FDA blocks imports of Pharmaxis asthma test

Shares in Pharmaxis (ASX:PXS) took another hit after the company revealed that the FDA has frozen the import of asthma test Aridol into the US market.

The FDA has included Aridol onto its Import Alert list, citing concerns that current manufacturing processes do not comply with best practice standards.

This has the effect of stopping all imports of the lung function test until it is removed from the list.

Pharmaxis said it has not been advised by the FDA as to why Aridol was listed, but that it probably relates to issues uncovered during a scheduled audit of a third-party contract packer.

Pharmaxis added that it is working with the packer on a response to the audit findings in an attempt to have Aridol removed from the list as soon as possible.

The FDA first approved Aridol in October 2010. Pharmaxis’s US sales for the product averaged around $33,000 per month during the March quarter and the company has around three months of inventory in the market.

Pharmaxis shares were trading 6.45% lower at $0.145 as of around 1.30 pm on Monday.

The price has fallen 36% since Thursday, the day before the company announced a sweeping restructure plan involving cutting 30% of its staff, as well as pursuing a partner strategy for most of the commercialisation efforts for cystic fibrosis and bronchiectasis treatment candidate Bronchitol.