ML Labs wins dual inhaler contract

The agreement, which could be worth upwards of £16.5 million (€24.8m) for ML Labs, ties in with the current trend towards bundling multiple medications in a single dosage form. This has the benefit of tackling more than one aspect of a disease at once, as well as reducing the dosing burden placed on patients.

The C200 is a multi-dose, breath-actuated dry powder inhaler developed by ML Labs' subsidiary Innovata Biotech, and this is the first licence agreement for the new technology. It is designed to deliver two drugs together, in the same breath, from separate reservoirs.

For many years, asthmatics relied on using different colour-coded inhalers to manage their condition. Patients with mild disease would tackle their symptoms on-demand using a beta agonist, but as symptoms worsened steroids would be delivered separately to tackle the underlying inflammation in asthma.

In the last few years, companies with asthma franchises have developed combination products, incorporating a long-acting beta agonist and steroid drug into the same inhaler, to help patients comply with their treatment and hopefully improve control of their symptoms.

Leading the way was GlaxoSmithKline, whose Seretide (salmeterol and fluticasone propionate) takes the lion's share of the combination asthma drug market with sales of £2.2 billion last year. Meanwhile, AstraZeneca is gaining ground with its Symbicort (budesonide/formoterol) product, which saw its sales rise 61 per cent last year to $549 million (€450m).

The overall market for combination asthma drugs is around $5 billion a year, forecast to exceed $6 billion in 2006.

Both GSK and AstraZeneca have compiled data showing that delivering asthma treatments in tandem can improve asthma rates (by reducing the rate of breakthrough attacks) and reduce the need for 'rescue' medication, a clear sign of improved day-to-day asthma control.

And last year, two other players in the asthma market, Novartis and Schering-Plough, joined forces to develop a dual inhaler product based on the latter's steroid drug triamcinolone and the former's beta agonist formoterol.

ML Labs' agreement covers Europe and certain other specified countries, with Innovata Biotech retaining the rights for all remaining territories including the US and Japan.

The agreement, which is the second with this licensee, provides for IB to receive access fees and milestone payments totalling £7.5 million, subject to certain targets being achieved, with the first tranche payable immediately.

In addition, Innovata Biotech will conduct the development programme on behalf of the licensee which could generate development fees of up to £9 million. The UK firm will receive rising royalties on sales, with first launch anticipated in 2008, and will supply C200 inhalers to the licensee on commercial terms.

Asthma is a highly prevalent chronic disease estimated to cost at least $13 billion in the US alone each year. In the UK, there are four times as many people with asthma than with diabetes. The number of patients with asthma in the seven largest pharmaceutical markets is set to rise from 51.4 million in 2003 to 62.4 million in 2013, stimulating greater demand for cost-effective asthma therapies.

Datamonitor estimates that the market for asthma and chronic obstructive pulmonary disease (COPD) products will reach $18 billion by 2011.