CUPERTINO, Calif., Jan. 5, 2021 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) today announced the appointment of two
new members to its board of directors, Gail
J. Maderis, MBA and Mohammad
Azab, M.D., M. Sc., MBA, two senior industry veterans with
extensive drug development, clinical research and medical affairs
experience.
"We are pleased to welcome Ms. Maderis and Dr. Azab to our board
as we continue to enhance our board in line with our maturing
company," stated James E. Brown,
D.V.M., President and Chief Executive Officer of DURECT. "Their
extensive expertise will be valuable as we continue to advance our
clinical pipeline and create value for our shareholders, in
particular as we advance the Phase 2b
AHFIRM study of our lead candidate DUR-928 for the treatment of
alcohol-associated hepatitis (AH) and plan for other indications
with DUR-928."
Ms. Maderis stated, "Clinical data from DURECT's lead clinical
asset DUR-928 in AH and non-alcoholic steatohepatitis (NASH) look
very promising and show the potential of DUR-928 for the
treatment of multiple organ injury and chronic liver diseases. I am
eager to work with the DURECT board and management team to bring
additional perspective as the company advances its clinical
pipeline and explores additional opportunities for DUR-928 to
fulfill unmet needs."
Dr. Azab added, "I am excited to be joining the DURECT board as
the company advances DUR-928 in the AHFIRM trial and gets closer to
potentially offering a life-saving therapy to people affected by
this life-threating condition. I look forward to working with the
team and providing guidance as DURECT continues to advance DUR-928
through development and eventually, to potential approval and
commercialization."
Gail Maderis has served as
President and CEO of Antiva Biosciences, a venture funded biopharma
company developing topical therapies to treat the pre-cancerous
lesions caused by HPV, since 2015. From 2009 to 2015, she led
BayBio, the industry organization representing and supporting
Northern California's life science
community. From 2003 to 2009, she served as President and CEO of
Five Prime Therapeutics, Inc., a protein discovery and development
company. Prior to FivePrime, Ms. Maderis held senior executive
positions at Genzyme Corporation, including founder and president
of Genzyme Molecular Oncology. She also practiced management and
strategy consulting with Bain & Co. She serves on the corporate
boards of Allarity Therapeutics and Valitor, Inc., as well as on
the non-profit boards of BIO (Emerging Company and Health
Sections), CLSI, The Termeer Foundation and the University of California Berkeley Foundation Board
of Trustees. She received a BS in business from UC Berkeley
and an MBA from Harvard Business
School.
Dr. Mohammad Azab served as
President and Chief Medical Officer of Astex Pharmaceuticals, Inc.
since 2014 after holding the position of Chief Medical Officer
there since 2009. As of November
2020, upon retirement from his management role, Dr. Azab has
served as the Chair of the Board of Directors for Astex
Pharmaceuticals, Inc, which is a wholly owned subsidiary of Otsuka
Pharmaceuticals, focused on the discovery and development of drugs
in oncology and other therapeutic areas. Previously, Dr. Azab
served as President and CEO of Intradigm Corporation, a developer
of siRNA cancer therapeutics. Prior to this, Dr. Azab served as
Executive Vice President of Research and Development, and Chief
Medical Officer of QLT Inc., and in several drug development
leadership positions at Astra Zeneca in the United Kingdom and Sanofi Pharmaceuticals in
France. During his carrier he has
led or has been involved with the development of 8 approved drugs,
7 in Oncology and one in Ophthalmology. Dr. Azab holds his
medical degree (MB ChB) from Cairo
University and an M.B.A. from the Richard Ivey School of Business,
University of Western Ontario. He
received post-graduate training and degrees in oncology research
from the University of Paris-Sud and biostatistics from the
University of Pierre et Marie Curie
in Paris, France. Dr. Azab has
more than 30 years of experience in clinical research, global drug
development, and business management and led the global development
of several drugs currently approved in oncology and other
therapeutic areas. Currently, he also serves on the board of
directors of Xenon Pharmaceuticals Inc.
About DURECT Corporation
DURECT is a
biopharmaceutical company committed to transforming the treatment
of acute organ injury and chronic liver diseases by advancing novel
and potentially lifesaving therapies based on its endogenous
epigenetic regulator program. DUR-928, the company's lead drug
candidate is in clinical development for the potential treatment of
alcohol-associated hepatitis (AH) for which FDA has granted a Fast
Track Designation, COVID-19 patients with acute liver or kidney
injury, and non-alcoholic steatohepatitis
(NASH). DURECT's proprietary drug 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® (bupivacaine sustained-release
solution), an investigational locally-acting, non-opioid analgesic
intended to provide up to three days of continuous pain relief
after surgery. For more information about DURECT, please
visit www.durect.com and follow us on
Twitter https://twitter.com/DURECTCorp.
DURECT Forward-Looking Statement
The statements in
this press release regarding clinical development plans for
DUR-928, including the potential use of DUR-928 to treat AH and
other acute organ injuries, including in COVID-19 patients, as well
as chronic liver diseases, such as NASH, and the potential use of
POSIMIR to provide pain relief after surgery 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 start of the AHFIRM trial or other
trials will be delayed due to COVID-19 or other factors, that the
AHFIRM trial will take longer than expected and may not replicate
results from earlier trials, that the clinical trial of DUR-928 in
COVID-19 patients is delayed or stopped because of changes to the
standard of care, the availability of alternative therapies,
required protocol changes or lack of available patients, the risk
that clinical trials of DUR-928 do not demonstrate the safety or
efficacy of DUR-928 in a statistically significant manner, the risk
that the FDA will not approve POSIMIR or approve POSIMIR with a
limited label, the risk that additional time and resources may be
required for development, testing and regulatory approval of
DUR-928 or the Company's other product candidates, potential
adverse effects arising from the testing or use of our drug
candidates, our potential failure to maintain our collaborative
agreements with third parties 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 November 3,
2020 under the heading "Risk Factors."
NOTE: POSIMIR® and SABER® are trademarks
of DURECT Corporation. Other referenced trademarks
belong to their respective owners. DUR-928 and POSIMIR are
investigational drug candidates under development and have not been
approved for commercialization by the U.S. Food and Drug
Administration or other health authorities for any
indication.
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SOURCE DURECT Corporation