AstraZeneca and Eli Lilly and Company have reached an agreement for the development and commercialization of the oral beta secretes cleaving enzyme (BACE) inhibitor, AZD3293, which might become a viable treatment for Alzheimer’s disease. The oral therapy is expected to prevent the formation of amyloid plaque, which is comprised of peptides called amyloid beta, and slow the disease progression.
The agreement established stipulates that AstraZeneca will pay up to $500 million in development and regulatory milestone payments. Lilly announced that it is planning on receiving the first milestone payment of $50 million in the first half of 2015. Future costs will be equally shared by both companies, including net global revenues post-launch.
“Alzheimer’s disease is one of the biggest challenges facing medical science today and BACE inhibitors have the potential to target one of the key drivers of disease progression,” said the executive vice president of Innovative Medicines & Early Development at AstraZeneca, Mene Pangalos. “We are looking forward to working with Lilly, an organization with a long term commitment to and expertise in treating Alzheimer’s disease.
The purpose of the agreement is to progress AZD 3293 as soon as possible into a phase II and III clinical trial, and test it in patients with early Alzheimer’s. The clinical development of the oral therapy will be lead by Lilly, in collaboration with scientists from AstraZeneca’s Innovative Medicines Unit for neuroscience. AstraZeneca, on the other hand, will be responsible for the manufacturing of the drug and both companies will take joint responsibility for its commercialization.
“We believe that, by combining the scientific expertise from our two organizations and by sharing the risks and cost of late stage development, we will be able to accelerate the advancement of AZD3293 and progress a promising new approach to support the treatment of Alzheimer’s patients around the world. What’s more, this alliance will enable AstraZeneca to further sharpen our strategic focus on core therapeutic areas, while leveraging external collaborations to maximize the potential of the strong science we have in our growing pipeline,” he added.
The oral AZD3293 works by inhibiting BACE, which is believed to stop the formation of amyloid plaque and consequently slow the disease progression. The phase I studies of the potent and selective small molecule inhibitor of BACE revealed its significant and dose-dependently ability to reduce the levels of amyloid beta in the cerebro-spinal fluid of Alzheimer’s patients and healthy volunteers.
“Lilly has been committed to research in Alzheimer’s disease for more than 25 years, and we’re dedicated to developing new medicines that can change and modify the course of this devastating disease,” said David Ricks, Lilly Senior Vice President and President, Lilly Bio-Medicines. “Lilly’s pipeline of potential medicines and diagnostic agents targeting the known hallmarks of the disease has been bolstered today by this alliance with AstraZeneca, which shares our passion to bring new medicines to patients suffering from this debilitating illness. This alliance moves us one step closer to achieving our goal of making Alzheimer’s dementia preventable by 2025.”