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8-K - CURRENT REPORT - Acer Therapeutics Inc. | opxa_8k.htm |
Exhibit 99.1
Acer Therapeutics Appoints Dr. William T. Andrews as Chief Medical
Officer
Dr. Andrews’s Appointment Supports Acer’s Progression
from Development to Potential
Commercialization of Therapies
CAMBRIDGE, MA – October 5, 2017 Acer Therapeutics Inc.,
(Nasdaq: ACER), a pharmaceutical company focused on the
acquisition, development and commercialization of therapies for
serious rare and
ultra-rare diseases with critical unmet medical need, today
announced the appointment of William T. Andrews, M.D., FACP as
Chief Medical Officer of the Company to succeed Robert D. Steiner,
M.D. in that position.
“We
are pleased to welcome Dr. Andrews to the executive management
team, as we continue to successfully and rapidly advance our lead
product candidate, EDSIVO™, a potential life-saving therapy
for patients with vEDS,” said Chris Schelling, CEO and
Founder of Acer. “Dr. Andrews brings tremendous experience to
this role and will be instrumental in preparing our NDA submission
of EDSIVO™, which we expect to accomplish in the first half
of 2018, and we look forward to his guidance in the medical
marketplace as we plan for our next steps. We thank Dr. Steiner for
his significant contributions to Acer during a critical time in the
Company’s growth.”
About William T. Andrews, M.D., FACP
Dr. Andrews joins Acer Therapeutics as Chief Medical Officer after
having worked in the biotech/pharmaceutical industry for 17 years
in both Clinical Development and Medical Affairs in multiple
therapeutic areas, with a focus and extensive experience in rare
diseases. Dr. Andrews has significant medical marketplace and
product launch experience, having served as the medical lead for
six product launches, including Xopenex HFA®, Brovana®, Alvesco®, Omnaris®, Catena®, and Juxtapid®. Most recently, he provided strategic consulting
services to rare disease companies in Clinical Development, Medical
Affairs, Go-To-Market/Launch planning, and Business
Development/Corporate Strategy. Previously, Dr. Andrews held senior
leadership positions and positions of increasing responsibility at
Aegerion Pharmaceuticals, Santhera Pharmaceuticals, Sepracor, and
ClinQuest. He received his undergraduate degree in Biology from
Harvard University and his M.D. degree from Yale University School
of Medicine. Dr. Andrews practiced medicine for 7 years full-time
and 11 years part-time in the
Boston area as a board-certified Internist and an Attending
Physician at Brigham and Women’s Hospital, and was on the
Clinical Faculty at Harvard Medical School.
About Acer Therapeutics
Acer,
headquartered in Cambridge, MA, is a pharmaceutical company focused
on the acquisition, development and commercialization of therapies
for patients with serious rare and ultra-rare diseases with
critical unmet medical need. Acer’s late-stage clinical
pipeline includes two candidates for severe genetic disorders for
which there are few or no FDA-approved treatments: EDSIVO™
(celiprolol) for vEDS, and ACER-001 (a fully taste-masked,
immediate release formulation of sodium phenylbutyrate) for urea
cycle disorders (UCD) and Maple Syrup Urine Disease (MSUD). There
are no FDA-approved drugs for vEDS and MSUD and limited options for
UCD, which collectively impact more than 4,000 patients in the
United States. Acer’s products have clinical proof-of-concept
and mechanistic differentiation, and Acer intends to seek approval
for them in the U.S. by using the regulatory pathway established
under section 505(b)(2) of the Federal Food, Drug, and Cosmetic
Act, or FFDCA, that allows an applicant to rely for approval at
least in part on third-party data, which is expected to expedite
the preparation, submission, and approval of a marketing
application.
For
more information, visit www.acertx.com.
Forward-Looking Statements
This
press release contains “forward-looking statements”
that involve substantial risks and uncertainties for purposes of
the safe harbor provided by the Private Securities Litigation
Reform Act of 1995. All statements, other than statements of
historical facts, included in this press release regarding
strategy, future operations, future financial position, future
revenue, projected expenses, prospects, plans and objectives of
management are forward-looking statements. Examples of such
statements include, but are not limited to, statements relating to
the potential for EDSIVO™ (celiprolol) and ACER-001 to safely
and effectively target diseases; the adequacy of the
company’s capital to support its future operations and its
ability to successfully initiate and complete clinical trials and
regulatory submissions; the nature, strategy and focus of the
company; and the development, expected timeline and commercial
potential of any product candidates of the company. Acer may not
actually achieve the plans, carry out the intentions or meet the
expectations or projections disclosed in the forward-looking
statements and you should not place undue reliance on these
forward-looking statements. Such statements are based on
management’s current expectations and involve risks and
uncertainties. Actual results and performance could differ
materially from those projected in the forward-looking statements
as a result of many factors, including, without limitation, risks
and uncertainties associated with the ability to project future
cash utilization and reserves needed for contingent future
liabilities and business operations, the availability of sufficient
resources of the company to meet its business objectives and
operational requirements, the fact that the results of earlier
studies and trials may not be predictive of future clinical trial
results, the protection and market exclusivity provided by
Acer’s intellectual property, risks related to the drug
development and the regulatory approval process and the impact of
competitive products and technological changes. Acer disclaims any
intent or obligation to update these forward-looking statements to
reflect events or circumstances that exist after the date on which
they were made. You should review additional disclosures we make in
our filings with the Securities and Exchange Commission, including
our Quarterly Reports on Form 10-Q and our Annual Report on
Form10-K. You may access these documents for no charge at
http://www.sec.gov.
Investor Contact:
Hans
Vitzthum
LifeSci
Advisors
Ph:
212-915-2568
hans@lifescieadvisors.com