FAJARDO, Puerto Rico and EAST WINDSOR, N.J., Nov. 1 /PRNewswire-FirstCall/ -- Warner Chilcott Company, Inc. (a subsidiary of Warner Chilcott, Ltd., [Nasdaq: WCRX]) and NexMed, Inc. (Nasdaq: NEXM), announced today that the two companies have entered into a licensing agreement granting Warner Chilcott the exclusive U.S. rights to NexMed's topically applied alprostadil cream for the treatment of erectile dysfunction (ED). NexMed submitted a New Drug Application with the Food and Drug Administration on September 21, 2007 and is awaiting confirmation of acceptance of its filing.
Under the terms of the agreement, Warner Chilcott has exclusive U.S. rights to develop and market NexMed's product. NexMed received an initial, up- front payment and is eligible to receive additional payments upon achievement of certain development and regulatory approval milestones. Further, Warner Chilcott will pay a royalty to NexMed on sales of the product. Specific financial details of the agreement were not disclosed.
"This exciting collaboration allows Warner Chilcott to expand into a complementary therapeutic area utilizing its proven sales and marketing expertise," said Roger Boissonneault, Chief Executive Officer of Warner Chilcott. "We believe that the NexMed product has the potential to be an important new therapy."
Commenting on today's news, Vivian Liu, President and Chief Executive Officer of NexMed, stated, "We are delighted to reach another major milestone in the history of this product. We look forward to working with Warner Chilcott in completing the remaining development including manufacturing." Ms. Liu further added, "I am confident in Roger and his team's ability to establish a major presence in urology. With their proven success in building new markets, Warner Chilcott is a great partner for launching this product."
About the ED Market
According to IMS data, the U.S. ED market in 2006 was about $1.5 billion - - dominated by oral PDE5 treatments. Despite the availability of today's oral and other therapies, there is still a need for new, safe and effective treatments, especially for those patients who cannot or do not respond well to oral medication. Alprostadil, well-recognized as a safe and effective drug for the treatment of ED, is currently marketed as both an injectable and intra- urethral pellet. NexMed's topical product provides a more patient-friendly alternative due to its non-invasive ease of administration.
About Warner Chilcott
Warner Chilcott is a specialty pharmaceutical company focused on developing, manufacturing, marketing and selling branded prescription pharmaceutical products in women's healthcare and dermatology in the United States. (WCRX-G) Read more on http://www.warnerchilcott.com.
NexMed, Inc. is leveraging its proprietary NexACT(R) drug delivery technology to develop innovative topical pharmaceutical products that address unmet medical needs. NexMed's novel, onychomycosis treatment, licensed to Novartis, is currently in pivotal Phase 3 trials in the U.S. and Europe. NexMed's pipeline also includes a Phase 2 treatment for female sexual arousal disorder and an early stage treatment for psoriasis.
Read more on http://www.nexmed.com
Warner Chilcott's Forward-Looking Statements
This press release contains forward-looking statements, including statements concerning our product development efforts. These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words "may," "might," "will," "should," "estimate," "project," "plan," "anticipate," "expect," "intend," "outlook," "believe" and other similar expressions are intended to identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of their dates. These forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties.
The following represent some, but not necessarily all, of the factors that could cause actual results to differ from historical results or those anticipated or predicted by our forward-looking statements: our substantial, indebtedness; competitive factors in the industry in which we operate; our ability to protect our intellectual property; a delay in qualifying our manufacturing facility to produce our products or production or regulatory problems with either third party manufacturers upon whom we rely for some of our products or our own manufacturing facility; pricing pressures from reimbursement policies of private managed care organizations and other third party payors, government sponsored health systems, the continued consolidation of the distribution network through which we sell our products, including wholesale drug distributors and the growth of large retail drug store chains; the loss of key senior management or scientific staff; an increase in litigation, including product liability claims and patent litigation; government regulation affecting the development, manufacture, marketing and sale of pharmaceutical products, including our ability and the ability of companies with whom we do business to obtain necessary regulatory approvals; our ability to successfully complete the implementation of a company-wide enterprise resource planning system without disrupting our business; our ability to manage the growth of our business by successfully identifying, developing, acquiring or licensing and marketing new products, obtain regulatory approval and customer acceptance of those products, and continued customer acceptance of our existing products; and other risks detailed in our annual report for 2006 filed with the Securities and Exchange Commission on Form 10-K and from time-to-time in our financial statements and other investor communications.
We caution you that the foregoing list of important factors is not exclusive. In addition, in light of these risks and uncertainties, the matters referred to in our forward-looking statements may not occur. We undertake no obligation to publicly update or revise any forward-looking statement as a result of new information, future events or otherwise, except as may be required by law.
NexMed's Forward-Looking Statements
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 risks and uncertainties that may individually or mutually impact the matters herein described, including, but not limited to, obtaining regulatory approval for its products under development, entering into partnering agreements, pursuing growth opportunities, and/or other factors, some of which are outside the control of the Company.
|SOURCE Warner Chilcott Company, Inc.|
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