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Mpex Candidate, MP-376, Granted U.S. Orphan Drug Status for the Treatment of Cystic Fibrosis
Date:3/4/2008

's marketing approval by the FDA. Orphan status also enables Mpex to apply for research funding, tax credits for certain research expenses, and a waiver from FDA user fees.

About MP-376

MP-376 is a proprietary formulation of levofloxacin that has been designed by Mpex scientists to enable aerosol administration. Levofloxacin is a powerful antibiotic that has been widely used in a variety of indications for over a decade and has established safety and efficacy when administered orally or intravenously against many bacterial pathogens including Pseudomonas aeruginosa. Administration of MP-376 with a high efficiency nebulizer to the lungs allows for the delivery of high concentrations of active drug directly to the site of infection, while minimizing systemic exposure. Mpex believes this approach has the potential to improve bacterial killing and reduce resistance development versus traditional oral or IV routes of administration.

Mpex recently completed a multi-center, 14-day placebo controlled clinical trial with MP-376 in 40 CF patients. Based on these results and consultations with the FDA and the Therapeutics Development Network (TDN) of the Cystic Fibrosis Foundation, the company expects to initiate a Phase 2b clinical trial in approximately 140 CF patients in the second quarter of 2008. Several dosing regimens of MP-376 will be compared, including once daily administration schedules. Results from this trial, if successful, are expected to enable the company to select dosing regimens for the pivotal Phase 3 clinical program in this indication.

About Mpex Pharmaceuticals

Mpex Pharmaceuticals is a clinical stage biopharmaceutical company whose mission is to develop important new therapies to combat the growing issue of antibiotic resistance. The company's internal development pipeline focuses on combining proprietary formulations, PK/PD strategies and novel potentiating agents with proven antibiotics to overcome or directly inhibi
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SOURCE Mpex Pharmaceuticals, Inc.
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