Barr Pharmaceuticals, Inc.'s BLA for Adenovirus Type 4 and 7 Live Oral Vaccines Accepted for Filing by FDA
Published: Dec 11, 2008
MONTVALE, N.J., Dec. 11 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. 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 www.barrlabs.com.
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.
CONTACT: Carol A. Cox of Barr Pharmaceuticals, Inc., +1-201-930-3720,
Web site: http://www.barrlabs.com/