MorphoSys Announces That Its Licensee Janssen Has Submitted Biologics License Application For Guselkumab
(Thomson Reuters ONE) -
MorphoSys AG /
MorphoSys Announces That Its Licensee Janssen Has Submitted Biologics License
Application For Guselkumab
. Processed and transmitted by Nasdaq 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 its licensee Janssen Research & Development, LLC (Janssen) through
one of its affiliaties, has submitted a Biologics License Application (BLA), to
the U.S. Food and Drug Administration (FDA) for guselkumab, an investigational
fully human monoclonal antibody against IL-23 identified from MorphoSys's HuCAL
antibody library. MorphoSys will receive a milestone payment from Janssen in
connection with the BLA filing which seeks approval for the treatment of
patients with moderate to severe plaque psoriasis. Financial details were not
disclosed.
"We are excited that our licensee has submitted a regulatory filing for
guselkumab to the FDA", said Dr. Marlies Sproll, Chief Scientific Officer of
MorphoSys AG. "Plaque psoriasis is a chronic disease affecting millions of
patients worldwide. We hope this therapy will be made available for patients
living with moderate to severe plaque psoriasis. If the FDA grants approval,
guselkumab could become the first marketed antibody based on MorphoSys's
proprietary antibody technology - with more than 100 other MorphoSys compounds
currently in development."
The BLA for guselkumab includes data from the Janssen pivotal phase 3 "VOYAGE
1" study, a randomized, double-blind, placebo- and active-comparator-controlled
study which evaluated guselkumab, in comparison to placebo and the active
comparator adalimumab (Humira®), in the treatment of 837 patients with moderate
to severe plaque psoriasis. Data from the study were presented on October
1st, 2016, at the 25th congress of the European Academy of Dermatology and
Venereology (EADV) in Vienna, Austria.
Further information about the BLA can be found in the press release issued by
Janssen today and on www.janssen.com.
About Psoriasis
Psoriasis is an autoimmune disease which is characterized by patches of abnormal
skin. These skin patches are typically red, itchy, and scaly. They may vary in
severity from small and localized to complete body coverage. There are five main
types of psoriasis: plaque, guttate, inverse, pustular, and erythrodermic.
Plaque psoriasis, also known as psoriasis vulgaris, makes up about 90% of cases.
It typically presents with red patches with white scales on top. Psoriasis is
usually chronic and has a high morbidity and negative impact on patients'
quality of life. In 2015 prevalence of the disease was 16 million patients in
the seven major countries (USA, Japan, France, Germany, Italy, Spain, and Great
Britain), as estimated by independent market intelligence experts.
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.
Humira® is a registered trademarks of AbbVie Inc.
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/2057752/771092.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: 17.11.2016 - 14:46 Uhr
Sprache: Deutsch
News-ID 507836
Anzahl Zeichen: 5780
contact information:
Town:
Martinsried / Munich
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 273 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"MorphoSys Announces That Its Licensee Janssen Has Submitted Biologics License Application For Guselkumab"
steht unter der journalistisch-redaktionellen Verantwortung von
MorphoSys AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
