Flamel Technologies Announces FDA Acceptance of New Drug Application
18 10월 2012 - 9:30PM
Marketwired
Flamel Technologies SA (NASDAQ: FLML) today announced that the U.S.
Food and Drug Administration (FDA) has accepted the company's New
Drug Application (NDA) for an undisclosed hospital-based product.
Flamel has received a Prescription Drug User Fee Act (PDUFA) date,
the target date for the FDA to complete its review of the NDA, of
May 31, 2013. For competitive reasons, the Company has decided not
to identify the product at this time, but intends to provide
additional information at a later date. Flamel believes that the
product could have a significant impact on the company's revenue
generation and favorably impact its progression to profitability.
If approved by the FDA, the product is expected to generate
approximately $25 million to $35 million or more in peak annual
revenues, subject to the Company being able to market and price the
product successfully, of which there can be no assurance.
"This NDA acceptance is an important milestone for our business
and we believe it demonstrates the expanded capabilities of
Flamel," said Michael S. Anderson, Chief Executive Officer. "This
is the first of what we expect to be multiple new product
applications to come from our internal pipeline over the next few
years."
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 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 partnered pipeline includes biological and chemical drugs
formulated with the Medusa® and Micropump® proprietary drug
delivery platforms. Several Medusa-based products are currently in
the clinical stages of development; Medusa's lead internal product
candidate IFN-alpha XL (long-acting interferon alpha-2b) is being
evaluated in a Phase 2b trial in HCV patients. The Company has
developed products and manufactures Micropump-based microparticles
under FDA-audited GMP guidelines. Flamel has collaborations with a
number of leading pharmaceutical and biotechnology companies,
including GlaxoSmithKline (Coreg CR®, carvedilol phosphate) and
Merck Serono (long acting interferon beta 1a). Flamel is
headquartered in Lyon, France and has operations in St. Louis,
Missouri, 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 acquisition of Éclat Pharmaceuticals may not
be successfully integrated or that certain payment acceleration
events may be triggered; the expected timing of the filing of our
first New Drug Application (NDA) with the FDA may be delayed; the
identified opportunities will not result in shorter-term, high
value results; clinical trial results may not be positive or our
partners may decide not to move forward; management transition to a
new chief executive officer may be disruptive or not succeed as
planned; 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, 2011 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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