Pharmaxis will collaborate with the Woolcock Institute of Medical Research to develop a tobramycin dry powder inhaler for the treatment of cystic fibrosis, the company has announced. A A$421,545 grant from the Australian National Health and Medical Research Council (NHMRC) will fund the research to develop a dry powder formulation for delivery by Pharmaxis’s Orbital device.
The Orbital inhaler is designed to deliver high doses of drug in a single inhalation and includes a dosing chamber that can hold up to 400mg of powder.
Pharmaxis CEO Gary Phillips commented, “This research will bring together the acknowledged expertise of the Woolcock Institute and Pharmaxis in the field of cystic fibrosis. We are pleased the NHMRC is supporting this research which we believe has potential to see Australian innovation translated into a commercial product ready for late stage clinical trials and partnering.”
Woolcock Institute Deputy Director and Head of Respiratory Technology Paul Young said, “While antibiotic treatment options for patients with cystic fibrosis has come a long way, the use of innovative devices such as the Orbital will be a significant step forward. Currently, CF patients have to grapple with loading multiple drug-containing capsules into their devices when taking their daily dose of antibiotics. With a lack of flexibility in this model, patients may encounter tolerability and cough issues along with logistical issues relating to loading, emptying and cleaning of their inhaler. The Orbital circumvents these problems by providing a press-button, single use device containing the whole antibiotic dose that the patient can inhale over a number of breaths that are suitable to them. This approach would not only improve the quality of life for CF sufferers but mark a revolutionary way in which we deliver antibiotics for CF.”
Pharmaxis markets the Bronchitol mannitol DPI for the treatment of CF in Europe, Russia, and Australia. In 2013, the FDA issued a complete response letter regarding the NDA for Bronchitol; Pharmaxis currently has a clinical trial underway to support the US application.
Read the Pharmaxis press release.