Members of the Committee for Medicinal Products for Human Use (CHMP) have indicated that they would vote against approval of Pharmaxis’s marketing application for Bronchitol as a treatment for cystic fibrosis (CF). The CHMP took the trend vote after hearing an oral presentation by Pharmaxis regarding the application at its meeting last week. The official vote to approve or reject the application is scheduled for June 23, 2011.
According to Pharmaxis, it “is in the process of reviewing its alternatives with respect to the European Union marketing application” and “If there are adequate grounds, the Company may appeal a negative decision.” Such an appeal would be based on the existing application and data and would have to be filed by September 2011.
“As an alternative,” the company says, it “may choose to withdraw its application before any final decision is made in June 2011 andresubmit an application for regulatory approval of Bronchitol in the EU at a later date. While any EU appeal is in progress, Pharmaxis would slow preparation of its US FDA marketing application.”
Pharmaxis CEO Alan Robertson said: “Although this is not the final stage in the application process, we are clearly disappointed with the outcome of this trend vote. All patients with cystic fibrosis have difficulty in breathing and in clearing their lungs and people born with cystic fibrosis will die at an unacceptably early age from respiratory failure; so there is evidently a high unmet medicalneed. Pharmaxis remains steadfastly positive about the benefit of Bronchitol and will work to address the Committee’s concerns, with the goal of making this important medication available to CF patients in the Europe Union.”
News outlets have reported that Robertson sold 500,000 shares of the company the day before the news broke and the subsequent 74% fall in share price.
Read the Pharmaxis press release
Read a news report about the stock sale.
