Schering-Plough Corporation and ViroPharma Incorporated announced that Schering-Plough has exercised its option to license ViroPharma's pleconaril for the treatment of the common cold in the United States and Canada.
Schering-Plough and ViroPharma expect to finalize the license agreement within the next 45 days. Under the agreement, Schering-Plough would assume responsibility for all future development and commercialization of the antiviral compound pleconaril. As previously disclosed, upon execution of the license agreement, Schering-Plough will pay ViroPharma an initial license fee of $10 million and will expense this payment to R&D in the quarter in which the transaction is finalized. Schering-Plough will purchase ViroPharma's existing inventory of bulk drug substance for an additional pre-determined fee. ViroPharma would be eligible to receive an additional $65 million in milestone payments upon achievement of certain targeted regulatory and commercial events, as well as royalties on Schering-Plough's sales of intranasal pleconaril in the licensed territories.
In November 2003, the two companies entered into an option agreement for intranasal pleconaril. Since then, ViroPharma conducted a series of clinical studies designed to evaluate the antiviral activity, safety and performance characteristics of the intranasal pleconaril formulation. Based on the assessment of these studies, Schering-Plough has decided to move forward and enter into a license agreement for the product. The new intranasal formulation of pleconaril represents an optimized delivery approach for this compound, as compared to the earlier oral formulation for which ViroPharma filed an NDA in 2001.
Michel de Rosen, ViroPharma's chief executive officer said, "Since the time we licensed the rights to pleconaril, we have believed that pleconaril was an exceptional antiviral product candidate with demonstrated activity against rhinovirus, the predominant virus that causes the common cold. We believe that an intranasal formulation is optimal for this type of product, enabling an efficient delivery of more drug to the site of infection than the oral formulation, while limiting its systemic exposure and minimizing the risk of drug interactions."
To date, pleconaril has been studied in more than 5,000 patients in clinical trials for the treatment of the common cold and in more than 700 patients as part of a compassionate use program in patients who have serious or life-threatening picornavirus infections.
In 1995, ViroPharma licensed rights to develop and commercialize pleconaril in the United States and Canada from Sanofi-Synthelabo who retains rights in all other territories.