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Bio Technology : October 2009
66 Australasian BioTechnology Volume 19 • Number 3 • October 2009 AusBioSTOCK SPOTLIGHT by Joanna Hill PHARMAXIS LTD (ASX: PXS) $2.38 Listed November 2003 Market Capitalisation $519M Month H $2.50 -- L $2.23 (vol 6.4 m 6 m transactions) Issued Capital: 217m OFP shares + 20m options Cash 31st June 2009 Aus $125M Major shareholders: Top 20 quoted 66.2% Unquated substantial holders (%) Orbis Global Equity Fund 18 Fortis Investemnt partners 10 Acorn Capital 7 PRINCIPAL ACTIVITY A specialty pharmaceutical company focused on the development of new products for the diagnosis and treatment of chronic respiratory and immune disorders. Bronchitol -- proprietary, inhaled dry powder mannitol formulation, for the treatment of cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD) and bronchiectasis; and for the treatment of other acute and chronic pulmonary conditions. Bronchitol has not yet been approved for any indication in any market. Aridol -- mannitol bronchial challenge test, a novel tool for the detection of airway hyperresponsiveness and to assist in the diagnosis and management of asthma. The Aridol test mimics the bronchoconstriction that can occur in inflamed airways from time to time in people with asthma. Airway hyperresponsiveness is one of the hallmarks of untreated or poorly controlled asthma. Aridol may also be used to determine the minimum effective doses of inhaled corticosteroid required for optimum control of asthma. ASX media releases 11 September 2009 Pharmaxis to present results of first Phase III trial of Bronchitol in Cystic Fibrosis at European Respiratiry Society Meeting -- Data from the pivotal study conducted in 295 children and adults with cystic fibrosis. A New Drug Application seeking approval to market Aridol was submitted to the U.S. FDA in March 2009 and a complete response is expected before the end of the year. At the conclusion of an extensive clinical development program, a marketing application for Bronchitol in cystic fibrosis will be submitted to the European regulatory agency later this year. 22 July 2009 Operational Highlights Second Quarter 2009 Phase 3 trial with Bronchitol in CF returns positive result • Oral presentation at the European annual cystic fibrosis • scientific meeting. Meetings with European regulators outlined regulatory • review path Aridol New Drug Application accepted for review by FDA • PXS25 presented at the 2009 American Thoracic Society • meeting in San Diego 13 July 2009 Pharmaxis to Voluntarily De-List from Nasdaq Pharmaxis has recently completed a review of the demand from existing and potential international investors for the secondary listing of its American Depositary Shares ('ADS's') on Nasdaq and the volume of Pharmaxis ADS trading in the secondary Nasdaq market. The review concluded that the benefits of the Nasdaq listing could no longer justify the related ongoing costs.