MARTINSRIED / MUNICH, Germany, Dec. 19, 2014 (GLOBE NEWSWIRE) -- MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX, OTC: MPSYY) was informed today that its partner Roche (SIX: RO, ROG; OTCQX: RHHBY) has decided to discontinue the phase 3 SCarletRoAD trial of gantenerumab in prodromal Alzheimer's Disease patients. The decision is based on a pre-planned futility analysis and a recommendation by the independent Data Monitoring Committee. According to Roche, no new safety signals were observed in the SCarletRoAD trial and the overall safety profile was similar to that seen in the phase 1 study. The second Roche-sponsored phase 3 trial of gantenerumab in mild Alzheimer's Disease patients (Marguerite RoAD) will continue. Today's news has no impact on MorphoSys's financial guidance.
"The discontinuation of the SCarletRoAD study is regrettable. Nevertheless, two trials in patients with mild Alzheimer's Disease and in genetically pre-disposed individuals are continuing", commented Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys AG. "MorphoSys has a very broad clinical pipeline including three programs in pivotal studies and ten in phase 2 trials. Due to the breadth of our pipeline we are not dependent on the outcome of individual trials and compounds in development."
MorphoSys's partnered and proprietary clinical pipeline currently comprises 21 unique antibody molecules which are being evaluated in more than 60 clinical trials. In total, MorphoSys's product pipeline comprises 94 partnered and proprietary programs which are being evaluated in a broad range of indications.
Gantenerumab, a fully human antibody targeting amyloid-beta, is in development for the treatment of Alzheimer's Disease. The discontinued SCarletRoAD study has enrolled 799 pre-symptomatic patients with so-called prodromal Alzheimer's Disease. Two additional clinical studies are currently ongoing. The Marguerite RoAD trial is a Phase 3 study evaluating gantenerumab in approx. 1,000 patients with mild Alzheimer's Disease. The second trial, run by the Dominantly Inherited Alzheimer Network (DIAN), assesses the safety, tolerability and biomarker efficacy of gantenerumab in individuals who have a genetic predisposition for Alzheimer's disease.
MorphoSys developed HuCAL, the most successful antibody library technology in the pharmaceutical industry. By successfully applying this and other patented technologies, MorphoSys has become a leader in the field of therapeutic antibodies, one of the fastest-growing drug classes in human healthcare.
Together with its pharmaceutical partners, MorphoSys has built a therapeutic pipeline of more than 90 human antibody drug candidates for the treatment of cancer, rheumatoid arthritis, and Alzheimer's disease, to name just a few. With its ongoing commitment to new antibody technology and drug development, MorphoSys is focused on making the healthcare products of tomorrow. MorphoSys is listed on the Frankfurt Stock Exchange under the symbol MOR. For regular updates about MorphoSys, visit http://www.morphosys.com.
HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT®, arYla®, Ylanthia® and 100 billion high potentials® are registered trademarks of MorphoSys AG.
Slonomics® is a registered trademark of Sloning BioTechnology GmbH, a subsidiary of MorphoSys AG.
This communication contains certain forward-looking statements concerning the MorphoSys group of companies. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve risks and uncertainties. Should actual conditions differ from the Company's assumptions, actual results and actions may differ from those anticipated. MorphoSys does not intend to update any of these forward-looking statements as far as the wording of the relevant press release is concerned.
For more information, please contact:
Dr. Claudia Gutjahr-Löser
Head of Corporate Communications & IR
Associate Director Corporate Communications & IR
Specialist Corporate Communications & IR
Specialist Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-404
Media Release (PDF) http://hugin.info/130295/R/1881944/663895.pdf