LYON, France I June 25, 2014 I Flamel Technologies (NASDAQ: FLML) today announced that its once weekly formulation of exenatide, based on its Medusa drug delivery platform, has been successfully tested in minipigs. Exenatide is a glucagon-like peptide-1 agonist (GLP-1 agonist) used to treat type 2 diabetes.
The product demonstrated close to 100% bioavailability with no initial release spike or burst effect in plasma. Two successive injections were administered with very similar release profiles. There were no adverse clinical signs and excellent local tolerability was observed.
The pharmacokinetic profile is compatible with a release over one week in humans.
Flamel Technologies expects to report phase I human clinical data in 2015.
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 markets Bloxiverz™ (neostigmine methylsulfate) in the USA and manufactures Micropump-based microparticles under FDA-audited GMP guidelines for Coreg CR® (carvedilol phosphate), marketed in the USA by GlaxoSmithKline. 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 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 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.
SOURCE: Flamel Technologies
Post Views: 344
LYON, France I June 25, 2014 I Flamel Technologies (NASDAQ: FLML) today announced that its once weekly formulation of exenatide, based on its Medusa drug delivery platform, has been successfully tested in minipigs. Exenatide is a glucagon-like peptide-1 agonist (GLP-1 agonist) used to treat type 2 diabetes.
The product demonstrated close to 100% bioavailability with no initial release spike or burst effect in plasma. Two successive injections were administered with very similar release profiles. There were no adverse clinical signs and excellent local tolerability was observed.
The pharmacokinetic profile is compatible with a release over one week in humans.
Flamel Technologies expects to report phase I human clinical data in 2015.
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 markets Bloxiverz™ (neostigmine methylsulfate) in the USA and manufactures Micropump-based microparticles under FDA-audited GMP guidelines for Coreg CR® (carvedilol phosphate), marketed in the USA by GlaxoSmithKline. 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 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 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.
SOURCE: Flamel Technologies
Post Views: 344
