DGAP-News

MorphoSys' Licensee Janssen Receives CHMP Positive Opinion for Tremfya(R) (guselkumab) for Treatment of Adults with Active Psoriatic Arthritis (PsA) in the European Union (EU)

DGAP-News: MorphoSys AG / Key word(s): Miscellaneous MorphoSys' Licensee Janssen Receives CHMP Positive Opinion for Tremfya(R) (guselkumab) for Treatment of Adults with Active Psoriatic Arthritis (PsA) in the European Union (EU) 19.10.2020 / 07:00 The issuer is solely responsible for the content of this announcement. MorphoSys' Licensee Janssen Receives CHMP Positive Opinion for Tremfya(R) (guselkumab) for Treatment of Adults with Active Psoriatic Arthritis (PsA) in the European Union (EU)

PLANEGG/MUNICH, Germany, October 19, 2020 - MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) announced today that its licensee Janssen Research & Development, LLC. (Janssen) has announced it received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the expanded use of Tremfya^(R) (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA) in the European Union (EU). Guselkumab is currently approved in the EU for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.¹

PsA is a chronic, immune-mediated, inflammatory disease that most commonly appears in adults aged 30 to 50. Progressive and irreversible, it is characterized by debilitating joint damage, inflammation, enthesitis, dactylitis, axial disease, and skin lesions generally associated with psoriasis.² There is no known cure, and it is estimated that up to a third of the 14 million people who are living with psoriasis in Europe will also go on to develop PsA.^3,4

"Active psoriatic arthritis, due to its irreversibility and chronic progression, is a high burden for both patients and their families", said Dr. Malte Peters, Chief Research and Development Officer at MorphoSys. "We are very pleased that Tremfya^(R) has been recommended for expanded use by the CHMP, which opens up new treatment opportunities to improve patients' lives in the EU."

The CHMP positive opinion is based on data from two first-in-class Phase 3 clinical studies - DISCOVER-1 and DISCOVER-2-that demonstrated both the efficacy and safety of guselkumab in the treatment of adult patients with active PsA. Both studies showed significant improvements in quality of life physical and mental component scores, and in both studies, guselkumab was well tolerated through week 24. Observed adverse events (AEs) showed to be generally consistent with previous studies of guselkumab and current Summary of Product Characteristics.¹