WOODCLIFF LAKE, N.J., Oct. 30 /PRNewswire-FirstCall/ -- Barr
Pharmaceuticals, Inc. (NYSE: BRL) today announced that its subsidiary, Barr
Laboratories, Inc., has received tentative approval from the U.S. Food and
Drug Administration (FDA) for its generic version of Boehringer Ingelheim
Pharmaceuticals, Inc.'s Mirapex(R) (Pramipexole Dihydrochloride) Tablets,
0.125mg, 0.25mg, 0.5mg, 1mg and 1.5mg. The Company believes that it is the
first to file an Abbreviated New Drug Application (ANDA) with a paragraph
IV certification for Mirapex.
Barr filed its Abbreviated New Drug Application (ANDA) for generic
Mirapex Tablets, 0.25mg containing a paragraph IV certification with the
FDA in May 2005 and in June 2005 amended its application to include the
tablet strengths 0.125mg, 0.5mg, 1mg, and 1.5mg. The Company received
notification of the application's acceptance for filing in July 2005.
Following receipt of the notice from the FDA, Barr notified Boehringer
Ingelheim, the New Drug Application (NDA) holder and patent owner. On
September 26, 2005, Boehringer Ingelheim filed suit in the U.S. District
Court in Delaware to prevent Barr from proceeding with the
commercialization of its product, formally initiating the patent challenge
process under the Hatch-Waxman Act.
Although trial of the case had been scheduled for November 5, 2007, due
to a judicial vacancy in the District Court, the trial is not expected to
commence then. A new trial date has not been set. The 30-month stay expires
on or about February 15, 2008.
Mirapex(R) (Pramipexole Dihydrochloride) tablets are indicated for the
treatment of the signs and symptoms of idiopathic Parkinson's disease. The
product had annual sales of approximately $324 million for the twelve
months ended August 2007, based on IMS sales data.
A tentative approval reflects FDA's preliminary determination that a
generic product satisfies the substantive requirements for approval,
subject to the expiration of all statutorily imposed non-approval periods.
A tentative approval does not allow the applicant to market the generic
drug product.
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.
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.
 back to top
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
|
