– Christopher Garabedian Resigns as Chief Executive Officer and
Member of the Board Effective Today –
– Company will host conference call at 8:00 a.m. EDT, April 1, 2015 –
Company Website:
http://www.sarepta.com
CAMBRIDGE, Mass. -- (Business Wire)
Sarepta Therapeutics, Inc. (NASDAQ: SRPT), a developer of innovative
RNA-targeted therapeutics, today announced the appointment of Edward
Kaye, M.D., the company’s Chief Medical Officer (CMO), as interim Chief
Executive Officer (CEO) effective immediately. He replaces Christopher
Garabedian, who resigned as President and Chief Executive Officer and as
a member of the Board, also effective immediately. Dr. Kaye, who will
continue in a dual capacity as CEO and CMO while the company conducts a
search for a new full-time CEO, will focus his efforts on heading the
regulatory and clinical process for the company’s lead product
candidate, eteplirsen, and follow on “exon” drug candidates for Duchenne
Muscular Dystrophy (DMD).
Dr. Kaye has been Sarepta’s CMO since June of 2011, during which time he
has been responsible for the company’s medical and clinical operations.
He was previously Group Vice President of Clinical Development at
Genzyme Corporation, one of the most successful biotechnology companies
in the United States, from April 2007 to June 2011, where he supervised
clinical development programs for rare diseases, including lysosomal
storage diseases and genetic neurological disorders. Prior to this, Dr.
Kaye held various roles at Genzyme Corporation since 2001, including
Vice President of Medical Affairs for Lysosomal Storage Diseases, Vice
President of Clinical Research and Interim Head of PGH Global Medical
Affairs.
“We believe this change will facilitate the company’s clinical and
regulatory discussions and relationships with the goal of meeting its
stated timelines for bringing a potentially disease-modifying treatment
to patients with DMD as soon as possible,” said John Hodgman, Sarepta’s
interim Chairman of the Board. “Dr. Kaye has a proven track record of
leading teams that have brought some of the most successful rare-disease
drugs to market, including Myozyme, Lumizyme and Fabrazyme. Further, he
has excellent relationships with the clinical, regulatory and patient
advocacy communities so critical to making this treatment a reality for
this underserved patient population.”
Dr. Kaye is a Neurological Consultant at the Children's Hospital of
Boston and is on the editorial boards of a number of journals, including
the Journal of Child Neurology. He is also on the
Medical/Scientific Advisory Boards of the United Leukodystrophy
Foundation, Spinal Muscular Atrophy Foundation, CureCMD, CureDuchenne
and the Prize4Life.
“We remain on track in collecting and analyzing the data requested by
the FDA necessary for us to submit the eteplirsen New Drug Application
in the middle of this year as planned,” said Dr. Kaye. “I’m pleased to
say that I have the full support of the entire executive team and the
Board to optimally focus and prepare for this important milestone. I
look forward to further strengthening our relationship with the FDA and
other regulatory agencies that share our goal of doing what’s in the
best interest of DMD patients and their families. I could not be more
excited to take full charge of our DMD clinical and regulatory efforts,
as well as to lead the advancement of our broader pipeline of treatments
for rare diseases.”
About Eteplirsen for DMD
Eteplirsen is Sarepta's lead drug candidate and is designed to address
the underlying cause of DMD by enabling the production of a functional
internally deleted dystrophin protein. Data from clinical studies of
eteplirsen in DMD patients have demonstrated a broadly favorable and
promising safety and tolerability profile and restoration of dystrophin
protein expression.
Eteplirsen uses Sarepta's novel phosphorodiamidate morpholino oligomer
(PMO)-based chemistry and proprietary exon-skipping technology to skip
exon 51 of the dystrophin gene, enabling the repair of specific genetic
mutations that affect approximately 13 percent of the total DMD
population. By skipping exon 51, eteplirsen may restore the gene's
ability to make a shorter, but still functional, form of dystrophin from
messenger RNA, or mRNA. Promoting the synthesis of an internally deleted
dystrophin protein is intended to stabilize or significantly slow the
disease process and prolong and improve the quality of life for patients
with DMD. Sarepta is also developing other PMO-based exon-skipping drug
candidates intended to treat additional patients with DMD.
About Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy (DMD) is an X-linked rare degenerative
neuromuscular disorder causing severe progressive muscle loss and
premature death. One of the most common fatal genetic disorders, DMD
affects approximately one in every 3,500 boys born worldwide. A
devastating and incurable muscle-wasting disease, DMD is associated with
specific errors in the gene that codes for dystrophin, a protein that
plays a key structural role in muscle fiber function. Progressive muscle
weakness in the lower limbs spreads to the arms, neck and other areas.
Eventually, increasing difficulty in breathing due to respiratory muscle
dysfunction requires ventilation support, and cardiac dysfunction can
lead to heart failure. The condition is universally fatal, and death
usually occurs before the age of 30.
Conference Call Details
The Company will be hosting a conference call at 8:00 a.m. EDT, April 1,
2015. The conference call may be accessed by dialing 800-708-4539 for
domestic callers and 847-619-6396 for international callers. The
passcode for the call is 39371595. Please specify to the operator that
you would like to join the “Sarepta Management Update Call.” The
conference call will be webcast live under the investor relations
section of Sarepta’s website at www.sarepta.com and
will be archived there following the call for 90 days. Please connect to
Sarepta’s website several minutes prior to the start of the broadcast to
ensure adequate time for any software download that may be necessary. An
audio replay will be accessible through April 30, 2015, by calling
888-843-7419 or 630-652-3042 and entering access code 39371595#.
About Sarepta Therapeutics
Sarepta Therapeutics is a biopharmaceutical company focused on the
discovery and development of unique RNA-targeted therapeutics for the
treatment of rare, infectious and other diseases. The Company is
primarily focused on rapidly advancing the development of its
potentially disease-modifying DMD drug candidates, including its lead
DMD product candidate, eteplirsen, designed to skip exon 51. Sarepta is
also developing therapeutics for the treatment of drug-resistant
bacteria and infectious, rare and other human diseases. For more
information, please visit us at www.sarepta.com.
Forward-Looking Statements
In order to provide Sarepta’s investors with an understanding of its
current results and future prospects, this press release contains
statements that are forward looking. Any statements contained in this
press release that are not statements of historical fact may be deemed
to be forward-looking statements. Words such as “believes,”
“anticipates,” “plans,” “expects,” “will,” “may,” “intends,” “prepares,”
“looks,” “potential,” “possible” and similar expressions are intended to
identify forward-looking statements. These forward-looking statements
include statements relating to Sarepta’s succession plan, including the
search for a new full-time CEO and the effect that the appointment of
Dr. Kaye as interim CEO will have on the Company’s regulatory and
clinical discussions and relationships, including its impact on the
expected timeline for bringing our product candidates to market, as well
as statements relating to Sarepta’s future operations, financial
performance, business plans, priorities and development of product
candidates, including: our plans to submit a New Drug Application (NDA)
for eteplirsen by mid-year 2015; our continued efforts to collect and
analyze the additional datasets requested by the U.S. Food and Drug
Administration (FDA); the data necessary for an NDA submission; the
enduring safety and tolerability of eteplirsen; Sarepta’s clinical and
regulatory plans for its investigational drugs; and eteplirsen’s ability
to stabilize or significantly slow the disease process, restore
dystrophin protein expression, and prolong and improve the quality of
life for patients with DMD.
These forward-looking statements involve risks and uncertainties,
many of which are beyond Sarepta’s control. Actual results could
materially differ from those stated or implied by these forward-looking
statements as a result of such risks and uncertainties. Known risk
factors include the following: we may not be able to capitalize on our
executive team’s relationship and expertise to meet our expected
timelines for NDA submission, clinical development plans and bringing
our product candidates to market; we may not be able to comply with all
FDA requests, including with respect to our planned NDA submission, in a
timely manner or at all; the FDA may determine that our NDA submission
for eteplirsen is incomplete or does not qualify for filing, even if we
provide additional supporting information and datasets requested; the
additional information and data we collect for the eteplirsen NDA
submission may not be consistent with prior data or results or may not
support an eteplirsen NDA submission, filing or approval; we may not be
able to complete clinical trials required by the FDA for approval of
eteplirsen and the results of our ongoing and new clinical trials may
not be positive or consistent with prior results and may not support the
safety and efficacy of or an NDA submission, filing or approval of
eteplirsen, our other product candidates and/or Sarepta’s anti-sense
based technology platform; there may be delays in our projected
timelines relating to eteplirsen clinical studies, our planned NDA
submission for eteplirsen, meetings and discussions with the FDA,
initiating new clinical trials for our product candidates, or making a
product commercially available for various reasons, including possible
limitations of Company resources and regulatory or agency decisions,
such as decisions by the United States Patent and Trademark Office with
respect to patents that cover our product candidates; scale-up of
manufacturing may not be successful and any or all of the Company’s drug
candidates may fail in development or may not receive required
regulatory approvals for commercialization (including potentially under
an accelerated pathway); we may need and may not be able to obtain
additional funds to conduct our planned research and development efforts
and execute our business plans; and those risks identified under the
heading “Risk Factors” in Sarepta’s Annual Report on Form 10-K for the
year ended December 31, 2014, filed with the Securities and Exchange
Commission (SEC) as well as other SEC filings made by the Company which
you are encouraged to review.
Any of the foregoing risks could materially and adversely affect the
Company’s business, results of operations and the trading price of
Sarepta’s common stock. You should not place undue reliance on
forward-looking statements.Sarepta does not undertake any
obligation to publicly update its forward-looking statements based on
events or circumstances after the date hereof, except to the extent
required by applicable law or SEC rules.
Internet Posting of Information
We routinely post information that may be important to investors in
the 'For Investors' section of our website at www.sarepta.com.
We encourage investors and potential investors to consult our website
regularly for important information about us.
Contacts:
Media and Investors:
Sarepta Therapeutics, Inc.
Ian Estepan,
617-274-4052
iestepan@sarepta.com
or
BrewLife,
a W2O Company
Ryan Flinn, 415-946-1059
rfinn@w2ogroup.com
Source: Sarepta Therapeutics, Inc.
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