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

HyperLight Demonstrates Low-Power 1.6T-DR8 TFLN-based Reference Transceiver Assembled by TFC16.3.2026 13:03:00 CET | Press release

HyperLight Corporation (“HyperLight”) today announced a major milestone in low-power optical networking with the demonstration of a 1.6T-DR8 optical transceiver leveraging HyperLight’s TFLN Chiplet™ Platform. The reference module was demonstrated with engineering and manufacturing support from Suzhou TFC Optical Communication Co., Ltd. (SZSE: 300394, or "TFC"). The reference design achieves 20W power consumption in a fully retimed 1.6T-DR8 module, representing approximately 20% lower module-level power compared to alternative technologies. The reduction is achieved through a simple drop-in transmitter implementation based on a single thin-film lithium niobate photonic integrated circuit (TFLN PIC). The TFLN transmitter enables the module to operate using a single continuous-wave (CW) laser, compared to the two to four lasers typically required in conventional implementations. Additional energy savings are achieved through the ability to operate directly from the native low-swing electr

GCE® Launches Gascontrol.com Website Showcasing Its Complete Gas Control Portfolio for Speciality, Medical, and Industrial Applications16.3.2026 13:00:00 CET | Press release

GCE®, a global market leader for gas control equipment, has launched gascontrol.com, a new website designed to better serve customers across its GCE Specialty, GCE Medical, and GCE Industrial product portfolios. The new site provides a streamlined, market-focused experience that makes it easier for users to explore GCE’s gas control solutions and identify the right products. A new Documentation Search Tool assists customers in easily finding documents such as instructions for use (IFUs), appendices, and certifications through an intuitive search interface. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260316410525/en/ GCE’s new website, gascontrol.com, provides a streamlined, market-focused experience across the GCE Specialty, GCE Medical, and GCE Industrial product portfolios. “The redesigned website reflects GCE’s role as a comprehensive, trusted supplier of gas control technologies that elevate industries and improve liv

SBC Medical Announces Opening of Brand Flagship "NEO Skin Clinic Ginza."16.3.2026 13:00:00 CET | Press release

Accelerating multi-branding strategy in aesthetic healthcare with global presence in Tokyo’s premier district SBC Medical Group Holdings Incorporated (Nasdaq: SBC) (“SBC Medical” or the “Company”), a Management Services Organization operating a wide range of franchise businesses across diverse medical fields, today announced that its specialized aesthetic brand, “NEO Skin Clinic,” will open its flagship location in Tokyo’s Ginza district, a globally recognized medical tourism hub and highly competitive district, on Saturday, March 28, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260312457783/en/ SBC Medical Announces Opening of Brand Flagship "NEO Skin Clinic Ginza." The Ginza flagship, located in a prime area near GINZA SIX, will feature dedicated VIP rooms for executive clientele and the growing number of international patients, strengthening the brand’s global presence. Leveraging its robust network of 283 affilia

Lebrikizumab Delivered Significant Skin Clearance and Improved Disease Severity in Children With Moderate-to-severe Atopic Dermatitis16.3.2026 11:53:00 CET | Press release

Almirall announces positive, top-line results from Phase 3 ADorable-1 trialADorable-1 met co-primary efficacy endpoints, with 63% of paediatric patients achieving meaningful skin improvement (EASI-75) and 44% reaching clear or almost clear skin (IGA 0,1) at week 16.Key secondary endpoints showed significant itch relief (Pruritus NRS ≥4 point improvement), reduced overall disease severity (EASI-90) and improved quality of life (CDLQI ≥6-Point Improvement) in children and adolescents with moderate-to-severe atopic dermatitis treated with lebrikizumab.Skin conditions can have a profound physical and emotional impact on people’s lives1, and Atopic Dermatitis (AD) peaks in childhood – with around 60% of cases appearing within the first year of life2. Almirall, S.A. (ALM), a global biopharmaceutical company focused on medical dermatology, today announced positive, top-line results from the pivotal Phase 3 ADorable-1 trial evaluating efficacy and safety of lebrikizumab for children and adoles

Experian Marks a Breakthrough in Consumer AI with the Next Evolution of Its Virtual Assistant16.3.2026 11:00:00 CET | Press release

Smarter, more adaptive assistant advances personalized, conversational financial guidance powered by trusted data Experian today unveiled the next evolution of the Experian Virtual Assistant, EVA™, a significant advancement in its Consumer First AI strategy that expands personalized, conversational financial guidance to millions of consumers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260316538160/en/ Experian today unveiled the next evolution of the Experian Virtual Assistant, EVA™. “This next generation of EVA reflects the direction of our consumer AI strategy,” said Debbie Hsu, Executive Vice President of Product, Experian Consumer Services. “We are bringing together conversational AI, personalization, and our trusted data foundation to deliver guidance that is intuitive, relevant, and actionable. Our focus is on helping consumers make smarter financial decisions in ways that feel simple and empowering.” Built to scal

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