Skyepharma Acquires Rights and IP for Inhaled Therapy Platform from Pulmagen

Skyepharma PLC, a drug-delivery company, has acquired the global rights and related intellectual property (including granted patents and patent applications) for an inhaled therapy platform from Pulmagen Therapeutics Limited, a UK-based drug development company that focuses on the development of treatments for respiratory diseases.

Skyepharma plans to develop a first product (SKP-2075) for chronic obstructive pulmonary disease (COPD) through to the completion of a Phase II efficacy and then seek to out-license SKP-2075 to a pharmaceutical partner for late-stage development and commercialization. Pulmagen will receive a share of Skyepharma’s potential future revenues and launch milestones from the successful exploitation of the acquired platform.  

Pulmagen discovered that the inhalation of an ultra-low dose of theophylline, which is prescribed as an oral bronchodilator for severe asthma and COPD, together with an established inhaled corticosteroid (ICS) has an effect of unlocking the anti-inflammatory potential of ICS in the treatment of COPD.  Based on preliminary data, the inhalation of an ultra-low dose of theophylline with an ICS is predicted to deliver efficacy with an appropriate tolerability and safety profile, according to Skyepharma. Pulmagen has already conducted a Phase II clinical trial in moderate to severe COPD patients where the observed treatment difference in lung function supported the hypothesis. Pulmagen and Skyepharma believe that the use of ultra-low dose inhaled theophylline to increase sensitivity to ICS could have applications in a range of COPD products, including combinations involving ICS, especially for patients whose condition is inadequately controlled by available therapies. The approach may also have potential for certain patients with bronchial asthma.

Skyepharma will begin development of SKP-2075 in the second half of 2014 and aims to have results of the Phase II efficacy and safety trial available in 2017. It anticipates spending approximately £14 million ($23 million) to develop SKP-2075 up to completion of the Phase II trial. Skyepharma plans to fund this development work from its own resources and cash-generation in line with the previous guidance given by its board future net expenditure on research and development.

The consideration payable to Pulmagen depends upon how Skyepharma commercializes SKP-2075 and other products developed using the therapy platform. Should Skyepharma out-license products developed using the platform, Pulmagen will be paid a proportion of Skyepharma’s licensing income which varies according to the amount of work which has been carried out by Skyepharma on the first product developed under the agreement at the time the product is out-licensed. This proportion starts at a substantial minority of licensing income and would be halved if relevant products are licensed out by Skyepharma after completion of the planned clinical study.  Alternatively, should Skyepharma market relevant products itself, Pulmagen would be entitled to a low single-digit percentage of net sales.  In both cases Pulmagen is entitled to certain launch milestones in specified countries.

Source: Skypharma

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