DURECT Licenses SABER Technology To Santen Pharmaceutical For Ophthalmology Drug

DURECT and Santen Pharmaceutical have entered into an agreement to use DURECT’s SABER technology to develop and commercialize a sustained release ophthalmology product. The companies announced the deal in a press release, stating that Santen will control and fund the development program. James E. Brown, President and CEO of DURECT, said, "We're pleased to be working on this program with Santen given their expertise and global leadership position in the ophthalmology field. We've been working together on this program as a feasibility project, and we are now delighted that Santen has chosen to advance this effort into a formal development program."

Durect and Santen Agreement

Under the terms of the agreement between Santen and DURECT, Santen will make an upfront payment of $2 million in cash. Upon the achievement of development and marketing milestones, Santen will make additional cash payments. If the product is approved and commercialized, DURECT will also receive royalties.

SABER Technology

DURECT’s SABER technology is used in Posidur, which the Food and Drug Administration (FDA) is reviewing for post-operative pain. Relday is another SABER drug, which is in Phase 1 trials for the treatment of schizophrenia and bipolar disorder. The company’s first FDA-approved SABER product was SucroMate Equine, an injectable containing the peptide deslorelin, launched in 2011. The patented technology is a sustained release, injectable system.

In February 2014, the FDA sent a Complete Response Letter (CLR) to DURECT, declining to approve Posidur for post-surgical analgesia. The FDA said that more trials were needed because the NDA was insufficient in proving that the drug was safe. Posidur is a bupivacaine injectable that provides long-acting relief of pain at the surgical site for up to 72 hours. The benefits of the formulation are reduced narcotic use, side effects, and recovery time.

DURECT relied on 15 trials of 1,060 people treated with Posidur, bupivacaine HCl solution, or a placebo. The company worked with the FDA on its clinical strategy. However, the FDA said in its CLR that it did not have enough safety information to approve the drug. In November, DURECT provided an update, stating that it suggested to the FDA that it would like to expedite approval by seeking only an indication of soft tissue post-surgical analgesia. The FDA stated that was acceptable and mandated one trial to generate the data for approval.