NexMed, Inc, a developer of innovative pharmaceutical products based on its proprietary, NexACT transdermal drug delivery technology, announced that Schering AG has terminated its license, supply and distribution agreement for Alprox-TD, NexMed's topical treatment for erectile dysfunction (ED), currently in clinical development. It is NexMed's belief that Alprox-TD is no longer a strategic fit for Schering.
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 in the amount of €500,000.
Commenting on the news, Richard J. Berman, NexMed's chief executive officer 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. We have already commenced discussions with a number of potential partners."
Berman noted that, to date, NexMed has completed two US phase 3 pivotal clinical studies for Alprox-TD, involving over 1,700 patients, which showed statistically significant efficacy (p<0.001) across all degrees of ED and co-morbidities. Moreover, Alprox-TD, which incorporates the active ingredient, alprostadil, has shown an excellent safety profile in clinical studies conducted to-date, with no serious side effects reported.
It is estimated that between 15 and 30 million US men suffer from ED, with only a small percentage of men seeking treatment. The worldwide market for ED is projected to reach $4.3 billion by 2010. NexMed's Alprox-TD is suited for patients who are unresponsive to currently available PDE-5 inhibitors or are on medications that are contraindicated for PDE-5 inhibitors, as well as men with diabetes or those who have undergone prostatectomies.
Berman continued, "We remain enthusiastic about the future prospects for NexMed. Our current cash position should give us a solid financial cushion for the next 15 months. Our exclusive global licensing agreement for our proprietary NM100060 nail lacquer treatment for onychomycosis (nail fungus), could also provide NexMed with up to $47 million in milestone payments over the next two years in addition to the upfront payment of $4 million which we received upon signing the deal. Beyond that, we will also receive royalties based on sales."
NexMed's is also developing Femprox, a topical treatment for female sexual arousal disorder which is currently in phase 2 in the US and NM100061 a proprietary early ejaculation ("EE") treatment under development. EE, commonly known as premature ejaculation, is the most prevalent male sexual dysfunction, affecting as many as one-third of men worldwide at some time in their lives. NexMed is pursuing co-development partners for all of its products under development.