CUPERTINO, Calif., Sept. 20, 2017 /PRNewswire/ -- DURECT Corporation
(Nasdaq: DRRX) announced today that Dr. Myriam Theeuwes has joined DURECT as Senior Vice
President, Clinical Development. Dr. Theeuwes joins DURECT
from Johnson & Johnson where she spent 18 years, most recently
as Compound Development Team Leader for Janssen Pharmaceutical's
global public health initiatives where she led the development and
launch of products including SIRTURO® (bedaquiline), the
first drug with a new mechanism of action to treat tuberculosis in
over 40 years. Since its original FDA approval in 2012, the
product has been widely registered in high burden areas and is
available in over 100 countries globally.
"Dr. Theeuwes' extensive experience and success in developing
pharmaceuticals for both major and rare diseases is an ideal fit
with DURECT's pipeline of products," stated James E. Brown, President and CEO of DURECT
Corporation. "We welcome her insights and leadership in
guiding the development of DUR-928, our lead product candidate for
the treatment of liver diseases, acute organ injuries and
inflammatory skin conditions, as it advances into Phase 2 clinical
testing."
"I am excited to be joining a talented team that has in a few
years taken this endogenous molecule from its discovery in an
academic setting through an extensive pre-clinical development
program and multiple Phase 1 studies," said Dr. Theeuwes.
"The breadth of activity and safety profile of DUR-928 demonstrated
to date suggests that it could potentially address multiple life
threatening medical conditions with high unmet need."
Prior to joining Janssen, Dr. Theeuwes spent 11 years at ALZA
Corporation in positions of increasing responsibility culminating
in her appointment as General Manager and Associate Medical
Director for Europe. Before her career in industry, Dr.
Theeuwes was a practicing resident dentist at the University of California San Francisco (UCSF) and
San Marcos Health Center in Honduras. She received her dental
degree from the University of Leuven, Belgium and obtained her California state dental license after
completing the Advanced General Dentistry Residency Program at
UCSF.
About DURECT Corporation
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 potential use of
REMOXY ER to treat pain, the potential use of DUR-928 to treat
NASH, other liver diseases, acute organ injury or inflammatory skin
conditions such as psoriasis, and potential markets for
POSIMIR, DUR-928 and REMOXY ER, 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 result in
data that will not support a successful NDA resubmission or product
approval, possible adverse events associated with the use of
POSIMIR, DUR-928 or REMOXY ER, delays and costs due to additional
work or other requirements imposed by regulatory agencies for
continued development, approval or sale of POSIMIR, DUR-928 or
REMOXY ER, that results from Phase 1 clinical trials of DUR-928
will not be replicated in Phase 2 trials, our ability to
manufacture, commercialize and obtain marketplace acceptance of
POSIMIR, DUR-928 or REMOXY ER, 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 August 9, 2017 under the heading "Risk
Factors."
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SOURCE DURECT Corporation