Barr Announces Approval of Generic Aredia(R) Injection, 30mg/mL, 60mg/mL and 90mg/mL Injectable

2008-08-20 07:19:00

    MONTVALE, N.J., Aug. 20 /EMWNews/ -- Barr Pharmaceuticals,

Inc. (NYSE: BRL) today announced that its subsidiary, PLIVA - Lachema a.s.,

has received final approval from the U.S. Food and Drug Administration

(FDA) for its generic version of Pfizer Inc.'s Aredia(R) (pamindronate

disodium) Injection, 30mg/mL, 60mg/mL, and 90mg/mL. The Company plans to

launch its product in the fourth quarter of calendar 2008. With this

approval, Barr's U.S. generic injectable portfolio now totals eight


    Barr's generic Aredia (pamindronate disodium) product will compete in a

market that had total annual sales of approximately $21 million for the

twelve months ended June 2008, 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 120 generic and

27 proprietary products in the U.S. and approximately 1,025 products

globally outside of the U.S. For more information, visit

    Forward-Looking Statements

    This communication contains "forward-looking statements" which

represent the current expectations and beliefs of management of Barr

Pharmaceuticals, Inc. (the "Company") concerning the proposed merger of the

Company with Boron Acquisition Corp., a wholly-owned subsidiary of Teva

Pharmaceutical Industries Ltd. (the "merger") and other future events and

their potential effects on the Company. The statements, analyses, and other

information contained herein relating to the proposed merger, as well as

other statements including words such as "anticipate," "believe," "plan,"

"estimate," "expect," "intend," "will," "should," "may," and other similar

expressions, are "forward-looking statements" under the Private Securities

Litigation Reform Act of 1995. These forward-looking statements are not

guarantees of future results and are subject to certain risks and

uncertainties that could cause actual results to differ materially from

those anticipated. Those factors include, without limitation: 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 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; 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;

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; the

reactions of the Company's customers and suppliers to the merger; and

diversion of management time on merger-related issues. These and other

applicable risks, cautionary statements and factors that could cause actual

results to differ from the Company's forward-looking statements are

included in the Company's filings with the U.S. Securities and Exchange

Commission ("SEC"), specifically as described in the Company's annual

report on Form 10-K for the fiscal year ended December 31, 2007. The

Company undertakes no obligation to update or revise any forward-looking

statements to reflect subsequent events or circumstances.

    Important Legal Information

    In connection with the proposed merger, the Company will prepare a

proxy statement to be filed with the SEC. When completed, a definitive

proxy statement and a form of proxy will be mailed to the stockholders of

the Company. Before making any voting decision, the Company's stockholders

are urged to read the proxy statement regarding the merger carefully and in

its entirety because it will contain important information about the

proposed merger. The Company's stockholders will be able to obtain, without

charge, a copy of the proxy statement (when available) and other relevant

documents filed with the SEC from the SEC's website at

The Company's stockholders will also be able to obtain, without charge, a

copy of the proxy statement and other relevant documents (when available)

by directing a request by mail or telephone to Barr Pharmaceuticals, Inc.,

225 Summit Avenue, Montvale, NJ, 07645 - Attention: Investor Relations.

    The Company and its directors and officers may be deemed to be

participants in the solicitation of proxies from the Company's stockholders

with respect to the proposed merger. Information about the Company's

directors and executive officers and their ownership of the Company's

common stock is set forth in the Company's annual report on Form 10-K for

the fiscal year ended December 31, 2007 and the Company's proxy statement

for the Company's 2008 Annual Meeting of Stockholders. Stockholders may

obtain additional information regarding the interests of the Company and

its directors and executive officers in the merger, which may be different

than those of the Company's stockholders generally, by reading the proxy

statement and other relevant documents regarding the proposed merger, when

filed with the SEC.

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