Amgen and Novartis Expand Alzheimer’s Collaboration with BAI

Novartis, Amgen and the Banner Alzheimer’s Institute (BAI) have now announced an expanded collaboration to initiate a new trial – the Alzheimer’s Prevention Initiative (API) Generation Study 2.

This will be an expansion of the two-year-old deal with BAI. This trail follows the launch of the Generation Study 1 and will determine whether the BACE1 inhibitor CNP520 can prevent or delay the onset of Alzheimer’s disease symptoms in a high-risk population. BACE1 is an enzyme that plays an important role in the production of Amyloid ß, a protein which accumulates in the brains of individuals with AD years before clinical symptoms begin.

“Expanding our collaboration with Banner Alzheimer’s Institute stands testament to our belief that preventing amyloid buildup is one of the most promising approaches to treating Alzheimer’s disease,” said Vas Narasimhan, M.D., Global Head Drug Development and Chief Medical Officer for Novartis. “If we determine that our BACE1 inhibitor can prevent or delay the onset of symptoms in healthy yet high-risk populations, this would represent a tremendous breakthrough for those that may face this debilitating disease.”

“As a leader in the challenging fight to unlock the biology of serious illnesses like Alzheimer’s disease, we are pleased to support the launch of the Generation Study 2 with our partners at Novartis and Banner Alzheimer’s Institute to further explore promising potential therapeutic options for this highly debilitating disease,” said Sean Harper, Amgen’s executive vice president of Research and Development, in a statement. “Through the unique combination of genetic testing and counseling in cognitively healthy adults, the Generation Study 2 exhibits an innovative clinical approach that may offer insight towards Alzheimer’s prevention for those at highest risk for developing the disease.”

“This expanded collaboration builds upon the API Generation Study 1 which launched last year, and is another step in our effort to take clinical trials to a critical new stage,” said Pierre N. Tariot, MD, co-director of API and director of BAI, a division of Banner Health, one of the largest nonprofit healthcare systems in the U.S. “This approach continues to shift the Alzheimer’s research paradigm from reversing disease damage to attacking its root cause before symptoms surface. It is our hope that by targeting people earlier, we will have a better chance of delaying or preventing the onset of the disease.”

The Alzheimer’s Prevention Initiative (API) is an international collaborative research program led by the Banner Alzheimer’s Institute. It conducts trials in cognitively healthy people at high-risk of Alzheimer’s with a focus on prevention. Part of the initiative is the establishment of brain imaging, biological and cognitive measurements to test promising prevention treatments and to assist registries in enrollment for future prevention trials.

The two companies, Amgen and Novartis, launched their Neuroscience Collaboration in 2016, with the intention to develop and commercialize therapies in the field of a migraine and Alzheimer’s disease.

In April 2017, the collaboration expanded to include co-commercialization of Aimovig in the U.S. Amgen retains exclusive rights to commercialize drugs other than Aimovig in the migraine program in the U.S. and Japan, and Novartis has exclusive commercialization rights in Europe, Canada and the rest of the world. The two companies are also collaborating on a BACE inhibitor program in Alzheimer’s disease.