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MorphoSys's MOR208 Program Receives Fast Track Designation from FDA for the Treatment of DLBCL

MARTINSRIED/MUNICH, Germany, Nov. 7, 2014 (GLOBE NEWSWIRE) -- MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced today that the Food & Drug Administration (FDA) has granted fast track designation to MOR208, MorphoSys's humanized Fc engineered monoclonal antibody against CD19, for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The FDA's fast track program aims to expedite the development and review of drugs that have the potential to fill an unmet medical need in serious or life-threatening conditions.

"First results of our ongoing Phase 2 trial, which we will present at this year's ASH conference in December, have helped to identify diffuse large B-cell lymphoma as a valuable development opportunity for MOR208. We are therefore delighted to have received the fast track designation for further development of MOR208 in DLBCL. The more frequent interactions with the FDA that this enables will help us to expedite the development of MOR208 in this particular subset of non-Hodgkin's lymphoma patients," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG.

DLBCL is the most common lymphoma and accounts for approximately 25 percent of all NHLs in the developed world. The disease occurs primarily in older individuals, though it can also occur in children and young adults in rare cases.

MOR208 is a humanized monoclonal antibody targeting the antigen CD19, which is being developed for the treatment of B-cell malignancies. The program is currently in phase 2 clinical development in chronic lymphocytic leukemia (CLL), acute lymphoblastic B-cell leukemia (B-ALL) and non-Hodgkin's lymphoma (NHL). MOR208 was in-licensed from Xencor Inc. in 2010.

About MorphoSys:

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:
MorphoSys AG
Dr. Claudia Gutjahr-Löser
Head of Corporate Communications & IR

Mario Brkulj
Associate Director Corporate Communications & IR

Alexandra Goller
Specialist Corporate Communications & IR

Jessica Rush
Specialist Corporate Communications & IR

Tel: +49 (0) 89 / 899 27-404
investors@morphosys.com

Media Release (PDF) http://hugin.info/130295/R/1869472/657322.pdf

HUG#1869472

Source:MorphoSys AG