Tuesday, April 16, 2019
Eagle Pharmaceuticals, Inc today announced that it has expanded its existing BENDEKA™ (bendamustine hydrochloride) licensing agreement with Teva Pharmaceuticals International GmbH (“Teva”). Under the terms of the revised licensing agreement, beginning on October 1, 2019, Eagle’s royalty payment will increase from 25% to 30% of BENDEKA net U.S. sales, provided that BENDEKA’s orphan drug exclusivity has not been rescinded, withdrawn or waived by such date. The royalty rate will increase by one percentage point on each anniversary of October 1, 2019 until it reaches 32%, and it will remain at 32% thereafter.
The revised agreement, effective April 13, 2019, also extends the U.S. BENDEKA royalty term until it is no longer sold in the United States. The previous U.S. royalty term was set to expire in 2025. The extended term recognizes the strength of the bendamustine patents with expiries through 2033, and the value of the product beyond the original ten-year period. As part of the agreement restructuring, Eagle will continue to manufacture BENDEKA for the U.S. market for so long as it is sold in the United States and has agreed to assume a portion of the BENDEKA-related patent litigation expenses.
“We are very pleased to deepen our relationship with Teva by extending and expanding our licensing agreement for BENDEKA. This agreement recognizes the long-term value of the product, which is supported by orphan drug exclusivity through December 7, 2022 and an extensive patent portfolio through 2033. Teva has been a strong commercial partner, and we look forward to exploring additional areas of cooperation,” stated Scott Tarriff, Chief Executive Officer of Eagle.
BENDEKA was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) and is approved for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.