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Pharmaceutical company Pharmaxis (ASX: PXS) today announced it has entered into an exclusive distribution and supply agreement with global pharmaceutical company Chiesi Farmaceutici SpA (Chiesi) for the commercialisation of Bronchitol® (mannitol) in the United States.  As a precursor to this agreement Pharmaxis has settled its dispute with NovaQuest Pharma Opportunities Fund III (NovaQuest) and entered an Amended and Restated Financing Agreement.

Under the terms of the commercialisation agreement Chiesi is responsible for funding up to US$22 million of the cost of the phase 3 clinical trial of Bronchitol which recently enrolled its first patient.  Subject to approval in the United States, Bronchitol will be sold as part of Chiesi’s cystic fibrosis portfolio which includes Bethkis®(tobramycin inhalation solution) and Pertzye® (pancrelipase) delayed-release capsules, both launched in the US earlier this year.  Milestones totaling up to US$25 million are payable tied to the launch of Bronchitol, and on achieving certain annual sales levels.

Pharmaxis will manufacture Bronchitol on commercial terms for Chiesi but should it be independently sourced in the future by Chiesi, the Agreement provides for an ongoing share of sales revenue for Pharmaxis.

Under the terms of the amended Financing Agreement, NovaQuest will receive reduced financial terms on its existing US$20 million investment and no further investment by NovaQuest is required.

Pharmaceutical company Pharmaxis (ASX: PXS) today announced that it has enrolled the first subject in its international clinical trial evaluating Bronchitol® in adults with cystic fibrosis (CF303).

The Phase 3 trial is being conducted in accordance with the requirements of the US Food and Drug Administration (FDA) to gain approval for Bronchitol (mannitol) to treat cystic fibrosis in the United States. As guided by the FDA, the clinical study protocol closely follows the design of the two large scale clinical trials already undertaken by Pharmaxis (CF 301 and CF 302).  The trial is a 26 week randomised, double-blind parallel group investigation of Bronchitol administered twice daily in patients with cystic fibrosis.  The trial will enroll between 350 and 440 cystic fibrosis patients aged 18 years and older, and will assess improvements in lung function, pulmonary exacerbations and safety.

Pharmaceutical development company Pharmaxis today announced that a positive new data analysis from its large scale study of Bronchitol in patients with bronchiectasis (B305) is being presented at the European Respiratory Society (ERS) meeting taking place in Germany from 6-10 September 2014.

The late breaking abstract, to be presented in a thematic poster session by Dr Anthony de Soyza, Honorary Consultant Physician and Senior Lecturer in Respiratory Medicine at Newcastle University UK, examined a higher risk subgroup from the trial who, despite best standard of care, continued to suffer breathlessness even at rest and frequent exacerbation.

In this subgroup analysis of patients from the clinical trial who were at higher risk of further exacerbations, Bronchitol demonstrated both clinically important and significant improvements in exacerbation rate, antibiotic use and total SGRQ* scores on top of existing best standard of care over a 12 month period. The authors concluded the post-hoc findings suggest a greater effect from Bronchitol in higher risk patients than observed in the broader non-CF bronchiectasis population studied.