MorphoSys AG [NASDAQ: MOR] revealed that its licensing partner Roche secured Breakthrough Therapy Designation by the U.S. FDA for gantenerumab for the cure of people suffering from Alzheimer’s disease (AD). The FDA Breakthrough Therapy Designation is a process intended to accelerate the expansion and evaluation of drug candidates that are proposed to cure critical or life-threatening conditions.
The FDA designation which Roche secured is based on data demonstrating that gantenerumab considerably decreased brain amyloid plaque, a pathological hallmark of AD, in the continuing SCarlet RoAD and Marguerite RoAD open-label extension trials, as well as other findings. Roche is striving to find the safety and efficacy of gantenerumab in two pivotal studies with more than 2,000 participants for more than two years. The trials are anticipated to be executed in the second half of 2022.
Gantenerumab is a trial IgG1 antibody intended to bind to accumulated forms of beta-amyloid and eliminate brain amyloid plaques, a pathological hallmark of Alzheimer’s disease (AD). The fully human monoclonal antibody was created by MorphoSys using its patented HuCAL antibody technology. As per the licensing agreement, Roche is fully entitled to the clinical development and marketing of gantenerumab.
Furthermore, the licensing agreement allows MorphoSys to secure tiered royalties, ranging from 5.5% to 7.0%, on net product sales and potential success-based regulatory breakthrough payments related to gantenerumab. MorphoSys will hold 40% of future royalties on gantenerumab, as summarized in the funding collaboration between MorphoSys and Royalty Pharma.