DURECT and Gilead Collaborate on HIV Therapy in Potential $320 Million+ Deal
Gilead picked up exclusive access to the SABER platform for HIV and Hepatitis B Virus (HBV) as well as an exclusive option to license more SABER-based products for HIV and HBV. Under the terms of the deal, Gilead is paying DURECT $25 million upfront with another $75 million in development and regulatory milestones, another $70 million in sales milestones, and tiered royalties on any products that are sold. Gilead also gained an exclusive option to license more SABER-based products for HIV and HBV for another $150 million per product in upfront, development, regulatory and sales-based milestones and tiered royalties.
“We are pleased to be working on this program with Gilead given their expertise and global leadership in the HIV and HBV fields,” stated James E. Brown, president and chief executive officer 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.”
SABER stands for sucrose acetate isobutyrate extended release and allows for sustained release of long-acting injectable products.
DURECT shares rocketed 39% premarket at the news.
Gilead has been busy lately. On July 19, the Foster City, California-based company licensed three preclinical antiviral programs from Novartis, including therapeutics to treat human rhinovirus, influenza and herpes viruses. They paid Novartis an undisclosed upfront amount and up to another $291 million in milestone payments.
On July 14, it signed a 10-year global research and development collaboration with Mechelen, Belgium-based Galapagos NV. Gilead picks up access to a portfolio of six drugs in the clinic and more than 20 preclinical programs. Gilead paid Galapagos $3.95 billion upfront and a $1.1 billion equity investment. They also amended their agreement concerning filgotinib, a candidate for rheumatoid arthritis and other inflammatory diseases.
On July 11, Gilead and the Renown Institute for Health Innovation (IHI) signed a strategic collaboration deal to collect and analyze genetic and electronic health data on nonalcoholic steatohepatitis (NASH). Gilead is paying for Renown to sequence and analyze the DNA of 15,000 people with NASH or nonalcoholic fatty liver disease (NAFLD) and a control cohort of 40,000 individuals.
DURECT, on the other hand, is trying to overcome a number of setbacks. In 2017, DURECT’s extended-release version of pain drug bupivacaine it was partnering with Novartis on failed in a Phase III clinical trial comparing it to regular bupivacaine. On July 17, 2019, DURECT resubmitted Posimir (bupivacaine extended-release solution to the U.S. Food and Drug Administration (FDA) in response to the FDA’s Complete Response Letter (CRL). It has a target action date of December 27, 2019.
“We are pleased that the FDA considers our Posimir submission to be complete and has set a user fee goal date of six months after submission,” Brown stated. “New non-opioid pain products are much needed in the post-operative pain setting and we believe that Posimir could be an important contributor.”
Posimir was designed to deliver a single dose of the drug for post-surgical pain for up to three days. In two clinical trials, patients undergoing inguinal hernia repair and subacromial decompression (shoulder) surgeries, the drug showed a significant decrease in pain and opioids taken over a 72-hour period after surgery compared to placebo.