In addition to the historical science-oriented strengths of Flamel as an innovator of drug delivery platforms, we now have enhanced our ability to pursue commercial opportunities and identify new product candidates and have gained a products portfolio in various stages of development.

Flamel anticipates this enhanced commercialization capability will allow us to retain a greater portion of the economic benefits associated with sales not only of two products (Bloxiverz® and Vazculep®, the two currently marketed products from the acquired Éclat’s portfolio), but additional “Unapproved to Approved” products as well. In addition, we intend to pursue FDA approval of new products developed using our drug delivery platforms.

Our versatile, proprietary drug delivery platforms (Micropump®, LiquiTime®, Trigger Lock™, Medusa™) allow us to select unique product development opportunities, representing either “life cycle” opportunities for marketed chemical and biological drugs (via 505(b)(2) or ANDA regulatory paths), or innovative formulation opportunities for NCEs or NBEs (via NDA regulatory path). Our drug delivery platforms allow us to generate competitive differentiated product profiles (e.g. improvement of pharmacokinetics, efficacy and/or safety). These product development opportunities offer the ability to grow market share and to protect market position, through patent protection and/or product differentiation in multiple marketplaces.

As part of our new business model, several products formulated using our proprietary drug delivery platforms are currently under various stages of development at Flamel, using a variety of regulatory pathways. These products will be marketed either by the Company and/or by partners via licensing / distribution agreements.