Warner Chilcott and NexMed Sign U.S. Collaboration for Topical Alprostadil Treatment for Erectile Dysfunction
02 November 2007 - 8:00AM
PR Newswire (US)
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/. About NexMed 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. DATASOURCE: Warner Chilcott Company, Inc. CONTACT:
Rochelle Fuhrmann, Director, Investor Relations of Warner Chilcott
Limited, +1-973-442-3200, ; or Mark Westgate, Chief Financial
Officer of NexMed, Inc., +1-609-371-8123 ext 159, Web site:
http://www.warnerchilcott.com/ http://www.nexmed.com/
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