Full Press Release Details
Flamel Technologies Announces FDA Approval
LYON, FRANCE - June 3, 2013 - 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 (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 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 , the first product from the portfolio of clat products acquired in March 2012,"
said Mike Anderson, Chief Executive Officer of Flamel.
Bloxiverz 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 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. "
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 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 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 , 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
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 clat 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- 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.