MONTREAL, Jan. 11, 2019 — Knight Therapeutics Inc. (TSX: GUD) (“Knight”), a Canadian specialty pharmaceutical company focused on acquiring, in-licensing, selling and marketing innovative prescription and over-the-counter pharmaceutical products, today announced it has entered into an exclusive License Agreement with Puma Biotechnology, Inc. (NASDAQ: PBYI) (“Puma“) granting Knight the exclusive right to commercialize NERLYNX® (neratinib) in Canada.
Puma filed a New Drug Submission for NERLYNX® with Health Canada in July 2018 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy. Under the terms of the License Agreement, Knight will be responsible for all commercial activities and future regulatory submissions for NERLYNX® in Canada. Puma will receive upfront and milestone payments up to $7.2 million USD throughout the term of this agreement, as well as double digit royalties on net sales of NERLYNX® in Canada.
“We are excited to partner with Puma to offer a new treatment option to Canadian breast cancer patients,” said Jonathan Ross Goodman, Chief Executive Officer of Knight. “While adjuvant trastuzumab-based therapy has been shown to reduce the risk of recurrence in early stage HER2-positive breast cancer, up to 25% of patients treated with adjuvant trastuzumab will have a recurrence. NERLYNX® has been shown to significantly reduce the risk of recurrence in those patients who were previously treated with trastuzumab.”
“Our new agreement with Knight demonstrates our commitment to bringing NERLYNX® to patients around the world while continuing to focus our commercial resources on the U.S. market,” stated Alan H. Auerbach, Chief Executive Officer and President of Puma. “We are confident this new partnership will help patients in Canada access NERLYNX® at the earliest opportunity.”
NERLYNX® is potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. NERLYNX® was approved by the FDA in the United States in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy. In September 2018, NERLYNX® was approved by the European Commission for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy. NERLYNX® is a registered trademark of Puma Biotechnology, Inc. For more information about Puma, please visit the corporate website at www.pumabiotechnology.com.
About Knight Therapeutics Inc.
Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian and select international markets. 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.gudknight.com or www.sedar.com.
Knight Forward-Looking Statement
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, 2017. 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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