US approval for Profile's nebuliser

Related tags Asthma

Profile Therapeutics of the UK has been granted approval from the
US Food and Drug Administration (FDA) for Prodose, its nebuliser
system that can improve the delivery of inhaled drugs.

Prodose is already launched in Europe to deliver Promixin (colistimethate sodium), an inhaled antibiotic for treatment of patients with cystic fibrosis, and Ventavis (iloprost), Schering's product for pulmonary hypertension. It has also been selected by CoTherix of the US for development of their inhaled iloprost product for pulmonary hypertension.

Profile's nebulisers are claimed to offer significant advantages over current delivery technologies, including more accurate and flexible dosing and improved patient compliance. For example, in the case of the asthma drug albuterol, the volume of drug required for nebulisation is reduced from 3ml to 0.7ml using the ProDose technology.

Prodose is Profile's second-generation Adaptive Aerosol Delivery (AAD) system. The third generation system, Prodose HandHeld, is in its final stages of development and planned to be available to patients for the first time later this year, according to the company.

This system is arguably the most commercially important of Profile's products, as it could extend the use of the technology into a much wider patient population by delivering drugs usually administered using a metered dose inhaler. Last year, Profile forged an alliance with Breath of the US to develop ProDose Handheld versions of some mainstay respiratory drugs, including albuterol, ipratropium bromide and an unnamed corticosteroid, which are due to roll out in 2004 or 2005.

M&A discussions ongoing

Meanwhile, it was reported in March that Profile was in discussions, which may or may not lead to a formal offer being made for the company. Profile has now confirmed that these discussions are ongoing and further announcements will be made in due course.

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