Company Confirms That Watson's Generic SEASONALE Application Approved by
FDA
WOODCLIFF LAKE, N.J., Sept. 7 /PRNewswire-FirstCall/ -- Barr
Pharmaceuticals, Inc. (NYSE: BRL) today announced that its subsidiary Barr
Laboratories, Inc. is launching a generic version of the Company's
proprietary SEASONALE(R) extended-cycle oral contraceptive under the
tradename Jolessa(TM). The Company launched its generic version of
SEASONALE following the final U.S. Food and Drug Administration (FDA)
approval of Watson Laboratories, Inc.'s Abbreviated New Drug Application
(ANDA) for SEASONALE. Watson received approval following the expiration of
the Company's 3-year New Product Exclusivity on September 5, 2006.
"While issues related to our application with the Patent and Trademark
Office to reissue the patent covering SEASONALE are being resolved, we will
take those steps appropriate to defend our interests in this proprietary
product," said Bruce L. Downey, Barr's Chairman and CEO. "It is our
obligation to preserve our rightful interests in this product, as well as
continue the promotion of our SEASONIQUE(TM) extended-cycle oral
contraceptive, which represents the next generation in a category we
created with the approval and launch of SEASONALE."
In May 2006, Barr received approval for its SEASONIQUE
(levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl
estradiol tablets 0.01 mg) extended-cycle oral contraceptive for the
prevention of pregnancy. SEASONIQUE represents the next generation of
extended-cycle oral contraceptives in a category the Company created with
the launch of the SEASONALE extended-cycle oral contraceptive in 2003.
SEASONIQUE was shipped to trade customers and was available by prescription
to women in July 2006. The Company initiated full scale detailing for
SEASONIQUE to healthcare providers in August using its Duramed Sales
Forces. The Company immediately initiated multiple marketing programs aimed
at healthcare providers and patients. Information about SEASONIQUE is
available at http://www.SEASONIQUE.com.
In June 2004 the Company announced that it received notification that
Watson Laboratories, Inc. had filed an ANDA containing a paragraph IV
certification asserting that the patent covering SEASONALE is invalid,
unenforceable or would not be infringed by Watson's generic product. Barr
did not initiate patent infringement litigation with respect to Watson's
ANDA. In July 2004, Barr filed an application seeking reissue of the '032
patent with the Patent and Trademark Office (PTO) in July 2004. In May
2006, the Company received a Non-Final Rejection notice from the PTO and in
July 2006 responded to the issues raised by the PTO in its Non-Final
Rejection. The PTO continues to evaluate the Company's application for
reissuance and in the meanwhile the '032 patent remains in effect and
continues to be listed in the FDA's Orange Book.
About Barr Pharmaceuticals, Inc.
Barr Pharmaceuticals, Inc. is a holding company whose principal
subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc.,
develop, manufacture and market generic and proprietary pharmaceuticals.
The Company is the leading marketer and manufacturer of oral contraceptive
products in the United States, based on industry data. The Company
currently markets 22 generic oral contraceptive products under its Barr
Laboratories, Inc. label and five proprietary (branded) oral contraceptive
products under the Duramed Pharmaceuticals, Inc. label.
Forward-Looking Statements
Except for the historical information contained herein, the statements
made in this press release 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. Forward-looking statements can be
identified by their use of words such as "expects," "plans," "projects,"
"will," "may," "anticipates," "believes," "should," "intends," "estimates"
and other words of similar meaning. Because such statements inherently
involve risks and uncertainties that cannot be predicted or quantified,
actual results may differ materially from those expressed or implied by
such forward-looking statements depending upon a number of factors
affecting the Company's business. These factors include, among others: the
difficulty in predicting the timing and outcome of legal proceedings,
including patent-related matters such as patent challenge settlements and
patent infringement cases; the outcome of litigation arising from
challenging the validity or non- infringement of patents covering our
products; the difficulty of predicting the timing of FDA approvals; court
and FDA decisions on exclusivity periods; the ability of competitors to
extend exclusivity periods for their products; our ability to complete
product development activities in the timeframes and for the costs we
expect; market and customer acceptance and demand for our pharmaceutical
products; our dependence on revenues from significant customers;
reimbursement policies of third party payors; our dependence on revenues
from significant products; the use of estimates in the preparation of our
financial statements; the impact of competitive products and pricing on
products, including the launch of authorized generics; the ability to
launch new products in the timeframes we expect; the availability of raw
materials; the availability of any product we purchase and sell as a
distributor; the regulatory environment; our exposure to product liability
and other lawsuits and contingencies; the increasing cost of insurance and
the availability of product liability insurance coverage; our timely and
successful completion of strategic initiatives, including integrating
companies and products we acquire and implementing our new enterprise
resource planning system; fluctuations in operating results, including the
effects on such results from spending for research and development, sales
and marketing activities and patent challenge activities; the inherent
uncertainty associated with financial projections; changes in generally
accepted accounting principles; and other risks detailed from time-to-time
in our filings with the Securities and Exchange Commission, including in
our Annual Report on Form 10-K for the fiscal year ended June 30, 2006.
The forward-looking statements contained in this press release speak
only as of the date the statement was made. The Company undertakes no
obligation (nor does it intend) to publicly update or revise any
forward-looking statements, whether as a result of new information, future
events or otherwise, except to the extent required under applicable law.
SOURCE Barr Pharmaceuticals, Inc.
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Related links:
http://www.barrlabs.com
http://www.SEASONIQUE.com
http://www.prnewswire.com/comp/089750.html/
CONTACT:
Carol A. Cox, +1-201-930-3720,
ccox@barrlabs.com, for Barr Pharmaceuticals, Inc.
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