Investigational Long-acting HIV Product
DURECT Corporation has entered into an agreement with Gilead Sciences to develop and commercialize a long-acting injectable HIV investigational product utilizing DURECT’s SABER® technology. Under the terms of the agreement, Gilead made an upfront payment to DURECT of $25 million and has made an initial development milestone payment of $10 million, with 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 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. DURECT will perform specified development activities, with Gilead funding certain portions of the development program. The lead formulation is currently being re-formulated and will undergo additional pre-clinical development work.
As a product concept, a long-acting injectable HIV product would have the potential to provide patients with multiple benefits, including the following:
- May improve compliance due to a less frequent dosing schedule
- May be preferred for patients who wish to avoid the daily reminder of their disease
- May improve patient satisfaction
- May avoid the need for pharmacy ordering and pick-up, providing additional privacy to patients
More than thirty years since the first cases were reported, HIV/AIDS remains one of the world’s foremost health challenges. More than 35 million people have died of AIDS, and nearly 37 million people are now living with HIV. In the absence of a vaccine and cure, testing people for HIV and providing treatment to those who are infected is a primary strategy for controlling the epidemic. The international community has made enormous progress in antiretroviral treatment provision. Between 2002 and 2017, the number of people receiving antiretroviral therapy increased from 300,000 to 21.7 million. Treatment has averted an estimated 13.1 million AIDS deaths since 2000, and growing evidence shows that when people with HIV take effective medications to suppress the virus, they are significantly less likely to transmit HIV to others. Yet substantial needs remain, and continuing to scale up treatment is a top health and humanitarian priority. The World Health Organization released guidelines in 2015 recommending immediate treatment for all HIV-infected individuals, meaning that 15 million people worldwide are still in need of antiretroviral therapy.
Source: Scaling up antiretroviral treatment sustainably. Gilead Sciences, Inc., 2019. Available at: https://www.gilead.com/-/media/files/pdfs/other/hiv-access-backgrounder-us-061219.pdf.
Commercial rights are owned by Gilead Sciences, Inc.
There are risks and uncertainties associated with our business. Please see our most recent SEC filings (10-K or 10-Q) for a complete description of these risks and uncertainties, which are incorporated herein by reference.