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MorphoSys AG. (12/15/14). "Press Release: MorphoSys's MOR208 Program Receives Positive Opinion for Orphan Medicinal Product Designation from EMA for DLBCL".

Region Region EU (European Union)
Organisations Organisation MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; Nasdaq: MOR)
  Group MorphoSys (Group)
  Organisation 2 EMA (European Medicines Agency)
  Group EU (govt)
Products Product MOR208 (MorphoSys/Xencor, formerly XmAb5574)
  Product 2 DRUGS, ORPHAN
Persons Person Schottelius, Arndt (Kymab 201806 EVP RnD before MorphoSys 200812–201701 Chief Developm Officer before Genentech)
  Person 2 Gutjahr-Löser, Claudia (MC Services 201710– Managing Director before MorphoSys 2002–2017 + Cassiopeia + Deutsche Bank)
     


MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced today that the Company has received a positive opinion from the European Medicines Agency (EMA) on the application for orphan medicinal product designation for MOR208, MorphoSys' humanized Fc engineered monoclonal antibody against CD19, for the treatment of diffuse large B-cell lymphoma (DLBCL). The positive opinion is to be adopted by the European Commission. Earlier in December the Company had also received the orphan drug designation by the Food & Drug Administration for MOR208 in the same indication.

"2014 was an excellent year for the MOR208 program with a number of advancements. We have gained the orphan drug and orphan medicinal product status for MOR208 for the treatment of DLBCL in addition to the same status in chronic lymphocytic leukemia we announced earlier in the year. We have also received fast track designation in DLBCL and published very promising phase 2 data in DLBCL and other subtypes of NHL at this year's ASH conference. Achieving all of these important regulatory and clinical milestones in 2014 has substantially strengthened this promising cancer program," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG.

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 five 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 ten 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.

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 an Fc-enhanced, 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).


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

   
Record changed: 2017-04-02

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