Healthcare Industry News: Transdermal
News Release - June 26, 2006
NexMed Announces Termination of Alprox-TD Agreement With Schering AG and Provides Operational UpdateConference Call Scheduled for 10:00 AM Today
EAST WINDSOR, NJ--(Healthcare Sales & Marketing Network)--Jun 26, 2006 -- NexMed, Inc. (NasdaqNM:NEXM ), a developer of innovative pharmaceutical products based on its proprietary, NexACT® Transdermal drug delivery technology, announced today 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 EUR 500,000.
Commenting on today's 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 U.S. We have already commenced discussions with a number of potential partners."
Mr. Berman noted that, to date, NexMed has completed two U.S. 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 U.S. 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.
Mr. 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 is also developing Femprox, a topical treatment for female sexual arousal disorder which is currently in Phase 2 in the U.S., 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.
NexMed management will host a conference call today, June 26, 2006 at 10:00 a.m. EST. The call can be accessed in the U.S. by dialing 877-407-9205 and outside of the U.S. by dialing 201-689-8055, and asking the conference operator for the NexMed Conference Call. The teleconference replay is available for one week by dialing in the U.S. 877-660-6853 and outside of the U.S. by dialing 201-612-7415. Replay pass codes 286 and 206862 are both required for playback. The conference call will also be Webcast live at URL http://www.vcall.com/IC/CEPage.asp?ID=106340.
About NexMed, Inc.
NexMed, an innovative drug developer, offers large pharmaceutical companies the opportunity to develop new patient-friendly Transdermal products, and extend patent lifespans and brand equity, through participation in early stage licensing and development partnerships. NexMed currently has a host of medicines in development, such as treatments for nail fungus, sexual disorders and more, all based on its proprietary NexACT drug delivery technology.
Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risk and uncertainties that may individually or mutually impact the matters herein described, including but not limited to the extent and timing of anticipated milestone payments, the initiation and completion of clinical trials, the dependence on compliance with FDA and other government regulations, the ability to enter into partnering agreements, raise financing on acceptable terms, pursue growth opportunities, effectively reduce expenses and/or other factors, some of which are outside the control of the Company.
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