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Puma, Bixink Ink Licensing Agreement to Commercialize Nerlynx in South Korea

NEW YORK – On Thursday, Puma Biotechnology said that it entered into an exclusive licensing agreement with South Korean company Bixink Therapeutics to commercialize neratinib (Nerlynx) in South Korea.

Bixink will be responsible for seeking regulatory approval in the country, and Puma will receive upfront and milestone payments of up to $6 million, in addition to royalties on the sales of neratinib in South Korea.

Neratinib was approved by the US Food and Drug Administration in February in combination with capecitabine for advanced or metastatic HER2-positive breast cancer patients who have received two or more anti-HER2 therapies.

The drug is also approved in Europe, Canada, Australia, Hong Kong, Singapore, and Argentina as an extended adjuvant therapy for patients with early-stage, HER2-overexpressed or amplified breast cancer following adjuvant treatment with trastuzumab (Genentech's Herceptin).