Press Releases
Flamel’s Medusa® Drug Delivery Technology
Proves the Principle of Sustained Release of Human
Insulin
Lyon, France, April 18, 2000 -- Flamel Technologies SA (Nasdaq: FLML) today announced that the first clinical study of LABI has been completed on schedule. A test formulation was given as a single dose to healthy volunteers. The study has proven the principle of LABI, formerly known as Basulin, as a long acting human insulin delivery system. The results have yielded important information for further optimization of the formulation. The study was commenced by Flamel Technologies on December 8, 1999. Since then, Flamel has entered into a development and licensing agreement with Novo Nordisk for LABI.
"It was important for Flamel to validate in humans the results that we obtained in animal models with the Medusa® technology," said Gérard Soula, President and CEO of Flamel. "We are now working with Novo Nordisk on the optimization of the polymer and the formulation before the start of new clinical studies on this new generation of long acting insulin."
Conducted in the UK, the objective of this double-blind placebo-controlled study was to compare, over a period of 24 hours, efficacy of LABI with NPH, Novo Nordisk’s long-acting human insulin. The investigation of the pharmacokinetic and pharmacodynamic properties was carried out using the euglycaemic glucose clamp technique in healthy volunteers to determine the duration of efficacy of LABI.
The worldwide market for long-acting or basal insulin is estimated to be a significant part of the global $2.3B insulin market.
Flamel Technologies plans to extend its Medusa® technology to other therapeutic proteins where cumbersome dosing regimes may result in poor patient compliance. "This first clinical result on insulin shows the potential of the Medusaâ technology and strongly encourages Flamel to develop other long-acting protein projects," said Dr. Soula.
The innovative Medusa® drug delivery technology has been developed by Flamel Technologies in response to the need for a system to optimize the delivery of fragile proteins and peptides to sites of action. Specific therapeutic proteins and peptides are encapsulated in nanoparticles, specially designed "protein-like" polyaminoacid polymers, taking care not to denature the molecules. The nanoparticle is carefully chosen to allow controlled release of the therapeutic agent and to allow slow natural degradation of the nanoparticle with few or no side affects for the patient.
Flamel Technologies is engaged in the development of advanced polymer technologies for unique life science applications. To meet important medical needs and develop commercially valuable products, the Company is building on its principal technology platforms: the controlled release of therapeutic drugs and proteins with its Micropump® and Medusa® systems; the efficient delivery of agrochemical active ingredients with its Agsome™ system; ColCys® biomaterial-based medical devices; and photochromic materials for eyeglass lenses.
Agsome™ and Basulin™ are trademarks, and Micropump®, Medusa® and ColCys® are registered trademarks of Flamel Technologies.
This document contains a number of matters, particularly as related to the status of various research projects and technology platforms, that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The presentation reflects the current view of management with respect to future events and is subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. These risks include risks that products in the development stage may not achieve scientific objectives or milestones or meet stringent regulatory requirements, uncertainties regarding market acceptance of products in development, the impact of competitive products and pricing, and the risks associated with Flamel’s reliance on outside parties and key strategic alliances. These and other risks are described more fully in Flamel’s Annual Report on the Securities and Exchange Commission Form 20-F for the year ended December 31, 1998.
