Puma and Pint Pharma to Commercialize NERLYNX (neratinib) in Latin America
Puma Biotechnology and Pint Pharma International have entered into an agreement for Pint Pharma to commercialize NERLYNX (neratinib) in Argentina, Brazil, Chile, Colombia, Mexico and the rest of Latin America.
NERLYNX is not approved currently for commercialization outside of the United States. Pint Pharma will be responsible for seeking the requisite regulatory approvals and, once approved on a country by country basis, for commercializing NERLYNX in Latin America. Puma will receive an upfront payment as well as potential regulatory and commercial milestone payments totaling up to $34.5 million. In addition, Puma will receive significant double-digit royalties on NERLYNX sales in Latin America.
“Puma is committed to making NERLYNX commercially available to breast cancer patients around the world,” stated Alan H. Auerbach, Chief Executive Officer and President of Puma. “Our new partnership with Pint Pharm in Latin America demonstrates our commitment to ensure NERLYNX access to patients globally while we continue to focus our commercial resources on the U.S. market. We are confident this new partnership will help patients in Latin America access NERLYNX at the earliest opportunity.”
“We are excited to be collaborating closely with Puma as we plan to file for regulatory approvals of NERLYNX throughout Latin America,” said David Muñoz Guzman, Chief Executive Officer of Pint. “NERLYNX is highly complementary to our comprehensive oncology product offering and it will be the first breast cancer treatment within our portfolio, strengthening Pint Pharma’s presence in the Latin American oncology market. Furthermore, we plan to accelerate patient access to NERLYNX via the various early access programs available throughout the region.”
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.