Flamel will investigate the protein, with Merck Serono funding the R&D efforts to be performed at Flamel. Financial terms of a license agreement up through potential commercialisation have been agreed between the companies. "We are delighted to enter into this partnership with Flamel, as it gives Merck Serono access to a technology that may further improve the therapeutic potential of compounds in our portfolio," Merck Serono head of research Bernhard Kirschbaum said. "As Flamel's Medusa technology allows for longer intervals between administrations of injectable proteins compared to standard formulations, we hope to offer an improved convenience for patients requiring treatment by injection."
Delivery of biologics has always been an area of concern, particularly in regards to side effects. With many first-generation biologics off patent or soon to come off patent, there are increasing moves for a second-generation of biologics to improve on the clinical benefits of the therapeutic proteins already marketed. Flamel's Medusa technology, aims to do just that. Medusa is a self-assembled poly-aminoacid nanoparticle system for long acting formulations of proteins peptides and other molecules.
The nanoparticles work by providing a better performance for second-generation formulations by offering extended-release action, high bioavailability and efficacy, reduced side effects and improved compliance. The polymer used is made of glutamic acid, a naturally occurring aminoacid, and Vitamin E. The polymer is amphiphilic and spontaneously forms stable nanoparticles in water. These nanoparticles have a hydrophobic nanodomain which is rich in Vitamin E and a hydrophilic nanodomain of polyglutamate, which is exposed to water. The design of the polymers allows for the non-covalent capture of drugs.
According to Flamel, the nanoparticles can withstand a wide range of pH values and can be stored in either liquid of dry formulations. The nanoparticles deliver a controlled release of the drug while preserving the structural integrity and biological activity of the protein by not denaturing it. This is unlike some other conventional methods such as protein engineering. Other advantages include reducing the intensity of the peak by five to 10 times and protein concentration has been shown to be maintained for at least two weeks. "We are pleased to have reached an agreement with Merck Serono," Flamel chief executive Stephen Willard said.
"The Medusa platform is a best-in-class technology for the controlled delivery of proteins, peptides, and other molecules. This applicability to a wide range of molecules is a key strength of the platform, as is the ability to sustain release without affecting bioactivity." Flamel has also used the technology for its own products, which are in various stages of development, including: FT-105, a next-generation formulation of long-acting native insulin; IFN alpha-2b XL, a second-generation long-acting native interferon alpha-2b; and IL-2 XL, a second-generation long-acting interleukin-2.
The company also has an agreement with Wyeth for the development of an undisclosed product using Medusa.