May 12, 2014 — AC Immune SA and Piramal Imaging, a division of Piramal Enterprises Ltd., have entered into an exclusive worldwide license agreement for the research, development and commercialization of AC Immune’s Tau protein positron emission tomography (PET) tracers supporting the diagnosis and clinical management of Alzheimer’s disease (AD) and potential Tau-related disorders.
The formation of Tau tangles in the human brain is recognized as one of two major hallmarks of Alzheimer’s disease pathology, with the other being beta-amyloid plaques. The development of the Tau tangle pathology appears to correlate well with cognitive decline, making it a potential strong target for diagnostic approaches. The availability of a Tau-PET tracer for imaging Tau tangles in the brain of patients would represent important progress towards relevant diagnostic endpoints and could be of significant value in guiding clinical trials for disease modifying AD therapeutics.
Under the terms of the agreement, AC Immune will receive an undisclosed upfront payment and is eligible for significant milestone payments on products achieving development goals in AD and other Tauopathies. Additionally, AC Immune is entitled to receive tiered royalties on net sales of products resulting from the partnership.
AC Immune will work in collaboration with Piramal Imaging to efficiently advance several lead candidates through late pre-clinical radio-pharmacology development. Piramal Imaging will have global rights for clinical development, manufacturing and commercialization of a Tau-PET Tracer resulting from the collaboration. Financial details were not disclosed.
The agreement between the two companies is based on a long-term relationship in which AC Immune has used Piramal Imaging’s beta-amyloid PET Tracer Neuraceq for imaging beta-amyloid plaques in the brain of patients undergoing Phase I/IIa clinical testing of AC Immune´s Alzheimer´s vaccine ACI-24.
Neuraceq received marketing authorization from the U.S. Food and Drug Administration (FDA) on March 19, 2014 for PET imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for AD and other causes of cognitive decline. Safety and effectiveness of Neuraceq have not been established for monitoring responses to therapies. Neuraceq received similar approval by the EC four weeks earlier.