Flamel Technologies Announces Receipt of Complete Response Letter From FDA Citing Issues at the Facility of the Supplier of t...
29 4월 2014 - 8:08PM
Marketwired
Flamel Technologies Announces Receipt of Complete Response Letter
From FDA Citing Issues at the Facility of the Supplier of the
Active Ingredient
LYON, FRANCE--(Marketwired - Apr 29, 2014) - Flamel
Technologies (NASDAQ: FLML) today announced today that it has
received a complete response letter (CRL) from the U.S. Food and
Drug Administration (FDA) for its second New Drug Application
(NDA) application from the Éclat portfolio. A CRL is issued by
the FDA when the review of the file is completed and questions
remain that preclude the approval of the NDA in its current
form.
In the CRL, the FDA noted that during a recent inspection of the
manufacturing facility of the active pharmaceutical ingredient's
(API) supplier, deficiencies were found. Satisfactory
resolution of these facility deficiencies is required before this
application may be approved. There were no other deficiencies
in the CRL. Final agreement on the draft product labeling is also
pending.
"While we are disappointed by this delay, we believe that our
application is sound and will work with the API supplier to resolve
any open issues. We will do everything in our power to submit
the information sought by the FDA in order for them to reconsider
our NDA as soon as possible," said Michael S. Anderson, President
and Chief Executive Officer. "Since the CRL was received late
yesterday on our PDUFA date, we do not feel it is prudent to
provide an estimate of the timing of the resubmission of the NDA,
or the timeline for eventual FDA action on that resubmission. We
will communicate any update on the status of this second NDA to our
investors when appropriate."
About Flamel Technologies. Flamel Technologies SA's (NASDAQ:
FLML) business model is to blend high-value internally developed
products with its leading drug delivery capabilities. The company
markets Bloxiverz™ (neostigmine methylsulfate) in the USA and
manufactures Micropump-based microparticles under FDA-audited GMP
guidelines for Coreg CR® (carvedilol phosphate), marketed in the
USA by GlaxoSmithKline. The Company has a proprietary pipeline of
niche specialty pharmaceutical products, while its drug delivery
platforms are focused on the goal of developing safer, more
efficacious formulations of drugs to address unmet medical needs.
Its pipeline includes biological and chemical drugs formulated with
its Medusa™ and Micropump® (and its applications to the development
of liquid formulations, i.e. LiquiTime® and of abuse-deterrent
formulations Trigger Lock™) proprietary drug delivery platforms.
Several Medusa-based products have been successfully tested in
clinical trials. The Company is headquartered in Lyon, France and
has operations in St. Louis, Missouri, USA, and manufacturing
facilities in Pessac, France. Additional information may be found
at www.flamel.com.
This release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995, including certain plans, expectations, goals and projections
regarding financial results, product developments and technology
platforms. All statements that are not clearly historical in nature
are forward-looking, and the words "anticipate," "assume,"
"believe," "expect," "estimate," "plan," "will," "may," and similar
expressions are generally intended to identify forward-looking
statements. All forward-looking statements involve risks,
uncertainties and contingencies, many of which are beyond our
control that could cause actual results to differ materially from
those contemplated in such forward-looking statements. These risks
include risks that the launch of Bloxiverz will not be as
successful as anticipated; our ability to bring other R&D
projects of the former Éclat Pharmaceuticals to market may be
unsuccessful; FDA may not take action on the status of unapproved
versions of neostigmine still on the market; clinical trial results
may not be positive or our partners may decide not to move forward;
products in the development stage may not achieve scientific
objectives or milestones or meet stringent regulatory requirements;
products in development may not achieve market acceptance;
competitive products and pricing may hinder our commercial
opportunities; we may not be successful in identifying and pursuing
opportunities to develop our own product portfolio using Flamel's
technology; and the risks associated with our reliance on outside
parties and key strategic alliances. These and other risks are
described more fully in Flamel's Annual Report on Form 20-F for the
year ended December 31, 2012 that has been filed with the
Securities and Exchange Commission (SEC). All forward-looking
statements included in this release are based on information
available at the time of the release. We undertake no obligation to
update or alter our forward-looking statements as a result of new
information, future events or otherwise.
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