Mpex Pharmaceuticals is a biopharmaceutical company developing new therapies to combat the growing issue of antibiotic resistance, with a particular focus on gram-negative organisms. 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 inhibit the molecular mechanisms in bacteria responsible for antibiotic resistance

Mpex's lead product candidate, MP-376, is a novel aerosol formulation of an approved antibiotic (levofloxacin). MP-376 is currently in Phase 2 clinical studies for the treatment of chronic bacterial infections in patients with CF and severe chronic obstructive pulmonary disease (COPD). This novel formulation, coupled with a high-efficiency nebulizer, is projected to enable delivery of drug directly to the lungs to produce greater antibacterial effects with a lower propensity for drug resistance, and a shorter administration time.

The Company is also developing inhibitors of bacterial multi-drug resistant efflux pumps. Efflux pumps are the major source of multi-drug resistance in many gram-negative pathogens. There are currently no approved treatments which can block this resistance mechanism. In preclinical studies, Mpex’s efflux pump inhibitors (EPIs) have been shown to restore the potency of numerous antibiotics against drug-resistant gram-negative organisms. These EPIs are now being optimized for clinical development. In June 2008, Mpex entered into a worldwide strategic alliance with GlaxoSmithKline to develop novel EPIs in combination with a variety of existing and development stage antibiotics.

Antibiotic Market

With annual sales of over $26 billion, antibiotics represent one of the largest therapeutic categories from a revenue perspective. We believe that the growing problem of drug-resistant bacteria will continue to drive growth in new and expanding market opportunities. While much attention has been focused on resistance in gram-positive pathogens such as methicillin-resistant Staphylococcus aureus (MRSA), increasing antibiotic resistance in gram-negative organisms such as Pseudomonas aeruginosa represents a significant threat, with far fewer treatment options available.

Cystic Fibrosis

There are 70,000 patients worldwide with CF, with 30,000 in the US. By the age of 18 years, more than 75% of CF patients are chronically infected with Pseudomonas aeruginosa. CF Foundation guidelines issued in 2007 call for chronic use of inhaled antibiotics in patients with moderate to severe lung disease and persistent infection with Pseudomonas aeruginosa in airways to prevent acute exacerbations and improve lung function. However, administration schedules with currently available options can be difficult for CF patients, leading to reduced adherence to therapy. Available data indicate that CF patients receive significantly less than the recommended number of courses of treatment per year.

Severe Chronic Obstructive Pulmonary Disease

There are more than 9 million patients with chronic obstructive pulmonary disease (COPD) in the U.S. Approximately 10% of these patients are characterized as having severe disease which typically results in multiple acute exacerbations per year. These exacerbations are a major cause of morbidity, mortality and healthcare expenditure. There is no cure for COPD and as such, current treatment is aimed at managing symptoms and preventing exacerbations.

Bacterial infections are a leading cause of these exacerbations and antibiotics are widely used to treat exacerbations when they occur. However, while the FDA has approved agents such as Advair® as maintenance therapies for reducing the incidence of exacerbations, there are currently no antibiotics that have been approved as a maintenance therapy to address the root cause of many of these exacerbations.