INDIANAPOLIS—AstraZeneca and Eli Lilly and Co. have inked an agreement for the joint development and commercialization of the former’s AZD3293, an oral, small-molecule beta secretase cleaving enzyme (BACE) inhibitor being developed as a potential treatment for Alzheimer’s disease.
The companies intend to rapidly progress the compound into a Phase 2/3 clinical trial in patients with early Alzheimer’s disease, with Lilly taking the lead on clinical development in concert with researchers from AstraZeneca’s Innovative Medicines Unit for neuroscience. For its part, AstraZeneca will be responsible for manufacturing, and both companies will be jointly responsible for commercialization.
Per the terms of the agreement, AstraZeneca stands to receive up to $500 million in development and regulatory milestone payments, with the first payment of $50 million expected in the first half of 2015. All future development and commercialization costs will be shared equally, as will net global revenues post-launch.
“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,” stated David Ricks, senior vice president of Lilly and president of 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.”
The chief culprit in Alzheimer’s disease is the formation of amyloid plaque in the brain, plaques that are composed of peptides known as amyloid beta. BACE is an enzyme associated with the development of these peptides, and it is thought that inhibition of BACE could prevent the formation of the plaques and slow the disease’s progression. In Phase 1 studies, AZD3293 has been shown to significantly and dose-dependently reduce levels of amyloid beta in the cerebro-spinal fluid of Alzheimer’s patients and healthy volunteers.
“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. We are looking forward to working with Lilly, an organization with a long-term commitment to and expertise in treating Alzheimer’s disease,” Mene Pangalos, executive vice president of Innovative Medicines & Early Development at AstraZeneca, said in a press release. “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.”
SOURCE: AstraZeneca press release