Novartis is conducting Phase II trials the long-acting beta-2 agonist, QAB149, in patients with asthma. The drug is claimed to be the first drug in its class that combines a quick onset of action with a full, 24-hour bronchodilating effect from a single dose.
SkyePharma is contributing its SkyeHaler device, a breath-activated multi-dose dry powder inhaler (MDDPI) device which has already been adopted by Novartis to deliver its Foradil (formoterol fumarate) long-acting beta agonist, and SkyeProtect, a powder formulation that protects the drug from atmospheric moisture.
The latter formulation also improves product stability and dose-to-dose reproducibility, according to the UK firm. SkyeProtect reduces moisture-sensitivity of powdered lactose/drug blends, which are notoriously sensitive to water ingress and usually rely on external barriers - such as blisters or a watertight device - to protect them.
The Foradil Certihaler product was co-developed by SkyePharma and Novartis and was submitted for regulatory review in the US and Europe in December 2002. In October the US Food and Drug Administration (FDA) issued an 'approvable' letter for the product, which means the product can be cleared by the agency subject to resolution of certain outstanding issues.
The terms of the new agreement have not been disclosed, but SkyePharma stands to receive an upfront licensing fee, payments on the achievement of development milestones and a royalty on any eventual sales of QAB149.