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MONTREAL, Oct. 6, 2022 (GLOBE NEWSWIRE) — Knight Therapeutics Inc. , (TSX: GUD) (“Knight”), a Pan-American specialty pharmaceutical company (formerly the U. S. )The U. S. Department of Health announced today that its Brazilian subsidiary, United Medical Ltd. , has submitted an application for marketing authorization for tafasitamab in combination with lenalidomide to ANVISA, Brazil’s fitness regulatory agency, for the treatment of adult patients with diffuse to giant lymphoma. Relapsed or refractory B mobiles (DLBCL) who are not eligible for autologous mobile transplant cure (ASCT).
In September 2021, Knight entered into an exclusive, distribution agreement with Incyte (NASDAQ: INCY), for the exclusive distribution rights to tafasitamab (sold as Monjuvi in the U. S. ). (USA) and Minjuvi®® in Europe), as well as pemigatinib (Pemazyre ®), in Latin America.
“We are very pleased to have reached this milestone for tafasitamab in Brazil,” said Samira Sakhia, president and CEO of Knight Therapeutics. “Once approved, the combined cure with tafasitamab and lenalidomide will be a new life-remedy option for eligible patients. “with recurrent or refractory DLBCL in Brazil. We look forward to continuing the work with the help of our partner, Incyte, as we move towards regulatory filings in other Latin American countries over the next year.
About tafasitamab
Tafasitamab is a cytolytic CD19-targeted immunotherapy modified with humanized Fc. In 2010, MorphoSys received exclusive international rights to expand and commercialize tafasitamab from Xencor, Inc. mechanism, adding antibody-dependent mobile-mediated cytotoxicity (ADCC) and antibody-dependent mobile 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 recurrent or unspecified DLBCL, adding DLBCL resulting from low-grade lymphoma, who are not eligible for autologous movable stem transplantation (ASCT). This indication is approved under an accelerated approval based on overall reaction rate. Continued approval for this indication would likely include verification and description of clinical benefits in one or more confirmatory trials.
In Europe, Minjuvi (tafasitamab) obtained conditional approval, in combination with lenalidomide, followed by Minjuvi® monotherapy, for the treatment of adult patients with relapsed or refractory diffuse giant B-mobile lymphoma (DLBCL) who are not eligible for mobile autologous stem cell therapy. transplant (TACM).
Tafasitamab is being studied clinically as a remedy option in B-cell malignancies in several ongoing combined trials.
Minjuvi and Monjuvi®® are registered trademarks of MorphoSys AG. Tafasitamab is jointly advertised through Incyte and MorphoSys with the Monjuvi logo in the United States, and is advertised through Incyte with the Minjuvi®® logo in Europe, the United Kingdom and Canada. region. As part of its agreement with MorphoSys, Incyte has won exclusive rights to commercialize tafasitamab outside the United States.
XmAb® is a registered trademark of Xencor, Inc.
About Knight Therapeutics Inc.
Knight Therapeutics Inc. , headquartered in Montreal, Canada, is a pharmaceutical corporation specializing in the acquisition, licensing and marketing of pharmaceutical products for Canada and Latin America. Knight’s Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics Inc. se industry shares on the TSX under the symbol GUD. For more information about Knight Therapeutics Inc. , visit the company’s online page at www. gud-knight. com or www. sedar. com.
Forward-Looking Statements
This document comprises forward-looking statements by Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve dangers and uncertainties that may also cause actual effects to differ materially from those realized through the forward-looking statements. Knight Therapeutics Inc. believes that the assumptions on which these forward-looking statements are based The statements on which they are based are cautious at the time they were prepared, but caution the reader that those assumptions regarding long-term events, many of the which are beyond the purview of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and hazards that may also cause actual effects to differ materially from existing expectations are discussed in Knight Therapeutics Inc. Annual Report and Knight Therapeutics Inc. Annual Information Form for the year ended December 31, 2021, as filed on www. sedar. com. Knight Therapeutics Inc. disclaims any objective or legal responsibility to update or revise any forward-looking statement, whether as a result of new data or long-term events, except as required by law.
Contact for investors:
Knight Therapeutics Inc.
Samira Sakhia
Arvind Utchanah
President and Chief Executive Officer
Cfo
Phone: 514. 484. 4483
Tel. 598. 2626. 2344
Fax. : 514. 481. 4116
Email: info@knighttx. com
Email: info@knighttx. com
Website: www. gud-knight. com
Website: www. gud-knight. com