CUPERTINO, Calif., April 25, 2019 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) announced today the appointment of two
new members to its board of directors. Dr. Gail M. Farfel, Executive Vice President and
Chief Development Officer of Zogenix, Inc., and Judith J. Robertson, most recently Chief
Commercial Officer of Aerie Pharmaceuticals, bring to DURECT
extensive product development, regulatory and commercialization
experience.
"We are very pleased to welcome Dr. Farfel and Ms. Robertson to
our board," said James E. Brown,
D.V.M., President and CEO of DURECT. "2019 is an important
year for DURECT as we focus on execution in the development of
DUR-928 for multiple indications. These two executives'
skills and experience advancing products from early development
through commercialization will be important and valuable additions
to the DURECT board at this exciting time for the company."
Gail M. Farfel, Ph.D., has served
as Zogenix's Executive Vice President and Chief Development Officer
since July 2015, where the company is
focused on developing and commercializing transformative therapies
for rare diseases. Their lead compound, FINTEPLA, is in
development for treatment of seizures associated with epileptic
encephalopathies. Dr. Farfel oversees Nonclinical and
Clinical development, Regulatory Affairs and Quality at
Zogenix. Before joining Zogenix, Dr. Farfel was Chief
Clinical and Regulatory Officer of Marinus Pharmaceuticals, a
biopharmaceutical company engaged in development for neurological
disorders. Prior to her entry into the biotech space,
Dr. Farfel served as Vice President and Therapeutic Area Head for
Neuroscience at Novartis Pharmaceuticals Corporation, where she
oversaw their portfolio of neurology and psychiatry products.
Dr. Farfel began her career in pharmaceutical drug
development at Pfizer, Inc., where she worked in Clinical
Development and Global Medical Affairs, directing programs through
all stages of clinical development and regulatory
submissions. Dr. Farfel is the author of over 50 scientific
articles in the areas of neuropsychopharmacology and drug effects
and is a Director on the Board of the American Society for
Experimental Neurotherapeutics. She holds a Ph.D. in
Neuropsychopharmacology from the University of
Chicago, where she is a Director on the Alumni Board.
Dr. Farfel also holds a bachelor's degree in Biochemistry
from the University of Virginia.
"The safety profile and breadth of activity shown by DUR-928
suggests that it may have clinical utility in multiple indications,
and I am excited to be joining the DURECT board during this
important time," stated Dr. Farfel.
Judith J. Robertson was the Chief
Commercial Officer of Aerie Pharmaceuticals from 2016 to 2018,
during which time she built the commercial organization and led the
successful commercial launch of Rhopressa® for
glaucoma. Ms. Robertson joined Aerie from the Janssen
Pharmaceutical Companies of Johnson & Johnson, where she was
the Vice President and Global Commercial Strategy Leader of
Immunology, Ophthalmology and Commercial Analytics from 2013 to
2016. Part of her duties at Janssen included evaluating all
external licensing and acquisition opportunities. Prior
to Janssen, she was Vice President Global Business Franchise Head
of Ophthalmology at Alcon, Vice President Global Franchise Head of
Respiratory at Novartis, Vice President of Sales & Marketing of
Respiratory and Dermatology at Novartis, and President of Bristol
Myers Squibb Canada. Ms.
Robertson holds a Master of Management degree from the Kellogg
School of Business at Northwestern
University and holds a bachelor's degree in Social Science
from Ryerson University.
"I look forward to working with the DURECT board and management
team in the upcoming years to bring additional commercial and
strategic perspective to their pipeline of products in
development," stated Ms. Robertson.
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. Late stage 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, 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, please visit www.durect.com.
DURECT Forward-Looking Statement
The statements in this press release regarding the potential use
of DUR-928 to treat acute organ injuries such as alcoholic
hepatitis (AH) and acute kidney injury (AKI), chronic hepatic
diseases such as nonalcoholic steatohepatitis (NASH), and
inflammatory skin disorders such as psoriasis and atopic
dermatitis, the use of POSIMIR to treat post-surgical pain, the use
of Indivior's PERSERIS™ to treat schizophrenia, as well
as the potential 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 risk of delays in the
enrollment of the ongoing clinical trials of DUR-928 in NASH, AH
and psoriasis, potential adverse effects arising from the testing
or use of DUR-928, the risk that the FDA may not approve the
POSIMIR NDA, the risk that PERSERIS will not have a successful
launch, our ability to avoid infringing patents held by other
parties and secure and defend patents of our own patents, and our
ability to manage and obtain capital to fund our operations and
expenses. Further information regarding these and other risks is
included in DURECT's Form 10-K dated March
8, 2019 under the heading "Risk Factors."
NOTE: ORADUR®, POSIMIR® and
SABER® are trademarks of DURECT Corporation.
Other referenced trademarks belong to their respective owners.
DUR-928, ORADUR-Methylphenidate ER Capsules and POSIMIR 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