A shot in the arm against HIV

DURECT and Gilead form deal around long-acting injectable for HIV; additional HIV and HBV candidates also in the mix

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CUPERTINO, Calif.—DURECT Corp. announced July 22 that it had entered into an agreement with Gilead Sciences Inc. granting Gilead the exclusive worldwide rights to develop and commercialize a long-acting injectable HIV product utilizing DURECT’s SABER (sucrose acetate isobutyrate extended release) technology. The SABER technology is also the basis for Durect’s Posimir (bupivacaine extended-release solution), an investigational locally-acting, non-opioid analgesic intended to provide up to three days of continuous pain relief after surgery.
In reaction to the out-license agreement, DURECT’s share value went up 39 percent premarket on light volume.
But this isn’t just a one-off deal. Gilead also receives exclusive access to the SABER platform for HIV and hepatitis B Virus (HBV) more generally, as well as the exclusive option to license additional SABER-based products directed to HIV and HBV.
“We’re pleased to be working on this program with Gilead given their expertise and global leadership in the HIV and HBV fields,” said James E. Brown, president and CEO of DURECT. “We’ve been working together on this program as a feasibility project, and are now delighted that Gilead has chosen to advance this effort into a formal development program.”
Under the terms of the agreement, Gilead will make an upfront payment to DURECT of $25 million, with the potential for up to an additional $75 million in development and regulatory milestones. DURECT also stands to receive up to an additional $70 million in sales-based milestones, as well as tiered royalties on product sales.
Gilead has 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 ambitions and abilities go beyond both HIV/HBV and injectables. The biopharmaceutical company is 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 and acute kidney injury; chronic hepatic diseases, such as nonalcoholic steatohepatitis; and inflammatory skin conditions, such as psoriasis and atopic dermatitis.
As the company puts it, “DURECT’s advanced oral and injectable delivery technologies are designed to enable new indications and enhanced attributes for small-molecule and biologic drugs.”
Posimir, as noted earlier, is one of the company’s key product candidates in this category, as well as Oradur-methylphenidate extended release capsules, approved in Taiwan as Methydur Sustained Release, where it is indicated for the treatment of attention deficit hyperactivity disorder.
As for Foster City, Calif.-based Gilead, this is just one of several deals the company has inked in July alone. July 11 saw a strategic collaboration with the Renown Institute for Health Innovation to collect and analyze genetic and electronic health data on nonalcoholic steatohepatitis. Then three days later, a global R&D deal was signed with Galapagos NV in which Gilead gains access to a portfolio of six drugs in clinic trials and more than 20 in the preclinical stage. And on July 19, Gilead licensed three preclinical antiviral programs from Novartis, including therapeutics to treat human rhinovirus, influenza and herpes viruses.

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