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PRESS RELEASE: MorphoSys' Licensee Janssen Receives CHMP Positive Opinion for Tremfya(R) (guselkumab) for Treatment of Adults with Active Psoriatic Arthritis (PsA) in the European Union (EU)

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DGAP-News: MorphoSys AG / Key word(s): Miscellaneous
MorphoSys' Licensee Janssen Receives CHMP Positive Opinion for Tremfya(R)
(guselkumab) for Treatment of Adults with Active Psoriatic Arthritis (PsA)
in the European Union (EU)

2020-10-19 / 07:00
The issuer is solely responsible for the content of this announcement.

*MorphoSys' Licensee Janssen Receives CHMP Positive Opinion for Tremfya(R)
(guselkumab) for Treatment of Adults with Active Psoriatic Arthritis (PsA)
in the European Union (EU)*

*PLANEGG/MUNICH, Germany, October 19, 2020 *- MorphoSys AG (FSE: MOR; Prime
Standard Segment; MDAX & TecDAX; NASDAQ: MOR) announced today that its
licensee Janssen Research & Development, LLC. (Janssen) has announced [1] it
received a positive opinion from the Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMA) recommending the
expanded use of Tremfya(R) (guselkumab) for the treatment of adult patients
with active psoriatic arthritis (PsA) in the European Union (EU). Guselkumab
is currently approved in the EU for the treatment of moderate to severe
plaque psoriasis in adults who are candidates for systemic therapy.1

PsA is a chronic, immune-mediated, inflammatory disease that most commonly
appears in adults aged 30 to 50. Progressive and irreversible, it is
characterized by debilitating joint damage, inflammation, enthesitis,
dactylitis, axial disease, and skin lesions generally associated with
psoriasis.2 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.3,4

"Active psoriatic arthritis, due to its irreversibility and chronic
progression, is a high burden for both patients and their families", said
Dr. Malte Peters, Chief Research and Development Officer at MorphoSys. "We
are very pleased that Tremfya(R) has been recommended for expanded use by
the CHMP, which opens up new treatment opportunities to improve patients'
lives in the EU."

The CHMP positive opinion is based on data from two first-in-class Phase 3
clinical studies - DISCOVER-1 and DISCOVER-2-that demonstrated both the
efficacy and safety of guselkumab in the treatment of adult patients with
active PsA. Both studies showed significant improvements in quality of life
physical and mental component scores, and in both studies, guselkumab was
well tolerated through week 24. Observed adverse events (AEs) showed to be
generally consistent with previous studies of guselkumab and current Summary
of Product Characteristics.1

Developed and marketed by Janssen, Tremfya(R) is the first approved fully
human monoclonal antibody that selectively binds to the p19 subunit of IL-23
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. It is currently
approved in 72 countries for the treatment of adults with moderate to severe
plaque psoriasis who are candidates for systemic therapy or phototherapy1,
and in Canada, Japan, Brazil, Ecuador and the U.S. for the treatment of
adult patients with active PsA. A final decision from the European
Commission (EC) regarding PsA indication expansion is expected later this
year.

*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), marketed by Janssen 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 the company's 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 [2] or
www.morphosys-us.com [3].

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 Janssen, the further clinical
development of guselkumab by Janssen 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 Janssen, the further clinical development of guselkumab by
Janssen 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. European Medicines Agency. TREMFYA Summary of Product Characteristics.
2019. Available at: www.medicines.org.uk/emc/medicine/34321 [4]. Accessed
September 2020.

2. Belasco J and Wei N. Psoriatic Arthritis: What is Happening at the Joint?
Rheumatol Ther 2019; 6:30 5-315.

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

4. 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.

*For more information, please contact:*

*MorphoSys*
*Media Contacts:* *Investor Contacts:*
Sophie Petersen Dr. Anja Pomrehn
Senior Specialist Senior Vice President
Tel: +49 (0)89 / 899 27 26033 Tel: +49 (0)89 / 899 27 26972
sophie.petersen@morphosys.com anja.pomrehn@morphosys.com
Jeanette Bressi Dr. Julia Neugebauer
Director, US Communications Director
Tel: +1 617-404-7816 Tel: +49 (0)89 / 899 27 179
jeanette.bressi@morphosys.com julia.neugebauer@morphosys.com

2020-10-19 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Archive at www.dgap.de
Language: English
Company: MorphoSys AG
Semmelweisstr. 7
82152 Planegg
Germany
Phone: +49 (0)89 899 27-0
Fax: +49 (0)89 899 27-222
E-mail: investors@morphosys.com
Internet: www.morphosys.com
ISIN: DE0006632003
WKN: 663200
Indices: MDAX, TecDAX
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover,
Munich, Stuttgart, Tradegate Exchange; Nasdaq
EQS News ID: 1141458

End of News DGAP News Service

1141458 2020-10-19


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October 19, 2020 01:01 ET ( 05:01 GMT)
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