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news.Schering AG has terminated its license, supply and distribution agreement for Alprox-TD, NexMed's topical treatment for erectile dysfunction currently in clinical development.
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The agreement, signed in July 2004, provided Schering AG with exclusive commercialization rights to Alprox-TD in Europe, Russia, the Middle East, South Africa, Australia and New Zealand. NexMed has not received any milestone payments under the agreement. However, pursuant to the terms of the agreement, Schering is now obligated to pay NexMed a termination fee of E500,000.
NexMed said it believes Schering made the decision to terminate the agreement as Alprox-TD is no longer a strategic fit for the German company.
Commenting on the news, Richard Berman, NexMed’s CEO, said, “While we regret losing Schering as an overseas marketing partner for Alprox-TD, we are pleased to have back in our possession these valuable licensing and marketing rights. We will use this opportunity to redouble our efforts to license Alprox-TD to a co-development partner who will commit financial resources to the completion of the clinical development program required for approval in Europe and the US.”
To date, NexMed has completed two US phase III pivotal clinical studies for Alprox-TD, involving over 1,700 patients, which showed statistically significant efficacy across all degrees of erectile dysfunction (ED) and co-morbidities. Moreover, Alprox-TD has shown an excellent safety profile in clinical studies conducted to-date, with no serious side effects reported.