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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 Inve
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SOURCE PARI Pharma
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