close

Mergers and Acquisitions

Date: 2014-08-13

Type of information: Product acquisition

Acquired company: inhaled therapy platform from Pulmagen Therapeutics (UK)

Acquiring company: Skyepharma (UK)

Amount:

Terms:

* On August 13, 2014, Skyepharma, the expert oral and inhalation drug delivery company, announced that it has acquired the global rights and related intellectual property (including granted patents and patent applications) to a novel inhaled therapy platform from Pulmagen Therapeutics. Pulmagen will receive a share of Skyepharma’s potential future revenues and launch milestones from the successful exploitation of the acquired platform as described in more detail below. The consideration payable to Pulmagen depends upon how Skyepharma commercialises SKP-2075 and other products developed using the therapy platform. Should Skyepharma out-licence 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.

Details:

Skyepharma will apply its proven expertise in inhaled drug development to develop a first product (SKP-2075) for chronic obstructive pulmonary disease (COPD) through to the completion of a phase II efficacy and safety trial sized to produce clinically significant data. It will then seek to out-licence SKP-2075 to a pharmaceutical partner for late-stage development and commercialisation.

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. 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. Peter Grant, CEO of Skyepharma, commented, “Pulmagen has already demonstrated better lung function with a nebulised form of SKP-2075 compared with ICS alone and this supports the concept that an ultra-low dose of inhaled theophylline could potentiate the effectiveness of inhaled corticosteroids in patients with COPD. If successful, SKP-2075 could offer COPD patients an important new treatment option and Skyepharma with a patented therapy platform from which to develop further products.”

Skyepharma will commence 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. The Group anticipates spending approximately £14 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 the Board for the Group’s future net expenditure on research and development.

Related:

Respiratory diseases

Is general: Yes