Knight Therapeutics Announces Launch of Minjuvi® in Brazil

Knight Therapeutics Inc., (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today the launch of Minjuvi ® (tafasitamab) by its Brazilian affiliate, United Medical Ltda. Minjuvi ® is indicated in combination with lenalidomide, followed by Minjuvi ® monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

DLBCL, the most common subtype of non-Hodgkin lymphoma, presents an aggressive clinical profile. Although a significant number of patients can be cured with standard front-line therapy, many will exhibit refractory disease or relapse following an initial response and are ineligible to transplant. These patients face a very poor prognosis and need novel treatment option to improve their outcomes 1 .

According to NCCN Guidelines, Minjuvi ® is listed as one of the preferred 2 nd line treatments for DLBCL patients who are ineligible for transplantation 2 . The marketing authorization was based on the data from L-MIND study, an open label, multicenter, single arm Phase 2 trial. The primary endpoint results showed an objective response rate (ORR) of 60%, which includes a complete response rate (CR) of 43% and a disease control rate (DCR) of 75% 3 .

"The launch of Minjuvi ® brings a new treatment option to relapsed or refractory non-transplant eligible DLBCL adult patients due to its innovative characteristics and proven efficacy, with a reasonable safety profile," said Dr Guilherme Perini, hematologist specialized in Lymphomas at Hospital Israelita Albert Einstein. "Minjuvi ® will improve patients' standard of care and it is a highly anticipated therapy for our patients," added Dr Perini.

In September 2021, Knight entered into a supply and distribution agreement with Incyte (NASDAQ: INCY), for the exclusive rights to distribute pemigatinib (Pemazyre ® ) as well as tafasitamab (sold as Monjuvi ® in the United States and Minjuvi ® in Europe) in Latin America. In July 2023, ANVISA (Agência Nacional de Vigilância Sanitária) granted Market Authorization for Minjuvi ® under the rare disease designation according to Resolution RDC 205/2017. Additionally, in October 2023, Knight received pricing approval for Minjuvi ® from the Drugs Market Regulation Chamber ("CMED").

"In line with Knight's commitment to advancing healthcare in Latin America, we are excited to launch Minjuvi in Brazil, an innovative treatment option for addressing a current unmet medical need," said Samira Sakhia, Knight Therapeutics President and CEO.

"Knight's team in Brazil is thrilled to make Minjuvi ® available to health care professionals and centers, improving DLBCL patient care in the country," said Cristiane Coelho, Knight Therapeutics Brazil General Manager.

About Tafasitamab (Minjuvi ® )

Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting immunotherapy. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. In 2024, Incyte was assigned such license and now exclusively holds such rights. 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 transplantation (ASCT). This indication has received accelerated approval based on the overall response rate. Continued approval for this indication may be contingent upon verification and description of the clinical benefit in 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 transplantation (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 indications have not been established in pivotal trials.

Minjuvi ® and Monjuvi ® are registered trademarks of Incyte. Tafasitamab is marketed under the brand name Monjuvi ® in the U.S. and under the brand name Minjuvi ® in Europe, the United Kingdom and Canada.

XmAb ® is a registered trademark of Xencor, Inc.

About Knight Therapeutics Inc.

Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight's Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics Inc.'s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at www.knighttx.com or www.sedarplus.ca .

Forward-Looking Statements for Knight Therapeutics Inc.

This document may contain forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2022 as filed on www.sedarplus.ca . Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements whether because of new information or future events, except as required by law.

References:

  1. Araújo, G et al. (2023). Landscape of Diffuse Large B-Cell Lymphoma (DLBCL) in Brazilian Public Healthcare System (SUS). 2023-11, ISPOR Europe 2023, Copenhagen, Denmark. Value in Health, Volume 26, Issue 11, S2 (December 2023). Available at https://www.ispor.org/docs/default-source/euro2023/postereph246131853-pdf.pdf?sfvrsn=17d37f1a_0
  2. National Comprehensive Cancer Network (NCCN) Guidelines. B-Cell Lymphomas dated January 18, 2024. Accessible at: Treatment by Cancer Type (nccn.org)
  3. Duell, J et al. (2021). Long-term outcomes from the Phase II L-MIND study of tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma. Haematologica. 2021 Sep 1;106(9):2417-2426. doi: 10.3324/haematol.2020.275958

CONTACT INFORMATION:

Knight Therapeutics Inc.
Samira Sakhia Arvind Utchanah
President & Chief Executive Officer Chief Financial Officer
T: 514.484.4483 T. +598.2626.2344
F: 514.481.4116
Email: IR@knighttx.com Email: IR@knighttx.com
Website: www.knighttx.com Website: www.knighttx.com

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  • Accelerates Solventum's business transformation and sharpens focus on strategic areas for growth to deliver long-term shareholder value

  • Strengthens balance sheet with proceeds to be used primarily for debt paydown

Solventum (NYSE: SOLV) today announced it has entered into a definitive agreement to sell its Purification & Filtration 1 business to Thermo Fisher Scientific Inc. (NYSE: TMO) (" Thermo Fisher ") for $4.1 billion . Solventum expects the transaction to be neutral to 2025 EPS and expects an estimated $3.4 billion in net proceeds, which it intends to use primarily to pay down debt. The transaction is expected to be completed by the end of 2025, subject to regulatory approval and customary closing conditions.

Solventum Logo (PRNewsfoto/3M Healthcare US Opco LLC)

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Morgan Stanley & Co. LLC, Perella Weinberg Partners and J.P. Morgan Securities LLC served as financial advisors to Solventum, and Cleary Gottlieb Steen & Hamilton served as legal advisor to Solventum.

1 Other than for its operations in Belgium , France and Ireland , for which Thermo Fisher granted a binding offer to Solventum

About Solventum  
At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better — while empowering healthcare professionals to perform at their best. See how at Solventum.com .

Forward-Looking Statements
This news release contains forward-looking information about Solventum's financial results, estimates, and business prospects that involve substantial risks and uncertainties. In particular, statements regarding the future performance of Solventum, including guidance for 2024, are forward-looking statements. You can identify these statements by the use of words such as "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "guidance," "intends," "may," "outlook," "plans," "projects," "seeks," "sees," "should," "targets," "will," "would," and other words and terms of similar meaning in connection with any discussion of future operating or financial performance or business plans or prospects. Among the factors that could cause actual results to differ materially are the following: (1) the effects of, and changes in, worldwide economic, political, regulatory, international, trade and geopolitical conditions, natural disasters, war, public health crises, and other events beyond Solventum's control; (2) operational execution risks; (3) damage to our reputation or our brands; (4) risks from acquisitions, strategic alliances, divestitures and other strategic events; (5) Solventum's business dealings involving third-party partners in various markets; (6) Solventum's ability to access the capital and credit markets and changes in Solventum's credit ratings; (7) exposure to interest rate and currency risks; (8) the highly competitive environment in which Solventum operates and consolidation in the healthcare industry; (9) reduction in customers' research budgets or government funding; (10) the timing and market acceptance of Solventum's new product and service offerings; (11) ongoing working relationships with certain key healthcare professionals; (12) changes in reimbursement practices of governments or private payers or other cost containment measures; (13) Solventum's ability to obtain components or raw materials supplied by third parties and other manufacturing and related supply chain difficulties, interruptions, and disruptive factors; (14) legal and regulatory proceedings and legal compliance risks (including third-party risks) with regards to antitrust, Foreign Corrupt Practices Act (FCPA) and other anti-bribery laws, environmental laws, anti-kickback and false claims laws, privacy laws, tax laws, and other laws and regulations in the United States and other countries in which Solventum operates; (15) potential liabilities related to a broad group of perfluoroalkyl and polyfluoroalkyl substances, collectively known as "PFAS"; (16) risks related to the highly regulated environment in which Solventum operates; (17) risks associated with product liability claims; (18) climate change and measures to address climate change; (19) security breaches and other disruptions to information technology infrastructure; (20) Solventum's failure to obtain, maintain, protect, or effectively enforce its intellectual property ("IP") rights; (21) pension and postretirement obligation liabilities; (22) any failure by the 3M Company (" 3M ") to perform any of its obligations under the various separation agreements in connection with the separation from 3M (the "Spin-Off"); (23) any failure to realize the expected benefits of the Spin-Off, and/or that the Spin-Off will not be completed within the expected time frame, on the expected terms or at all; (24) a determination by the IRS or other tax authorities that the distribution or certain related transactions should be treated as taxable transactions; (25) expected financing transactions undertaken in connection with the separation and risks associated with additional indebtedness; (26) the risk that incremental costs of operating on a standalone basis (including the loss of synergies), costs of restructuring transactions and other costs incurred in connection with the separation will exceed Solventum's estimates; and (27) the impact of the Spin-Off on its businesses and the risk that the Spin-Off may be more difficult, time-consuming or costly than expected, including the impact on its resources, systems, procedures and controls, diversion of management's attention and the impact on relationships with customers, suppliers, employees and other business counterparties.

Changes in such assumptions or factors could produce significantly different results. A further description of these factors is located under "Cautionary Note Regarding Forward-Looking Statements" and "Risk Factors" in Solventum's periodic reports on file with the U.S. Securities & Exchange Commission. Solventum assumes no obligation to update any forward-looking statements discussed herein as a result of new information or future events or developments.

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SOURCE Solventum

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