Novartis announces AMG 334 significantly reduces patients' monthly migraine days in phase II study of chronic migraine prevention - Seite 3
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).
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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.