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) - Seite 2

Developed and marketed by Janssen, Tremfya^(R) is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. It was generated utilizing MorphoSys' proprietary HuCAL^(R) antibody technology and became the first drug based on MorphoSys' antibody technology to receive regulatory approval for the treatment of plaque psoriasis in 2017. It is currently approved in 72 countries for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy¹, and in Canada, Japan, Brazil, Ecuador and the U.S. for the treatment of adult patients with active PsA. A final decision from the European Commission (EC) regarding PsA indication expansion is expected later this year.


About the DISCOVER program
DISCOVER-1 and DISCOVER-2 were Phase 3 randomized, double-blind, placebo-controlled studies that evaluated the safety and efficacy of Tremfya^(R) in 1,120 adult patients with active PsA who had inadequate response to standard therapies. DISCOVER-1 evaluated 381 participants with active PsA who had an inadequate response to standard therapies, including participants previously treated with anti-tumor necrosis factor (TNF) alpha biologics. DISCOVER-2 included 739 patients who were biologic-naïve only and had an inadequate response to standard therapies.

About MorphoSys
MorphoSys (FSE & NASDAQ: MOR) is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. In 2017, Tremfya^(R), marketed by Janssen for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval of the company's proprietary product Monjuvi^(R) (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma. Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has ~500 employees. More information at www.morphosys.com or www.morphosys-us.com.