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

MONTREAL, Quebec and LUGANO, Switzerland – 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, today announced 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”).  According to IQVIA, sales of AKYNZEO® in Canada and Brazil were approximately $7 million in 2021.

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: http://www.mascc.org/

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

Helsinn is a fully integrated, global biopharma company headquartered in Lugano, Switzerland. It is focused on improving the lives of cancer patients all over the world with a leading position in cancer supportive care and an innovative pipeline of cancer therapeutics.

Helsinn is a third-generation family-owned company, that since 1976 has been focused on improving the lives of patients, guided by core values of respect, integrity and quality. It operates a unique licensing business model with integrated drug development and manufacturing capabilities. Helsinn has a commercial presence in 190 countries either directly, with operating subsidiaries in the U.S. and China, or via its network of long-standing trusted partners. Helsinn also has a fully integrated supply chain and product development through its subsidiary in Ireland, Helsinn Birex Pharmaceuticals Ltd.

Helsinn plays an active and central role in promoting social transformation in favor of people and the environment. Corporate social responsibility is at the heart of everything we do, which is reinforced in the company’s strategic plan by a commitment to sustainable growth.

For more information, please visit www.Helsinn.com and follow us on Twitter and LinkedIn.

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 owns Biotoscana Investments S.A., a pan-Latin American specialty pharmaceutical company. 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.gud-knight.com or www.sedar.com.

Forward-Looking Statements for Knight Therapeutics Inc.

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, 2021 as filed on www.sedar.com. 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.

Helsinn Media Contact:

Paola Bonvicini
Group Head of Communication
Lugano, Switzerland
Tel: +41 (0) 91 985 21 21
Email: Info-hhc@helsinn.com

For more information, please visit www.helsinn.com and follow us on Twitter and LinkedIn

Investor Contact for Knight Therapeutics Inc.:

Knight Therapeutics Inc.
Samira Sakhia
President & Chief Executive Officer
T: 514.484.4483
F: 514.481.4116

Arvind Utchanah
Chief Financial Officer
T. 598.2626.2344
Email: info@knighttx.com
Website: www.gud-knight.com