Planegg/Munich, Germany, September 25, 2018
MorphoSys Announces its Licensee Janssen has Initiated a Phase 3 Trial (PROTOSTAR) to Evaluate Guselkumab in Pediatric Psoriasis Patients
MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) announced today that its licensee Janssen Research & Development, LLC, has initiated a phase 3 clinical trial of guselkumab in pediatric patients suffering from chronic plaque psoriasis. According to clinicaltrials.gov, the trial, PROTOSTAR, is expected to enroll approximately 125 children between 6 and 18 years of age with plaque psoriasis and will evaluate the efficacy, safety and pharmacokinetics of guselkumab against etanercept and placebo.
Guselkumab is a fully human anti-IL-23 monoclonal antibody developed by Janssen, and was generated utilizing MorphoSys's proprietary HuCAL antibody technology.
Dr. Markus Enzelberger, Chief Scientific Officer of MorphoSys AG, said: "We are very pleased that our licensee Janssen has started phase 3 development for the treatment of chronic plaque psoriasis in children. If successful, we hope that this study will contribute to providing more therapeutic options to this patient group."
Guselkumab (tradename Tremfya(R)) has been approved in the U.S., Canada, the European Union, and several other countries for the treatment of plaque psoriasis in adult patients, and in Japan for the treatment of both psoriasis and psoriatic arthritis. Moreover, guselkumab is currently being investigated in two phase 3 trials in psoriatic arthritis and also in a phase 2/3 clinical study program in Crohn's disease.
More information about guselkumab clinical studies is available on clinicaltrials.gov.
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 29 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 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 and on the U.S. stock exchange Nasdaq, 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, expectations regarding the start of the phase 3 trial with Tremfya(R) in pediatric patients with plaque psoriasis and the further development of Tremfya(R) in psoriasis, psoriatic arthritis and Crohn's disease. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are that MorphoSys' expectations regarding the start of the phase 3 trial with Tremfya(R) in pediatric patients with plaque psoriasis and the further development of Tremfya(R) in psoriasis, psoriatic arthritis and Crohn's disease, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements, MorphoSys' reliance on collaborations with third parties and other risks indicated in the risk factors included in MorphoSys's Registration Statement on Form F-1 and other filings with the US Securities and Exchange Commission may be incorrect. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.
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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