July 13, 2017 / 11:14 pm, CEST
Planegg/Munich, Germany, July 13, 2017
MorphoSys Announces That Its Licensee Janssen Has Received US FDA Approval for Tremfya(TM) (Guselkumab) for the Treatment of Moderate to Severe Plaque Psoriasis
First antibody generated from MorphoSys's HuCAL library technology to receive marketing approval
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced today that its licensee Janssen Biotech, Inc. (Janssen), has reported that the U.S. Food and Drug Administration (FDA) has approved Tremfya(TM) (guselkumab) for the treatment of patients with moderate to severe plaque psoriasis. Tremfya is a fully human anti-IL-23 monoclonal antibody developed by Janssen and was generated utilizing MorphoSys's proprietary HuCAL antibody library technology. MorphoSys will receive a milestone payment from Janssen in connection with the BLA approval. Financial details were not disclosed.
Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG, said: "It is a very exciting day for all of us at MorphoSys to have the first antibody generated from our proprietary HuCAL antibody technology receive marketing approval. We are grateful to Janssen for their development efforts and look forward to the launch of Tremfya. Plaque psoriasis is a chronic disease affecting millions of people worldwide, and it is fantastic news that this therapy will now be made available to patients living with moderate to severe disease. We are also very pleased that Janssen is pursuing the development of Tremfya in several additional indications."
Dr. Moroney continued: "With more than 100 MorphoSys compounds currently in development, we look forward to advancing novel antibodies in a wide variety of serious diseases where we see a strong need for alternative treatment options."
Further information can be found in the press release issued by Janssen on July 13, 2017.
MorphoSys will provide information on on financial guidance at a later date.
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, including 14 million Europeans, and approximately 20% of people affected have cases that are considered moderate to severe.
MorphoSys is committed to developing exceptional new treatments for patients suffering from serious diseases. A leader in the field of therapeutic antibodies today, MorphoSys is driven by the ambition of creating the most valuable pipeline of biopharmaceuticals in the biotechnology industry. Based on its proprietary technology platforms, MorphoSys, together with its partners, has built a therapeutic pipeline of more than 110 programs in R&D, around a quarter of which is currently in clinical development.
In its proprietary development segment, MorphoSys, alone or with partners, is developing new therapeutic candidates, mainly focusing on cancer and inflammation. In its partnered discovery segment, MorphoSys uses its technologies to discover new drug candidates for pharmaceutical partners and participates from the programs' further development success, through success-based payments and royalties. 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(TM) 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.
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