-----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, OR2fTPnm/oJafcJ50eG6ylIPwYC0pWd2jfrhWb4/QMjNZ3kAZ3w6JQL7AcWyo9KR hHrUUVOxJO48MhIigdYzHg== 0000950123-05-004429.txt : 20050413 0000950123-05-004429.hdr.sgml : 20050413 20050413125740 ACCESSION NUMBER: 0000950123-05-004429 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 7 CONFORMED PERIOD OF REPORT: 20050413 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050413 DATE AS OF CHANGE: 20050413 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: 05747903 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 y07801e8vk.htm FORM 8-K 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) April 13, 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)
  (IRS Employer
Identification No.)
         
400 Chestnut Ridge Road, Woodcliff Lake, NJ
  07677-7668
(Address of principal executive offices)
  (Zip code)

(201) 930-3300
(Registrant’s telephone number, including area code)

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))



 


 

     
Item 7.01 —   Regulation FD Disclosure

Today Barr Pharmaceuticals, Inc. issued a joint press release with Kos Pharmaceuticals, Inc. announcing the resolution of patent litigation involving Kos’ Niaspan® products that resulted in its entering into Co-Promotion, Licensing and Manufacturing, and Settlement and License Agreements with Kos. At the same time, Barr issued a press release announcing a conference call with investors to discuss the agreements, which was held at 8:30 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 Noon Eastern time on April 13th through 11:59 PM Eastern time April 15th, and can be accessed by dialing (800) 475-6701 in the United States or (320) 365-3844 Internationally and using the access code 779048.
     
Item 9.01 —   Financial Statements and Exhibits
        
  (c)   Exhibits
          
  99.1   Joint press release issued by Barr Pharmaceuticals, Inc. and Kos Pharmaceuticals, Inc., dated April 13, 2005, announcing the entering into of definitive Co-Promotion, Manufacturing, and Settlement Agreements.
       
  99.2   Press release issued by Barr Pharmaceuticals, Inc., dated April 13, 2005, announcing an investor conference call to discuss the agreements entered into with Kos.

 


 

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: April 13, 2005
  /s/ William T. McKee
   
  William T. McKee
Vice President, Chief Financial Officer, and Treasurer

 

EX-99.1 2 y07801exv99w1.htm EX-99.1: JOINT PRESS RELEASE EXHIBIT 99.1
 

Exhibit 99.1

(LOGO)   (LOGO)
     
1 Cedar Brook Drive
  400 Chestnut Ridge Road
Cranbury, New Jersey 08512
  Woodcliff Lake, NJ 07677
609-495-0500
  201-930-3300
CONTACT:
  CONTACT:
Constance Bienfait, 954-331-3760
  Carol A. Cox, 201-930-3720
EMAIL: cbienfait@kospharm.com
  EMAIL: ccox@barrlabs.com

KOS AND BARR ANNOUNCE DEFINITIVE CO-PROMOTION,
MANUFACTURING, AND SETTLEMENT AGREEMENTS

  •   Agreements offer benefits to expanded universe of female patients
 
  •   Barr to co-promote Niaspan® and Advicor® to health care professionals with an interest in women’s healthcare
 
  •   Barr to provide back-up manufacturing for Kos’ Niaspan product
 
  •   License and Settlement Agreement resolves Niaspan patent litigation

WOODCLIFF, NJ and CRANBURY, NJ, April 13, 2005 – Kos Pharmaceuticals, Inc. (Nasdaq: KOSP) and Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that that they have signed Co-Promotion, Licensing and Manufacturing, and Settlement and License Agreements relating to the resolution of the patent litigation involving Kos’ Niaspan® products. The United States District Court for the Southern District of New York entered into a Consent Dismissal ending the pending litigation between the two companies. These arrangements have been established to provide benefits to millions of female patients who have multiple lipid disorders and are candidates for Kos’ niacin-based pharmaceutical cholesterol products.

Co-Promotion Agreement

The Co-Promotion Agreement provides that Kos and Duramed Pharmaceuticals, a subsidiary of Barr Pharmaceuticals, will co-promote the current Niaspan and Advicor® products, as well as future dosage formulations, strengths or modified versions of those products (“the Products”), to obstetricians, gynecologists and other practitioners with a focus on women’s healthcare in the United States using a Duramed specialty sales force. Under the terms of the seven-year agreement (with renewal rights), Kos will train a 40-person Duramed specialty sales force, which will begin promoting the Products in mid-2005. In consideration of the Co-Promotion, Kos will pay Duramed royalties based on quarterly and yearly net sales of the Products, subject to certain maximum sales levels. The Co-Promotion would address a new discrete population of obstetricians, gynecologists and other practitioners with a focus on women’s healthcare who have not previously been detailed on Kos’ cholesterol products. Kos’ cholesterol products could directly serve the growing need to treat the risks of cardiovascular disease in the 28 million

-more-

 


 

Page 2

women identified by the American Heart Association (AHA) who require HDL-C (the “good” cholesterol) raising therapy.

In February 2004, the AHA raised its guidelines for HDL-C in women from 40 mg/dl to 50 mg/dl. The new guidelines also recommended that women maintain triglycerides levels below 150 mg/dl, a 25% change from past guidelines. These new guidelines essentially tripled the number of women who are candidates for Niaspan and Advicor therapy to about 28 million.

At the same time, a second study published in Circulation found that nearly two-thirds of women at highest risk for a heart attack receive no treatment at all, despite having levels of “good” and “bad” cholesterol that endanger them. Only 7 percent of women had lipid levels considered optimal by the AHA women’s guidelines issued last year (LDL-C of less than 100mg/dL and HDL-C above 50 mg/dL).

Settlement and License Agreement

The Settlement and License Agreement permits Barr Laboratories to launch generic versions of Niaspan and Advicor, as well as future dosage formulations, strengths or modified versions of the Products, under terms of an exclusive license commencing on September 20, 2013, approximately four years earlier than the last-to-expire Kos patent. Upon launch, Barr would pay Kos a royalty equal to a portion of profits generated from the sales of generic versions of the Products. As part of the settlement, Barr admits that Kos’ patents are valid and enforceable and that Barr infringes the Kos patents.

License and Manufacturing Agreement

In a separate License and Manufacturing Agreement, Barr Laboratories has agreed to stand ready to supply Kos Life Sciences, Inc. quantities of Niaspan 500 mg, 750 mg and 1000 mg Extended-Release Niacin Tablets and Advicor 500 mg/20 mg, 750 mg/20 mg and 1000 mg/20 mg Extended Release Niacin/Lovastatin Tablets, under or pursuant to the approval of Barr’s Abbreviated New Drug Applications (ANDAs). Under the terms of the License and Manufacturing Agreement, Barr will receive an initial license fee and quarterly payments to stand ready to meet Kos’ manufacturing requirements. In addition, if Kos engages Barr to manufacture these products, Kos will purchase such products at an agreed upon supply price.

“We believe the agreements announced today provide an equitable way to resolve our Niaspan patent litigation that creates a benefit for consumers, as well as Barr’s shareholders,” said Bruce L. Downey, Barr’s Chairman and Chief Executive Officer. “We believe these agreements open the door for significant opportunities for both Barr and Kos, including an additional Duramed sales force that can be utilized to promote Kos’ products, Duramed’s products, and other proprietary products. In addition, the agreements provide the certainty of generic entry four years before the patents expire, or potentially earlier in certain circumstances.”

“This agreement with Barr not only benefits both companies, but most importantly, it broadens the utility of our niacin-based pharmaceutical cholesterol products to a wider female patient population, thereby saving more lives,” said Adrian Adams, President and CEO of Kos. “Kos

 


 

Page 3

has spent significant time and money developing these products, conducting studies, securing and defending intellectual property and expanding medical education on the need to treat a broad range of lipid parameters. Now, not only will we be able to continue to market and grow our cholesterol franchise, but we will also be able to leverage Barr’s excellent relationships and competencies with the obstetric/gynecology community that expands our products’ reach into an entirely new market segment. This partnership will proliferate the medical education on the unique benefits of Niaspan and Advicor in reducing the risk of cardiovascular disease in women, a uniquely underserved population. Lastly, it provides us with additional manufacturing capabilities if needed, which we were already exploring.”

About Barr

Barr Pharmaceuticals, Inc., a holding company that operates through its principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals.

About Kos

Kos Pharmaceuticals, Inc. is a fully integrated specialty pharmaceutical company engaged in developing, commercializing, manufacturing and marketing proprietary prescription products for the treatment of chronic diseases. The Company’s principal product development strategy is to reformulate existing pharmaceutical products with large market potential to improve safety, efficacy, or patient compliance. The Company currently markets Niaspan and Advicor for the treatment of cholesterol disorders, and Azmacortâ for the treatment of asthma. Kos is developing additional products, has proprietary drug delivery technologies in solid-dose and aerosol metered-dose inhalation administration and is pursuing certain strategic business development and licensing opportunities.

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.

The forward-looking statements contained in this press release speak only as of the date the statement was made. The companies undertake no obligation (nor do they 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.

For Kos: These factors include the Company’s ability to attract and retain sales professionals, the Company’s ability to build awareness for Niaspan and Advicor within the medical

 


 

Page 4

community, the continuing growth of the cardiovascular and respiratory markets, the Company’s ability to maintain its compliance with FDA regulations and standards, the effect of conditions in the pharmaceutical industry and the economy in general, as well as certain other risks, including without limitation those discussed in Kos’s public reports filed with the U.S. Securities and Exchange Commission, including its Form 10-K for its December 31, 2004 fiscal year.

For Barr: These factors include those discussed in its public reports filed with the U.S. Securities and Exchange Commission, including its Form 10-K for the June 30, 2004 fiscal year.

[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) or Kos’ website (www.kospharm.com). For complete indications, warnings and contraindications, contact Barr Laboratories’ Product Information Department at 1-800-Barr Lab and Kos Pharmaceuticals’ Medical Inquiries at 1-888-454-7437. All trademarks referenced herein are the property of their respective owners.]

# # #

 

EX-99.2 3 y07801exv99w2.htm EX-99.2: PRESS RELEASE EXHIBIT 99.2
 

Exhibit 99.2

(LOGO)    
400 Chestnut Ridge Road
Woodcliff Lake, NJ 07677
201-930-3300
  (NEWS RELEASE)
     
CONTACT: Carol A. Cox, 201-930-3720
  EMAIL: ccox@barrlabs.com

Barr Will Host Conference Call to Discuss Agreements Related to Resolution of Patent Litigation Involving Kos’ Niaspan® Products

Woodcliff Lake, NJ — April 13, 2005...Barr Pharmaceuticals, Inc. (NYSE-BRL) today announced that the Company will host a Conference Call at 8:30 AM Eastern time on Wednesday, April 13th to discuss the agreements it has signed with Kos Pharmaceuticals related to the resolution of patent litigation involving Kos’ Niaspan® products. The Company and Kos issued a joint release this morning related to the signed Co-Promotion, Licensing and Manufacturing, and Settlement and License Agreements.

The number to call from within the United States is: (888) 428-4479 and (612) 288-0329 Internationally. A replay of the conference call will be available from 12 Noon Eastern time on April 13th through 11:59 PM Eastern time April 15th, and can be accessed by dialing (800) 475-6701 in the United States or (320) 365-3844 Internationally and using the access code 779048.

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., a holding company that operates through its principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., is engaged in the development, manufacture and marketing of 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;

 


 

(LOGO)

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 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, 2004.

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.]

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