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Tuesday, May 12, 2009

PARI Pharma wins orphan drug designation for cystic fibrosis therapy

PARI Pharma wins orphan drug designation for cystic fibrosis therapy


PARI Pharma, a division of PARI GmbH and a developer of aerosol therapies, has received an orphan drug designation from the European Commission based on a positive recommendation by the European Medicines Agency for inhaled PARI Tobramycin 100 delivered via a customized investigational eFlow nebulizer system.

This is reported to be the second orphan drug designation (ODD) 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.

PARI Pharma said that it 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 cystic fibrosis (CF) patients worldwide.

Martin Knoch, president of PARI Pharma, said: "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 CF. The ODD acknowledges the therapeutic value that this delivery concept will offer to patients suffering from CF."

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