April 06, 2018 / 7:30 am, CEST
Planegg/Munich, Germany, April 6, 2018
MorphoSys Announces Approval of Tremfya(R) (Guselkumab) for the Treatment of Moderate to Severe Forms of Psoriasis and Psoriatic Arthritis in Japan
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced today that its licensee Janssen Pharmaceutical K.K. (Janssen) reported that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Tremfya(R) (guselkumab) for the treatment of three forms of psoriasis (plaque, pustular, and erythrodermic) and psoriatic arthritis in patients with moderate-to-severe disease for whom other existing treatments have failed.
Tremfya(R) is a fully human anti-IL-23 monoclonal antibody developed by Janssen and was generated utilizing MorphoSys's proprietary HuCAL antibody library technology.
MorphoSys is eligible to receive royalties on net sales of Tremfya(R).
Dr. Markus Enzelberger, Chief Scientifc Officer of MorphoSys AG, said: "We are very pleased about yet another Tremfya(R) approval in such a short period of time. In addition to recent approvals in Australia and Brazil as well as the approvals in the U.S., Canada and the European Union seen last year, Japan is now the first Asian country where Tremfya(R) has been approved. Moreover, Japan is the first country where Tremfya(R) has also been approved for the treatment of psoriatic arthritis. We expect Tremfya(R) will continue to provide an important treatment option for patients living with moderate-to-severe plaque psoriasis."
In addition to psoriasis, Tremfya(R) is in phase 3 development for psoriatic arthritis. Janssen has announced plans to investigate guselkumab in Crohn's disease.
Further information about the Japanese approval of Tremfya(R) can be found in a press release issued by Janssen on March 23, 2018.
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, and approximately 20% of people affected have cases that are considered moderate to severe.
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a chronic, immune-mediated inflammatory disease characterised by both joint inflammation and the skin lesions associated with psoriasis. An estimated 600,000 Americans-and more than 12 million people worldwide-have PsA. Up to 30 percent of people with psoriasis are estimated to also develop psoriatic arthritis. The disease causes pain, stiffness and swelling in and around the joints and commonly appears between the ages of 30 and 50, but can develop at any time. Though the exact cause of psoriatic arthritis is unknown, genes, the immune system and environmental factors are all believed to play a role in the onset of the disease.
MorphoSys is a late-stage, biopharmaceutical company devoted to the development of innovative and differentiated therapies for patients suffering from serious diseases. Based on its technological leadership in generating antibodies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 28 are currently in clinical development. This broad pipeline spans MorphoSys's two business segments: Proprietary Development, in which the Company invests in product candidates for its own account, and Partnered Discovery, in which product candidates are developed exclusively for our a variety of Pharma and Biotech partners. In 2017, Tremfya(R) (guselkumab), marketed by Janssen, became the first therapeutic antibody based on MorphoSys's proprietary technology to receive marketing approval for the treatment of moderate-to-severe plaque psoriasis in the United States, the European Union and Canada. 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.
Tremfya(R) is a trademark of Janssen Biotech, 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:
Associate Director Corporate Communications & IR
Associate Director Corporate Communications & IR
Dr. Claudia Gutjahr-Loeser
Investor Relations Officer
Tel: +49 (0) 89 / 899 27-404