US-based Puma Biotechnology has signed an exclusive licensing agreement with French pharmaceutical group Pierre Fabre under which the latter will develop and commercialise its Nerlynx (neratinib) drug in Europe and some African markets.
Neratinib is an irreversible tyrosine kinase inhibitor (TKI) designed to block signal transduction through the epidermal growth factor receptors (EGFRs), HER1, HER2 and HER4.
While Puma Biotechnology believes that the drug could help in treating a variety of cancers, the company’s initial focus is on oral treatment for HER2-positive breast cancer.
In September last year, the drug received the European marketing authorisation as an extended adjuvant treatment for early stage hormone receptor positive HER2-overexpressed/amplified breast cancer.
It is indicated for adult patients who are less than one year from the completion of prior adjuvant trastuzumab-based therapy.
The licensing agreement will provide Pierre Fabre with exclusive commercialisation rights to Nerlynx in European markets, except Russia and Ukraine, as well as North African countries and francophone countries in West Africa.
In addition, the company will carry out further clinical studies and regulatory activities related to the European Medicines Agency (EMA).
Pierre Fabre Pharmaceuticals CEO Frederic Duchesne said: “Pierre Fabre has developed a strong expertise and presence in the breast cancer treatment and the addition of Nerlynx to our historical oncology portfolio will allow us to strengthen our commercial presence.”
The company intends to roll out the drug across Europe, beginning with Germany, in 2019 and 2020.
As part of the agreement, Pierre Fabre will pay an upfront payment of $60m to Puma Biotechnology, along with up to $345m in regulatory and commercial milestones.
Puma Biotechnology is also eligible for double-digit royalties on Nerlynx sales across the territory covered under the licensing agreement.
Puma Biotechnology CEO and president Alan Auerbach said: “Puma is committed to providing access to Nerlynx to patients around the world and soon physicians and patients in Europe will have commercial availability.
“Pierre Fabre has a robust commercial and medical oncology infrastructure that we hope will lead to rapid commercial access to Nerlynx.”
Neratinib also holds the US regulatory approval for the extended adjuvant treatment of adults with early stage HER2-overexpressed/amplified breast cancer after adjuvant trastuzumab-based therapy.