Press Release: Novartis, Amgen and Banner Alzheimer's Institute discontinue clinical program with BACE inhibitor CNP520 for Alzheimer's prevention

Novartis International AG / Novartis, Amgen and Banner Alzheimer's

Institute discontinue clinical program with BACE inhibitor CNP520 for

Alzheimer's prevention. Processed and transmitted by West Corporation.

The issuer is solely responsible for the content of this announcement.

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.

Disclaimer

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.

About Novartis

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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Media release (PDF): http://hugin.info/134323/R/2246940/888069.pdf

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Source: Novartis International AG via Globenewswire

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(END) Dow Jones Newswires

July 11, 2019 16:30 ET (20:30 GMT)