Profile: Flamel Technologies SA (FLML.O)
19 Dec 2013
Flamel Technologies S.A. (Flamel), incorporated in August 1990, is a biopharmaceutical company. Flamel is engaged in the development and licensing of two polymer-based drug delivery technologies. Its drug delivery technology business is built primarily on two technologies: Medusa and Micropump. Its hydrogel Medusa technology is designed to provide controlled release following injection of therapeutic proteins, peptides and other large and small molecules. Its Micropump technology is a microparticle technology for oral administration of small molecule drugs with applications in controlled-release, taste-masking and bioavailability enhancement. In March 2012, the Company acquired, Eclat Pharmaceuticals, LLC (Eclat), through its wholly owned subsidiary Flamel US Holdings, Inc. (Flamel US). The Company has two direct wholly owned subsidiaries: Flamel US Holdings, Inc. and Flamel Technologies, Inc.
In March 2012, the Company announced the completion of the Phase 1 Study conducted by Merck Serono in connection with the development and license agreement for a long-acting, controlled release subcutaneously-administered formulation of beta interferon using the Medusa platform. In October 2011, the Company also announced that it entered into a license and development agreement with Eagle Pharmaceuticals for the development of a Medusa-based hydrogel depot formulation of the small molecule antibiotic, tigecycline. In June 2011, the Company announced that it entered into a joint development agreement for the pre-clinical and clinical development of multiple products with Digna Biotech SL. Digna Biotech SL is a clinical stage biotech company that has developed three molecules to clinical phase in six years.
Products Under Development Based on the Medusa Technology
Interferon-alpha is a naturally occurring protein that the body uses as part of its immune response, and which is part of the current standard of care for the treatment of Hepatitis C virus. The analysis of the Phase 2 study of its long-acting interferon alpha-2b (IFN-α XL was presented in November 2011. The upcoming data presentation suggests that the antiviral activity of IFN-α XL is similar to that of reference PEGIFN-α 2b in this 3-month course of combined therapy, which would confirm the non-inferiority objective. The Company’s application of its Medusa technology microparticulate application is a depot delivery formulation of insulin targeted to meet the long-acting, basal insulin requirements of diabetic patients. Using a microparticulate adaptation of its Medusa delivery system, the Company has been able to form Medusa hydrogel of human insulin and aggregate these to produce a long-acting, injectable insulin formulation known as FT-105. The microparticulate formulation of Medusa polymer has a longer release profile than the hydrogel. The Company is working on nine Medusa projects with various pharmaceutical partners.
Micropump: Delivery System for the Oral Administration of Drugs
Flamel’s drug delivery platform, Micropump, is a technology for the controlled release of small molecule drugs following oral administration. A Micropump tablet, capsule, sachet, liquid formulation, or any other presentation form, contains 5,000 to 50,000 discrete microparticles that disassociate from one another in the intestine, and each of which then acts as a miniature pump, releasing its drug independently from all of the other individual microparticles. The size range of Micropump microparticles typically is between 100 and 500 micrometers. Each independent microparticle comprises an inert core surrounded by the active drug, and coated with a polymer which defines the controlled release properties.
Trigger Lock is a application based on its Micropump technology designed to provide a technical solution to the serious societal problems of intentional and unintentional abuse and misuse of narcotics and other dangerous, but pharmaceutically important, drugs. LiquiTime is another adaptation of the Micropump platform that it has developed for formulations targeted at elderly and pediatric patient populations, or others who have difficulty swallowing.
Products Based on the Micropump Technology
The product using its Micropump technology is Coreg CR, which it developed with GSK, and which is approved, marketed and sold in the United States Coreg CR is an extended-release formulation of Coreg (carvedilol phosphate), a beta blocker that is considered the standard of care for the treatment of moderate to severe heart failure and left ventricular dysfunction following myocardial infarction. Coreg CR was approved by the Food and Drug Administration (FDA) for use in the treatment of moderate to severe congestive heart failure; left ventricular dysfunction following myocardial infarction; and hypertension.
From January 1, 2011 until October, 2011, the Company supplied Coreg CR microparticles to GSK as a unilateral accommodation. In October, 2011, the Company announced that it signed a supply agreement with GSK for the production of Coreg CR microparticles and it remains the sole supplier of Coreg CR microparticles for GSK. Coreg and Coreg CR are the only beta blockers indicated for the severe form of heart failure. Carvedilol is a non-selective antagonist of Beta 1, Beta 2 adrenergic receptors and a selective antagonist of Alpha 1 adrenergic receptors. It has been demonstrated to have notable anti-inflammatory properties, in distinction to other beta blockers.
The Company is working on three separate molecules to be formulated using its Trigger Lock technology, as it has been engaged with a specialty healthcare company, on a separate project previously announced. The Company is also conducting a Trigger Lock feasibility study with a pharmaceutical company for the development of a combination product using the Trigger Lock platform. The Company has licensed its Micropump formulation of controlled release aspirin to New Haven Pharmaceuticals. Eclat has one FDA-approved product on the market in the United States-Hycet, a hydrocodone bitartrate and acetaminophen oral solution and its generic equivalent. Hycet is targeted for the relief of moderate to severe pain in patients age two or older. It contains the prescribed dose of hydrocodone bitartrate (7.5 milligrams/15 milliliters) in combination liquid form and has an acetaminophen concentration (325 milligrams/15 milliliters)
The Company competes with Alkermes, Inc., Enzon Pharmaceuticals, Human Genome Sciences, Nektar Therapeutics, Ambrx, SkyePharma, plc, Durect, Depomed, Tris Pharma, Covidien and Hi-Tech.
Flamel Technologies SA
33, avenue du Dr. Georges Levy,
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