Ivax Corporation received a new product approval from the Medicines and Healthcare Product Regulatory Agency (MHRA) for Qvar in Ivax's patented Easi-Breathe inhaler. This is Ivax's first approval of Qvar in its Easi-Breathe inhaler. The product will be launched in the United Kingdom by Ivax's subsidiary, Ivax Pharmaceuticals UK Limited.

Qvar, a maintenance medicine used to reduce the frequency and severity of asthma attacks, is currently the only CFC-free (free of the chlorofluorocarbons that delete ozone from the atmosphere) aerosol corticosteroid for the treatment of asthma in the US. Qvar delivers the smallest medication particle size, 1.1 microns, of any drug in its category. This smaller particle size allows for greater lung deposition in the smallest airways of the lung, release from Ivax said.

In October 2003, Ivax started selling Qvar in nine European countries: United Kingdom, Ireland, France, Germany, Netherlands, Finland, Norway, Denmark and Sweden. In both the US and abroad, Ivax has been selling Qvar in a standard metered dose inhaler.

According to the release, Ivax believes that Easi-Breathe is the best breath-activated aerosol inhaler in the world. The benefit of the breath-activated Easi-Breathe is that it eliminates the need to coordinate the manual release of the medication with the inhalation of the medicine which is required by the standard metered dose aerosol inhaler. This coordination can be difficult especially for the young and elderly, or anyone coping with the urgencies of an asthma attack. Sub-optimal synchronization can result in medicine remaining in the mouth and throat and not reaching the lungs.

In the United States, Ivax has filed an NDA for a CFC-free formulation of albuterol, a rescue medicine for asthma, in the Easi-Breathe device and has received an "approvable" letter from the Federal Food and Drug Administration (FDA) in July 2004. Additionally, Ivax has recently started a phase III clinical trial in the US for Qvar in this same breath-activated device. Ivax also recently started a phase II clinical trial for asthma with our soft corticosteroid, Respicort (BNP-166), in our patented multi-dose dry powder inhaler, Airmax.