-----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, QGgT+8yZNW3mICQ5QCq+BB38kIdQPHCHIpqOqPhy5N3N9vJizNeW60Ccr77mARhb nKpMrNa9dmeI8pKwIODbPQ== 0000950123-05-012247.txt : 20051018 0000950123-05-012247.hdr.sgml : 20051018 20051018123200 ACCESSION NUMBER: 0000950123-05-012247 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20051018 ITEM INFORMATION: Entry into a Material Definitive Agreement FILED AS OF DATE: 20051018 DATE AS OF CHANGE: 20051018 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BARR PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000010081 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 221927534 STATE OF INCORPORATION: DE FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-09860 FILM NUMBER: 051142462 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 FORMER COMPANY: FORMER CONFORMED NAME: BARR LABORATORIES INC DATE OF NAME CHANGE: 19920703 8-K 1 y13683e8vk.htm BARR PHARMACEUTICALS, INC. FORM 8-K
Table of Contents

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):   October 18, 2005
 

BARR PHARMACEUTICALS, INC.
 
(Exact Name of Registrant as Specified in its Charter)

         
Delaware   1-9860   42-1612474
 
(State or Other
Jurisdiction of
Incorporation)
  (Commission
File Number)
  (I.R.S. Employer
Identification No.)
     
400 Chestnut Ridge Road, Woodcliff, NJ   07677
 
(Address of Principal Executive Offices)   (Zip Code)
     
Registrant’s telephone number, including area code:   (201) 930-3300
 

 

(Former Name or Former Address, if Changed Since Last Report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

     
o
  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
   
o
  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
   
o
  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
   
o
  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 


TABLE OF CONTENTS

Item 1.01 — Entry into a Material Definitive Agreement
SIGNATURES
EX-99.1: PRESS RELEASE
EX-99.2: PRESS RELEASE


Table of Contents

Item 1.01 – Entry into a Material Definitive Agreement
Today Barr Pharmaceuticals, Inc. announced that its subsidiary, Duramed Pharmaceuticals, Inc., has signed a definitive agreement to acquire FEI Women’s Health, LLC for $281.5 million in a strategic transaction that will expand the Company’s presence into the non-hormone contraceptive product marketplace. At the same time, Barr issued a press release announcing a conference call with investors to discuss the agreement, which was held at 9:00 AM Eastern time this morning. Copies of those two press releases are attached to this current report as Exhibits 99.1 and 99.2 and are incorporated herein by reference.
     A replay of the conference call will be available from 12:30 PM Eastern time on October 18th through 11:59 PM Eastern time October 20th, and can be accessed by dialing (800) 475-6701 in the United States or (320) 365-3844 Internationally and using the access code 799708.
  (c)   Exhibits
  99.1   Press release issued by Barr Pharmaceuticals, Inc. and FEI, dated October 18, 2005, announcing the entering into a definitive agreement by Duramed Pharmaceuticals, Inc. to acquire FEI Women’s Health, LLC.
 
  99.2   Press release issued by Barr Pharmaceuticals, Inc., dated October 18, 2005, announcing an investor conference call to discuss the agreement with FEI Women’s Health LLC.

 


Table of Contents

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 PHARMACEUTICALS, INC.
 
   
Date: October 18, 2005
  /s/ William T. McKee
 
   
 
  William T. McKee
Vice President, Chief Financial Officer, and Treasurer

 

EX-99.1 2 y13683exv99w1.htm EX-99.1: PRESS RELEASE EXHIBIT 99.1
 

(BARR LOGO)
     
400 Chestnut Ridge Road
  N E W S R E L E A S E
Woodcliff Lake, NJ 07677
   
201-930-3300
   
     
CONTACT: Carol A. Cox, 201-930-3720
  EMAIL: ccox@barrlabs.com
Duramed to Acquire FEI Women’s Health and Its ParaGard® IUD Product
Expands Women’s Healthcare Portfolio to Include Unique, Non-Hormone Contraceptive Product
Woodcliff Lake, NJ – October 18, 2005 ... Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc. (NYSE: BRL), today announced that it has signed a definitive agreement to acquire FEI Women’s Health, LLC, for $281.5 million in a strategic transaction that will expand the Company’s presence into the non-hormone contraceptive product marketplace. FEI owns the New Drug Application (NDA) for the ParaGard® T 380A (Intrauterine Copper Contraceptive) IUD, which is approved for continuous use for the prevention of pregnancy for up to 10 years. ParaGard® was approved in 1984 and has been marketed in the United States since 1988. Sales of ParaGard® in the United States and internationally were approximately $48 million for calendar year 2004.
This transaction is subject to the satisfaction of certain conditions, including Hart-Scott-Rodino antitrust filings. Barr said it expects to close the transaction before December 31, 2005.
“With this transaction, we will expand our commitment to contraception beyond oral contraceptive products into a new arena for the Company,” said Bruce L. Downey, Barr’s Chairman and Chief Executive Officer. “IUDs represent an under-utilized contraceptive option for women in the United States, and we believe that we are well positioned to grow this category through consumer and professional education and marketing. Adding ParaGard® to our portfolio of products will provide new opportunities for our Specialty Sales Force, which we anticipate increasing substantially from the current 40-person level as a result of this transaction. In addition, this transaction further strengthens our commitment to leadership in female healthcare by offering enhanced contraceptive options, particularly given that ParaGard® is the only hormone-free IUD, and the only product approved for continuous use for a 10-year period.”
“More than 76 million women worldwide have safely utilized ParaGard® over the past 17 years,” Downey continued. “We believe that the uniqueness of this safe and effective product, combined with our position in the contraceptive marketplace, and our targeted female healthcare sales and marketing capabilities, will enable us to realize significant value from this acquisition.”
FEI is a women’s health care company that manufactures, sells and markets the ParaGard® T 380A. ParaGard® is the only contraceptive approved for 10 years of continuous use and is more than 99% effective at preventing pregnancy.

 


 

(BARR LOGO)
FEI currently promotes ParaGard® in the United States to female healthcare practitioners and public health institutions with its 50-person Specialized Sales Force established in late 2004. ParaGard® is known as the Copper T Model TCu 380A outside the United States .
Financial Impact
Excluding charges associated with the acquisition, including amortization charges related to an inventory write-up, Barr anticipates that the transaction will be neutral to earnings in fiscal 2006 and accretive for fiscal 2007 and thereafter.
Safety Information on ParaGard®
ParaGard® does not protect against HIV/AIDS or other sexually transmitted diseases. A woman must not use ParaGard® if she currently has acute Pelvic Inflammatory Disease (PID) or engages in current behavior suggesting a high risk for PID. ParaGard® is also not an option for women who might be pregnant, have had a post-pregnancy or post-abortion uterine infection in the past 3 months, have cancer of the uterus or cervix, have an infection in the cervix, have an allergy to any component of ParaGard®, or have Wilson’s disease.
The most common side effects of ParaGard ® are heavier and longer periods for a few months after placement; some women have spotting between periods. For most women, this typically subsides after a few months. If you ever miss a period, call your healthcare professional without delay, as you might be pregnant.
Some possible serious complications that have been associated with intrauterine contraceptives, including ParaGard ® , are pelvic inflammatory disease (PID), perforation of the uterus, and expulsion (where the contraceptive falls completely or partially out of the uterus).
Barr Pharmaceuticals, Inc. is a holding company whose principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., develop, manufacture and market generic and proprietary pharmaceuticals.
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

 


 

(BARR LOGO)
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; 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 and products we acquire and implementing our new 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; changes in generally accepted accounting principles; and other risks detailed from time-to-time in our filings with the Securities and Exchange Commission, including in our Annual Report on Form 10-K for the fiscal year ended June 30, 2005.
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.
[EDITOR’S ADVISORY: Barr Pharmaceuticals, Inc. news releases are available free of charge through PR Newswire’s News On-Call site at http://www.prnewswire.com/comp/089750.html. Barr news releases and corporate information are also available on Barr’s website (www.barrlabs.com). For complete indications, warnings and contraindications, contact Barr Laboratories’ Product Information Department at 1-800-Barr Lab. All trademarks referenced herein are the property of their respective owners.]
# # #

 

EX-99.2 3 y13683exv99w2.htm EX-99.2: PRESS RELEASE EXHIBIT 99.2
 

(BARR LOGO)
     
400 Chestnut Ridge Road
  N E W S R E L E A S E
Woodcliff Lake, NJ 07677
   
201-930-3300
   
     
CONTACT: Carol A. Cox, 201-930-3720
  EMAIL: ccox@barrlabs.com
Barr Will Host Conference Call to Discuss Duramed’s Acquisition of FEI Women’s Health and Its ParaGard® IUD Product
Woodcliff Lake, NJ – October 18, 2005...Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that the Company will host a Conference Call at 9:00 AM Eastern time on Tuesday, October 18th to discuss its acquisition of FEI Women’s Health and its ParaGard® IUD product by Barr’s subsidiary, Duramed Pharmaceuticals, Inc. The Company issued a release this morning related to the acquisition.
The number to call from within the United States is: (888) 423-3273 and (612) 234-9960 Internationally. A replay of the conference call will be available from 12:30 PM Eastern time on October 18th through 11:59 PM Eastern time October 20th, and can be accessed by dialing (800) 475-6701 in the United States or (320) 365-3844 Internationally and using the access code 799708.
The Conference Call will also be Webcast live on the Internet. Investors and other interested parties may access the live webcast through the Investor Relations section, under Calendar of Events, on Barr’s website at www.barrlabs.com.
Log on at least 15 minutes before the call begins to register and download or install any necessary audio software.
Barr Pharmaceuticals, Inc. is a holding company whose principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., develop, manufacture and market generic and proprietary pharmaceuticals.
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

 


 

(BARR LOGO)
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; 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 and products we acquire and implementing our new 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; changes in generally accepted accounting principles; and other risks detailed from time-to-time in our filings with the Securities and Exchange Commission, including in our Annual Report on Form 10-K for the fiscal year ended June 30, 2005.
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.
[EDITOR’S ADVISORY: Barr Pharmaceuticals, Inc. news releases are available free of charge through PR Newswire’s News On-Call site at http://www.prnewswire.com/comp/089750.html. Barr news releases and corporate information are also available on Barr’s website (www.barrlabs.com). For complete indications, warnings and contraindications, contact Barr Laboratories’ Product Information Department at 1-800-Barr Lab. All trademarks referenced herein are the property of their respective owners.]
# # #

 

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