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    MOR   DE0006632003

MORPHOSYS AG

(MOR)
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PRESS RELEASE: MorphoSys and Incyte Announce the Acceptance of the Swissmedic Marketing Authorization Application for Tafasitamab

01/05/2021 | 02:01am EDT
 
 DGAP-News: MorphoSys AG / Key word(s): Miscellaneous 
MorphoSys and Incyte Announce the Acceptance of the Swissmedic Marketing 
Authorization Application for Tafasitamab 
 
2021-01-05 / 08:00 
The issuer is solely responsible for the content of this announcement. 
 
*Media Release* 
 
*MorphoSys and Incyte Announce the Acceptance of the Swissmedic Marketing 
Authorization Application for Tafasitamab* 
 
*- *_The Swissmedic MAA seeks approval for tafasitamab in combination with 
lenalidomide for the treatment of adult patients with relapsed or refractory 
diffuse large B-cell lymphoma_ 
 
*PLANEGG/MUNICH, Germany and MORGES, Switzerland - January 5, 2021 *- 
MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) 
and Incyte (NASDAQ:INCY) today announced that the Swiss Agency for 
Therapeutic Products (Swissmedic) has accepted the marketing authorization 
application (MAA) for tafasitamab, a humanized Fc-modified cytolytic CD19 
targeting monoclonal antibody. The MAA seeks approval for tafasitamab, in 
combination with lenalidomide, followed by tafasitamab monotherapy, for the 
treatment of adult patients with relapsed or refractory diffuse large B-cell 
lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are 
not candidates for autologous stem cell transplantation (ASCT). The MAA will 
now enter the formal review process by Swissmedic. 
 
The Swissmedic MAA for tafasitamab will be reviewed as part of the U.S. Food 
and Drug Administration's (FDA) modified Project Orbis, which provides a 
framework for concurrent submission and review of oncology drug applications 
among the FDA's international collaborators. Collaboration among 
international regulators may allow patients with cancer to receive earlier 
access to products in other countries. 
 
"Currently about 40% of DLBCL patients do not respond to initial therapy or 
relapse thereafter leading to a high medical need for new, effective 
therapies," said Peter Langmuir, M.D., Group Vice President, Targeted 
Therapeutics, Incyte. "The acceptance of the MAA for tafasitamab for review 
by Swissmedic is a pivotal step towards bringing tafasitamab in combination 
with lenalidomide to eligible patients in Switzerland." 
 
"Tafasitamab in combination with lenalidomide may represent an important new 
targeted treatment option for patients with relapsed or refractory DLBCL," 
said Mike Akimov, M.D., Ph.D., Head of Global Clinical Development, 
MorphoSys. "We look forward to continuing to work with the regulatory 
authorities alongside our partners at Incyte to bring this novel therapeutic 
option to eligible patients with a high unmet medical need." 
 
The Swissmedic application, submitted by Incyte in collaboration with 
MorphoSys, is supported by data from the L-MIND study evaluating tafasitamab 
in combination with lenalidomide as a treatment for patients with relapsed 
or refractory DLBCL and data from the RE-MIND study, an observational 
retrospective study in relapsed or refractory DLBCL. If approved, Incyte 
will hold the marketing authorization, and have exclusive commercialization 
rights for tafasitamab in Switzerland. 
 
Incyte has exclusive commercialization rights for tafasitamab outside the 
United States. 
 
*About Diffuse Large B-cell Lymphoma (DLBCL)* 
DLBCL is the most common type of non-Hodgkin lymphoma in adults 
worldwide[1], characterized by rapidly growing masses of malignant B-cells 
in the lymph nodes, spleen, liver, bone marrow or other organs. It is an 
aggressive disease with about 40% of patients not responding to initial 
therapy or relapsing thereafter[2]. In Europe, each year approximately 
16,000 patients are diagnosed with relapsed or refractory DLBCL[3],[4],[5]. 
 
*About L-MIND* 
The L-MIND trial is a single arm, open-label, multicenter Phase 2 study 
(NCT02399085) investigating the combination of tafasitamab and lenalidomide 
in patients with relapsed or refractory diffuse large B-cell lymphoma 
(DLBCL) who have had at least one, but no more than three prior lines of 
therapy, including an anti-CD20 targeting therapy (e.g. rituximab), who are 
not eligible for high-dose chemotherapy or refuse subsequent autologous stem 
cell transplant. The study's primary endpoint is Overall Response Rate 
(ORR). Secondary outcome measures include Duration of Response (DoR), 
Progression-Free Survival (PFS) and Overall Survival (OS). In May 2019, the 
study reached its primary completion. 
 
For more information about L-MIND, visit 
https://clinicaltrials.gov/ct2/show/NCT02399085 [1] 
 
*About RE-MIND* 
RE-MIND, an observational retrospective study (NCT04150328), was designed to 
isolate the contribution of tafasitamab in combination with lenalidomide and 
to prove the combinatorial effect. The study compares real-world response 
data of patients with relapsed or refractory diffuse large B-cell lymphoma 
(DLBCL) who received lenalidomide monotherapy with the efficacy outcomes of 
the tafasitamab-lenalidomide combination, as investigated in MorphoSys' 
L-MIND trial. RE-MIND collected the efficacy data from 490 relapsed or 
refractory DLBCL patients in the U.S. and the EU. Qualification criteria for 
matching patients of both studies were pre-specified. As a result, 76 
eligible RE-MIND patients were identified and matched 1:1 to 76 of 80 L-MIND 
patients based on important baseline characteristics. Objective Response 
Rates (ORR) were validated based on this subset of 76 patients in RE-MIND 
and L-MIND, respectively. The primary endpoint of RE-MIND was met and shows 
a statistically significant superior best ORR of the 
tafasitamab-lenalidomide combination compared to lenalidomide monotherapy. 
 
For more information about RE-MIND, visit 
https://clinicaltrials.gov/ct2/show/NCT04150328 [2]. 
 
*About Tafasitamab* 
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal 
antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop 
and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an 
XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis 
and immune effector mechanism including Antibody-Dependent Cell-Mediated 
Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). 
 
Monjuvi(R) (tafasitamab-cxix) is approved by the U.S. Food and Drug 
Administration (FDA) in combination with lenalidomide for the treatment of 
adult patients with relapsed or refractory diffuse large B-cell lymphoma 
(DLBCL) not otherwise specified, including DLBCL arising from low grade 
lymphoma, and who are not eligible for autologous stem cell transplant 
(ASCT). This indication is approved under accelerated approval based on 
overall response rate. Continued approval for this indication may be 
contingent upon verification and description of clinical benefit in a 
confirmatory trial(s). 
 
In January 2020, MorphoSys and Incyte entered into a collaboration and 
licensing agreement to further develop and commercialize tafasitamab 
globally. Monjuvi is being co-commercialized by Incyte and MorphoSys in the 
United States. Incyte has exclusive commercialization rights outside the 
United States. 
 
Tafasitamab is being clinically investigated as a therapeutic option in 
B-cell malignancies in a number of ongoing combination trials. 
 
Monjuvi(R) is a registered trademark of MorphoSys AG. 
 
XmAb(R) is a registered trademark of Xencor, Inc. 
 
*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 [3] or www.morphosys-us.com [4]. 
 
Monjuvi(R) is a registered trademark of MorphoSys AG. 
 
Tremfya(R) is a registered trademark of Janssen Biotech, Inc. 
 
*About Incyte * 
Incyte is a Wilmington, Delaware-based, global biopharmaceutical company 
focused on finding solutions for serious unmet medical needs through the 
discovery, development and commercialization of proprietary therapeutics. 
For additional information on Incyte, please visit Incyte.com [5] and follow 
@Incyte [6]. 
 
_MorphoSys Forward-looking Statements _ 
This communication contains certain forward-looking statements concerning 
the MorphoSys group of companies, including the expectations regarding 
Monjuvi's ability to treat patients with relapsed or refractory diffuse 
large B-cell lymphoma, the further clinical development of tafasitamab-cxix, 
including ongoing confirmatory trials, additional interactions with 
regulatory authorities and expectations regarding future regulatory filings 
and possible additional approvals for tafasitamab-cxix as well as the 
commercial performance of Monjuvi. The words "anticipate," "believe," 
"estimate," "expect," "intend," "may," "plan," "predict," "project," 
"would," "could," "potential," "possible," "hope" and similar expressions 
are intended to identify forward-looking statements, although not all 
forward-looking statements contain these identifying words. The 
forward-looking statements contained herein represent the judgment of 
MorphoSys as of the date of this release and involve known and unknown risks 

(MORE TO FOLLOW) Dow Jones Newswires

January 05, 2021 02:00 ET (07:00 GMT)

Stocks mentioned in the article
ChangeLast1st jan.
INCYTE CORPORATION 1.27% 75.99 Delayed Quote.-13.73%
MDAX -0.75% 35292.99 Delayed Quote.14.60%
MORPHOSYS AG 3.58% 41.71 Delayed Quote.-55.54%
NASDAQ COMP. -0.91% 15043.967518 Real-time Quote.17.64%
ORBIS AG 0.00% 7.95 Delayed Quote.24.22%
TECDAX -0.47% 3882.56 Delayed Quote.20.85%
TECDAX PERFORMANCE INDEX 9:00-20:00 -0.16% 3894.13 Delayed Quote.21.21%
XENCOR, INC. 3.44% 34.57 Delayed Quote.-20.77%
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Analyst Recommendations on MORPHOSYS AG
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Financials
Sales 2021 171 M 200 M 200 M
Net income 2021 -194 M -228 M -228 M
Net cash 2021 715 M 838 M 838 M
P/E ratio 2021 -9,52x
Yield 2021 -
Capitalization 1 423 M 1 671 M 1 669 M
EV / Sales 2021 4,15x
EV / Sales 2022 3,19x
Nbr of Employees 607
Free-Float 99,7%
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Mean consensus OUTPERFORM
Number of Analysts 14
Last Close Price 41,71 €
Average target price 90,54 €
Spread / Average Target 117%
EPS Revisions
Managers and Directors
Jean-Paul Kress CEO & Chairman-Management Board
Sung H. Lee Chief Financial Officer
Marc Cluzel Chairman-Supervisory Board
Malte Peters Chief Research & Development Officer
Roland Wandeler Chief Operating Officer
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