MorphoSys’ Licensing Partner Roche Provides Update on Phase 3 GRADUATE Program for Gantenerumab in Early Alzheimer’s Disease
MorphoSys AG (FSE: MOR; NASDAQ: MOR) announced today that its licensing partner Roche (SIX: RO, ROG; OTCQX: RHHBY) provided an update on the GRADUATE I and II studies evaluating gantenerumab in people with early Alzheimer’s disease (AD). The studies did not meet their primary endpoint of slowing clinical decline. The level of beta-amyloid removal, the protein that builds up to make plaques in the brains of people with Alzheimer`s disease, was lower than expected. Gantenerumab was well tolerated, including the subcutaneous administration.
The GRADUATE Phase 3 program evaluated the safety and efficacy of gantenerumab in people with mild cognitive impairment (MCI) due to Alzheimer’s and mild Alzheimer’s dementia over 27 months. 1,965 study participants across 30 countries were randomized 1:1 to receive gantenerumab or placebo by subcutaneous injection titrated to reach a target dose of 510 mg administered every two weeks. Gantenerumab is a fully-human monoclonal IgG1 antibody that was discovered in collaboration with Roche.
“We are disappointed by these results as there are millions of people impacted every day by Alzheimer`s disease,” said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. “We are grateful to Roche, our long-standing partner, for their work on the GRADUATE program and their commitment to the Alzheimer’s community.”
The topline findings of the GRADUATE I and II studies will be presented at the upcoming Clinical Trials on Alzheimer’s Disease (CTAD) Conference on Wednesday, November 30, 2022 at 16:15 PT.
In September 2000, MorphoSys entered into a global collaboration agreement with Roche. As part of the agreement, Roche is fully responsible for the clinical development and potential commercialization 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 and pass 60% to Royalty Pharma. This is outlined in the funding agreement between MorphoSys and Royalty Pharma, which helped MorphoSys acquire Constellation Pharmaceuticals Inc. – expanding its potential best-in-class oncology pipeline.
About MorphoSys:
At MorphoSys, we are driven by our mission: More life for people with cancer. As a global commercial-stage biopharmaceutical company, we use groundbreaking science and technologies to discover, develop, and deliver innovative cancer medicines to patients. MorphoSys is headquartered in Planegg, Germany, and has its U.S. operations anchored in Boston, Massachusetts.