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Profile: Flamel Technologies SA (FLML.O)

FLML.O on Consolidated Issue listed on NASDAQ Global Market

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28 Jul 2016
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Flamel Technologies S.A., incorporated on July 21, 1990, is a specialty pharmaceutical company. The Company is engaged in the development and commercialization of pharmaceutical products, including controlled-release therapeutic products based on its polymer based technology. The Company has a balanced business model consisting of an Unapproved Marketed Drugs (UMDs) business with over two approved products in the United States, Bloxiverz (neostigmine methylsulfate injection) and Vazculep (phenylephrine hydrochloride injection) that are marketed; a branded pediatric business, and a branded business, focusing on the development of products utilizing Flamel's drug delivery platforms. The Company owns and develops drug delivery platforms, including Micropump, LiquiTime, Trigger Lock and Medusa. The Company has two direct operating subsidiaries: Flamel US Holdings, Inc. and Flamel Irish Holdings, Ltd.

The Company's Micropump platform permits either extended or delayed delivery of small molecule drugs through the oral route. Micropump is a microparticulate system that allows the development and marketing of modified and/or controlled release of solid, oral dosage formulations of drugs. Micropump consists of a multiple-particulate system containing 5,000 to 10,000 microparticles per capsule or tablet. The 200-500 microns diameter-sized microparticles are released in the stomach and pass into the small intestine, where each microparticle, operating as a miniature delivery system, releases the drug at an adjustable rate and over an extended period of time. The design of the Micropump microparticles allows an extended release in the gastro-intestinal (GI) tract allowing mean plasma residence times to be extended for approximately 24 hours. The microparticles' design can be adapted to each drug's specific characteristics by modifying the coating composition and thickness, as well as the composition of the excipients encapsulated with the drug. The platform is applicable to poorly soluble (< 0.01 milligram/liter), as well as highly soluble (> 500 gram per liter) and to low dose or high dose drugs, while providing mouth feel and taste masking properties. Micropump allows the release of single or combination of drugs, in a range of formats, such as tablets, capsules, sachet, or liquids (LiquiTime), while preserving the targeted release rate over the shelf-life of the product. The Company's LiquiTime platform uses Micropump's advantages to allow it to develop modified/controlled release in liquid suspension formulations. The LiquiTime products are particularly suitable for dosing to children and for use by patients having issues swallowing tablets or capsules. It has two LiquiTime-based products in development: ibuprofen LiquiTime and guaifenesin LiquiTime.

The Company's Trigger Lock platform utilizes Micropump's advantages to allow the development of abuse-resistant modified/controlled release formulations of narcotics and other drugs susceptible to abuse. The Company's Medusa is a hydrogel depot formulation approach that does not alter the drug substance, enables the modified/controlled delivery from 1 day up to 1 week of drugs. Medusa is particularly suited to the development of subcutaneously administered formulations. Medusa allows the development of extended/modified release of injectable dosage formulations of drugs (peptides, polypeptides, proteins and small molecules).The Medusa platform consists of drug carrier polymers that form hydrogel depots after injection. Medusa polymers are made of glutamic acid, a naturally occurring aminoacid, and alpha tocopherol (Vitamin E). These polymers are amphiphilic and spontaneously form stable hydrogels in water. These hydrogels contain hydrophobic nanodomains rich in Vitamin E and hydrophilic polyglutamate that are exposed to water. The hydrogels are robust over a range of potential of Hydrogen (pH) values and can be stored, in particular as a stable freeze-dry form, that can be reconstituted in water for Injection. The drug is loaded in the hydrogel (nano- or micro-gel) through non-covalent, hydrophobic and electrostatic, bonds. Once in the body, the hydrogel releases the drugs in a controlled manner with no initial burst effect, lower Cmax and uniform plasma concentration, over an extended period of time. Both drug loading (in fully aqueous solution, and usually, under solvent- and surfactant-free conditions) and release (by displacement of the loaded drug by circulating endogenous proteins) are non-denaturing, which preserves structural integrity, and hence activity, of the drug. The transient, non-covalent interactions dictate the pharmacokinetic parameters (Cmax and bioavailability in particular) of the released drugs.

Bloxiverz

Bloxiverz is a drug used intravenously in the operating room for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. Bloxiverz is the food and drug administration (FDA)-approved version of neostigmine methylsulfate. Neostigmine is used for the reversal of the effects of other agents used for neuromuscular blocks.

Vazculep

Vazculep is the FDA-approved version of phenylephrine hydrochloride injection to be available in all over three vial sizes. The Company's subsidiary Eclat Pharmaceuticals, LLC delivers Vazculep (in approximately one milliliter single use vials, and over five milliliter and approximately 10 milliliter pharmacy bulk package vials) to wholesalers. West-Ward Pharmaceuticals Corp. (West Ward) commercializes over one milliliter single-dose vial, as an approved product in the United States.

Karbinal ER

Karbinal ER is an H1 receptor antagonist (antihistamine) indicated for children two years of age and older, is the first generation extended release oral suspension antihistamine available in the United States. Karbinal ER provides physicians with a treatment option for children with seasonal and perennial allergic rhinitis that need symptomatic relief for runny nose, sneezing, itchy nose or throat and itchy and watery eyes.

AcipHex Sprinkle

AcipHex Sprinkle is a delayed-release capsule, in dosages of over 5 milligrams and approximately 10 milligrams, indicated for the treatment of gastroesophageal disease (GERD) in children 1 to 11 years of age for approximately 12 weeks. AcipHex Sprinkle can be sprinkled on a small amount of soft food (applesauce, fruit or vegetable-based baby food, or yogurt) or the capsule granules can be emptied into a small amount of liquid (infant formula, apple juice, or pediatric electrolyte solution).

Cefaclor

Cefaclor is indicated for the treatment of otitis media, lower respiratory infections, pharyngitis and tonsillitis, urinary tract infections, and skin and skin structure infections, caused by susceptible organisms. It is a second generation cephalosporin antibiotic used to treat certain infections, caused by susceptible bacteria.

Flexichamber

Flexichamber is a collapsible holding chamber for use by patients under the care or treatment of a licensed healthcare professional to administer aerosolized medication from pressurized metered dose inhalers (MDI), is a prescription medical device. Flexichamber consists of antistatic materials to help improve delivery of medication from MDIs to the patient, while minimizing the adherence of the medication to the walls of the chamber. Flexichamber can be used with or without a mask.

Coreg CR

Coreg CR is an extended-release formulation (once-a-day) of Coreg (carvedilol phosphate), a non-selective antagonist of Beta 1, Beta 2 adrenergic receptors and a selective antagonist of Alpha 1 adrenergic receptors. Coreg and Coreg CR are beta blockers indicated for the treatment of moderate to severe heart failure and left ventricular dysfunction following myocardial infarction.

The Company competes with Alkermes plc, COSMO Pharmaceuticals SpA, Depomed, Inc., Durect Corp., Supernus Pharmaceuticals, Inc., Veloxis Pharmaceuticals A/S, Neos Therapeutics, Inc., Tris Pharma, Inc., Acura Pharmaceuticals, Inc., Altus Formulation, Cephalon, Collegium Pharmaceutical, Inc., Durect Corp., Egalet Corporation, Elite Pharmaceuticals, Inc., Ethypharm, Grunenthal Group, Intellipharmaceutics International, Inc., QRx Pharma, Ltd., KemPharm, Inc., Biodel Inc., Debiopharm Group, Durect Corp., LG Life Sciences, InnoCore Pharmaceuticals, Marina Biotech, Inc., MedinCell SA, Dr. Reddy's, Onxeo, Pacira Pharmaceuticals, Inc., Midatech, REcoly N.V., Soligenix, Inc., Surmodics, Inc. and Xenetic Biosciences plc.

Company Address

Flamel Technologies SA

33 avenue du Dr. Georges Levy
Parc Club Du Moulin A Vent
VENISSIEUX     69200
P: +334.72783434
F: +334.72783435

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