Novartis expands global collaboration with Amgen to commercialize first-in-class AMG 334 (erenumab) program in migraine prevention in the US and Canada
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Novartis International AG /
Novartis expands global collaboration with Amgen to commercialize first-in-class
AMG 334 (erenumab) program in migraine prevention in the US and Canada
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* Novartis and Amgen to co-commercialize AMG 334 (erenumab) in the US;
Novartis to gain exclusive rights in Canada
* Novartis retains commercial rights in rest of world; Amgen retains
commercial rights in Japan
* Companies to combine capabilities and leverage Novartis strong and
established neuroscience presence in the US and across the globe to maximize
launch of AMG 334 (erenumab)
Basel, April 24, 2017 - Novartis today announced an expanded commercialization
agreement with Amgen for AMG 334 (erenumab), which is being investigated for the
prevention of migraine. This agreement builds on a 2015 global collaboration
between Novartis and Amgen, and leverages almost 70 years of Novartis experience
in neuroscience to more effectively reach people with migraine. Novartis and
Amgen will co-commercialize AMG 334 (erenumab) in the US. Novartis will retain
exclusive rights to commercialize the drug in rest of world and will gain
commercialization rights in Canada. Amgen retains exclusive commercialization
rights in Japan. The companies will continue global co-development.
AMG 334 (erenumab) is a fully human monoclonal antibody specifically designed
for the prevention of migraine. It targets and blocks the Calcitonin Gene-
Related Peptide (CGRP) receptor, believed to play a critical role in mediating
the incapacitating pain of migraine.[1] Positive results from a Phase II study
and two Phase III studies of AMG 334 (erenumab) in migraine prevention were
announced in 2016. In these studies, once-monthly subcutaneous AMG 334
(erenumab) significantly reduced monthly migraine days versus placebo and
demonstrated a safety profile comparable to placebo.[2],[3],[4] Detailed results
from the Phase III studies are being presented at the annual meeting of the
American Academy of Neurology and submitted for publication. These data will
help support discussions with regulatory agencies, with filing anticipated in
the second quarter of 2017.
"Migraine is a debilitating neurological disease associated with significant
personal, economic, and societal burden. There is an urgent need for effective
and well-tolerated preventive treatments that positively impact the lives of
people with migraine," said Paul Hudson, Chief Executive Officer, Novartis
Pharmaceuticals. "We are excited to expand our collaboration with Amgen. We look
forward to combining capabilities and leveraging our strong heritage in
neuroscience in the US and Canada to bring erenumab to more patients in need, as
fast as we can."
Under the terms of the agreement, Amgen will receive milestone payments from
Novartis, expected to begin in 2017. Novartis will share US commercialization
costs with Amgen. Amgen will book sales of AMG 334 (erenumab) in the US, and
will pay a royalty to Novartis on net sales in the US. Novartis will book sales
in rest of the world, excluding Japan, and will pay Amgen royalties on the net
sales in those countries. Amgen will book sales in Japan, since it will remain
an exclusive territory for the company. Novartis will assume agreed upon
remaining global development costs up to a cap and share global development
costs thereafter.
The agreement is an expansion of a global collaboration with Amgen announced in
August 2015 in neuroscience, involving joint development and commercialization
of pioneering treatments in the field of Alzheimer's disease and migraine.[5]
About AMG 334 (erenumab)
AMG 334 (erenumab) is a fully human monoclonal antibody specifically designed to
target and block the Calcitonin Gene-Related Peptide (CGRP) receptor, believed
to play a critical role in mediating the incapacitating pain of migraine.[1] AMG
334 (erenumab) has been studied in several large global, randomized, double-
blind, placebo-controlled trials to assess its safety and efficacy in migraine
prevention. Following the initial Phase II dose finding study, the efficacy of
AMG 334 (erenumab) in migraine prevention has been shown in a Phase II trial and
two Phase III trials. The safety profile of AMG 334 (erenumab) in these studies
was comparable to placebo.[2],[3],[4]
About Migraine
Migraine is a distinct neurological disease.[6] It involves recurrent attacks of
moderate to severe head pain that is typically pulsating, often unilateral and
associated with nausea, vomiting and sensitivity to light, sound and odors.[7]
Migraine is associated with personal pain, disability and reduced quality of
life, and financial cost to society.[8] It has a profound and limiting impact on
an individual's abilities to carry out everyday tasks, and was declared by the
World Health Organization to be one of the top 10 causes of years lived with
disability for men and women.[9] It remains under-recognized and under-
treated.[8],[10] Existing preventive therapies have been repurposed from other
indications and are often associated with poor tolerability and lack of
efficacy, which lead to increasing discontinuation rates and dissatisfaction
among patients.[11]
About the Amgen and Novartis Neuroscience Collaboration
In August 2015, Novartis entered into a global collaboration with Amgen to
jointly develop and commercialize pioneering neuroscience treatments in the
field of Alzheimer's disease (AD) and migraine. The companies are partnering in
the development and commercialization of a beta-secretase 1 (BACE) inhibitor
program in AD. Novartis' oral therapy CNP520 (currently in a Phase II/III study
for AD) will be the lead molecule and further compounds from both companies'
pre-clinical BACE inhibitor programs may be considered as novel follow-on
molecules. The 2015 collaboration also focuses on innovative investigational
Amgen drugs in the migraine field, including AMG 334 (erenumab) in migraine
prevention and AMG 301 (currently in a Phase I study for migraine).
Novartis in Neuroscience
Novartis has a strong ongoing commitment to neuroscience and to bringing
innovative treatments to patients suffering from neurological conditions where
there is a high unmet need. We are committed to supporting patients and
physicians in multiple disease areas, including Multiple Sclerosis (MS),
Alzheimer's disease (AD), Parkinson's disease, Epilepsy and Attention Deficit
Hyperactivity Disorder, and have a promising pipeline in MS, AD, migraine and
specialty neurology (e.g. neuropathic pain).
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "to co-commercialize," "to gain," "to combine," "launch,"
"being investigated," "builds on," "will," "believed to," "submitted,"
"anticipated," "excited," "look forward," "expected," "pioneering," "may,"
"investigational," "ongoing," "commitment," "pipeline," or similar terms, or by
express or implied discussions regarding potential marketing approvals for AMG
334, CNP520, AMG 301, other BACE inhibitors of Novartis and Amgen, and other
investigational compounds of Novartis and Amgen subject to the collaboration,
potential new indications or labeling for products in the Novartis Neuroscience
portfolio, or regarding potential future revenues from such investigational
compounds and products, and potential future revenues from the 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 AMG 334, CNP520, AMG 301, other BACE
inhibitors of Novartis and Amgen, or other investigational compounds of Novartis
and Amgen subject to the collaboration 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 will achieve any or all of its intended goals and
objectives, or be commercially successful. Nor can there be any guarantee that
any product in the Novartis Neuroscience portfolio 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 AMG 334, CNP520, AMG 301, any of
the other investigational compounds subject to the collaboration with Amgen, or
any product in the Novartis Neuroscience portfolio will be commercially
successful in the future. In particular, management's expectations regarding
such investigational compounds and products, and the collaboration with Amgen,
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; 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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References
[1] Bigal ME et al. Calcitonin Gene-Related Peptide (CGRP) and Migraine Current
Understanding and State of Development. Headache. 2013;53(8):1230-1244.
[2] Novartis presents new positive data at EHMTIC showing AMG 334 significantly
reduces monthly migraine days in chronic
migraine. https://www.novartis.com/news/media-releases/novartis-presents-new-
positive-data-ehmtic-showing-amg-334-significantly-reduces. Accessed April 2017.
[3] Novartis announces Phase III study shows AMG 334 significantly reduces
monthly migraine data in people with episodic
migraine. https://www.novartis.com/news/media-releases/novartis-announces-phase-
iii-study-shows-amg-334-significantly-reduces-monthly. Accessed April 2017.
[4] Novartis announces AMG 334 significantly reduces monthly migraine days in
second pivotal Phase III episodic migraine study.
https://www.novartis.com/news/media-releases/novartis-announces-amg-334-
significantly-reduces-monthly-migraine-days-second. Accessed April 2017.
[5] Novartis announces global partnership with Amgen to develop and
commercialize pioneering neuroscience treatments.
https://www.novartis.com/news/media-releases/novartis-announces-global-
partnership-amgen-develop-and-commercialize-pioneering. Accessed April 2017.
[6] Migraine Research Foundation. Migraine Fact Sheet. 2015.
http://www.migraineresearchfoundation.org/fact-sheet.html. Accessed April 2017.
[7] National Institute for Neurological Disorders and Stroke.
https://www.ninds.nih.gov/Disorders/All-Disorders/Migraine-Information-Page
(link is external). Accessed April 2017.
[8] World Health Organization. Headache disorders.
http://www.who.int/mediacentre/factsheets/fs277/en/ (link is external). Accessed
October 2016.
[9] World Health Organization. Estimates for 2000-2012. Disease Burden. 2012.
[10] Diamond S et al. Patterns of Diagnosis and Acute and Preventive Treatment
for Migraine in the United States: Results from the American Migraine Prevalence
and Prevention Study. Headache. 2007;47(3):355-63.
[11] Hepp Z, et al. Adherence to oral migraine-preventive medications among
patients with chronic migraine. Cephalalgia. 2015; 35(6):478-88.
# # #
Novartis Media Relations
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E-mail: media.relations(at)novartis.com
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Novartis Global Media Relations Novartis Global Pharma Communications
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+41 79 593 4202 (mobile) + 41 79 752 6955 (mobile)
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Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 24.04.2017 - 22:30 Uhr
Sprache: Deutsch
News-ID 537964
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contact information:
Town:
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Kategorie:
Business News
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