Flamel Technologies Announces Intent to Resubmit Second NDA
05 6월 2014 - 9:00PM
Marketwired
Flamel Technologies Announces Intent to Resubmit Second NDA
LYON, FRANCE--(Marketwired - Jun 5, 2014) - Flamel Technologies
(NASDAQ: FLML) announced today that it has been informed by the
Active Pharmaceutical Ingredient (API) supplier for its second New
Drug Application (NDA) that the Food and Drug Administration (FDA)
has now classified its facility as acceptable. This
application had been subjected to a Complete Response Letter (CRL)
on its April 28, 2014 PDUFA date, citing certain facility issues as
the primary cause. Based on this information, Flamel plans to
resubmit the NDA to the FDA in the very near future. The
Company expects to make an announcement prior to the end of June as
to whether the FDA will grant a Class 1 or Class 2 status for the
resubmission.
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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