Novartis International AG: Novartis announces AMG 334 significantly reduces monthly migraine days in second pivotal Phase III episodic migraine study

Novartis International AG / Novartis announces AMG 334 significantly reduces monthly migraine days in second pivotal Phase III episodic migraine study . Processed and transmitted by Nasdaq Corporate Solutions. 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 (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 (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 (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 (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 (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/ (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/ (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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