Eagle Pharmaceuticals & Flamel Technologies Announce License & Development Agreement

Flamel Technologies SA and Eagle Pharmaceuticals, Inc. recently announced that the two companies have entered into a license and development agreement for a Medusa-based hydrogel depot formulation of the small molecule antibiotic, tigecycline. Following the promising results generated in the frame of an initial feasibility study established between Flamel and Eagle Pharmaceuticals, Eagle Pharmaceuticals has decided to exercise its option to pursue its partnership with Flamel. Under the terms of the license and development agreement, Flamel will receive up-front, milestone, and double-digit royalty payments. Additionally, Flamel is entitled to receive a percentage of any sub-licensing revenues received by Eagle Pharmaceuticals. All development expenses are the sole responsibility of Eagle Pharmaceuticals.

“We have been extremely pleased with the data we have seen thus far for this program,” said Scott L. Tarriff, President and Chief Executive Officer at Eagle Pharmaceuticals. “We hope to offer reduced costs to hospitals and improved convenience for patients requiring this antibiotic treatment. Tigecycline is currently dosed twice-a-day by slow intravenous infusion to patients that are typically hospitalized. Flamel’s Medusa platform potentially enables switching the route of administration from intravenous to subcutaneous injection through the creation of once-a-day sustained-release injectable tigecycline, reducing Cmax and consequently the side effects associated with tigecycline. We anticipate this formulation may allow some patients to leave the hospital earlier and be treated at home.”

“The progress we have achieved with Eagle Pharmaceuticals thus far highlights Medusa’s strength with small molecules,” added Stephen H. Willard, Flamel Technologies’ Chief Executive Officer. “This is in addition to our prior successes with proteins, peptides, and other biologics. We believe that our formulations can offer important improvements to patients’ quality of life and demonstrate key advantages of the Medusa platform: excellent local tolerance, with a noticeable reduction of swelling, pain, and irritation at the injection site; full activity of the molecule being delivered; and applicability to a wide range of drugs. Eagle Pharmaceuticals has been an excellent partner, and we look forward to expanding our work on this program, and potentially collaborating with Eagle on additional programs.”

The Medusa drug delivery platform consists of proprietary depot hydrogels for the formulation and/or the extended release of a broad range of biologics (including proteins, antibodies, peptides, and vaccines) and of small molecules (injectable drugs). The hydrogel has been proven to be safe and biodegradable. Flamel Technologies filed a Type IV DMF for Medusa with the FDA on February 12, 2011 (assigned number 024634). Medusa enables the controlled delivery from 1 day up to 14 days of non-denatured or non-modified drugs that maintain full bioactivity. It is used to develop Biobetters with potentially improved efficacy and reduced toxicity, as well as greater patient convenience. The Medusa drug delivery platform is being developed in partnerships with leading large pharmaceutical and biotechnology companies.

Flamel Technologies SA is a leading drug delivery company focused on the goal of developing safer, more efficacious formulations of drugs that address unmet medical needs. Its product development pipeline includes biological and chemical drugs formulated with the Medusa and Micropump proprietary platforms.

Eagle Pharmaceuticals, Inc. is a specialty pharmaceutical company that develops improved formulations of injectable products. Eagle has a development portfolio in excess of 15 products and currently has one marketed drug.