Puma Biotechnology out-licenses Nerlynx in Canada

USA-based Puma Biotechnology (Nasdaq: PBYI) has entered into an exclusive license agreement granting Knight Therapeutics (TSX: GUD) the exclusive right in Canada to commercialize Nerlynx (neratinib), which generated global sales of $52.6 million in the third quarter of 2018.

Puma Biotechnology 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 deal, 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 throughout the term of this agreement, as well as double digit royalties on net sales of the drug in Canada.

“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 US market,” stated Alan Auerbach, chief executive officer and president of Puma.