CUPERTINO, Calif., June 19,
2017 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) today announced that
the previously disclosed development and commercialization
agreement with Sandoz AG, a division of Novartis (NYSE:
NVS), to develop and market in the United States DURECT's POSIMIR®
(SABER®-Bupivacaine), an
investigational locally acting, non-opioid analgesic
intended to provide up to three days of continuous pain relief
after surgery, has cleared review under the
Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 and has
become effective.
Under the terms of the agreement, Sandoz has made an upfront
payment to DURECT of $20 million,
with the potential for up to an additional $43 million in development and regulatory
milestones, up to an additional $230
million in sales-based milestones, as well as a tiered
double-digit royalty on product sales in the United States. DURECT remains responsible
for the completion of the ongoing PERSIST Phase 3 clinical trial
for POSIMIR as well as FDA interactions through approval.
"We are pleased to be collaborating on POSIMIR with Sandoz given
their strong hospital presence in the U.S. and their strong record
of commercializing innovative and value-added products that serve
unmet medical needs," said James E.
Brown, President and CEO of DURECT Corporation.
Sandoz is a global leader in driving sustainable access to
high-quality healthcare. Sandoz's differentiated product
portfolio includes a range of state-of-the-art technologies,
formulations and devices. In the U.S., Sandoz Inc. has
a dedicated hospital sales and marketing organization, with
expertise and relationships, which will be employed to
deliver POSIMIR to the market.
About POSIMIR®
(SABER-Bupivacaine)
POSIMIR is an investigational extended-release depot utilizing
DURECT's patented SABER technology intended to continuously deliver
bupivacaine to the surgical site for 72 hours, to provide up to
three days of continuous pain relief after surgery. DURECT is
currently conducting PERSIST, a Phase 3 trial in patients
undergoing laparoscopic cholecystectomy (gall bladder removal),
comparing the effects of POSIMIR to bupivacaine HCl. DURECT expects
to complete dosing patients in PERSIST in the second quarter of
2017 and to have top-line results in the fourth quarter of 2017.
POSIMIR is a drug candidate under development and has not been
approved for commercialization by the U.S. Food and Drug
Administration or other health authorities.
About DURECT
DURECT is a biopharmaceutical company actively developing new
therapeutics based on its Epigenetic Regulator Program and
proprietary drug delivery platforms. DUR‑928, a new chemical
entity in Phase 1 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, chronic metabolic diseases such as
nonalcoholic fatty liver disease (NAFLD), nonalcoholic
steatohepatitis (NASH) and other liver diseases with both broad and
orphan populations, and inflammatory skin conditions such as
psoriasis. DURECT's advanced oral, injectable, and
transdermal delivery technologies are designed to enable new
indications and enhanced attributes for small-molecule and biologic
drugs. One late-stage product candidate in this category is
POSIMIR® (SABER®-Bupivacaine), an
investigational locally-acting, non-opioid analgesic intended to
provide up to 3 days of continuous pain relief after surgery.
Another late stage product candidate is REMOXY® ER
(oxycodone), an investigational pain control drug based on DURECT's
ORADUR® technology. For more information, please
visit www.durect.com.
NOTE: POSIMIR®,
SABER®, and ORADUR® are
trademarks of DURECT Corporation. Other referenced trademarks
belong to their respective owners. POSIMIR, DUR-928,
and REMOXY ER are drug candidates under development and have not
been approved for commercialization by the U.S. Food and Drug
Administration or other health authorities.
DURECT Forward-Looking Statement
The statements in this press release regarding the
potential benefits and uses of our drug candidates, including the
potential use of POSIMIR to treat post-surgical pain, the
anticipated timing of the enrollment of the PERSIST trial and the
obtaining of top-line results from that trial, the potential
milestone payments and royalties receivable from Sandoz, and the
potential use of DUR-928 to treat NAFLD, NASH, other liver
diseases, acute organ injury or inflammatory skin diseases such as
psoriasis 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
PERSIST clinical trial of POSIMIR will take longer to conduct than
anticipated or result in data that will not support a successful
NDA resubmission or product approval, failure to achieve the
performance milestones or commercial sales that trigger the
referenced payments or royalties, possible adverse events
associated with the use of POSIMIR, delays and costs due to
additional work or other requirements imposed by regulatory
agencies for continued development, approval or sale of POSIMIR,
our ability to manufacture, commercialize and obtain marketplace
acceptance of POSIMIR, and avoid infringing patents held by other
parties and secure and defend patents of our own, and risks related
to our ability to obtain capital to fund operations and
expenses. Further information regarding these and
other risks is included in DURECT's Form 10-Q filed on May 10, 2017 under the heading "Risk
Factors."
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SOURCE DURECT Corporation