MorphoSys Announces That Its Licensee Janssen Has Submitted a Marketing Authorisation Application For Guselkumab in Europe
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MorphoSys AG /
MorphoSys Announces That Its Licensee Janssen Has Submitted a Marketing
Authorisation Application For Guselkumab in Europe
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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 its licensee Janssen Research & Development, LLC (Janssen) through
one of its affiliates, has submitted a Marketing Authorisation Application (MAA)
to the European Medicines Agency (EMA) seeking approval of guselkumab for the
treatment of adults living with moderate to severe plaque psoriasis. Guselkumab
is a fully human anti-IL-23 monoclonal antibody discovered by Janssen utilizing
the HuCAL antibody library technology licensed from MorphoSys.
"The submission for marketing authorization of guselkumab with the EMA by our
licensee comes shortly after its filing in the U.S. and is another important
step towards making this therapy available to patients with moderate to severe
plaque psoriasis," said Dr. Marlies Sproll, Chief Scientific Officer of
MorphoSys AG. "If approved, guselkumab could become the first marketed antibody
based on MorphoSys's proprietary antibody technology."
According to a press release issued by Janssen, data from four studies
evaluating the efficacy and safety of guselkumab when administered by
subcutaneous injection in the treatment of adults living with moderate to severe
plaque psoriasis served as the basis for the submission: the VOYAGE 1, VOYAGE 2
and NAVIGATE phase 3 studies, and the X-PLORE phase 2 study.
Further information can be found in the press release issued by Janssen on
November 25, 2016 and on www.janssen.com.
About Psoriasis
Psoriasis is a chronic, autoimmune inflammatory disorder that results in the
overproduction of skin cells, characterised by raised, inflamed, scaly, red
lesions, or plaques, which can cause itching and physical pain. It is estimated
that as many as 125 million people worldwide have psoriasis, including 14
million Europeans, and approximately 20% of people affected have cases that are
considered moderate to severe.
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 100 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®,
100 billion high potentials®, Slonomics®, Lanthio Pharma® and LanthioPep® are
registered trademarks of the MorphoSys Group.
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
Anke Linnartz
Head of Corporate Communications & IR
Jochen Orlowski
Associate Director Corporate Communications & IR
Alexandra Goller
Senior Manager Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-404
investors(at)morphosys.com
Media Release (PDF):
http://hugin.info/130295/R/2059680/772059.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq 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
Unternehmensinformation / Kurzprofil:
Datum: 28.11.2016 - 12:07 Uhr
Sprache: Deutsch
News-ID 509401
Anzahl Zeichen: 5003
contact information:
Town:
Martinsried / Munich
Kategorie:
Business News
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