-----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, F6Teyh1qvx6yQh/MbBgIngEA2tetA7D+TGO9fboX5BF/v4Rcvv++NWOrtxRIpWH1 ueM5vU0ByAKbAYv0nBXIvg== 0000950134-07-002775.txt : 20070212 0000950134-07-002775.hdr.sgml : 20070212 20070212135612 ACCESSION NUMBER: 0000950134-07-002775 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20070206 ITEM INFORMATION: Termination of a Material Definitive Agreement ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070212 DATE AS OF CHANGE: 20070212 FILER: COMPANY DATA: COMPANY CONFORMED NAME: REPLIDYNE INC CENTRAL INDEX KEY: 0001180145 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-52082 FILM NUMBER: 07601815 BUSINESS ADDRESS: STREET 1: 1450 INFINITE DRIVE CITY: LOUISVILLE STATE: CO ZIP: 80027 BUSINESS PHONE: 303-665-3450 8-K 1 d43518e8vk.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 earliest event reported) February 12, 2007 (February 6, 2007)
REPLIDYNE, INC.
(Exact name of registrant as specified in its charter)
         
Delaware
(State or other jurisdiction of
incorporation or organization)
  000-52082
(Commission File Number)
  84-1568247
(I.R.S. Employer
Identification No.)
         
1450 Infinite Drive,
Louisville, Colorado

(Address of principal executive offices)
      80026
(Zip Code)
303-996-5500
(Registrant’s telephone number, including area code)
Not Applicable
(Former name, former address and former fiscal year, 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))
 
 

 


 

INFORMATION TO BE INCLUDED IN THE REPORT
Section 1 -— Registrant’s Business and Operations
Item 1.02 Termination of a Material Definitive Agreement.
On February 6, 2007, Replidyne, Inc. announced that its collaboration and commercialization agreement for faropenem medoximil (faropenem) with Forest Laboratories, Inc. was terminated. This termination follows the issuance in October 2006 of a non-approvable letter by the U.S. Food and Drug Administration (“FDA”) for the Company’s new drug application for faropenem that was submitted to the FDA in December 2005. As a result, Replidyne will reacquire all U.S. rights to faropenem. In accordance with the termination provisions of the collaboration agreement, Forest Laboratories will cooperate with Replidyne to assure a smooth transition of the faropenem programs for a period of up to six months. No penalty fees were incurred by either party in connection with the termination of the collaboration agreement.
Section 7 -— Regulation FD
Item 7.01 Regulation FD Disclosure.
On February 6, 2007, Replidyne issued a press release regarding the termination of its collaboration agreement with Forest Laboratories, as further described in Item 1.02. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.
In accordance with General Instruction B.2. of Form 8-K, the information presented under this Item 7.01 and attached as Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.
Section 9 — Financial Statements and Exhibits
Item 9.01 Financial Statements and Exhibits.
(c) Exhibits.
     
99.1
  Press Release, dated February 6, 2007, Entitled “Replidyne and Forest End Faropenem Collaboration.”

 


 

SIGNATURE
     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.
         
  REPLIDYNE, INC.
 
 
Dated: February 12, 2007  By:   /s/ Mark L. Smith    
    Mark L. Smith   
    Chief Financial Officer  
    Principal Accounting Officer  
 

 


 

EXHIBIT INDEX
     
Exhibit No.   Description
 
   
99.1   Press Release, dated February 6, 2007, Entitled “Replidyne and Forest End Faropenem Collaboration.”

 

EX-99.1 2 d43518exv99w1.htm PRESS RELEASE exv99w1
 

EXHIBIT 99.1
(Replidyne LOGO)

Replidyne contact:
Sabrina B. Oei
Dir. Investor & Public Relations
T: (303) 996-5535

Replidyne and Forest End Faropenem Collaboration
Louisville, CO, February 6, 2007 — Replidyne, Inc. (Nasdaq: RDYN) and Forest Laboratories, Inc. (Forest) announced today that they have ended a February 2006 collaboration for the commercialization of faropenem medoxomil (faropenem), a novel community antibiotic in late-stage clinical development. As a result of this termination, Replidyne will re-acquire all U.S. adult and pediatric rights previously granted to Forest.
“We remain confident in the viability of faropenem. As the first oral penem community antibiotic developed in the U.S., supported by a favorable tolerability profile, faropenem could offer important advantages over current therapy. Though the regulatory requirements for the approval of antibiotics have changed, we believe that faropenem can meet these new standards and are we working closely with the FDA to define a regulatory pathway for faropenem approval,” stated Kenneth J. Collins, Replidyne’s President and CEO. “Upon approval, faropenem has the potential to be a valuable asset in a market which should have limited promoted competition at that time.”
In October 2006, the FDA issued a non-approvable letter for faropenem for four adult indications: acute bacterial sinusitis (ABS), community-acquired pneumonia (CAP), acute exacerbation of chronic bronchitis (AECB) and uncomplicated skin and skin structure infections (SSSI). In the non-approvable letter, the FDA recommended further clinical studies for all indications including studies using a superiority design for the indications of ABS and AECB, more extensive microbiologic confirmation, and consideration of alternate dosing regimens. The FDA did not raise any safety concerns or chemistry, manufacturing or controls (CMC) issues related to the product.
Replidyne will host a conference call at 8:30 A.M. ET to discuss today’s announcement and respond to questions. Callers may participate in the conference call by dialing 866-203-3206 (U.S. participants) or 617-213-8848 (international participants), and providing the passcode Replidyne. To access the live webcast, please log on to the company’s website at www.Replidyne.com and go to the Investor Relations section.

 


 

A replay of the conference call will be available approximately one hour after the completion of the call through Wednesday, February 21, 2007 at midnight. Callers may access the replay by dialing 888-286-8010 (U.S. participants) or 617-801-6888 (international participants). The audio replay passcode is 38989681. To access a replay of the webcast, visit the Investor Relations section of the company’s website at www.Replidyne.com.
About Faropenem
Faropenem is a member of the penem subclass within the beta-lactam class of antibiotics. Beta-lactams are generally characterized by their favorable safety and tolerability profiles, as well as their broad spectrum of activity, and as a result are often used as first line therapy in many respiratory and skin infections in adult and pediatric patients.
Faropenem medoxomil is an investigational compound being developed for oral treatment of community-acquired respiratory infections and uncomplicated skin and skin structure infections. Community antibiotics are generally used to treat infections acquired in a public setting, rather than at the hospital.
About Replidyne, Inc.
Replidyne is a biopharmaceutical company focused on discovering, developing, in-licensing and commercializing innovative anti-infective products. Replidyne’s lead product, faropenem medoxomil, is a novel oral, community antibiotic, expected to be appropriate for use as a first-line antibiotic for treatment of respiratory and skin infections in adult and pediatric patients. An IND for Replidyne’s second drug candidate, REP8839, was submitted to the FDA in May 2006. REP8839 is a topical anti-infective product under development for the treatment of skin and wound infections, including methicillin resistant S. aureus (MRSA) infections. Replidyne is also pursuing the development of other novel anti-infective products based on its in-house discovery research.
Safe Harbor
This press release contains plans, intentions, objectives, estimates and expectations that constitute forward-looking statements about Replidyne, Inc. that involve significant risks and uncertainties. Actual results could differ materially from those discussed due to a number of factors including, the success and timing of pre-clinical studies and clinical trials; the Company’s ability to obtain and maintain regulatory approval of product candidates and the labeling under any approval that may be obtained; plans to develop and commercialize product candidates; the loss of key scientific or management personnel; the size and growth of the potential markets for the Company’s product candidates and the Company’s ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of Company estimates regarding expenses, future revenues and capital requirements; the Company’s ability to obtain and maintain intellectual property protection for our product candidates; the successful development of the Company’s sales and marketing capabilities; the success of competing drugs that are or become available; and the performance of third party manufacturers. These and additional risks and uncertainties are described more fully in the Company’s Form S-1 and most recent periodic report filed with the SEC under the Securities Exchange Act of 1934. Copies of filings made with the SEC are available through the SEC’s electronic data gather analysis and retrieval system (EDGAR) at www.sec.gov. All forward-looking statements made in the press release are made as of the date hereof and the Company assumes no obligation to update the forward-looking statements in the document.
- ENDS -

 

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