broker commentary

Pharmaxis

GARRY O'NEILL

WILSON HTM

PHARMAXIS (PXS) expects to have a pre-NDA meeting with the FDA to prepare a New Drug Application (NDA) for submission in first half 2011. The company hopes to get accelerated approval and has fast track status for Bronchitol to treat Cystic Fibrosis (CF). This has the potential of reducing the review time from approximately 12 months to six months. We maintain a 12-month timeline in our forecasts and valuation.

We are very confident of EMA and TGA (Australian) approval for CF by the end of 2010, and that PXS will launch Bronchitol in the UK and Germany early in 2011.

A decision on whether/when to order an additional spray dryer to be installed at the company's new facility can be expected in 2011. The major criterion for this decision is how rapidly Bronchitol is taken up in Europe, as the plant can only manufacture sufficient Bronchitol for 40,000 patients per annum.

The company again emphasised the positive market research results it has seen for Bronchitol in Europe for treatment of CF.