After review of clinical data from the Generation Program studies, the sponsors concluded that the potential benefit for participants taking CNP520 no longer outweighs the risk
Basel, July 11, 2019 - Novartis, Amgen and Banner Alzheimer's Institute today announced the decision to discontinue investigation of the BACE1 inhibitor CNP520 (umibecestat) in two pivotal Phase II/III studies in the Alzheimer's Prevention Initiative Generation Program. An assessment of unblinded data during a regular pre-planned review identified worsening in some measures of cognitive function. Given these findings, the sponsors concluded that the potential benefit for participants in the studies did not outweigh the risk.
John Tsai (M.D.), Head of Global Drug Development and Chief Medical Officer, said: "Novartis has a strong research focus and commitment to patients. As researchers we have to accept today's disappointing news as part of the search for innovative new treatments. We remain committed to advancing science in Alzheimer's disease and continue to seek future solutions for people with neurodegenerative conditions."
Alzheimer's is a complex disease and one of the largest challenges facing healthcare today. The Generation Program sponsors are grateful to the participants and their study partners and the medical community for their contributions to advancing Alzheimer's research.
CNP520 was being assessed for safety and efficacy in the prevention or delay of the onset of Alzheimer's in people at high risk for developing symptoms based on their age and genetic status. The study sponsors are informing investigators of the decision to discontinue the clinical program of CNP520 in Alzheimer's prevention, and advising that participants should stop taking the investigational treatment. The clinical investigators will contact participants to discuss what happens next, including follow-up appointments as appropriate.
The study sponsors intend to further assess and present the data at a future scientific venue. Dr. Tsai said: "Beyond presenting our analyses, we will go a step further and will also share our data with the scientific community, not only to contribute to the increasing body of knowledge in Alzheimer's research but to add value to ongoing discussions with governments, multilateral organizations, patient groups, pharmaceutical companies, and society, to ensure that we collectively address the public health challenges presented by this disease."
Novartis has a strong ongoing commitment to neuroscience and to bringing innovative treatments to patients with or at risk of developing neurological conditions where there is a high unmet need. We are committed to supporting patients and physicians in many disease areas, including Multiple Sclerosis (MS), migraine, Spinal Muscular Atrophy (SMA) and specialty neurological conditions. Our neuroscience pipeline remains robust with four molecules currently in clinical development, as well as early assets in Alzheimer's.
About the Novartis and Amgen Neuroscience Collaboration
In August 2015, Novartis entered into a global collaboration with Amgen to develop and commercialize pioneering treatments in the field of migraine and Alzheimer's disease.
The Generation Program studies are sponsored by Novartis and Amgen, in collaboration with Banner Alzheimer's Institute. Novartis is the regulatory sponsor, while Amgen and Novartis are co-development partners.
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products or the collaboration with Amgen. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations 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 the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling 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, or within any particular time frame. Nor can there be any guarantee that such products or the collaboration with Amgen will be commercially successful in the future. In particular, our expectations regarding such 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; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the outcome of litigation and legal disputes, including the legal dispute with Amgen regarding our collaboration agreements in the field of migraine; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, 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.
Novartis is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis products reach more than 750 million people globally and we are finding innovative ways to expand access to our latest treatments. About 105 000 people of more than 140 nationalities work at Novartis around the world. Find out more at www.novartis.com.
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