(RTTNews) – MorphoSys AG (MOR) said that its licensing partner Roche (RHHBY) received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration, for the treatment of people living with Alzheimer’s disease.
The designation is based on data showing that gantenerumab significantly reduced brain amyloid plaque, a pathological hallmark of Alzheimer’s disease, in the ongoing Scarlet RoAD and Marguerite RoAD open-label extension trials, as well as other studies.
MorphoSys noted that Roche is evaluating the safety and efficacy of gantenerumab in these two pivotal trials with more than 2,000 participants for more than two years. The trials are expected to be completed in the second half of 2022.
The FDA Breakthrough Therapy Designation is a process designed to expedite the development and review of drug candidates that are intended to treat serious or life-threatening conditions with preliminary evidence that indicates they may demonstrate a substantial improvement over available therapies that have received full FDA approval.
Gantenerumab is an investigational IgG1 antibody designed to bind to aggregated forms of beta-amyloid and remove brain amyloid plaques, a pathological hallmark of Alzheimer’s disease.
The fully human monoclonal antibody was generated by MorphoSys using its proprietary HuCAL antibody technology. As per the terms of the licensing deal, Roche is fully responsible for the clinical development and potential commercialisation of gantenerumab.
MorphoSys is entitled to receive tiered royalties, ranging from 5.5% to 7.0%, on net product sales and potential success-based regulatory milestone payments related to gantenerumab.
MorphoSys will retain 40% of future royalties on gantenerumab, as outlined in the funding partnership between MorphoSys and Royalty Pharma.