MorphoSys's MOR208 Program Receives Positive Opinion for Orphan Medicinal Product Designation from EMA for DLBCL
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MorphoSys AG /
MorphoSys's MOR208 Program Receives Positive Opinion for Orphan Medicinal
Product Designation from EMA for DLBCL
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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 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(at)morphosys.com
Media Release (PDF):
http://hugin.info/130295/R/1880000/662956.pdf
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: MorphoSys AG via GlobeNewswire
[HUG#1880000]
Unternehmensinformation / Kurzprofil:
Datum: 15.12.2014 - 07:30 Uhr
Sprache: Deutsch
News-ID 359257
Anzahl Zeichen: 6332
contact information:
Town:
Martinsried / Munich
Kategorie:
Business News
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