- Two Novartis anti-amyloid investigational treatments will be studied in people with a genetic risk of developing Alzheimer's Disease (AD)
- The build-up of amyloid in the brain is believed to be a critical factor in the development of AD
- The innovative study will assess whether it is possible to prevent or delay the development of AD; current treatments provide only symptomatic relief
Novartis announced on July 15th a collaboration with Banner Alzheimer's Institute (BAI) on a pioneering clinical study in Alzheimer's disease (AD) prevention. The study will determine whether two Novartis investigational anti-amyloid treatments can prevent or delay the emergence of symptoms of AD in people identified as being at genetic risk for developing the late-onset form of the disease.
Using an innovative trial design, the two treatments will be given in cognitively healthy people at genetic risk of developing the build-up of amyloid protein in the brain that may eventually lead to AD. One treatment is an active immunotherapy, a treatment that stimulates an immune response, and triggers the production of natural antibodies against amyloid. This investigational treatment, given via an injection, is in phase II clinical development. The second treatment, a BACE inhibitor, is an oral medication about to enter phase I trials and is designed to prevent the production of different forms of amyloid.
Early in the course of Alzheimer's disease, amyloid build-up in the brain is evident and is thought to be a key factor in driving the subsequent progressive damage and clinical symptoms in AD. The aim of the study is to assess whether these investigational treatments could prevent, slow or delay the loss of memory and other cognitive abilities associated with Alzheimer's disease. Current treatments for AD only address the symptoms of the disease. It is estimated that around 44 million people globally have Alzheimer's or a related dementia.
"We are delighted to announce this collaboration with the Banner Alzheimer's Institute." said David Epstein, Division Head, Novartis Pharmaceuticals. "This trial reinforces Novartis' focus to following the science of the disease and outlines our continued commitment to the study of Alzheimer's Disease.There is a huge unmet need for treatments that prevent or delay the development of the disease and we are excited about taking research in Alzheimer's to the next level."
The study, which will be run in collaboration with the BAI, will involve more than 1,300 cognitively healthy adults, ages 60 to 75, with a genetic risk of developing symptoms of AD because they inherited two genetic copies of the apolipoprotein E epsilon 4 (APOE4) allele - one from each parent. About 2 percent of the world's population has this genetic profile, which is strongly linked to late-onset AD. Participants in the study will be given either the active immunotherapy, the BACE inhibitor or placebo. Pending regulatory approval, the study is planned to start in 2015 in sites in North America and Europe.
About Novartis in Alzheimer's Disease
Novartis has a strong commitment to the treatment of Alzheimer's Dementia. Exelon® Patch (rivastigmine transdermal system) is approved for the treatment of mild-to-moderate Alzheimer's disease dementia (AD) in more than 90 countries. Exelon Patch is also approved for the treatment of patients with severe AD in the US and nine additional countries. In Europe, the high-dose patch (15 cm2) for mild-to-moderately severe AD was launched in several markets in 2013. Exelon Patch has been used to treat more than 3 million patients in clinical trials and the post-marketing setting.
It is estimated that around 44 million people globally have Alzheimer's or a related dementia1. Alzheimer's disease is an irreversible, progressive brain disease that slowly destroys memory and thinking skills and, eventually even the ability to carry out the simplest tasks of daily living. In most people with Alzheimer's, symptoms first appear after age 60. Alzheimer's disease is the most common cause of dementia among older people. Although treatment can help manage symptoms in some people, currently there is no cure for this devastating disease.
The foregoing release contains forward-looking statements that can be identified by words such as "pioneering," "will," "may," "investigational," "about to," "aim," "could," "commitment," "planned," or similar terms, or by express or implied discussions regarding potential future marketing submissions or approvals for CAD106 and the investigational BACE inhibitor, or regarding potential future revenues from CAD106, the investigational BACE inhibitor and Exelon Patch. 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 CAD106 or the investigational BACE inhibitor will be submitted or approved for sale in any market, or at any particular time. Nor can there be any guarantee that CAD106, the investigational BACE inhibitor or Exelon Patch will be commercially successful in the future. In particular, management's expectations regarding such investigational compounds and Exelon Patch 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 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 Banner Alzheimer's Institute
Banner Alzheimer's Institute (BAI) is a nonprofit organization dedicated to the goal of ending Alzheimer's disease without losing another generation. It is helping to launch a new era of Alzheimer's research-detection, treatment and prevention at the pre-symptomatic stage-and to establish a comprehensive model of care that can be the national standard. BAI was founded in 2006 by Phoenix-based Banner Health, one of the country's largest nonprofit healthcare systems. For more information, go to www.banneralz.org.
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, cost-saving generic pharmaceuticals, preventive vaccines, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 135,000 full-time-equivalent associates and sell products in more than 150 countries around the world. For more information, please visit http://www.novartis.com.
 Policy Brief for Heads of Government: The Global Impact of Dementia 2013-205. Published by Alzheimer's Disease International (ADI), London. December 2013.