Knight Therapeutics and Helsinn Healthcare SA Enter into Exclusive License, Distribution, and Supply Agreement for Akynzeo® and Aloxi®

On May 12, 2022 Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, and Helsinn Healthcare SA ("Helsinn"), a fully integrated, global biopharma company with a diversified pipeline of innovative oncology assets and strong track record of commercial execution, reported that Knight, through one of its wholly-owned subsidiaries, and Helsinn have entered into an exclusive license, distribution and supply agreement for AKYNZEO oral/IV (netupitant/palonosetron / fosnetupitant/palonosetron) in Canada, Brazil, Argentina, Uruguay and Paraguay, and ALOXI oral/IV (palonosetron) in Canada (the "Products") (Press release, Knight Therapeutics, MAY 12, 2022, View Source;Distribution–and-Supply-Agreement-for-Akynzeo174–and-Aloxi174–5-12-2022 [SID1234614406]). According to IQVIA, sales of AKYNZEO in Canada and Brazil were approximately $7 million in 2021.

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Under the terms of the agreement, Knight shall have the exclusive right to distribute, promote, market and sell the Products in the licensed territories. Knight will begin commercial activities following a transition period from Helsinn’s current licensees.

"We are very excited to enter into this agreement with Helsinn for AKYNZEO in Canada, Brazil and other selected Latin American countries, and ALOXI in Canada," said Samira Sakhia, President and CEO of Knight. "These products are highly synergistic with our oncology portfolio and commercial footprint, and we look forward to widening access to these therapies in our target markets. AKYNZEO and ALOXI are leading, guideline-recommended1,2,3 antiemetics that help to prevent one of the most common side effects of chemotherapy."

"AKYNZEO and ALOXI form a key part of Helsinn’s commercial engine of supportive cancer care products," said Giorgio Calderari, Helsinn CEO. "Knight has a unique footprint with strong capabilities across Canada and Latin America, and we look forward to collaborating with them as they work to ensure patients in these geographies have access to these important medicines."

The financial terms of the transaction were not disclosed.

About Akynzeo

AKYNZEO is the first and only 5-HT3 and NK1 receptor antagonist fixed combination approved for the prevention of chemotherapy-induced acute and delayed nausea and vomiting. A single dose of AKYNZEO given with dexamethasone has been shown to prevent chemotherapy-induced nausea and vomiting for up to 5 days. AKYNZEO oral is approved and marketed in Canada for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy and the prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy that is uncontrolled by a 5-HT3 receptor antagonist alone in adults. AKYNZEO oral is also approved and marketed in Argentina and Brazil for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults.

About Aloxi

ALOXI is a second generation 5-HT3 receptor antagonist with high receptor binding affinity and a duration of action up to 5 days after chemotherapy administration4,5. ALOXI solution for injection is approved and marketed in Canada for the prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy and highly emetogenic cancer chemotherapy, including high dose cisplatin in adults. In Canada, the product is also indicated in pediatric patients aged 2 to 17 years for the prevention of acute nausea and vomiting associated with moderately and highly emetogenic cancer chemotherapy. ALOXI oral is approved in Canada for use in adults for the prevention of acute nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

References
1 Roila F. et al. Ann Oncol. 2016 Sep;27(suppl 5):v119-v133. MASCC/ESMO Antiemetic Guideline 2016 V.1.4 last update July 2019. Available at: View Source;
2 Hesketh J. et al. J Clin Oncol. 2020 Aug 20;38(24):2782-2797. doi: 10.1200/JCO.20.01296. Epub 2020 Jul 13;
3 NCCN: National Comprehensive Cancer Network; NCCN Clinical Practice Guidelines in Oncology; Version 2.2022. Available at: www.nccn.org
4 Rojas C, Slusher BS. Eur J Pharmacol 2012;684(1-3):1-7; 6;
5 Navari RM and Aapro M. N Engl J Med 2016;374:1356-67.