Pierre Fabre SA and Puma Biotechnology, Inc. have broadened the geographic coverage of their license agreement on commercialisation of Nerlynx® (neratinib).

According the extended agreement, Pierre Fabre may not only market the breast cancer recurrence blocker Nerlynx® (neratinib) within Europe and part of Africa but also in the Middle East and several African territories. Puma will receive US$4m upfront, as well as additional regulatory and sales-based milestone payments totaling up to US$3m. Net sales of the tyrosine kinase from the countries in this extension territory will be included in the calculation ofpayments related to sales milestones and royalties from the original license agreement signed earlier this year.

Pierre Fabre estimates 20 to 25 percent of breast cancer tumors to overexpress 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 Roche’s trastuzumab (Herceptin®) can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.