DURECT Earns $10-Million Milestone Payment From Gilead

DURECT Corporation recently announced that further development of a long-acting injectable HIV investigational product utilizing DURECT’s SABER technology has triggered a $10-million milestone payment from Gilead Sciences, Inc. to DURECT under the license agreement between the companies.

“We are pleased that Gilead has been rapidly advancing this program,” stated James E. Brown, President and CEO of DURECT. “We believe that long-acting injectables using our SABER platform have the potential to improve the lives of people with HIV.”

“Our license agreement with Gilead is part of DURECT’s broader strategy to enter into selective collaborations and other arrangements for our technologies and product development programs,” continued Dr. Brown. “By leveraging our resources with corporate collaborators, we believe we can retain commercial interest in multiple product candidates and maximize value for our shareholders.”

In July 2019, DURECT and Gilead entered into an agreement granting Gilead the exclusive worldwide rights to develop and commercialize a long-acting injectable HIV product utilizing DURECT’s SABER technology. Under the terms of the agreement, Gilead made an upfront payment to DURECT of $25 million, and further development has triggered an additional $10-million milestone payment. Remaining milestones include the potential for up to an additional $65 million in development and regulatory milestones, up to an additional $70 million in sales-based milestones, as well as tiered royalties on product sales. Gilead also received exclusive access to the SABER platform for HIV and hepatitis B virus (HBV) and the exclusive option to license additional SABER-based products directed to HIV and HBV for an additional $150 million per product in upfront, development, regulatory, and sales based milestones as well as tiered royalties on sales. The parties will collaborate on specified development activities with Gilead controlling and funding the development programs.

DURECT’s SABER Technology (Sucrose acetate isobutyrate extended release) is a patented technology designed to provide sustained release for long-acting injectable products. The SABER technology is also the basis of POSIMIR (bupivacaine extended-release solution under investigation for the management of postoperative pain).

DURECT is a biopharmaceutical company actively developing therapeutics based on its Epigenetic Regulator Program and proprietary drug delivery platforms.  DUR‑928, a new chemical entity in Phase 2 development, is the lead candidate in DURECT’s Epigenetic Regulator Program.  An endogenous, orally bioavailable small molecule, DUR-928 has been shown in preclinical studies to play an important regulatory role in lipid homeostasis, inflammation, and cell survival.  Human applications may include acute organ injury such as alcoholic Hepatitis (AH) and acute kidney injury (AKI), chronic hepatic diseases such as nonalcoholic steatohepatitis (NASH), and inflammatory skin conditions such as psoriasis and atopic dermatitis. DURECT’s advanced oral and injectable delivery technologies are designed to enable new indications and enhanced attributes for small-molecule and biologic drugs.  Key product candidates in this category include POSIMIR (bupivacaine extended-release solution), an investigational locally-acting, non-opioid analgesic intended to provide up to 3 days of continuous pain relief after surgery, a long-acting injectable SABER-based HIV investigational product being developed with Gilead, and ORADUR-Methylphenidate ER Capsules, approved in Taiwan as Methydur Sustained Release Capsules, where it is indicated for the treatment of attention deficit hyperactivity disorder (ADHD).  In addition, for the assignment of certain patent rights, DURECT receives single digit sales-based earn-out payments from US net sales of Indivior’s PERSERIS (risperidone) drug for schizophrenia, which was commercially launched in February 2019.  For more information about DURECT, visit www.durect.com.

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