-----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, NBLSoLIVe8yLUNwGbZX7hq+nNFDQkW9GTmuXBpITwZZ0EAgw+kelVfAI6cDLlfrJ cJ+4FvJ9U6zidiqCmG0AOg== 0000893220-09-001312.txt : 20090601 0000893220-09-001312.hdr.sgml : 20090601 20090601083103 ACCESSION NUMBER: 0000893220-09-001312 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20090529 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090601 DATE AS OF CHANGE: 20090601 FILER: COMPANY DATA: COMPANY CONFORMED NAME: VALEANT PHARMACEUTICALS INTERNATIONAL CENTRAL INDEX KEY: 0000930184 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 330628076 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-11397 FILM NUMBER: 09863623 BUSINESS ADDRESS: STREET 1: ONE ENTERPRISE CITY: ALISO VIEJO STATE: CA ZIP: 92656 BUSINESS PHONE: 949-461-6000 MAIL ADDRESS: STREET 1: ONE ENTERPRISE CITY: ALISO VIEJO STATE: CA ZIP: 92656 FORMER COMPANY: FORMER CONFORMED NAME: ICN PHARMACEUTICALS INC DATE OF NAME CHANGE: 19941114 FORMER COMPANY: FORMER CONFORMED NAME: ICN MERGER CORP DATE OF NAME CHANGE: 19940915 8-K 1 w74329e8vk.htm FORM 8-K e8vk
 
 
UNITED STATES
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 the earliest event reported): May 29, 2009
Valeant Pharmaceuticals International
(Exact name of registrant as specified in its charter)
         
Delaware   1-11397   33-0628076
(State or other jurisdiction of   (Commission File Number)   (I.R.S Employer
incorporation or organization)       Identification No.)
One Enterprise
Aliso Viejo, California 92656

(Address of principal executive offices) (Zip Code)
(949) 461-6000
(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 1.01 Entry into a Material Definitive Agreement
     On May 29, 2009, Valeant Pharmaceuticals International (“Valeant” or the “Company”) entered into an exclusive option agreement with Schering Corporation (“Schering”) and Schering-Plough Ltd (together with Schering, “SP”) for taribavirin in Japan. Under the terms of the option agreement, Valeant granted Schering an option to enter into an exclusive license agreement for the development and commercialization of taribavirin in Japan. In exchange for the exclusive option, SP agreed to waive and release the right of last refusal on taribavirin under a 2000 agreement between Valeant and SP. Upon exercising the option and entering into the exclusive license agreement, Schering would provide Valeant with a $2 million upfront payment and pay mid-single digit royalties on net sales of taribavirin in Japan.
     The foregoing summary of the option agreement does not purport to be complete and is subject to, and qualified in its entirety by, the full text of the option agreement. The Company expects to file a copy of the option agreement as a part of its Quarterly Report on Form 10-Q for the quarter ending June 30, 2009. Portions of the Agreement may be omitted in accordance with a request for confidential treatment that Valeant expects to submit to the Securities and Exchange Commission. The press release dated June 1, 2009 announcing the option agreement is attached as Exhibit 99.1 and is incorporated hereto.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
99.1   Press Release, dated June 1, 2009

 


 

SIGNATURES
     Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
         
  VALEANT PHARMACEUTICALS
INTERNATIONAL
 
 
Date: June 1, 2009  /s/ Steve T. Min    
  Steve T. Min   
  Executive Vice President
and General Counsel 
 
 

 

EX-99.1 2 w74329exv99w1.htm EX-99.1 exv99w1
Exhibit 99.1
(VALEANT LOGO)
International Headquarters
One Enterprise Aliso Viejo, CA 92656
949.461.6000 FAX 949.461.6636
Contact:
Laurie W. Little
Valeant Pharmaceuticals
949-461-6002
laurie.little@valeant.com
VALEANT GRANTS SCHERING-PLOUGH EXCLUSIVE OPTION IN JAPAN FOR
TARIBAVIRIN IN EXCHANGE FOR RELEASE OF LAST RIGHT OF REFUSAL
     ALISO VIEJO, Calif., June 1, 2009 – Valeant Pharmaceuticals International (NYSE:VRX) announced today that it has entered into an exclusive option agreement with Schering-Plough (NYSE: SGP) for taribavirin in Japan. In exchange for the exclusive option, Schering-Plough has agreed to waive and release its right of last refusal on taribavirin under a 2000 agreement, providing more flexibility for Valeant to actively pursue partnering arrangements for the rest of the world.
     Under the terms of the option agreement, Valeant granted Schering-Plough the option to enter into an exclusive license agreement for the development and commercialization of taribavirin in Japan. Upon exercising the option and entering into the exclusive license agreement, Schering-Plough would provide a $2 million upfront payment to Valeant and pay mid-single digit royalties on net sales of taribavirin in Japan.
     Taribavirin, a prodrug of ribavirin, is in Phase II development for the treatment of chronic hepatitis C in conjunction with a pegylated interferon.
     “This option agreement with Schering-Plough releases our company from the right of last refusal and provides us more flexibility to pursue partnering opportunities with other companies,” said J. Michael Pearson, Valeant’s chairman and chief executive officer. “With the data we have seen so far from the Phase IIb trial, we believe that taribavirin presents an attractive licensing opportunity.”
About Taribavirin
     Taribavirin is an investigational compound that has not been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory agency for the diagnosis, mitigation, treatment or cure of any disease or illness. It may not be sold or promoted in the United States unless and until FDA has approved a New Drug Application. Similar restrictions apply in other countries.
     Recent data from the Phase IIb study demonstrates that the 60-week viral response data continues to show comparable reductions in viral load for weight-based doses of taribavirin and

 


 

(VALEANT LOGO)
ribavirin in a difficult-to-treat population of patients chronically infected with hepatitis C genotype 1. At the end of week 60, a statistically significantly lower anemia rate for patients receiving taribavirin in the 20mg/kg and 25mg/kg arms versus the ribavirin control arm was maintained at a rate similar to that seen at the end of treatment (week 48).
About Valeant
     Valeant Pharmaceuticals International (NYSE:VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of products primarily in the areas of neurology and dermatology. More information about Valeant can be found at www.valeant.com.
FORWARD-LOOKING STATEMENTS
     This press release may contain forward-looking statements, including, but not limited to, statements regarding the potential efficacy and safety of taribavirin in the treatment of hepatitis C, and the continuing role of ribavirin or taribavirin in the treatment of hepatitis C. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties related to relating to the clinical development of new products, regulatory approval processes, that interim results from a phase IIb clinical trial are not necessarily predictive of the entire phase IIb trial or a phase III trial, and other risks and uncertainties discussed in the company’s most recent annual or quarterly report filed with the SEC, which factors are incorporated herein by reference. These risks are among the factors that could cause actual results to differ materially from the expectations described in the forward-looking statements and undue reliance should not be placed on any of these forward-looking statements. Valeant undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes.
# # #

 

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