Business Wire

DE-INCYTE

5.2.2024 22:47:32 CET | Business Wire | Press release

Share
Incyte Gains Exclusive Global Development and Commercialization Rights to Tafasitamab (Monjuvi®)

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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240205431773/en/

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com
DK

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Strategic Combination of ITC Infotech and Happiest Minds Technologies to Create a Scaled, Future-Ready, AI-First Global Technology Services Enterprise with US$ 1 Billion Revenue by FY28[1]31.8.2026 23:35:00 CEST | Press release

ITC Infotech Board approves proposed acquisition of 22.1% promoter stake and a Scheme of Amalgamation of the two companies ITC Infotech (ITCI), a wholly owned subsidiary of ITC Limited and a leading global technology services player, today announced the proposed strategic combination with Happiest Minds Technologies Limited (Happiest Minds) to create a scaled, future-ready, AI-first global technology services enterprise. The ITCI Board approved a proposal to acquire 22.1% equity stake from the promoter of Happiest Minds in two tranches under a Share Purchase Agreement. The transaction would be funded through a Rights Issue by ITC Infotech. ITCI Board has also approved a proposed Scheme of Amalgamation of Happiest Minds with ITCI which will be effected after the share acquisition. Pursuant to the scheme, the shares of ITCI will be listed on the stock exchanges. The proposed transaction has also been endorsed by the Board of Directors of ITC Limited. This strategic combination will syner

Angel’s Profits Grew Robustly in the First Half of 2026 with Europe and North America Turning Profitable Ahead of Schedule31.8.2026 21:07:00 CEST | Press release

Angelalign Technology Inc. (“Angel” or the “Company”) (6699.HK) (angelaligner.com), the second largest clear aligner supplier by revenue, announced today that its revenue grew 42.9% to US$230.7 million and net profit grew 79.6% to $25.5 million for the six months ending June 30, 2026. Angel’s business in Europe and North America crossed into profitability ahead of plan while the business in Chinese mainland delivered market share gains well above expectations. Doctors and staff in every region report that they are increasingly selecting Angel’s solutions after experiencing more predictable outcomes, especially on complex cases, and embracing the positive culture of the company. Dr. Mark Holt D.D.S., M.S. of Holt Orthodontics in Northern California, states: “We treat over half of our patients with clear aligners and our experience with Angel’s treatment plans and clear aligners has been tremendous.” “Our main focus is to provide great service to and being a rock-solid partner for our cu

BeOne Medicines Announces Voluntary Agreement with U.S. Government to Expand Access to Innovative Cancer Medicines31.8.2026 21:00:00 CEST | Press release

Agreement advances patient access and strengthens BeOne's long-term commitment to U.S. innovation and manufacturing BeOne Medicines, Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced a voluntary agreement with the U.S. Government to expand access to innovative cancer medicines for American patients while strengthening our U.S manufacturing footprint and further expanding the capabilities needed to deliver medicines at scale. The agreement builds on BeOne's longstanding commitment to patient access and investment in research and scientific innovation. John V. Oyler, Co-Founder, Chairman and CEO, BeOne Medicines, said: “At BeOne, we believe every patient should benefit from innovative cancer therapies. We appreciate the Trump Administration’s commitment to advancing solutions that broaden access and scientific progress for American patients. This agreement reflects our purpose to reach more patients as we expand our U.S. investment in additional res

MEX Exchange, Part of MultiBank Group, Announces Senior Leadership Appointments31.8.2026 15:36:00 CEST | Press release

David Ogg appointed Vice Chairman and Brian Andreyko named CEO MEX Exchange, the institutional electronic trading platform of MultiBank Group, has announced two senior leadership appointments, with David Ogg promoted to Vice Chairman and Brian Andreyko promoted to Chief Executive Officer. The appointments strengthen the company’s leadership as it advances the development of its institutional electronic trading platform. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260831401493/en/ MEX Exchange, part of MultiBank Group, Announces Senior Leadership Appointments with David Ogg appointed Vice Chairman and Brian Andreyko named CEO. David Ogg brings more than four decades of experience in foreign exchange trading and trading technology and is widely recognised within the institutional FX industry as the “Father of the ECN.” He founded HotspotFX in 1999, the first institutional FX electronic communications network, before going o

Rimini Street Announces Stock Repurchase and Debt Reduction Transactions31.8.2026 15:00:00 CEST | Press release

The Company recently completed an additional $5.0 million of common stock repurchases and $5.0 million of debt prepayment that brings total fiscal year-to-date capital return and balance sheet optimization to $30.9 million Rimini Street, Inc., (Nasdaq: RMNI), a global provider of end-to-end enterprise software support, managed services and Agentic AI ERP innovation solutions, and the leading third-party support provider for Oracle, SAP and VMware software, today announced additional, recent capital return and balance sheet optimization actions as noted below during the fiscal third quarter through August 28, 2026: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260831961587/en/ Rimini Street Announces Stock Repurchase and Debt Reduction TransactionsDebt Reduction: The Company prepaid $5.0 million of its term loan and has reduced term loan debt by a total of $25.9 million fiscal year-to-date, reducing the outstanding balance t

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye