MorphoSys' Licensee Announces Approval by the European Commission for Tremfya(R) (guselkumab) for Treatment of Adults with Active Psoriatic Arthritis (PsA)

DGAP-News: MorphoSys AG / Key word(s): Miscellaneous
02.12.2020 / 22:02
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Media Release

MorphoSys' Licensee Announces Approval by the European Commission for Tremfya^(R) (guselkumab) for Treatment of Adults with Active Psoriatic Arthritis (PsA)

PLANEGG/MUNICH, Germany, December 2, 2020-MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) announced today that its licensee Janssen Research & Development, LLC. (Janssen) reported the European Commission's approval for the use of Tremfya^(R) (guselkumab) in the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.

Developed and marketed by Janssen, Tremfya is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23-an important driver of the progression of inflammatory diseases¹ and inhibits its interaction with the IL-23 receptor. It was generated utilizing MorphoSys' proprietary HuCAL^(R) antibody technology and became the first drug based on MorphoSys' antibody technology to receive regulatory approval for the treatment of plaque psoriasis in 2017. Tremfya is currently approved in 76 countries for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy², and in Brazil, Canada, Ecuador, Japan, Taiwan and the U.S. for the treatment of adult patients with active PsA.

"As a new, first-in-its-class treatment option for patients with psoriatic arthritis, Tremfya provides much-needed treatment opportunities to improve the lives of patients suffering from this debilitating disease", said Dr. Malte Peters, Chief Research and Development Officer at MorphoSys. "We are very pleased and extremely proud that Tremfya has been approved by the European Commission for the treatment of adult patients with active psoriatic arthritis in the European Union."

PsA is a multifaceted, chronic, immune-mediated, inflammatory disease that is progressive and irreversible. It is characterized by debilitating joint damage, inflammation, enthesitis, dactylitis, axial disease, and skin lesions generally associated with psoriasis. In addition, due to the stiffness and the painful swelling of the joints and the connective tissue, carrying out daily tasks can become difficult.^3,4 There is no known cure, and it is estimated that up to a third of the 14 million people who are living with psoriasis in Europe will also go on to develop PsA.^5,6

As Janssen announced, the approval for this new indication is based on the results of Janssen's DISCOVER-1 and DISCOVER-2 Phase 3 clinical studies which assessed the safety and efficacy of guselkumab in adult patients with active PsA. In both studies, guselkumab was well-tolerated and observed adverse events (AEs) were generally consistent with previous studies of guselkumab and the current prescribing information.

The approval by the European Commission for Tremfya follows a CHMP positive opinion in October 2020 for treatment of adults with active psoriatic arthritis in the European Union (EU).

About the DISCOVER program
DISCOVER-1 and DISCOVER-2 were Phase 3 randomized, double-blind, placebo-controlled studies that evaluated the safety and efficacy of Tremfya^(R) in 1,120 adult patients with active PsA who had inadequate response to standard therapies. DISCOVER-1 evaluated 381 participants with active PsA who had an inadequate response to standard therapies, including participants previously treated with anti-tumor necrosis factor (TNF) alpha biologics. DISCOVER-2 included 739 patients who were biologic-naïve only and had an inadequate response to standard therapies.

About MorphoSys
MorphoSys (FSE & NASDAQ: MOR) is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. In 2017, Tremfya^(R), developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval of MorphoSys' proprietary product Monjuvi^(R) (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma. Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has ~500 employees. More information at www.morphosys.com or www.morphosys-us.com.

Monjuvi^(R) and HuCAL^(R) are registered trademarks of MorphoSys AG.
Tremfya^(R) is a registered trademark of Janssen Biotech, Inc.

MorphoSys Forward-Looking Statements
This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including the clinical development of guselkumab in psoriatic arthritis led by a licensee of MorphoSys, the further clinical development of guselkumab as well as interactions with regulatory authorities and expectations regarding regulatory filings and possible approvals for guselkumab in psoriatic arthritis. 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 MorphoSys' expectations regarding the clinical development of guselkumab in psoriatic arthritis led by a licensee of MorphoSys, the further clinical development of guselkumab as well as interactions with regulatory authorities and expectations regarding regulatory filings and possible approvals for guselkumab in psoriatic arthritis, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the US Securities and Exchange Commission. 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.

References:

1. Benson JM, et al. Discovery and Mechanism of Ustekinumab: A Human Monoclonal Antibody Targeting interleukin-12 and interleukin-23 for Treatment of Immune-Mediated Disorders. MAbs 2011;3:535-545.

2. European Medicines Agency. TREMFYA Summary of Product Characteristics. 2019. Available at: www.medicines.org.uk/emc/medicine/34321. Accessed September 2020.

3. Busse K, Liao W. Which Psoriasis Patients Develop Psoriatic Arthritis? Psoriasis Forum 2010;16(4):17-25.

4. Belasco J, Wei N. Psoriatic Arthritis: What is Happening at the Joint? Rheumatol Ther 2019;6(3):305-315.

5. Ogdie A and Weiss P. The Epidemiology Psoriatic Arthritis. Rheum Dis Clin North Am 2015;41(4):545-568

6. Ortonne JP and Prinz JC. Alefacept: A Novel and Selective Biologic Agent for the Treatment of Chronic Psoriasis. Eur J Dermatol 2004;14:41-45.

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