August 29, 2007
For Immediate Release
Barr’s Portia® Generic Oral Contraceptive
Approved and Launched in Canada
First Generic OC in Canada to be Marketed Under Agreement with
Apotex, Inc.
Woodcliff Lake, NJ (August 29, 2007) — 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® generic oral contraceptive as a
generic equivalent of Wyeth Laboratories’ Min-Ovral® 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® 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.
[EDITOR'S ADVISORY: Barr Pharmaceuticals, Inc. news releases are
available free of charge through PR Newswire’s News On-Call site at
http://www.prnewswire.com/comp/089750.html. Barr news releases and
corporate information are also available on Barr’s website (www.barrlabs.com).
For complete indications, warnings and contraindications, contact Barr
Laboratories' Product Information Department at 1-800-Barr Lab. All
trademarks referenced herein are the property of their respective
owners.]
-30-
For further information:
Mr. Elie Betito
Director Public & Government Affairs
Tel: 416-749-9300 Ext. 7366
Cell: 416-558-5491
ebetito@apotex.com
Ms. Carol A. Cox
Barr Pharmaceuticals Inc.
Tel: 201-930-3720
ccox@barrlabs.com
|
|
