Flamel Technologies Announces FDA Approval of Bloxiverz

Flamel Technologies Announces FDA Approval of Bloxiverz 
LYON, FRANCE -- (Marketwired) -- 06/03/13 --  Flamel Technologies
(NASDAQ: FLML) today announced that the U.S. Food and Drug
Administration (FDA) has approved the company's New Drug Application
(NDA) for Bloxiverz(TM) (neostigmine methylsulfate), a drug used
intravenously in the operating room for the reversal of the effects
of non-depolarizing neuromuscular blocking agents after surgery.
Flamel expects to launch Bloxiverz(TM) in July 2013 in 0.5 and 1.0
mg/mL strengths.  
"We are extremely excited and pleased to receive this FDA approval
for Bloxiverz(TM), the first product from the portfolio of Eclat
products acquired in March 2012," said Mike Anderson, Chief Executive
Officer of Flamel.  
Bloxiverz(TM) is the first FDA-approved version of neostigmine, even
though other versions of neostigmine have been on the market as
unapproved, grandfathered products under the Food, Drug and Cosmetic
Act of 1938. Today, neostigmine is the most common agent used for the
reversal of the effects of other agents used for neuromuscular
blocks.  
"Based on our marketing experience, we believe that hospitals will
welcome the addition of Bloxiverz(TM) as an FDA-approved version of
neostigmine," continued Mr. Anderson. "In addition, unapproved
versions of neostigmine have been in short supply for nearly a year,
which may add to the need for a reliable source of FDA-approved
product."  
Safety Information
 The most common adverse reactions during
treatment include bradycardia, nausea and vomiting. Atropine or
glycopyrrolate should be administered prior to Bloxiverz to minimize
the risk of bradycardia. Bloxiverz should be used with caution in
patients with arrhythmias, recent acute coronary syndrome, vagotonia,
hyperthyroidism, myasthenia gravis, epilepsy or peptic ulcer. Because
of the possibility of hypersensitivity in an occasional patient,
atropine and medications to treat anaphylaxis should always be
readily available. Large doses of Bloxiverz administered when
neuromuscular blockade is minimal can produce neuromuscular
dysfunction. The dose of Bloxiverz should be reduced if recovery from
neuromuscular blockade is nearly complete.  
About Bloxiverz (neostigmine)
 Bloxiverz (neostigmine) is a
cholinesterase inhibitor that inhibits the hydrolysis of
acetylcholine by competing with acetylcholine for attachment to
acetylcholinesterase at sites of cholinergic transmission. It
enhances cholinergic action by facilitating the transmission of
impulses across neuromuscular junctions. Neostigmine's ability to
increase synaptic acetylcholine levels underlies its effectiveness in
reversing neuromuscular blockade produced by neuromuscular blocking
agents used during surgery. Neostigmine does not readily cross the
blood-brain barrier and therefore does not significantly affect
cholinergic function in the central nervous system. 
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 its Medusa(R) and Micropump(R) (and
its applications to the development of liquid formulations, i.e.
LiquiTime(TM) and of abuse-deterrent formulations Trigger Lock(TM))
proprietary drug delivery platforms. Several Medusa-based products
have been successfully tested in clinical trials. The Company has
developed products and manufactures Micropump-based microparticles
under FDA-audited GMP guidelines. Flamel Technologies has
collaborations with a number of leading pharmaceutical and
biotechnology companies, including GlaxoSmithKline (Coreg CR(R),
carvedilol phosphate). 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. 
Safe Harbor 
 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
continued integration of Eclat Pharmaceuticals may not be successful
or that certain payment acceleration events may be triggered; the
reacquisition of the exclusive rights to develop and commercialize
IFN-β XL worldwide and identification of an alternative
strategic partner for the program may not be successful; 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; 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. 
Investor Contact:
Bob Yedid 
ICR Inc.
(646) 277-1250
bob.yedid@icrinc.com 
 
 
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