Novartis announces AMG 334 significantly reduces patients' monthly migraine days in phase II study of chronic migraine prevention
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Novartis announces AMG 334 significantly reduces patients' monthly migraine days
in phase II study of chronic migraine prevention
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* Phase II 20120295 study of AMG 334 met primary endpoint, confirming efficacy
and safety in patients with chronic migraine over 12 weeks of treatment
* Migraine is a leading cause of disability, affecting more than 10% of people
worldwide - within the overall migraine population, people with chronic
migraine experience the greatest impact on daily activities and quality of
life
* AMG 334 is being co-developed by Novartis and Amgen
Basel, 8 June 2016 - Novartis today announced positive first results from the
global phase II 20120295 study, investigating the efficacy and safety of the
fully human monoclonal antibody AMG 334 (erenumab) in chronic migraine
prevention. The study evaluated AMG 334 at two doses, 70mg and 140mg,
administered subcutaneously once a month, with both doses meeting the study's
primary endpoint of a statistically significant reduction in the number of
monthly migraine days versus placebo.
"Patients with chronic migraine live with the debilitating and disabling
symptoms of this disease for 15 or more days each month, significantly impacting
their everyday life and ability to work," said Vasant Narasimhan, Global Head,
Drug Development and Chief Medical Officer, Novartis. "We are delighted that
with this positive outcome, we are one step closer to providing patients with a
much-needed new treatment option to prevent chronic migraine. Also, we are
looking forward to assessing the benefit of AMG 334 in two ongoing phase III
studies in episodic migraine, with initial data from these studies expected
later this year."
Overall, patients had a mean baseline of 18 migraine days per month. Patients
randomized to the 70mg and 140mg dose groups experienced a mean 6.6-day
reduction from baseline in monthly migraine days in both groups. The results
were statistically significant compared with 4.2 days observed in the placebo
group.
The safety and tolerability profile of AMG 334 was similar to placebo in both
treatment groups. No adverse event was reported in greater than five percent of
patients treated with AMG 334; the most commonly reported adverse events
included injection site pain, infection of the upper respiratory tract and
nausea.
Additional analyses of these data are ongoing and are expected to be submitted
to a future medical meeting and for publication.
More complex than a headache, migraine is the most prevalent of all neurological
disorders, affecting more than 10% of the worldwide population.[1]-[4] Migraine
has a profound and limiting impact on patients' abilities to carry out everyday
tasks and as a result it is classed as the sixth leading cause of years lived
with disability.[3],[5] Chronic migraine patients experience the greatest impact
on daily activities and quality of life, with at least 15 headache days per
month, of which eight or more are migraines, for more than three
months.[4],[6],[7],[8],[9]
AMG 334 is being co-developed by Amgen and Novartis. As part of the
collaboration, Amgen retained commercialization rights in the U.S., Canada and
Japan, and Novartis has rights in Europe and rest of world.
About the 20120295 Study
The 20120295 study is a global phase II, randomized, 12-week, double-blind,
placebo-controlled study evaluating the efficacy and safety of AMG 334 in
chronic migraine prevention.[10] In the study, 667 patients were randomized to
receive once-monthly subcutaneous placebo or AMG 334 (70mg or 140mg) in a 3:2:2
ratio respectively.[10] The primary outcome measure was the change in monthly
migraine days from baseline to the last four weeks of the 12-week treatment
phase in patients with chronic migraine (the number of migraine days between
weeks 9 and 12).[10] Secondary study endpoints included proportion of patients
with at least a 50% reduction from baseline in monthly migraine days in the last
four weeks of the 12-week treatment phase (50% responder rate), acute migraine-
specific medication use days, cumulative hours of headache, and safety and
tolerability.[10]
About Migraine
Migraine 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.[11] Migraine is associated with personal
and societal burdens of pain, disability, reduced quality of life and financial
cost, and it remains under-recognized and under-treated with more than 40% of
people going undiagnosed.[5],[12] Chronic migraine is characterized by at least
15 headache days per month, of which eight or more are migraines, for more than
three months.[7]
About AMG 334
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, which is believed to transmit
signals that can cause pain.[13] AMG 334 is currently under evaluation in
several large global, randomized, double-blind, placebo-controlled trials to
assess its safety and efficacy in chronic and episodic migraine prevention.
About the Amgen and Novartis Neuroscience Collaboration
In August 2015, Novartis entered into a global collaboration with Amgen to
commercialize and develop 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 I/IIa study for AD)
will be the lead molecule and further compounds from both companies' pre-
clinical BACE inhibitor programs may be considered as follow-on molecules. The
collaboration also focuses on investigational Amgen drugs in the migraine field,
including AMG 334 (currently in phase III studies for episodic migraine and a
phase II study for chronic migraine) and AMG 301 (currently in a phase I study
for migraine). For the migraine program, Novartis will have global co-
development rights and commercial rights outside the U.S., Canada, and Japan.
About Novartis in Neuroscience
Novartis has a strong ongoing commitment to neuroscience (NS) and to bringing
innovative treatments to patients suffering from neurological conditions where
there is a high unmet need. We currently offer patients and physicians a large
drug portfolio encompassing Multiple Sclerosis (MS), Alzheimer's disease,
Parkinson's disease, Epilepsy and Attention Deficit Hyperactivity Disorder, and
have a promising pipeline in MS, Alzheimer's disease, migraine and specialty
neurology (e.g. neuropathic pain).
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "one step closer," "looking forward," "ongoing," "expected,"
"under investigation," "under evaluation," "pioneering," "will," "may,"
"commitment," "promising," "pipeline," or similar terms, or by express or
implied discussions regarding potential marketing approvals for AMG 334, AMG
301, CNP520, and the other investigational compounds of Novartis and Amgen
subject to the collaboration, regarding potential new indications or labeling
for the products in the Novartis Neuroscience portfolio, or regarding potential
future revenues from such products and investigational compounds, 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, AMG 301, CNP520, and the 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 any
of the products in the Novartis Neuroscience portfolio will be submitted or
approved for any additional indications or labeling in any market, or at any
particular time. Nor 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. Neither can there be any guarantee that any of AMG
334, AMG 301, CNP520, the other investigational compounds subject to the
collaboration with Amgen, or the products 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 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, 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 visit
http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
References
[1] Edvinsson L. CGRP receptor antagonists and antibodies against CGRP and its
receptor in migraine treatment. Br J Clin Pharmacol 2015; 80(2):193-9
[2] Hirtz D et al. How common are the "common" neurologic disorders? Neurology.
2007; 68(5):326-37
[3] Vos T et al. Global Burden of Disease Study. Lancet. 2015;386(9995):743-800
[4] Stovner L, et al. The global burden of headache: a documentation of headache
prevalence and disability worldwide. Cephalalgia. 2007; 27(3):193-210
[5] World Health Organization. Headache disorders.
http://www.who.int/mediacentre/factsheets/fs277/en/ (link is external). Accessed
June 2016.
[6] World Health Organization. Atlas Country Resources for Neurological
Disorders 2004. http://www.who.int/mental_health/neurology/neurogy_atlas_lr.pdf
(link is external). Accessed June 2016
[7] International Headache Society. The International Classification of Headache
Disorders. http://ihs-
classification.org/en/02_klassifikation/02_teil1/01.05.01_migraine.html (link is
external). Accessed June 2016
[8] Natoli JL et al. Global prevalence of chronic migraine: a systematic review.
Cephalalgia. 2010; 30(5):599-609
[9] Adams A et al. The impact of chronic migraine: The Chronic Migraine
Epidemiology and Outcomes (CaMEO) Study methods and baseline results.
Cephalalgia. 2015; 35(7): 563-578
[10] ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of AMG 334
in Chronic Migraine Prevention.
https://clinicaltrials.gov/ct2/show/NCT02066415?term=20120295&rank=1 (link is
external). Last accessed June 2016
[11] National Institute for Neurological Disorders and Stroke. Headache: Hope
Through Research.
http://www.ninds.nih.gov/disorders/headache/detail_headache.htm (link is
external). Accessed June 2016.
[12] 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
[13] Hansen JM et al. Calcitonin gene-related peptide triggers migraine-like
attacks in patients with migraine with aura. Cephalalgia. 2010; 30(10):1179-86
# # #
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Datum: 08.06.2016 - 22:30 Uhr
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News-ID 476637
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