Knight Therapeutics Announces Regulatory Approval of TAVALISSE® in Mexico

MONTREAL, Dec. 12, 2024 (GLOBE NEWSWIRE) — Knight Therapeutics Inc., (TSX: GUD) (“Knight”) a pan-American (ex-USA) specialty pharmaceutical company, announced today that its Mexican affiliate, Grupo Biotoscana de Especialidad S.A. de C.V., received regulatory approval from COFEPRIS for TAVALISSE^® (fostamatinib disodium hexahydrate) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

“Treating chronic ITP is challenging due to the disease’s diversity, making it difficult to predict individual patient responses to available treatments and not all patients can find an effective solution. The approval of fostamatinib by COFEPRIS offers physicians a new therapeutic alternative with an innovative mechanism of action,” said Dr. Luis Antonio Meillón García. Dr. Meillón García is a medical doctor from Universidad La Salle and a hematologist trained at Universidad Nacional Autónoma de México. He further specializes in hemostasis and thrombosis at the University of Rochester and currently practices professionally at Centro Médico ABC.

Knight previously announced its agreement with Rigel Pharmaceuticals, Inc. on May 24, 2022, securing exclusive rights to commercialize fostamatinib in Latin America. Fostamatinib is an orally administered spleen tyrosine kinase (SYK) inhibitor. It is currently available in the United States as TAVALISSE^® (100mg and 150mg tablets) and in Europe under the brand name TAVLESSE^® for the treatment of adult chronic ITP with an insufficient response to a previous treatment.

“We are excited to receive the approval of TAVALISSE^® in Mexico, providing a vital new treatment option for adult patients with chronic ITP,” said Samira Sakhia, President and CEO of Knight Therapeutics. “This milestone not only marks an important step in expanding treatment options for ITP patients but also reinforces our commitment to improving patient outcomes across Latin America. We expect the launch of TAVALISSE^® in Mexico in the first half of 2026.”

About ITP

In patients with ITP, the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters like thrombopoietin receptor agonists (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

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

This document contains 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, 2023, as filed on www.sedarplus.ca. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law.

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