Neratinib enters new turf

LOS ANGELES—Puma Biotechnology, Inc. and Bixink Therapeutics Co. Ltd., a South Korean company working in the field of anti-cancer drugs and digital therapeutics, have entered into an exclusive agreement under which Bixink will commercialize Puma’s Nerlynx (neratinib) in South Korea.

“Our new agreement with Bixink 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 excited about the potential to provide South Korean breast cancer patients with access to Nerlynx.”

Under the terms of the agreement, Bixink will be responsible for seeking the requisite regulatory approval, and for commercializing Nerlynx in South Korea. Puma will receive upfront and milestone payments of up to $6 million, as well as significant double-digit royalties on the sales of Nerlynx in South Korea.

“We are excited about the opportunity to provide Nerlynx to patients with HER2-positive breast cancer in South Korea and plan to file for its market authorization before the end of 2020. Nerlynx is our top priority as we aspire to be a leading South Korean company in the field of oncology therapeutics,” added Dr. Sung Chul Kim, chief executive officer of Bixink Therapeutics.

Neratinib is approved in the U.S. for both the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and HER2-positive metastatic breast cancer.

The U.S. Food and Drug Administration (FDA) approved Puma’s supplemental New Drug Application (sNDA) for neratinib back in February. The approval was based on results of the Phase 3 NALA trial, a randomized controlled trial of neratinib plus capecitabine in patients with HER2-positive metastatic breast cancer who have received two or more prior anti-HER2-based regimens.

“Although there have been many new treatment options for patients with HER2-positive breast cancer, patients still need additional treatment options once they progress” Auerbach noted in a press release about the approval. “Based on the results of our NALA data, we believe Nerlynx could be a promising therapeutic opportunity for these patients.”

In Europe, Nerlynx is approved 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 completion of prior adjuvant trastuzumab-based therapy. Nerlynx has also received approval for use in the extended adjuvant setting in Canada, Australia, Hong Kong, Singapore and Argentina.

Puma says that the company expects to seek approval of this second indication in all countries where Nerlynx is currently approved.