Eagle Pharmaceuticals, Inc. and Flamel Technologies SA (NASDAQ: FLML) today announced that the two companies 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. 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 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.” Stephen H. Willard, Flamel Technologies’ Chief Executive Officer, stated, “The progress we have achieved with Eagle Pharmaceuticals thus far highlights Medusa’s strength with small molecules. 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.”
About Tigecycline. Tigecycline is a glycylcycline antibiotic marketed by Wyeth (now Pfizer) under the brand name Tygacil. It was given a US Food and Drug Administration (FDA) fast-track approval and was approved on June 17, 2005. It was developed in response to the growing prevalence of antibiotic resistance in bacteria such as Staphylococcus aureus and Acinetobacter baumannii. Tigecycline is given by slow intravenous infusion (30 to 60 minutes); a single dose of 100 mg is given first, followed by 50 mg every twelve hours after that.About Medusa®. 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. Additional information can be found at http://www.flamel.com/technology-platforms/medusa/. About Flamel Technologies Flamel Technologies SA (NASDAQ: FLML) 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. Several Medusa-based products are at various clinical stages of development; Medusa’s lead internal product candidate IFN-alpha XL (long-acting interferon alpha-2b) is currently the subject of a Phase 2 trial in HCV patients. The Company has developed approved products in the US and in EU and manufactures Micropump-based microparticles. Flamel Technologies has collaborations with a number of leading pharmaceutical and biotechnology companies, including Baxter, GlaxoSmithKline (Coreg CR®, carvedilol phosphate), Merck Serono (long-acting interferon beta) and Pfizer. Further information can be found at www.flamel.com. About Eagle Pharmaceuticals, Inc. Eagle Pharmaceuticals, Inc. is a specialty pharmaceutical company which develops improved formulations of injectable products. Eagle has a development portfolio in excess of 15 products and currently has one marketed drug. Eagle’s pipeline provides benefits to the healthcare community at large by 1) reducing the need to reconstitute drugs, 2) reducing the number of injections, 3) reducing pain at the injection site, 4) reducing side effects, 5) providing new formulations which may lead to additional indications. Eagle was established in 2007. This document contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including certain plans, expectations, goals and projections regarding financial results, product developments and technology platforms. All statements that are not clearly historical in nature are forward-looking, and the words “anticipate,” “assume,” “believe,” “expect,” “estimate,” “plan,” will,” and similar expressions are generally intended to identify forward-looking statements. All forward-looking statements involve risks, uncertainties and contingencies, many of which are beyond our control, 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, 2010. All forward-looking statements included in this release are based on information available at the time of the release. We undertake no obligation to update or alter our forward-looking statements as a result of new information, future events or otherwise.