-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, EVG0sGP/l6xAVq9cfAMhO6qBi1jaCElmqInQeRK1T09HzgeRoIiW01L7md2HGrUw Xnn1wngkMVH5Z2B90Q8Vng== 0000950123-03-010436.txt : 20030916 0000950123-03-010436.hdr.sgml : 20030916 20030916093909 ACCESSION NUMBER: 0000950123-03-010436 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20030915 ITEM INFORMATION: Other events FILED AS OF DATE: 20030916 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BARR LABORATORIES INC CENTRAL INDEX KEY: 0000010081 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 221927534 STATE OF INCORPORATION: NY FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-09860 FILM NUMBER: 03896763 BUSINESS ADDRESS: STREET 1: 2 QUAKER RD BOX 2900 CITY: POMONA STATE: NY ZIP: 10970-0519 BUSINESS PHONE: 8453621100 MAIL ADDRESS: STREET 1: 2 QUAKER RD STREET 2: BOX 2900 CITY: POMONA STATE: NY ZIP: 10970-0519 8-K 1 y89955e8vk.txt FORM 8-K SECURITIES AND EXCHANGE COMMISSION Washington, D. C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported) September 15, 2003 BARR LABORATORIES, INC. (Exact name of registrant as specified in its charter) New York 1-9860 22-1927534 (State or other jurisdiction (Commission (IRS Employer of incorporation) File Number) Identification No.) Two Quaker Road, P.O. Box 2900, Pomona, New York 10970-0519 (Address of principal executive offices) (Zip code) (845) 362-1100 (Registrant's telephone number, including area code) Item 5. Other Events and Regulation FD Disclosure. On September 15, 2003, Barr Laboratories, Inc. issued a press release acknowledging the decision by the U.S. District Court for the District of Minnesota in the suit between Natural Biologics, LLC and Wyeth. The decision permanently enjoins Natural Biologics from selling equine-based conjugated estrogens raw material and orders Natural Biologics to withdraw its Drug Master File (DMF) for equine-based conjugated estrogens raw material from the U.S. Food & Drug Administration (FDA). The Company said that it would review its options regarding the application and is assessing the potential financial impact of the decision. The Company is informed that Natural Biologics will either seek a re-hearing or appeal the District Court ruling. The ultimate resolution will depend on the outcome of these further proceedings. A copy of the release is attached hereto as Exhibit 99.0 and is incorporated herein by reference.
Exhibit Number Exhibit - -------------- ------- 99.0 Barr Laboratories, Inc. September 15, 2003 press release
SIGNATURES Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. BARR LABORATORIES, INC. Date: September 15, 2003 /s/ William T. McKee ------------------------------------------ William T. McKee Senior Vice President, Chief Financial Officer, and Treasurer
EX-99.0 3 y89955exv99w0.txt PRESS RELEASE Exhibit 99.0 [BARR LABORATORIES, INC. GRAPHIC] 400 Chestnut Ridge Road NEWS RELEASE Woodcliff Lake, NJ 07677 201-930-3300 CONTACT: Carol A. Cox, 201-930-3720 EMAIL: ccox@barrlabs.com Barr To Review Options Following District Court Ruling on Natural Biologics' Generic Premarin(R) Raw Material WOODCLIFF LAKE, NJ - SEPTEMBER 15, 2003...Barr Laboratories, Inc. (NYSE-BRL) today acknowledged that the decision by the U.S. District Court for the District of Minnesota in the suit between Natural Biologics, LLC and Wyeth instructs Natural Biologics to withdraw its Drug Master File (DMF) for equine-based conjugated estrogens raw material from the U.S. Food & Drug Administration (FDA) and consequently, if the ruling stands, Barr will not be allowed to use the raw material in its pending application for an AB-rated conjugated estrogens product. The Company said that it would review its options regarding the application and is informed that Natural Biologics will either seek a re-hearing or appeal the District Court ruling. The ultimate resolution will depend on the outcome of these further proceedings. "The decision by Minnesota District Court Judge Joan N. Ericksen is a set-back in our continuing efforts to develop a product that is AB-rated to Wyeth's Premarin, but we will continue our efforts to bring a generic version of Premarin to market," said Bruce L. Downey, Barr's Chairman and Chief Executive Officer. In March 2002, Barr announced that it had signed a series of agreements with Natural Biologics to develop an "AB" rated conjugated estrogens product based on Natural Biologics' equine-based raw material and on June 30, 2003 Barr filed its application with the FDA. Barr is currently owed approximately $16 million in principal and interest by Natural Biologics under these agreements and the Company is currently evaluating the potential impact of these legal proceedings on the collectibility of these amounts. Barr Laboratories, Inc. is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals. Safe Harbor Statement: To the extent that any statements made in this report contain information that is not historical, these statements are essentially forward-looking. Forward-looking statements can be identified by the use of words such as "expects," "plans," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning. These statements are subject to risks and uncertainties that cannot be predicted or quantified and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include: the difficulty in predicting the timing and outcome of legal proceedings, including those relating to patent challenge settlements and patent infringement cases; the difficulty of predicting the timing of U.S. Food and Drug Administration, or FDA, approvals; court and FDA decisions on exclusivity [BARR LABORATORIES, INC. GRAPHIC] periods; the ability of competitors to extend exclusivity periods for their products; market and customer acceptance and demand for our pharmaceutical products; reimbursement policies of third party payors; our ability to market our proprietary products; the successful integration of acquired businesses and products into our operations; the use of estimates in the preparation of our financial statements; the impact of competitive products and pricing; the ability to develop and launch new products on a timely basis; the availability of raw materials; availability of any product we purchase and sell as a distributor; the regulatory environment; fluctuations in operating results, including spending for research and development, sales and marketing and patent challenge activities; and, other risks detailed from time-to-time in our filings with the Securities and Exchange Commission. The Company undertakes no obligation to publicly update any forward-looking statements. [EDITOR'S ADVISORY: Barr Laboratories, Inc. news releases are available free of charge through PR Newswire's News On-Call site at http://www.prnewswire.com/corp /089750.html. Barr news releases and corporate information are also available on Barr's website (www.barrlabs.com). Premarin(R) is a registered trademark of Wyeth.] # # #
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