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Agreements

Date: 2011-10-13

Type of information: Development agreement

Compound: Medusa-based hydrogel depot formulation of tigecycline

Company: Eagle Pharmaceuticals (USA) Flamel Technologies (France)

Therapeutic area: Infectious diseases

Type agreement:

development
licensing

Action mechanism:

Disease:

Details:

Eagle Pharmaceuticals and Flamel Technologies have entered into a license and development agreement for the development of 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. 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.

The Medusa® drug delivery platform consists of proprietary depot hydrogels for the formulation and/or the extended release of a broad range of biologics and of small molecules. 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.

Financial terms:

Under the terms of the license and development agreement, Flamel will receive upfront, 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 Ea gle Pharmaceuticals.

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