Schering-Plough and ViroPharma in licence agreement for intranasal formulation of pleconaril
US companies Schering-Plough Corporation and ViroPharma have entered into an option agreement to license ViroPharma's intranasal formulation of the antiviral compound pleconaril to Schering-Plough for the treatment of the common cold in the US and Canada.
US companies Schering-Plough Corporation and ViroPharma have entered into an option agreement to license ViroPharma's intranasal formulation of the antiviral compound pleconaril to Schering-Plough for the treatment of the common cold in the US and Canada.
In 1995, ViroPharma licensed rights to develop and commercialise intranasal pleconaril in the US and Canada from Sanofi-Synthelabo.
Under terms of the agreement, Schering-Plough will pay ViroPharma an upfront option fee of US$3m. ViroPharma will then conduct a series of clinical studies designed to evaluate the antiviral activity, safety and other performance characteristics of the new intranasal pleconaril formulation.
Results from these studies are scheduled to be available in mid-2004 and based on these Schering-Plough has the option to trigger a full license agreement with ViroPharma, under which it would assume responsibility for all future development and commercialisation of intranasal pleconaril in the US and Canada.
To date, oral pleconaril has been studied in more than 5,000 patients in clinical trials for the treatment of the common cold. In 2002, the FDA issued a 'not approvable' letter for an oral tablet formulation. The new intranasal formulation of pleconaril is said to represent an optimised delivery approach for this compound.
'We hope to demonstrate that this formulation can deliver significantly more drug to the site of active common cold infection than the oral formulation, while limiting its systemic exposure and thereby minimising the risk of drug interactions,' said Mark McKinlay, ViroPharma's vice president of research and development.