MorphoSys AG Announces That Its Licensee Janssen-Cilag International NV Received CHMP Positive Opinion For Tremfyatm (Guselkumab) Recommending Approval In Europe
Published: Sep 18, 2017
September 18, 2017 / 7:30 am, CEST
Planegg/Munich, Germany, September 18, 2017
MorphoSys Announces that its Licensee Janssen received CHMP Positive Opinion for TremfyaTM (Guselkumab) Recommending Approval in Europe
Janssen's TremfyaTM could become the first antibody generated from MorphoSys's HuCAL technology to receive market approval in Europe following U.S. FDA approval for the treatment of patients with moderate to severe plaque psoriasis in July 2017
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced today that Janssen-Cilag International NV (Janssen) received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of TremfyaTM (guselkumab) for the treatment of patients with moderate to severe plaque psoriasis in Europe.
TremfyaTM is a fully human anti-IL-23 monoclonal antibody developed by Janssen and was generated utilizing MorphoSys's proprietary HuCAL antibody technology.
Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG, said: "We are very pleased that Janssen has received a positive opinion of the EMA's CHMP recommending to approve TremfyaTM in Europe. Assuming approval by the European Commission, we expect this drug to provide a valuable treatment option for patients living with moderate to severe plaque psoriasis in Europe, after Janssen received U.S. FDA approval for TremfyaTM for the same indication earlier this year."
MorphoSys is eligible to royalties on net sales based on the product sales of Janssen related to TremfyaTM.
Further information can be found in the press release issued by Janssen on September 15, 2017.
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's mission is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. Innovative technologies and smart development strategies are central to our approach. Success is created by our people, who focus on excellence in all they do, collaborate closely across disciplines and are driven by a desire to make the medicines of tomorrow a reality. Success benefits all of our stakeholders.
Based on its proprietary technology platforms, particularly in the field of fully human therapeuc antibodies, 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.
TremfyaTM 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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