Puma Biotechnology and Specialised Therapeutics Asia have entered into an exclusive agreement under which Specialised Therapeutics will commercialize NERLYNX (neratinib) throughout South East Asia, beginning with Australia, Singapore, Malaysia, Brunei and New Zealand. Currently, Specialised Therapeutics markets Abraxane and other oncology products in these countries.
NERLYNX is not approved currently for commercialization outside of the United States. Specialised Therapeutics will be responsible for seeking the requisite regulatory approvals and, once approved, for commercializing NERLYNX in those countries. Puma will receive upfront and milestone payments of up to $4.5 million throughout the term of this agreement, as well as significant double digit royalties on NERLYNX sales in all regions in which Specialised Therapeutics commercializes NERLYNX.
“Our new agreement with Specialised Therapeutics demonstrates our commitment to bringing NERLYNX to patients around the world while continuing to focus our commercial resources on the U.S. market,” said Alan H. Auerbach, Chief Executive Officer and President of Puma. “We are confident this new partnership will help patients in our new partner’s regions access NERLYNX at the earliest opportunity.”
Neratinib was approved by the U.S. Food and Drug Administration (FDA) 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 (neratinib) tablets.
Approximately 20% to 25% of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.