Novartis announces AMG 334 significantly reduces monthly migraine days in second pivotal Phase III episodic migraine study
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Novartis International AG /
Novartis announces AMG 334 significantly reduces monthly migraine days in second
pivotal Phase III episodic migraine study
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The issuer is solely responsible for the content of this announcement.
* STRIVE, the first six-month placebo-controlled study of AMG 334 (erenumab)
in migraine, met the primary endpoint, showing a statistically significant
reduction in monthly migraine days versus placebo
* Episodic migraine, characterized by up to 14 migraine days each month, can
lead to individuals missing days from work, school and social activities
* AMG 334 is being co-developed by Novartis and Amgen; companies to pursue
discussions with regulatory agencies for potential filings in respective
territories
Basel, November 16, 2016 - Novartis today announced positive topline results
from the global Phase III STRIVE study, evaluating the efficacy and safety of
the fully human monoclonal antibody AMG 334 (erenumab) in episodic migraine
prevention. Once-monthly subcutaneous AMG 334 was evaluated at 70mg and 140mg
doses, with both doses meeting the study's primary endpoint, demonstrating a
statistically significant reduction from baseline in mean monthly migraine days
at six months versus placebo.[1] AMG 334 is specifically designed to target and
block the Calcitonin Gene-Related Peptide (CGRP) receptor that is believed to
have a critical role in mediating the incapacitating pain of migraine.[2]
"Migraine is one of the world's most disabling diseases, and it remains under-
recognized and under-treated. There is a significant need for effective,
preventative treatments," said Vasant Narasimhan, Global Head Drug Development
and Chief Medical Officer for Novartis. "We have now seen positive results with
AMG 334 from two Phase III studies in episodic migraine and the Phase II study
in chronic migraine, involving almost 2,200 people with migraine. We're really
excited that these new six-month data provide further evidence of the potential
benefit AMG 334 could provide to people living with the debilitating symptoms of
this disease."
Patients enrolled in STRIVE were randomized to receive either placebo, or one of
two AMG 334 doses, 70mg or 140mg, subcutaneously, once monthly, for six
months.[1] Patients experienced between four and 14 migraine days each month,
with an average of 8.3 migraine days per month at baseline.[1] Over the last
three months of the double-blind treatment phase, patients in the 70mg and
140mg AMG 334 treatment arms experienced a statistically significant 3.2-day and
3.7-day reduction from baseline in mean monthly migraine days, respectively, as
compared to a 1.8-day reduction in the placebo arm.[1]
The safety profile of AMG 334 was comparable to placebo across both treatment
arms over the six-month double-blind evaluation.[1] The most frequently reported
adverse events were nasopharyngitis, upper respiratory tract infection and
sinusitis.[1]
Further analysis of the STRIVE data is ongoing. Positive results from ARISE, the
first Phase III study of AMG 334 in episodic migraine prevention, and results
from a Phase II study of AMG 334 in chronic migraine prevention, were announced
earlier this year.[3,4] These data will help support discussions with regulatory
agencies, with filing anticipated in 2017.
More complex than just a headache, migraine has been declared by the World
Health Organization to be one of the top 10 causes of years lived with
disability for men and women.[5] It has a profound and limiting impact on an
individual's ability to carry out everyday tasks and there is a real need for
more effective preventative treatments to help reduce the number of monthly
migraine days individuals experience.[6] People with episodic migraine
experience up to 14 migraine days each month.[7]
AMG 334 is being co-developed by Amgen and Novartis. As part of the
collaboration, Amgen has commercialization rights in the U.S., Canada and Japan,
and Novartis has commercialization rights in Europe and the rest of the world.
About the STRIVE study (NCT02456740)
STRIVE (NCT02456740) is a global Phase III, multicenter, randomized 24-week,
double-blind, placebo-controlled study evaluating the safety and efficacy of AMG
334 in episodic migraine prevention.[8] In the study, 955 patients were
randomized to receive once-monthly subcutaneous placebo, or AMG 334 (70mg or
140mg) in a 1:1:1 ratio.[1,8] Patients experienced between four and 14 migraine
days each month, with an average of 8.3 migraine days per month at baseline.[1]
The primary endpoint was change in mean monthly migraine days from baseline over
the last three months of the double-blind treatment phase of the study (months
four, five and six).[1,8]
Secondary study endpoints assessed in the last three months of a six-month
double-blind treatment phase included the proportion of patients with a
reduction of at least 50% from baseline in mean monthly migraine days, change
from baseline in mean monthly acute migraine-specific medication days, and
reductions from baseline in both mean impact on everyday activities domain and
mean physical impairment domain scores on the Migraine Physical Function Impact
Diary (MPFID).[8]
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.[9] Migraine is associated with personal
pain, disability and reduced quality of life, and financial cost to society.[10]
It remains under-recognized and under-treated with more than 40% of people going
undiagnosed.[10,11] Worldwide, approximately 90% of people diagnosed with
migraine have episodic migraine, which is characterized by up to 14 migraine
days a month.[7,12,13 ]The remaining 10% have chronic migraine, which is
characterized by at least 15 headache days per month, of which eight or more
days have migraine features, for more than three months.[12,13]
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 have a critical role in mediating the incapacitating pain of migraine.[2]
Following the initial Phase II dose finding study in the prevention of episodic
migraine, the efficacy of AMG 334 in migraine prevention has been shown in a
Phase II trial in chronic migraine and two Phase III trials in episodic
migraine.[1,3,4] The safety profile of AMG 334 in these trials was comparable to
placebo.[1,3,4] AMG 334 is being studied in several large global, randomized,
double-blind, placebo-controlled trials to assess its safety and efficacy in
migraine prevention.
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 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 collaboration also focuses on innovative investigational Amgen drugs in the
migraine field, including AMG 334 (currently in Phase III studies for episodic
migraine as well as open-label studies in episodic and chronic migraine) and AMG
301 (currently in a Phase I study). 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 "believed," "can," "being co-developed," "to pursue,"
"potential," "excited," "could," "ongoing," "will," "anticipated," "may,"
"commitment," "promising," "pipeline," or similar terms, or by express or
implied discussions regarding potential marketing approvals for AMG 334, CNP520
and AMG 301, potential new indications or labeling for products in the Novartis
Neuroscience portfolio, or regarding potential future revenues from such
investigational compounds and products. 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 or
AMG 301 will be submitted or approved for sale in any market, or at any
particular time. Neither 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. Nor can there
be any guarantee that AMG 334, CNP520, AMG 301 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 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.
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References
1 Novartis data on file.
2 Bigal ME et al. Calcitonin Gene-Related Peptide (CGRP) and Migraine Current
Understanding and State of Development. Headache. 2013;53(8):1230-1244.
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 October 2016.
4 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
October 2016.
5 World Health Organization. Estimates for 2000-2012. Disease Burden. 2012.
6 Buse DC et al. Assessing and Managing All Aspects of Migraine: Migraine
Attacks, Migraine-Related Functional Impairment, Common Comorbidities, and
Quality of Life. Mayo Clin Proc. 2009;84(5):422-435.
7 Katsarava Z et al. Chronic migraine: Classification and comparisons.
Cephalalgia. 2011;31:520-529.
8 ClinicalTrials.gov. Study to Evaluate the Efficacy and Safety of AMG 334 in
Migraine Prevention (STRIVE).
https://clinicaltrials.gov/ct2/show/NCT02456740 (link is external).
Accessed October 2016.
9 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 October 2016
10 World Health Organization. Headache disorders.
http://www.who.int/mediacentre/factsheets/fs277/en/ (link is external).
Accessed October 2016.
11 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.
12 National Migraine Centre. What is migraine?
http://www.nationalmigrainecentre.org.uk/migraine-and-headaches/migraine-
and-headache-factsheets/what-is-migraine/ (link is external). Accessed
October 2016.
13 Headache Classification Subcommittee of the International Headache Society.
The International Classification of Headache Disorders, 3rd edition (beta
version). Cephalalgia. 2013;33:629-808.
# # #
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Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 16.11.2016 - 22:30 Uhr
Sprache: Deutsch
News-ID 507633
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