Profile on the verge of take-off?

UK inhaled drug delivery specialist Profile Therapeutics has reported strong growth in sales and a reduced operating loss for the year-ended June 30 and expects this trend to continue, according to CEO John Lisle.

Turnover at the firm rose 8.7 per cent to £13.8 million (€19.7m) while operating loss was down 19 per cent to £4.7 million helped by a 33 per cent reduction in R&D expenses to £3.3 million as two of the firm's main pipeline projects - ProDose and ProDose Handheld - reach fruition.

These nebuliser machines 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.

Lisle, who is approaching his first anniversary at the helm of Profile, told In-Pharmatechnologist.com​ that the last year has been an exciting time for the firm as it forged its most significant deal to date - a joint venture​ with Breath of the USA.

This agreement centres on the development of ProDose Handheld versions of some mainstay respiratory drugs, including albuterol, ipratropium bromide and an unnamed corticosteroid, which are due to roll out in 2004.

In addition, Profile is on the verge of putting pen to paper on a deal with a marketing partner for these products. The company in question is already selling medicines into an appropriate clinician segment, Lisle said, and has 100 sales representatives that could detail ProDose Handheld products.

The improved versions of well-established respiratory drugs will form the first wave of products based on Profile's ProDose technology, alongside the company's existing franchise in inhaled antibiotics for treating infections in cystic fibrosis patients.

The lead product in the latter category, Promixin (colistimethate sodium), was launched in the UK earlier this year and has made initial sales of £63,000 through the sales of around 100 devices. However, with a total European market of $30 million (€27m) for inhaled antibiotics for CF this is never going to be a big-selling product, and is far more important to Profile as proof of the validity of the ProDose technology.

Down the line, Lisle sees the ProDose technology extending into the delivery of newer drugs, with one example being the use of the delivery technology alongside Schering of Germany's prostacyclin analogue Ventavis (iloprost) in patients with pulmonary hypertension. Another longer-term project could see the development of an inhaled version of insulin using ProDose, but this is still at a very speculative stage.

One possibility is that the improvements in drug delivery using ProDose - and particularly the HandHeld variant - might make it appropriate for drugs usually delivered using a metered dose inhaler. Lisle told In-Pharmatechnologist.com​ that this is an interesting idea, but at present no more than a source of discussion for Profile's management team; the current market for nebulised drugs stands at around $2 billion a year, which is quite enough for Profile to address for now.

Respiratory equipment​

Profile's other main business area is in respiratory equipment and supplies, with product lines - including conventional aerosol devices and equipment for sleep disordered breathing and ventilation - for both home and hospital use. This division of the company is already profitable, with sales up 9 per cent to £13.4 million and margins hitting 50 per cent for the year.

The US was a particular success for this division, with sales up 70 per cent on the back of improved distribution through the homecare segment of Profile's Sidestream nebulisers.