Warner Chilcott and Watson Pharmaceuticals Announce Agreements on Loestrin(R) 24 and Femcon(R) Fe Patent Litigation
12 January 2009 - 11:00PM
PR Newswire (US)
- Companies Enter Into Co-Promotion Agreement for Femring(R) and
License and Supply Agreements for Development-Stage Oral
Contraceptive - HAMILTON, Bermuda and CORONA, Calif., Jan. 12
/PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE:WPI)
and Warner Chilcott Limited (NASDAQ: WCRX) announced today that
they have entered into Settlement and License Agreements to resolve
pending patent litigation related to Warner Chilcott's oral
contraceptive products, Loestrin(R) 24 and Femcon(R) Fe.
Separately, Warner Chilcott and Watson have entered into a
Co-Promotion Agreement relating to Warner Chilcott's Femring(R)
product and License and Supply Agreements relating to a Warner
Chilcott development-stage oral contraceptive product. Loestrin(R)
24 and Femcon(R) Fe Settlement and License Agreements Under the
terms of the settlement agreements, Warner Chilcott has granted
Watson a non-exclusive license to the U.S. patents covering
Loestrin(R) 24 Fe (norethindrone acetate and ethinyl estradiol
tablets, USP and ferrous fumarate tablets) and Femcon(R) Fe
(norethindrone, ethinyl estradiol tablets, chewable, ferrous
fumarate tablets). The agreement covering Loestrin(R) 24 Fe will
permit Watson to commence marketing its generic equivalent product
on the earlier of January 22, 2014 or the date on which another
generic version of Loestrin(R) 24 Fe enters the U.S. market. The
agreement covering Femcon(R) Fe will permit Watson to commence
marketing its generic equivalent product on the earlier of 180 days
after Barr Laboratories, Inc. (now Teva Pharmaceutical Industries,
Ltd.) enters the market with a generic equivalent product, or
January 1, 2013. The parties will promptly file dismissals without
prejudice that will conclude both litigations. Additional details
concerning the settlements have not been disclosed. Co-Promotion
Agreement In a separate agreement, Watson will co-promote Warner
Chilcott's hormone therapy product, Femring(R). Watson's Specialty
Products sales force will promote the product to obstetricians and
gynecologists commencing in 2009, for which it will receive
fee-based compensation. Warner Chilcott will also pay Watson a
portion of the net sales of Femring(R) above an agreed upon level
for the duration of the agreement. Warner Chilcott's net sales of
Femring(R) were approximately $15.7 million for the twelve months
ended September 30, 2008. License and Supply Agreements Under
separate license and supply agreements, Warner Chilcott has granted
Watson an exclusive license to market and sell an oral
contraceptive product (WC3026) currently in late-stage development.
Warner Chilcott is responsible for completing development and
obtaining approval of this product and expects to submit a new drug
application to the FDA in the second half of 2009. Warner Chilcott
will exclusively supply Watson with the product on a cost plus
margin basis and Watson will pay Warner Chilcott royalties based on
product net sales. 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 U.S. WCRX-G Read more on http://www.warnerchilcott.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 (including the approval and introduction of
generic or branded products that compete with our products); 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 may 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; adverse outcomes in our outstanding litigation or an
increase in the number of litigation matters to which we are
subject; 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
manage the growth of our business by successfully identifying,
developing, acquiring or licensing new products at favorable prices
and marketing such new products; our ability to obtain regulatory
approval and customer acceptance of new products, and continued
customer acceptance of our existing products; changes in tax laws
or interpretations that could increase our consolidated tax
liabilities; the other risks identified in our Annual Report on
Form 10-K for the year ended December 31, 2007; and other risks
detailed from time-to-time in our public filings, 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. Press
inquiries: Rochelle Fuhrmann, Senior Director, Investor Relations
of Warner Chilcott Limited, +1-973-442-3281, or Patty Eisenhaur,
Executive Director, Investor Relations of Watson Pharmaceuticals,
Inc., 951-493-5611, About Watson Pharmaceuticals, Inc. Watson
Pharmaceuticals, Inc. is a leading specialty pharmaceutical company
that develops, manufactures, markets, sells and distributes generic
and specialty brand pharmaceutical products. Watson pursues a
growth strategy combining internal product development, strategic
alliances and collaborations and synergistic acquisitions of
products and businesses. For press releases and other company
information, visit Watson Pharmaceutical's Web site at
http://www.watson.com. Watson's Forward-Looking Statement Any
statements contained in this press release that refer to future
events or other non-historical facts are forward-looking statements
that reflect Watson's current perspective of existing trends and
information as of the date of this release. Except as expressly
required by law, Watson disclaims any intent or obligation to
update these forward-looking statements. Actual results may differ
materially from Watson's current expectations depending upon a
number of factors affecting Watson's business. These factors
include, among others, risks that resolution of patent infringement
litigation through settlement could result in investigations or
actions by private parties or government authorities, including the
U.S. Department of Justice and /or the Federal Trade Commission;
the difficulty of predicting the timing or outcome of product
development efforts and FDA or other regulatory agency approvals or
actions, if any; risks that development efforts, including clinical
studies and other information, will not be sufficient to support
FDA approval of development stage products; delays regarding the
regulatory approval process, including the timing and scope of
approval received, if any; the impact of competitive products and
pricing, market acceptance of and continued demand for Watson's
products; difficulties or delays in manufacturing; and other risks
and uncertainties detailed in Watson's periodic public filings with
the Securities and Exchange Commission, including but not limited
to Watson's Annual Report on Form 10-K for the year ended December
31, 2007. (Logo:
http://www.newscom.com/cgi-bin/prnh/20020214/WATSONLOGO)
http://www.newscom.com/cgi-bin/prnh/20020214/WATSONLOGO
http://photoarchive.ap.org/ DATASOURCE: Watson Pharmaceuticals,
Inc.; Warner Chilcott Limited CONTACT: Press inquiries, Rochelle
Fuhrmann, Senior Director, Investor Relations of Warner Chilcott
Limited, +1-973-442-3281, ; or Patty Eisenhaur, Executive Director,
Investor Relations of Watson Pharmaceuticals, Inc.,
+1-951-493-5611, Web site: http://www.watson.com/
http://www.warnerchilcott.com/
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