CUPERTINO, Calif., July 22, 2019 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) announced today that it has 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® technology. 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.
"We're 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
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, 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.
About SABER® Technology
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).
About DURECT Corporation
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 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 U.S. net
sales of Indivior's PERSERIS™ (risperidone) drug for
schizophrenia, which was commercially launched in February
2019. For more information about DURECT, please visit
www.durect.com.
DURECT Forward-Looking Statement
The statements in this press release regarding the development
of a long-acting HIV product, the potential licensing by Gilead of
additional products directed to HIV and HBV and potential milestone
and royalty payments to DURECT, as well as statements about
potential uses and benefits of DUR-928 and DURECT's oral and
injectable delivery technologies, as well as potential revenues
from commercial sales of Indivior's PERSERIS, are forward-looking
statements involving risks and uncertainties that can cause actual
results to differ materially from those in such forward-looking
statements. Potential risks and uncertainties include, but are not
limited to, the risks that the milestones triggering payments to
DURECT by Gilead will not be achieved and that the long-acting HIV
product will not be developed, that Gilead may decide not to
license additional products from DURECT, that potential adverse
effects may arise from the testing or use of DUR-928, that DURECT
may not avoid infringing patents held by other parties or be unable
to secure and defend its own patents, and DURECT'S ability to
manage and obtain capital to fund operations and expenses. Further
information regarding these and other risks is included in DURECT's
Form 10-Q on May 8, 2019 under the
heading "Risk Factors."
NOTE: POSIMIR®, SABER® and
ORADUR™, are trademarks of DURECT Corporation. Other
referenced trademarks belong to their respective owners. DUR-928,
POSIMIR and ORADUR-Methylphenidate ER Capsules are drug candidates
under development and have not been approved for commercialization
by the U.S. Food and Drug Administration or other health
authorities. Full prescribing information for PERSERIS, including
BOXED WARNING, and Medication Guide can be found at
www.perseris.com.
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SOURCE DURECT Corporation