CUPERTINO, Calif., Sept. 9, 2019 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) announced today 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."
DURECT's Collaboration with Gilead
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.
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 under investigation for the management of
postoperative pain).
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 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 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 investigational product, potential milestone
and royalty payments to DURECT, and the potential licensing by
Gilead of additional products directed to HIV and HBV and, 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 additional
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 POSIMIR may not be approved by
the FDA, that ORADUR-Methylphenidate ER may not be commercially
successful in territories where it is approved or approved in other
territories, that Indivior will not generate significant sales of
PERSERIS, 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 filed on August 2, 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