Nerlynx is intended for the extended adjuvant treatment of adults with early stage HER2-overexpressed/amplified breast cancer. Credit: Dr. Cecil Fox.

Canada-based Knight Therapeutics signed an exclusive licence agreement with Puma Biotechnology to commercialise Nerlynx (neratinib) medicine in the country.

Nerlynx is intended for the extended adjuvant treatment of adults suffering from early stage HER2-overexpressed/amplified breast cancer after adjuvant trastuzumab-based therapy.

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In July last year, Puma Biotechnology submitted a new drug application to Health Canada seeking authorisation for Nerlynx.

The licence agreement gives Knight Therapeutics the rights to carry out all commercial activities and future regulatory submissions for 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.”

Knight Therapeutics CEO Ross Goodman said: “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.”

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As per the agreement, Puma Biotechnology will receive up to $7.2m in upfront and milestone payments over the term of the deal. The US-based company will also receive royalties on net sales of the drug in Canada.

Puma Biotechnology CEO and president Alan Auerbach said: “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.

“We are confident this new partnership will help patients in Canada access Nerlynx at the earliest opportunity.”

Nerlynx secured approval from the US Food and Drug Administration (FDA) in July 2017 for the extended adjuvant treatment of adults with early stage HER2-overexpressed/amplified breast cancer after adjuvant trastuzumab-based therapy.

In September last year, the drug received marketing authorisation from the European Commission (EC).