Planegg/Munich, Germany, April 5, 2018
MorphoSys Announces Approvals for Tremfya(R) (Guselkumab) for the Treatment of Moderate-to-Severe Plaque Psoriasis in Brazil and Australia
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced today that country subsidiaries of its licensee Janssen reported that Tremfya(R) (guselkumab) has been approved for the treatment of adults living with moderate to severe plaque psoriasis in Brazil and Australia.
As reported by Janssen-Cilag Farmacêutica Ltda. (Janssen), the Brazilian National Health Surveillance Agency ("ANVISA") has approved Tremfya(R) for the treatment of adults living with moderate to severe plaque psoriasis. Janssen-Cilag Pty Limited (Janssen) announced that Tremfya(R) has been approved by the Therapeutic Goods Administration (TGA) and registered on the Australian Register of Therapeutic Goods (ARTG) for the treatment of adults living with moderate to severe plaque psoriasis in Australia.
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 the Tremfya(R) approvals in Brazil and Australia. Thus Tremfya(R) has now been approved in a number of territories worldwide, including the U.S., Canada, the European Union, Brazil, and Australia. 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 in psoriatic arthritis. Janssen has announced plans to investigate guselkumab in Crohn's disease.
Further information about the approvals of Tremfya(R) in Brazil and Australia can be found in press releases issued by Janssen.
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. According to Janssen about five million people in Brazil are expected to be impacted by psoriasis.
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
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