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MorphoSys AG: MorphoSys's MOR208 Program to Receive Orphan Drug Designation from FDA and EMA for the Treatment of CLL/SLL

MorphoSys AG / MorphoSys's MOR208 Program to Receive Orphan Drug Designation
from FDA and EMAfor 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.

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
therapeuticpipelineof 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,

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

Media Release (PDF)


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: MorphoSys AG via Globenewswire


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