Puma Biotechnology revises Neratinib licensing deal with Pfizer

Currently, Puma is developing PB272 for the treatment of patients with HER2-positive breast cancer as well as for patients with non-small cell lung cancer, breast cancer and other solid tumors that have a HER2 mutation.

At the time when PB272 was licensed from Pfizer, a number of ongoing clinical trials that had been previously started by Pfizer were transferred to Puma.

Puma said that the original license deal set a limit on the amount of external expenses that it would incur in completing these legacy clinical trials and the limit was met in the fourth quarter of 2012.

The company said that the original license agreement also provided that Pfizer would be responsible for all expenses for these ongoing trials above the pre-determined limit until the trials were completed.

Under the revised license agreement, Puma will be solely responsible for the expenses associated with the ongoing legacy clinical trials.

Puma expects that this will result in an increase in research and development expenses, which will total about $30m.

Additionally, according to the terms of the original license agreement, upon commercialization of neratinib, Puma is obligated to pay Pfizer incremental annual royalties ranging between 10-20% of net sales of neratinib.

As part of the revised deal, upon commercialization of neratinib, Puma will be obligated to pay Pfizer annual royalties on net sales of neratinib at a fixed rate in the low- to mid- teens.