UK drugmaker SkyePharma and Abbott Laboratories have amended their US development and commercialisation deal for the former’s asthma drug Flutiform, after the US group agreed to turn its involvement up a notch.

Under the terms of the adjusted deal, Abbott will assume responsibility and pay for the additional clinical work required by US regulators to advance the product’s filing, as well as handle the submission of its New Drug Application.

As a result, SkyePharma will no longer incur the planned research and development expenses of around $20 million on the additional Phase III FDA-required studies, but is now eligible for reduced milestone payments instead. Consequently, the company says it may now receive up to $124.5 million in total milestones instead of $165 million, and sales-related milestones and royalty rates remain unchanged.

Patient enrolment complete
The news comes hot on the heels of SkyePharma’s announcement that patient enrolment in three extra clinical trials with Flutiform, being conducted to satisfy a request by the US Food and Drug Administration for additional information, is now complete.

The trials are designed to show that Flutiform - a unique combination of the fast onset long-acting beta-agonist (formoterol) and the most commonly prescribed steroid (fluticasone) - is superior to the individual components and placebo in treating asthma.

Following their completion in April next year, the studies, involving nearly 1,400 patients, will form the basis of the drug’s US NDA, which is now scheduled to be filed in the second half of 2008 as opposed to the first quarter, as well as support registration in Europe, the group said.