Barr Signs Deal to Develop Its First Follow-On Biologic
Barr Laboratories is taking the plunge into the follow-on biologics market, announcing March 30 that it is partnering with Croatian biopharmaceutical firm PLIVA to develop its first biogeneric product.
Under the terms of the agreement, Barr and two PLIVA subsidiaries, PLIVA Croatia and PAM, will develop, manufacture and market granulocyte-colony stimulating factor (G-CSF), a biopharmaceutical used to regulate white blood cell production in patients with chemotherapy-induced neutropenia.
The companies plan to seek approval for the product in the U.S. and Canada as a generic version of Amgen's Neupogen (filgrastim). G-CSF products generated U.S. sales of approximately $900 million in 2004, according to IMS Health data.
The G-CSF deal calls for PLIVA to have full responsibility for product development, including for data necessary to submit an application to the FDA. Barr, meanwhile, has the responsibility for all regulatory activities and has exclusive marketing rights to the product after it's approved. Barr will be responsible for all costs related to clinical trials and marketing activities, and will have exclusive rights to purchase the product from PLIVA.