Incyte Gains Exclusive Global Development and Commercialization Rights to Tafasitamab (Monjuvi®)
Incyte has entered into an asset purchase agreement with MorphoSys AG, gaining exclusive global rights to tafasitamab, a humanized Fc-modified CD19-targeting immunotherapy marketed in the U.S. as Monjuvi® and outside of the U.S. as Minjuvi®. The new agreement allows Incyte to realize significant operating efficiencies and cost synergies. 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. 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, including first-line DLBCL, relapsed or refractory follicular lymphoma (FL), and relapsed or refractory marginal zone lymphoma (MZL).
The asset purchase agreement between Incyte and MorphoSys AG regarding tafasitamab represents a strategic move that could have a significant financial impact on both companies. Incyte's acquisition of exclusive global rights for tafasitamab not only consolidates its portfolio but also potentially increases its revenue streams, as it now stands to gain all profits from the drug's sales without sharing with MorphoSys. The upfront payment of $25 million to MorphoSys, while seemingly modest, shifts the financial burden of clinical development and commercialization solely to Incyte. This move could be seen as a calculated risk, considering the potential market size for DLBCL treatments and the additional indications tafasitamab is being evaluated for.
For stakeholders, the short-term implications involve observing how Incyte will manage the increased operational costs and whether it can achieve the operating efficiencies and cost synergies it anticipates. In the long-term, the success of ongoing pivotal trials and subsequent FDA approvals could significantly affect Incyte's market position and financial health. However, this also exposes Incyte to higher financial risk if tafasitamab does not perform as expected in these trials or in the market.
The significance of tafasitamab's clinical development cannot be overstated in the context of treating hematological malignancies like DLBCL, FL and MZL. Incyte's full control over tafasitamab's development could streamline the clinical trial process and expedite the time-to-market for additional indications, if the trials prove successful. This is particularly relevant given the competitive landscape of oncology drugs and the need for new therapies that can offer improved outcomes for patients with limited treatment options.
The potential benefits of tafasitamab, as a CD19-targeting immunotherapy, lie in its mechanism of action, which involves recruiting the body's immune system to attack cancer cells. The ongoing Phase 3 trials will be critical in determining the drug's efficacy and safety profile in broader patient populations. Positive trial results could lead to increased adoption and market penetration, ultimately benefiting patients and positioning Incyte as a leader in this therapeutic area.
Understanding the market dynamics for DLBCL and related lymphomas is essential for evaluating the impact of this agreement. The global oncology market is highly competitive, with numerous companies vying for market share in the treatment of hematological cancers. Incyte's move to acquire exclusive rights to tafasitamab suggests confidence in the drug's market potential and its ability to compete with existing therapies. Market research would focus on the size of the target patient population, current treatment paradigms and the competitive landscape to forecast the potential market share and revenue that tafasitamab could capture.
Additionally, market analysts would assess the impact of Incyte's increased marketing and sales efforts as it takes over full commercialization responsibilities. The analysis would also consider potential market reactions to the new agreement, including investor confidence in Incyte's strategic decision-making and its implications for the company's stock performance. The long-term market outlook would depend on the outcomes of the ongoing clinical trials and the subsequent regulatory decisions.
02/05/2024 - 04:46 PM
– 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
WILMINGTON, Del. --(BUSINESS WIRE)--
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 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
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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Source: Incyte
The asset purchase agreement gives Incyte exclusive global rights to tafasitamab, a humanized Fc-modified CD19-targeting immunotherapy marketed in the U.S. as Monjuvi® and outside of the U.S. as Minjuvi®.
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 first-line DLBCL, relapsed or refractory follicular lymphoma (FL), and relapsed or refractory marginal zone lymphoma (MZL).
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.
