Knight Therapeutics Announces Relaunch of ONICIT® in Brazil and Mexico
MONTREAL, May 07, 2025 (GLOBE NEWSWIRE) — Knight Therapeutics Inc., (TSX: GUD) ('Knight') a pan-American (ex-USA) specialty pharmaceutical company, announced today that has assumed full commercial activities and is relaunching ONICIT® IV (palonosetron) in Brazil and Mexico, through its affiliates in those countries (United Medical Ltd. and Grupo Biotoscana de Especialidad S.A. de C.V., respectively).
In May 2022, Knight and Helsinn Healthcare SA ('Helsinn') had entered into an exclusive license, distribution and supply agreement for oral/IV AKYNZEO® (netupitant/palonosetron - fosnetupitant /palonosetron) in Canada, Brazil, Argentina, Uruguay and Paraguay, and ALOXI® oral/IV (palonosetron) in Canada. In January 2025, Knight and Helsinn announced that they expanded their existing relationship and entered into an exclusive license, distribution and supply agreement for ONICIT® IV (palonosetron) in Mexico, Brazil, and other LATAM countries. ONICIT® is marketed under the brand name ALOXI® in Canada.
ONICIT® solution for injection is approved and marketed in Brazil and Mexico for the prevention of acute nausea and vomiting associated with the initial and repeated cycles of moderately and highly emetogenic chemotherapy for cancer, and for the prevention of delayed nausea and vomiting associated with the initial and repeated cycles of moderately emetogenic chemotherapy for cancer in adults. In addition, ONICIT® is indicated for the prevention of postoperative nausea and vomiting (PONV) in adults, for up to 24 hours after surgery. In Brazil, ONICIT® is also indicated for pediatric patients, from 1 month to 17 years of age, for the prevention of acute nausea and vomiting associated with the initial and repeated cycles of emetogenic chemotherapy for cancer, including highly emetogenic chemotherapy.
'We are proud to continue providing patients and health care professionals with advanced treatments like ONICIT® to help mitigate the debilitating effects of chemotherapy induced nausea and vomiting,' said Samira Sakhia, President and CEO of Knight. 'ONICIT® is synergistic with our existing oncology portfolio and will continue leveraging the existing commercial and medical footprint.'
About ONICIT®
ONICIT® is a second generation 5-HT3 receptor antagonist with higher affinity for the 5-HT3 receptor compared to first-generation 5-HT3 receptor antagonists.1 A single dose of ONICIT® prior to chemotherapy provides protection over the entire overall phase (days 1–5) hence providing a simple and effective regimen. Efficacy was demonstrated both in the acute (day 1) and in the delayed (days 2-5) phase after chemotherapy.2,3
References
1 Rojas C, Slusher BS. Pharmacological mechanisms of 5-HT₃ and tachykinin NK₁ receptor antagonism to prevent chemotherapy-induced nausea and vomiting.
Eur
J
Pharmacol
. 2012;684(1-3):1-7. doi:10.1016/j.ejphar.2012.01.046
2 Navari RM, Aapro M. Antiemetic Prophylaxis for Chemotherapy-Induced Nausea and Vomiting.
N Engl J Med
. 2016;374(14):1356-1367. doi:10.1056/NEJMra1515442
3 Aapro MS. Palonosetron as an anti-emetic and anti-nausea agent in oncology.
Ther Clin Risk Manag
. 2007;3(6):1009-1020.
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
.
About Helsinn
Helsinn is a global pharmaceutical company that builds, manufactures, launches, and commercializes products to improve the quality of life for patients with cancer and chronic disease, with a focus on supportive care, oncology and dermato-oncology. Helsinn, headquartered in Lugano, Switzerland, has direct commercial operations in the U.S. and a consolidated network of partners to reach out to patients in about 150 countries worldwide.
Established in 1976, Helsinn is a fourth-generation family-owned company with broad pharmaceutical and technical expertise. Helsinn is proud of its history of operating with great integrity, passion and quality. The company is committed to continuously striving for innovation for its patients and embracing sustainable growth as a core element of its strategic vision.
To learn more about Helsinn, please visit
www.helsinn.com
or follow us on
LinkedIn
and
X
.
Forward-Looking Statements
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, 2024, 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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These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q and Form 10-K, in each case including in the sections thereof captioned 'Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in our subsequent reports on Form 8-K. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise. References: Tselios K, Gladman DD, Touma Z, et al. Disease course patterns in systemic lupus erythematosus. Lupus. 2019;28(1):114-122. Fanouriakis A, Tziolos N, Bertsias G, et al. Update οn the diagnosis and management of systemic lupus erythematosus. Ann Rheum Dis. 2021;80(1):14-25. doi:10.1136/annrheumdis-2020-218272 Petri M. Epidemiology of systemic lupus erythematosus. Best Pract Res Clin Rheumatol. 2002;16(5):847-58. Epub 2002/12/11. doi: 10.1053/berh.2002.0259. PubMed PMID: 12473278. Rees F, Doherty M, Grainge M, Davenport G, Lanyon P, Zhang W. The incidence and prevalence of systemic lupus erythematosus in the UK, 1999-2012. Ann Rheum Dis. 2016;75(1):136-41. Epub 2014/10/01. doi: 10.1136/annrheumdis-2014-206334. PubMed PMID: 25265938; PubMed Central PMCID: PMCPMC4717400. Pons-Estel GJ, Ugarte-Gil MF, Alarcón GS. Epidemiology of systemic lupus erythematosus. Expert Rev Clin Immunol. 2017;13(8):799-814. Carter EE, Barr SG, Clarke AE. The global burden of SLE: prevalence, health disparities and socioeconomic impact. Nat Rev Rheumatol. 2016;12(10):605-20. Epub 2016/08/26. doi: 10.1038/nrrheum.2016.137. PubMed PMID: 27558659. Kheir JM, Guthridge CJ, Johnston JR, Adams LJ, Rasmussen A, Gross TF, et al. Unique clinical characteristics, autoantibodies and medication use in Native American patients with systemic lupus erythematosus. Lupus Sci Med. 2018;5(1):e000247. Epub 2018/03/14. doi: 10.1136/lupus-2017-000247. PubMed PMID: 29531773; PubMed Central PMCID: PMCPMC5844376. Mehta B, Luo Y, Xu J, Sammaritano L, Salmon J, Lockshin M, et al. Trends in Maternal and Fetal Outcomes Among Pregnant Women With Systemic Lupus Erythematosus in the United States: A Cross-sectional Analysis. Ann Intern Med. 2019;171(3):164-71. Epub 2019/07/10. doi: 10.7326/M19-0120. PubMed PMID: 31284305. Bitencourt N, Bermas BL. Pharmacological Approach to Managing Childhood-Onset Systemic Lupus Erythematosus During Conception, Pregnancy and Breastfeeding. Paediatr Drugs. Furie RA, Bruce IN, Dörner T, et al. Phase 2 randomized, placebo-controlled trial of dapirolizumab pegol in patients with moderate to severe active systemic lupus erythematosus (SLE). Rheumatology (Oxford).2021;60(11): 5397-407. (NCT04294667). A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (PHOENYCS GO) 2023 [cited August 2024] Available at: Retrieved July 25, 2024. MEDIA CONTACTS:UCBAdriaan Snauwaert+32 497 70 23 BiogenJack Cox+1 781 464 INVESTOR CONTACTS:UCBAntje Witte+32 2 559 Power+ 1 781 464 2442IR@
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