Barr's BLA for Adenovirus Type 4 and 7 Live Oral Vaccines Accepted for Filing by FDA
11 Dezember 2008 - 3:53PM
PR Newswire (US)
MONTVALE, N.J., Dec. 11 /PRNewswire-FirstCall/ -- Barr
Pharmaceuticals, Inc. (NYSE:BRL) today announced that the U.S. Food
and Drug Administration (FDA) has accepted for review Duramed
Pharmaceuticals, Inc.'s Adenovirus Types 4 and 7 Live Oral Vaccines
Biologics License Application (BLA). These oral vaccines represent
Barr's first in-house biologics development initiative and
demonstrate the Company's ability to develop, manufacture and
conduct clinical trials for biologic products. The Prescription
Drug User Fee Action (PDUFA) date for the Adenovirus BLA is July
31, 2009. "We are very pleased to have our first BLA accepted for
filing by the FDA, and believe that we have achieved a significant
step in building our biologics program," said Bruce L. Downey,
Barr's Chairman and Chief Executive Officer. "Working together with
Department of Defense (DOD) over the past six years we have made
significant progress in meeting a critical unmet medical need for
our Armed Forces. DOD's efforts to efficiently execute the clinical
trial have enabled us to achieve this clinical milestone." The
pivotal clinical data supporting the Company's BLA for the
Adenovirus (ADV) Vaccines, Types 4 and 7 resulted from a large
placebo-controlled Phase 3 designed to evaluate the safety and
efficacy of Type 4 ADV oral vaccine to prevent wild type 4
adenovirus-associated Acute Respiratory Disease (ARD) and for the
Type 7 ADV oral vaccine to induce neutralizing antibody to type 7
adenovirus. The study involved over 4,000 male and female recruits
at Naval and Army training facilities. The clinical trial results
support the safety and tolerability of the oral Type 4 and Type 7
ADV vaccines, the efficacy of the oral Type 4 ADV vaccine in
reducing the attack rate of wild type 4 adenovirus-associated
febrile ARD and the ability of Type 7 ADV vaccine to produce
neutralizing antibodies. Barr/DOD Project Summary In 2001, Barr
entered into a multi-year agreement with the U.S. Department of
Defense (DOD) for clinical development of the Adenovirus Vaccines,
Type 4 and 7. As part of the agreement, Barr constructed a
dedicated facility to support the production of supplies necessary
to complete the approval process and support projected needs of the
DOD. The Company completed the Phase I study in April 2006, and
completed the Phase III clinical program in April 2008. The
finished dosage form is an orally administered enteric-coated
tablet, with an inner tablet core containing live adenovirus --
type 4 or type 7 -- surrounded by an outer tablet coat and a final
enteric coating. The vaccines are administered as individual oral
tablets taken together. 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
http://www.barrlabs.com/. 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 (the "merger") with Boron Acquisition Corp.,
a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd.
(the "Teva") 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, Teva has
filed a registration statement on Form F-4 containing a proxy
statement/prospectus for shareholders of the Company with the SEC,
and the Company and Teva may be filing other documents regarding
the proposed transaction with the SEC as well. Before making any
voting or investment decision, investors are urged to read the
proxy statement/prospectus regarding the proposed transaction, as
well as the other documents referred to in the proxy
statement/prospectus carefully in their entirety when they become
available because they will contain important information about the
proposed transaction. The definitive proxy statement/prospectus has
been mailed to the Company's shareholders. Shareholders may obtain
a free copy of the proxy statement/prospectus, as well as other
filings containing information about Teva and the Company, without
charge, at the SEC's Internet site (http://www.sec.gov/). Copies of
the proxy statement/prospectus and the filings with the SEC that
are incorporated by reference in the proxy statement/prospectus can
also be obtained, without charge, 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 filed with the SEC. DATASOURCE: Barr Pharmaceuticals, Inc.
CONTACT: Carol A. Cox of Barr Pharmaceuticals, Inc.,
+1-201-930-3720, Web Site: http://www.barrlabs.com/
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