- 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, rfuhrmann@wcrx.com or Patty
Eisenhaur, Executive Director, Investor Relations of Watson Pharmaceuticals,
Inc., 951-493-5611, patty.eisenhaur@watson.com
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.
SOURCE Watson Pharmaceuticals, Inc.; Warner Chilcott Limited
CONTACT:
Press inquiries,
Rochelle Fuhrmann,
Senior Director, Investor
Relations
of Warner Chilcott Limited,
+1-973-442-3281,
rfuhrmann@wcrx.com;
or
Patty Eisenhaur,
Executive Director,
Investor Relations
of Watson
Pharmaceuticals, Inc.,
+1-951-493-5611,
patty.eisenhaur@watson.com
Web site:
http://www.watson.com
http://www.warnerchilcott.com/