First Generic OC in Canada to be Marketed Under Agreement with Apotex, Inc.
WOODCLIFF LAKE, N.J., Aug. 28 /PRNewswire-FirstCall/ -- Barr
Pharmaceuticals, Inc. (NYSE: BRL) today announced that its subsidiary, Barr
Laboratories, Inc., has received approval from the Therapeutic Products
Directorate (TPD) of Health Canada for its Abbreviated New Drug Submission
(ANDS) for its Portia(R) generic oral contraceptive as a generic equivalent
of Wyeth Laboratories' Min-Ovral(R) Tablets. This represents the first
approval of a generic oral contraceptive for Canadian consumers.
Under the terms of an agreement with Apotex, Inc., Barr will
manufacture the product and Apotex will market it in Canada. Apotex will
record the Canadian sales of Portia and will pay Barr a royalty from those
sales.
"This approval represents an historic first for Canadian consumers,"
said Bruce L. Downey, Barr's Chairman and CEO. "In partnership with Apotex,
Canada's largest pharmaceutical company, we are pleased to bring the first
generic oral contraceptive to this important, untapped North American
marketplace. This approval and marketing agreement will enable our two
companies to provide Canadian women with an additional, more affordable
option in oral contraception."
"Canadian Provincial Drug Programs have been under a great deal of
pressure due to increasing costs; this provides them with an alternative
where none existed," stated Jack Kay, President and Chief Operating
Officer.
Barr has marketed its Portia product in the United States since 2002,
when it was approved as the generic equivalent of Nordette(R) oral
contraceptive tablets. Nordette is currently marketed in the United States
by Duramed Pharmaceuticals, Inc.
Portia, Nordette and Min-Ovral are regimens of oral contraceptives that
contain 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol and is
indicated for the prevention of pregnancy in women who elect to use this
product as a method of contraception. Min-Ovral is supplied in 21-day and
28-day regimens in Canada and had annual sales of approximately $6 million
for the twelve months ended June 2007, based on IMS sales data.
About Barr Pharmaceuticals, Inc.
Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company
that operates in more than 30 countries worldwide and is engaged in the
development, manufacture and marketing of generic and proprietary
pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients.
A holding company, Barr operates through its principal subsidiaries: Barr
Laboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and its
subsidiaries. The Barr Group of companies markets more than 115 generic and
25 proprietary products in the U.S. and more than 1,200 products globally
outside of the U.S.
About Apotex
Apotex is this country's largest Canadian-owned pharmaceutical company,
headquartered in Ontario with 5,500 employees and 21 facilities. They
export medicines to 115 countries with an R&D budget expenditure planned of
$2 billion over the next 10 years. They research, develop and manufacture
over 300 medicines and fill over 72 million prescriptions in Canada.
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 in the markets where we operate;
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 (such as PLIVA d.d.) and
products we acquire and implementing our new SAP 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; our expansion into
international markets through our PLIVA acquisition, and the resulting
currency, governmental, regulatory and other risks involved with
international operations; our ability to service our significantly
increased debt obligations as a result of the PLIVA acquisition; changes in
generally accepted accounting principles; and other risks detailed in our
SEC filings, including in our Transition Report on Form 10-K/T for the six
months ended December 31, 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.prnewswire.com/comp/089750.html/
CONTACT:
Carol A. Cox of Barr Pharmaceuticals, Inc.,
+1-201-930-3720, ccox@barrlabs.com; or Mr. Elie Betito of Apotex,
Inc., +1-416-749-9300, ebetito@apotex.com
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