody under investigation for the prevention of migraine.
AMG 334 inhibits the activity of Calcitonin-Gene-Related-Peptide (CGRP) by
targeting its receptor. CGRP is believed to play a key role in the
development of migraine. AMG 334 is currently under evaluation in several
large global, randomized, double-blind, placebo-controlled phase III trials
to assess its safety and efficacy in migraine prevention. In addition to AMG
334, the migraine portfolio will include the development of AMG 301 and
potentially another investigational compound of Amgen. AMG 301 is a
monoclonal antibody being investigated in phase I trials for the prevention
of migraine.

The partnership with Amgen follows two recent developments in the Novartis
neuroscience portfolio aimed at complementing Novartis' neuroscience presence
and pipeline in, among others, multiple sclerosis, AD and neuromuscular
diseases. In July 2015 Novartis acquired Spinifex Pharmaceuticals adding
phase II compound EMA401 for the treatment of neuropathic pain to the
portfolio. In August 2015 Novartis announced that it has entered into an
agreement to acquire all remaining rights to Ofatumumab from GlaxoSmithKline
plc (GSK) for relapsing-remitting multiple sclerosis (RRMS) and certain other
autoimmune indications; closing of this transaction is subject to expiry of
any waiting period under the US Hart-Scott-Rodino Act and other customary
closing conditions.

Under the terms of the arrangement, Novartis and Amgen will share
responsibilities for development and commercialization of the BACE inhibitor
program. Amgen will pay an upfront payment and milestone payments as well as
disproportional research and development costs for an agreed upon period
followed by a 50/50 cost and profit share arrangement. For the compounds in
the migraine field, Novartis receives global co-development rights and
commercial rights outside the U.S., Canada and Japan to the investigative
molecules in Amgen's migraine portfolio. This includes AMG 334 in phase III
and AMG 301 in phase I as well as an option to commercialize an additional
early-stage Amgen molecule in these territories. Novartis will fund
disproportional global R&D expenses for an agreed period on the migraine
programs and will pay Amgen double-digit royalties on sales.

About Alzheimer's
It is estimated that around 44 million people globally have Alzheimer's or a
related dementia[2]. Alzheimer's Disease is an irreversible, progressive
brain disease that slowly destroys memory and thinking skills and, eventually
even the ability to carry out the simplest tasks of daily living. In most
people with Alzheimer's, symptoms first appear after age 60. Alzheimer's
Disease is the most common cause of dementia among older people. Although
treatment can help manage symptoms in some people, currently there is no cure
for this devastating disease.

About Migraine

Migraine is a type of headache disorder that involves recurrent attacks of
moderate to severe pain that is typically pulsating, often unilateral and
often associated with nausea, vomiting and sensitivity to light, sound and
odors.[1] Headache disorders are underestimated, under-recognized and
under-treated throughout the world and are associated with personal and
societal burdens of pain, disability, damaged quality of life and financial
cost.[3]There is a significant need for tolerable and efficacious preventive
medications for migraine as discontinuation rates for existing oral
preventive medications are high.[4]

About Novartis in Alzheimer's Disease

Novartis has a strong commitment to the treatment and prevention of
Alzheimer's Dementia.

Exelon® Patch (rivastigmine transdermal system) is approved for the treatment
of mild-to-moderate Alzheimer's Disease (AD) dementia in more than 90
countries, including more than 20 countries where it is also approved for
Parkinson's disease dementia. Exelon Patch is also indicated for the
treatment of patients with severe AD in 14 countries, including the US.

Novartis AD pipeline includes CNP520,an oral drug designed to prevent the
production of different forms of amyloid that has the potential to prevent,
slow or delay the symptoms associated with AD. It is currently in phase I/IIa
trials. The pipeline also includes investigational compound CAD106. This is
an anti-amyloid active immunotherapy which has completed phase IIa trials.

About collaboration with Banner Alzheimer's Institute (BAI)

In collaboration with the Banner Alzheimer's Institute (BAI), Novartis is
conducting a pioneering prevention study. The study with Banner is part of a
ground-breaking research program known as the Alzheimer's Prevention
Initiative and will involve more than 1,300 cognitively healthy adults, ages
60 to 75, with a genetic risk of developing symptoms of AD because they
inherited two genetic copies of the apolipoprotein E epsilon 4 (APOE4) allele
- one from each parent. About 2 percent of the world's population has this
genetic profile, which is strongly linked to late-onset AD. One in four
people carries one copy of the APOE4 gene. Participants in the study will be
given either CAD106 (not included in the collaboration with Amgen), CNP520,
or placebo. Pending regulatory approval, the study is planned to start in
late 2015/early 2016 in sites in North America and Europe.

Disclaimer

The foregoing release contains forward-looking statements that can be
identified by words such as "plan," "will," "expected," "commitment," "may,"
"under investigation," "under evaluation," "potentially," "investigational,"
"being investigated," "aimed," "subject to," "investigative," "pipeline,"
"pending," "planned," or similar terms, or by express or implied discussions
regarding potential marketing approvals for CNP520, AMG 334, AMG 301, CAD106,
other BACE inhibitors of Novartis and Amgen, and other investigational
compounds of Novartis and Amgen subject to the partnership and collaboration,
new indications or labeling for Exelon Patch, or regarding potential future
revenues from such investigational compounds and products, and potential
future revenues from the partnership and collaboration with Amgen. 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 CNP520, AMG 334, AMG 301, CAD106, other BACE
inhibitors of Novartis and Amgen, and other investigational compounds of
Novartis and Amgen subject to the partnership and collaboration will be
submitted or approved for sale in any market, or at any particular time. Nor
can there be any guarantee that Exelon Patch will be submitted or approved
for any additional indications or labeling in any market, or at any
particular time. Neither can there be any guarantee that the partnership and
collaboration with Amgen will achieve any or all of its intended goals and
objectives, or be commercially successful. Nor can there be any guarantee
that Exelon Patch or any of the investigational compounds subject to the
partnership and collaboration with Amgen will be commercially successful in
the future. In particular, management's expectations regarding such
investigational compounds and products, and the partnership and collaboration
with Amgen could be affected by, among other things, 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; 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 issues; unexpected manufacturing or quality 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...

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