Puma Biotechnology, Knight Therapeutics enter into license agreement for NERLYNX
Puma Biotechnology announced that it has entered into an exclusive License Agreement with Knight Therapeutics that grants Knight the exclusive right to commercialize NERLYNX in Canada. 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 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 $7.2M throughout the term of this agreement, as well as double digit royalties on net sales of NERLYNX in Canada. Neratinib was approved by the U.S. Food and Drug Administration in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX tablets.