Flamel Technologies Announces FDA Acceptance of New Drug

Flamel Technologies Announces FDA Acceptance of New Drug Application 
LYON, FRANCE -- (Marketwire) -- 10/18/12 --  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(R) and Micropump(R)
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 pharma
ceutical and
biotechnology companies, including GlaxoSmithKline (Coreg CR(R),
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 Eclat 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. 
Contact:
Michael S. Anderson 
Phone: 33 (0) 4 72 78 34 34
Fax: 33 (0) 4 72 78 34 35
E-mail: anderson@flamel.com 
 
 
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