May 24, 2017 / 11:32 am, CEST
Planegg/Munich, Germany, May 24, 2017
MorphoSys Announces That Its Licensee Janssen Reported Updates on the Development of Guselkumab
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced today that its licensee Janssen Research & Development, LLC (Janssen), has provided an update on the development of guselkumab. Guselkumab is a fully human anti-IL-23 monoclonal antibody developed by Janssen, and was generated by MorphoSys utilizing its proprietary HuCAL antibody library technology.
According to information provided recently, Janssen has applied a priority review voucher to the guselkumab biologics license application (BLA) with the goal of accelerating the approval process in moderate to severe plaque psoriasis. Pending a positive decision by the FDA, Janssen anticipates a potential US approval of guselkumab may be possible in Q3 2017.
In addition, Janssen announced plans for three new phase 3 clinical trials with guselkumab. These include a phase 3 study to evaluate the comparative efficacy of guselkumab versus secukinumab (Cosentyx(R)) for the treatment of moderate to severe plaque-type psoriasis (ECLIPSE study); a planned phase 3 study in psoriatic arthritis; and plans for a phase 3 program Crohn's disease. According to Janssen the ECLIPSE study has been initiatied and the psoriatic arthritis study is planned to begin enrolling in Q3 2017.
"Following on from our licensee Janssen's successful phase 3 studies VOYAGE 1, VOYAGE 2 and NAVIGATE in moderate to severe plaque psoriasis and the regulatory filings for approval submitted in the U.S. and Europe, we were delighted to learn of Janssen's recent update on guselkumab," said Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "We are also delighted to hear of Janssen's plans for potentially expanding the range of indications of guselkumab."
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.
MorphoSys is committed to developing exceptional new treatments for patients suffering from serious diseases. A leader in the field of therapeutic antibodies today, MorphoSys is driven by the ambition of creating the most valuable pipeline of biopharmaceuticals in the biotechnology industry. Based on its proprietary technology platforms, MorphoSys, together with its partners, has built a therapeutic pipeline of more than 110 programs in R&D, around a quarter of which is currently in clinical development.
In its proprietary development segment, MorphoSys, alone or with partners, is developing new therapeutic candidates, mainly focusing on cancer and inflammation. In its partnered discovery segment, MorphoSys uses its technologies to discover new drug candidates for pharmaceutical partners and participates from the programs' further development success, through success-based payments and royalties. MorphoSys is listed on the Frankfurt Stock Exchange under the symbol MOR. For regular updates about MorphoSys, visit http://www.morphosys.com.
HuCAL(R), HuCAL GOLD(R), HuCAL PLATINUM(R), CysDisplay(R), RapMAT(R), arYla(R), Ylanthia(R), 100 billion high potentials(R), Slonomics(R), Lanthio Pharma(R) and LanthioPep(R) are registered trademarks of the MorphoSys Group.
Cosentyx(R) is a registered trademark of Novartis 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.
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