Durect has signed a development and commercialisation agreement with Sandoz, a division of Novartis, to develop and market Posimir (Saber-Bupivacaine) in the US.
Posimir is an investigational, locally acting, non-opioid analgesic indicated to provide up to three days of continuous pain relief following surgery.
It uses the Saber technology that consistently delivers bupivacaine to the surgical site for 72 hours.
Durect is currently conducting PERSIST, a Phase III trial in patients undergoing laparoscopic cholecystectomy (gall bladder removal) to compare its effect with bupivacaine HCl.
Posimir is a drug candidate and is yet to receive approval from the US Food and Drug Administration (FDA) or other health authorities.
Durect president and CEO James Brown said: “We are delighted to collaborate with a company with the market presence and resources of Sandoz to commercialise Posimir in the US.
“We believe that Posimir has the potential to become a cornerstone of multi-modal, post-operative pain management.
“As a non-opioid local analgesic, we believe Posimir may be an important contributor to the ongoing efforts to reduce the use of opioid-based medications following surgery.”
Under the agreement, Sandoz will make an upfront payment of $20m to Durect, along with the potential for up to an additional $43m in development and regulatory milestones, as well as another $230m in sales-based milestones along with a double-digit royalty on product sales in the US.
Durect will carry out the ongoing PERSIST Phase III clinical trial for Posimir, as well as FDA interactions through approval.
The transaction is expected to be completed in the second quarter of this year, subject to completion of review under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976.