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PARI Pharma Receives 2nd ODD From EMEA; Moves Inhaled Tobramycin - eFlow Technology Program Forward
Date:5/7/2009

MUNICH and MONTEREY, Calif., May 7 /PRNewswire/ -- PARI Pharma GmbH received an Orphan Drug Designation (ODD) by the European Commission based on a positive recommendation by the EMEA for inhaled PARI Tobramycin 100 delivered via a customized Investigational eFlow Nebulizer System. This is the second ODD designation that PARI Pharma has received for a product in its proprietary drug pipeline; the first ODD was granted for PARI's inhaled cyclosporine delivered via an eFlow Technology device.

"In clinical trials, we have seen a reduction to one fourth of the inhalation time for PARI Tobramycin 100 compared to TOBI. This is a significant improvement that relates directly to patients' quality of life and ease of use. We believe this will lead to increased adherence to the antibiotic therapy, which is a major challenge for patients with cystic fibrosis. The ODD designation acknowledges the therapeutic value that this delivery concept will offer to patients suffering from cystic fibrosis," said Dr. Martin Knoch, President of PARI Pharma GmbH.

PARI Pharma is currently in discussions with multinational pharmaceutical companies to evaluate the efficacy of PARI Tobramycin 100 in a Phase III clinical study and to ultimately make this next-generation treatment available to CF patients worldwide.

The EMEA regulation on orphan medicinal products is designed to promote the development of drugs, which may provide significant benefit to patients suffering from rare diseases identified as "life-threatening or very serious." In addition to potential 10-year EU market exclusivity following marketing approval, orphan drug status provides regulatory assistance and helps accelerate the approval of a drug product via a centralized procedure at reduced regulatory fees.

PARI conducted a Phase I clinical trial as a randomized, open label, crossover, single-dose deposition study of PARI Tobramycin 100 in an Investigational eFlow Nebulizer System versus TOBI/LC PLUS in 16 cystic fibrosis patients, including 8 adults and 8 children. Tobramycin lung deposition for both applications was between 46mg and 47mg. Results from the study will be presented at the European Cystic Fibrosis Conference (ECFC) in June 2009.

In addition, a Phase II multicenter clinical trial (10 sites) assessed safety and tolerability of PARI Tobramycin 100 (150mg/1.5mL) administered via an Investigational eFlow Nebulizer System in comparison to TOBI (tobramycin 300mg/5mL) delivered via the PARI LC PLUS. 78 patients suffering from cystic fibrosis (36 adults and 42 children) inhaled the study medication for 28 days in a parallel study design.

While key deposition and safety thresholds were maintained, the marked difference was a reduction in the average inhalation time to 4 - 4 1/2 minutes for the PARI Tobramycin 100, down from 16 - 17 minutes for the TOBI therapy, a 73% reduction in treatment time. Results for both formulations show no difference in the ratio of peripheral to central lung deposition. Maximum tobramycin serum levels were below recommended safety thresholds for systemic and inhaled tobramycin applications. Although tobramycin sputum concentrations were slightly higher in the T100 cohort, plasma levels and adverse reaction rates were slightly, but not significantly, lower being regarded as desirable. It appears that, for a twice-daily treatment with PARI Tobramycin 100 delivered via an Investigational eFlow Nebulizer System, approximately 10+ hours of inhalation time per month can be saved compared to TOBI.

About PARI Tobramycin 100

PARI Tobramycin 100 is an investigational proprietary aqueous solution of 150mg tobramycin/1.5mL for inhalation delivery via an optimized Investigational eFlow Nebulizer System, both developed by PARI Pharma, as a potential treatment for patients suffering from bacterial infections caused by Pseudomonas aeruginosa. Patents on both the drug formulation and device were granted in Europe and several other countries. Low volume/high concentration drug products such as PARI Tobramycin 100 delivered using eFlow Technology have been shown to substantially shorten nebulized treatments and are believed to offer an improvement for patients. The volume reduction to 1.5 mL and high drug concentration of 100 mg/mL developed for delivery via a customized Investigational eFlow Nebulizer System (with about two-fold higher delivery efficiency compared to jet nebulizer systems) are prerequisites to offer such treatment advantages.

About the Investigational eFlow Nebulizer System and eFlow Technology

The Investigational eFlow Nebulizer System uses eFlow Technology to enable highly efficient aerosolization of liquid medications via a vibrating, perforated membrane that includes thousands of small holes that produce the aerosol mist. Compared to other nebulization technologies, eFlow Technology produces aerosols with a very high density of active drug, a precisely defined droplet size, and a high proportion of respirable droplets delivered in the shortest possible period of time. Combined with its silent mode of operation, small size (it fits in the palm of your hand), light weight, and battery use, products incorporating eFlow Technology reduce the burden of taking daily, inhaled treatments. The Investigational eFlow Nebulizer System and eFlow Technology are proprietary to PARI Pharma.

PARI Pharma partners with pharmaceutical companies to develop new or improved therapies with eFlow Technology and other advanced delivery platforms. Investigational eFlow Nebulizer Systems are optimized and customized per investigational drug product and are currently in clinical trials for cystic fibrosis, asthma, COPD, respiratory syncytial virus (RSV) infection, and treatments for lung transplant patients among other indications.

About PARI Pharma

PARI Pharma focuses on the development of aerosol delivery devices, drug formulations, and therapies. Based on PARI's 100-year history working with aerosols, PARI Pharma develops treatments for pulmonary and nasal administration optimized with advanced delivery technologies, such as eFlow Technology.

PARI Pharma provides comprehensive inhalation drug development, including nebulizer formulation development and optimization, analytics, aerosol characterization, clinical protocol development, and regulatory guidance, all in compliance with CMC/GCP guidelines. PARI Pharma has several clinical development programs ongoing, either partnered or on its own. PARI Pharma, a PARI Medical Holding company, is located in Munich, Germany with a major presence in the United States. Online at www.paripharma.com


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