Sandoz is paying $20 million upfront to secure U.S. development and commercialization rights to Durect’s non-opioid, post-surgical analgesic Posimer® (SABER®-bupivacaine). The drug, which is currently undergoing Phase III development, has been formulated using Durect’s SABER (sucrose acetate isobutyrate extended release) technology and is designed to continuously deliver bupivacaine to the surgical site for 72 hours, and so provide up to 3 days of continuous pain relief.
Under terms of the deal, Durect could receive up to another $43 million in development and regulatory milestones, and an additional $230 million in sales-based milestones, plus tiered double-digit sales royalties.
The ongoing Phase III PERSIST study is comparing treatment using Posimer, with bupivacaine HCl therapy in patients undergoing laparoscopic cholecystectomy. Topline data are expected shortly after completion of patient dosing, which is expected during Q3 2017.
“We believe that Posimer has the potential to become a cornerstone of multimodal post-operative pain management,” commented James E. Brown, D.V.M., president and CEO at Durect. “As a non-opioid local analgesic, we believe Posimer may be an important contributor to the ongoing efforts to reduce the use of opioid-based medications following surgery.”
Durect is separately developing additional products using the SABER platform. At the back end of 2014, the firm granted Santen Pharmaceuticals exclusive global rights to develop and commercialize a sustained-release ophthalmology drug utilizing the Saber technology. Relday® is a SABER-risperidone product, which Durect licensed to Zogenix in 2011. Zogenix is looking for a partner to initiate Phase III trials with Relday.
In addition to the SABER drug delivery technology, Durect is developing products based on its TRANSDUR® transdermal delivery technology and using its ORADUR® abuse-deterrent technology. In 2014, Durect and Impax reported an agreement for global development and commercialization of Eladur®, a TRANSDUR transdermal bupivacaine patch for treating post-herpatic neuralgia pain. In 2002, Pain Therapeutics negotiated global rights to develop and commercialize four oral sustained-release, abuse-deterrent opioid analgesic products based on the ORADUR platform.
Durect's Epigenetic Regulator Program (ERP) is headed by lead candidate DUR-928, an endogenous, orally bioavailable small molecule that Durect is evaluating as a potential treatment for chronic metabolic diseases, including nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH), and potentially other nonmetabolic liver disorders, acute organ injury, and psoriasis. Phase Ib studies have been completed or are ongoing in patients with NASH, impaired renal function, and psoriasis. Durect’s ERP program is a collaboration between the company and the Department of Internal Medicine at Virginia Commonwealth University (VCU), the VCU Medical Center, and the McGuire VA Medical Center.