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MorphoSys Announces That Its Licensee Janssen Reported Updates on the Development of Guselkumab

DGAP-News: MorphoSys AG / Key word(s): Research Update MorphoSys Announces That Its Licensee Janssen Reported Updates on the Development of Guselkumab (news with additional features) 24.05.2017 / 11:32 The issuer is solely responsible for the content of this announcement. 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."