MorphoSys's MOR208 Program to Receive Orphan Drug Designation from FDA and EMA for the Treatment of CLL/SLL
May 20, 2014 - London
MorphoSys AG /MorphoSys's MOR208 Program to Receive Orphan Drug Designation from FDA and EMA for the Treatment of CLL/SLL . Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely responsible for the content of this announcement.
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced today that the Food & Drug Association (FDA) has granted orphan drug designation to MOR208, MorphoSys' humanized Fc engineered monoclonal antibody against CD19, for the treatment of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL). Additionally, the Company has received a positive opinion from the European Medicines Agency (EMA) for an orphan medicinal product application for MOR208 in these indications.
"We are pleased that the FDA and the EMA support our applications for an orphan drug and orphan medicinal product status for MOR208 for the treatment of CLL or SLL. These are important regulatory milestones for the program," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. "We will continue to work closely with the FDA and the EMA as we advance MOR208 through clinical development and the associated regulatory processes."
Orphan drug and orphan medicinal product status are granted by the US and European health authorities respectively to promote the development of promising therapeutics for the treatment of rare diseases affecting fewer than 200,000 people in the US annually and no more than 5 in 10,000 people in the European Union. Orphan drug designation includes benefits such as a seven-year period of marketing exclusivity in the United States and 10 years of market exclusivity in the European Union after approval. Other potential advantages come in the form of protocol assistance, the ability to apply for research funding, tax credits for certain research expenses, and fee waivers for the regulatory procedures.
MOR208 is a humanized monoclonal antibody that targets the antigen CD19 for treatment of B cell malignancies and autoimmune diseases. The program is currently in phase 2 clinical development in CLL, acute lymphoblastic B-cell leukemia and non-Hodgkin's lymphoma. MOR208 has been engineered to possess significantly enhanced antibody-dependent cell-mediated cytotoxicity (ADCC), thus improving a key mechanism for tumor cell killing and offering potential for enhanced efficacy compared to traditional antibodies for the treatment of cancer. The program was in-licensed from Xencor in 2010.
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 80 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.
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Specialist Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-404
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Source: MorphoSys AG via Globenewswire