Incyte Gains Exclusive Global Development and Commercialization Rights to Tafasitamab (Monjuvi®)
05 Febrero 2024 - 3:46PM
Business Wire
– Tafasitamab is approved in combination with
lenalidomide for the treatment of relapsed or refractory diffuse
large B-cell lymphoma (DLBCL), and is currently in Phase 3 trials
for multiple indications
Incyte (Nasdaq:INCY) announced it has entered
into an asset purchase agreement with MorphoSys AG (FSE: MOR;
NASDAQ: MOR) which gives Incyte exclusive global rights for
tafasitamab, a humanized Fc-modified CD19-targeting immunotherapy
marketed in the U.S. as Monjuvi® (tafasitamab-cxix) and outside of
the U.S. as Minjuvi® (tafasitamab).
“This new agreement with MorphoSys provides Incyte with
exclusive global rights to tafasitamab and full control over its
development and commercialization, allowing us to realize
significant operating efficiencies and cost synergies,” said Hervé
Hoppenot, Chief Executive Officer, Incyte.
In the previous agreement, MorphoSys and Incyte were
collaborating and sharing costs for the clinical development and
commercialization of tafasitamab in the U.S.; Incyte had exclusive
rights outside of the U.S. Under the terms of the new agreement,
MorphoSys will receive a payment of $25 million from Incyte and
Incyte will gain global development and commercialization rights
for tafasitamab. Incyte will now recognize revenue and cost for all
U.S. commercialization and clinical development and MorphoSys will
no longer be eligible to receive future milestone, profit split and
royalty payments. The agreement is effective immediately.
In addition to its approved indication, tafasitamab is being
evaluated as a therapeutic option in ongoing pivotal trials for
first-line DLBCL, relapsed or refractory follicular lymphoma (FL)
and relapsed or refractory marginal zone lymphoma (MZL).
About Tafasitamab Tafasitamab is a humanized
Fc-modified CD19-targeting immunotherapy. In 2010, MorphoSys
licensed exclusive worldwide rights to develop and commercialize
tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb®
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).
In the United States, Monjuvi® (tafasitamab-cxix) is approved by
the U.S. Food and Drug Administration in combination with
lenalidomide for the treatment of adult patients with relapsed or
refractory 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).
Please see the U.S. full Prescribing Information for Monjuvi for
important safety information.
In Europe, Minjuvi® (tafasitamab) received conditional marketing
authorization in combination with lenalidomide, followed by Minjuvi
monotherapy, for the treatment of adult patients with relapsed or
refractory diffuse large B-cell lymphoma (DLBCL) who are not
eligible for autologous stem cell transplant (ASCT).
Tafasitamab is being clinically investigated as a therapeutic
option in B-cell malignancies in several ongoing combination
trials. Its safety and efficacy for these investigational uses have
not been established in pivotal trials.
Monjuvi® and Minjuvi® are registered trademarks of Incyte.
Tafasitamab is marketed by under the brand name Monjuvi® in the
U.S., and under the brand name Minjuvi® in the EU and Canada.
XmAb® is a registered trademark of Xencor, Inc.
About Incyte A global biopharmaceutical company on
a mission to Solve On., Incyte follows the science to find
solutions for patients with unmet medical needs. Through the
discovery, development and commercialization of proprietary
therapeutics, Incyte has established a portfolio of first-in-class
medicines for patients and a strong pipeline of products in
Oncology and Inflammation & Autoimmunity. Headquartered in
Wilmington, Delaware, Incyte has operations in North America,
Europe and Asia.
For additional information on Incyte, please visit Incyte.com or
follow us on social media: LinkedIn, X, Instagram, Facebook,
YouTube.
Incyte Forward-looking Statements Except for the
historical information set forth herein, the matters set forth in
this press release contain predictions, estimates and other
forward-looking statements, including without limitation statements
regarding: the operating efficiencies and cost synergies Incyte
expects to gain by virtue of this transaction; Incyte’s
expectations regarding revenue and cost for U.S. commercialization
and clinical development of tafasitamab; and the potential for
tafasitamab as a therapeutic option in first-line DLBCL, relapsed
or refractory follicular lymphoma (FL) and relapsed or refractory
marginal zone lymphoma (MZL).
These forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially,
including unanticipated developments in and risks related to:
obtaining regulatory approval for this planned collaboration;
research and development efforts related to the collaboration
programs; the possibility that results of clinical trials may be
unsuccessful or insufficient to meet applicable regulatory
standards or warrant continued development; other market or
economic factors, including other scientific developments;
unanticipated delays; the effects of market competition; risks
associated with relationships between collaboration partners; the
impact of governmental actions regarding pricing, importation and
reimbursement for pharmaceuticals; and such other risks detailed
from time to time in each company's reports filed with the
Securities and Exchange Commission, including our annual report and
our quarterly report on Form 10-Q for the quarter ended September
30, 2023. We disclaim any intent or obligation to update these
forward-looking statements.
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