DURECT has entered into an amendment to the development and commercialization agreement with Sandoz, a division of Novartis, regarding POSIMIR (SABER-bupivacaine) in the United States.
DURECT received an upfront payment from Sandoz of $20 million at the time the agreement between the two companies became effective in June 2017 and was initially eligible for up to an additional $43 million in payments based on successful development and regulatory milestones (of which $30 million is feasible following the results of the PERSIST Phase 3 clinical trial), and up to an additional $230 million in sales-based milestones. Sandoz received exclusive commercialization rights for POSIMIR in the U.S. upon regulatory approval with sole funding responsibility for commercialization activities. Sandoz has agreed to pay DURECT a tiered double-digit royalty on product sales for a defined period.
Pursuant to the amended agreement, DURECT is now eligible for up to $30 million in milestone payments based on NDA approval, and remains eligible for up to an additional $230 million in sales-based milestones. Each party, pursuant to the Amendment, is also permitted to develop or commercialize competing products. The Amendment also includes modifications to DURECT's development obligations and to both parties' termination provisions, including a right for DURECT to terminate for convenience prior to NDA approval. There is also a new termination fee payable to DURECT in the event that Sandoz terminates the agreement for convenience. The agreement between the two companies remains in full force and effect, except as expressly covered in the Amendment.
POSIMIR is an investigational extended-release depot utilizing DURECT's patented SABER technology intended to continuously deliver bupivacaine to the surgical site for 72 hours, to provide up to three days of continuous pain relief after surgery. POSIMIR is a drug candidate under development and has not been approved for commercialization by the U.S. Food and Drug Administration (FDA) or other health authorities.