-----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, VFidCNoBc706Rq0La0gMromNAIRg4VTdl8cdSLYiP5CsfhlSBtfGFEXMNVrO7/1U uAOYMGkBw7cCUle+bcejtQ== 0000950137-05-011333.txt : 20050915 0000950137-05-011333.hdr.sgml : 20050915 20050915145735 ACCESSION NUMBER: 0000950137-05-011333 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20050714 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050915 DATE AS OF CHANGE: 20050915 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AKORN INC CENTRAL INDEX KEY: 0000003116 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 720717400 STATE OF INCORPORATION: LA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-32360 FILM NUMBER: 051086554 BUSINESS ADDRESS: STREET 1: 2500 MILLBROOK DRIVE CITY: BUFFALO GROVE STATE: IL ZIP: 60089 BUSINESS PHONE: 8472796100 MAIL ADDRESS: STREET 1: 2500 MILLBROOK DRIVE CITY: BUFFALO GROVE STATE: IL ZIP: 60089 8-K 1 c98480e8vk.htm CURRENT REPORT e8vk
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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
Date of Report: September 14, 2005
(Date of Earliest Event Reported)
Akorn, Inc.
(Exact Name of Registrant as Specified in its Charter)
         
Louisiana   0-13976   72-0717400
(State or other
Jurisdiction of
Incorporation)
  (Commission
File Number)
  (I.R.S. Employer
Identification No.)
2500 MILLBROOK DRIVE
BUFFALO GROVE, ILLINOIS

(Address of principal executive offices)
(847) 279-6100
(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 (See General Instruction A.2. below):
o   Written communication 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 communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o   Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240. 13e-4(c))
 
 

 


TABLE OF CONTENTS

Item 7.01 Regulation FD Disclosure
Item 9.01 Financial Statements and Exhibits.
SIGNATURES
Press Release
Presolicitation Notice


Table of Contents

Item 7.01 Regulation FD Disclosure
     Reference is made to Exhibits 99.1 and 99.2, attached.
     The preceding information is being furnished under Item 7.01 “Regulation FD Disclosure.” This information shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
     We expressly disclaim any obligation to update this presentation and caution that it is only accurate on the date it was presented. The inclusion of any data or statements in this presentation does not signify that the information is considered material.
Item 9.01 Financial Statements and Exhibits.
  (c)   Exhibits.
  99.1   Press release dated September 15, 2005 (solely furnished and not filed herewith pursuant to Item 7.01).
 
  99.2   Presolicitation Notice

 


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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Current Report on Form 8-K to be signed on its behalf by the undersigned hereunto duly authorized.
         
    AKORN, INC.
 
       
 
  By:   /s/ Jeffrey A. Whitnell
 
       
 
      Jeffrey A. Whitnell
Chief Financial Officer, Treasurer
and Secretary
 
       
Date: September 15, 2005
       

 

EX-99.1 2 c98480exv99w1.htm PRESS RELEASE exv99w1
 

EXHIBIT 99.1
At the Company:
Akorn, Inc.
Arthur S. Przybyl
President and CEO
(847) 279-6100
FOR IMMEDIATE RELEASE
Akorn, Inc. Updates Status of Calcium – DTPA and Zinc-DTPA
Strategic National Stockpile Order
Buffalo Grove, IL, September 15, 2005 – Akorn, Inc. (AMEX: AKN) today announced that it has received a public pre-solicitation notice (“Acquisition of Ca DTPA and Zn DTPA to support a pubic emergency response to a radiological or nuclear event”) from the federal government as a Notice of Intent to negotiate for the procurement of Calcium – DTPA and Zinc – DTPA. The U.S. Government has an urgent need to acquire and maintain within the Strategic National Stockpile an inventory of both drugs. A commercial item award resulting from a written Request For Proposal is anticipated. The anticipated award date is on or about November 15, 2005.
About Akorn, Inc.
Akorn, Inc. manufactures and markets sterile specialty pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois and Somerset, New Jersey and markets and distributes an extensive line of hospital and ophthalmic pharmaceuticals. Additional information is available at the Company’s website at www.akorn.com.
Materials in this press release may contain information that includes or is based upon forward-looking statements within the meaning of the Securities Litigation Reform Act of 1995. Forward-looking statements give our expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” and other words and terms of similar meaning in connection with a discussion of future operating or financial performance. In particular, these include statements relating to future steps we may take, prospective products, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results.
Any or all of our forward-looking statements here or in other publications may turn out to be wrong. They can be affected by inaccurate assumptions or by known or unknown risks and uncertainties. Many such factors will be important in determining our actual future results. Consequently, no forward-looking statement can be guaranteed. Our

 


 

actual results may vary materially, and there are not guarantees about the performance of our stock.
Any forward-looking statements represent our expectations or forecasts only as of the date they were made and should not be relied upon as representing our expectations or forecasts as of any subsequent date. We undertake no obligation to correct or update any forward-looking statements, whether as a result of new information, future events or otherwise, even if our expectations or forecasts change. You are advised, however, to consult any further disclosures we make on related subjects in our reports filed with the SEC. In particular, you should read the discussion in the section entitled “Cautionary Statement Regarding Forward-Looking Statements” in our most recent Annual Report on Form 10-K, as it may be updated in subsequent reports filed with the SEC. That discussion covers certain risks, uncertainties and possibly inaccurate assumptions that could cause our actual results to differ materially from expected and historical results. Such factors include, but are not limited to, risks and uncertainties relating to the resolution of the FDA compliance issues at our Decatur, Illinois manufacturing facility. Other factors besides those listed there could also adversely affect our results.

 

EX-99.2 3 c98480exv99w2.htm PRESOLICITATION NOTICE exv99w2
 

EXHIBIT 99.2
68 — Acquisition of Ca DTPA and Zn DTPA (Calcium and Zinc Diethylenetriaminepentaacetate) to
support a public health emergency response to a radiological or nuclear event
    Modification 01 — Posted on Sep 14, 2005
General Information
     
Document Type:
  Presolicitation Notice
Solicitation Number:
  RFP-DHHS-ORDC-DDA-05-10 
Posted Date:
  Sep 14, 2005 
Original Response Date:
  Sep 29, 2005 
Current Response Date:
  Sep 29, 2005 
Original Archive Date:
  Dec 31, 2005 
Current Archive Date:
  Dec 31, 2005 
Classification Code:
  68 — Chemicals & chemical products
Naics Code:
  325414 — Biological Product (except Diagnostic) Manufacturing
Contracting Office Address
Department of Health and Human Services, Office of the Secretary, Office of Public Health Emergency Preparedness, Office of Research and Development Coordination 200 Independence Avenue, SW Room 636G, Washington, DC, 20201
Description
This is a Notice of Intent to negotiate on a Sole Source basis. The U.S. Government has an urgent need to acquire and maintain within the Strategic National Stockpile (SNS) Ca-DTPA and Zn-DTPA (Calcium and Zinc Diethylenetriaminepentaacetate). Currently there is only one manufacturer with a Food and Drug Administration (FDA) Approved Ca-DTPA and Zn-DTPA to treat internal contamination from radioactive elements, Hameln Pharmaceuticals, Gmbh, of Hameln, Germany. Hameln Pharmaceuticals has been granted by the FDA Orphan Drug Exclusivity for a period of 7 years from the date of approval of the New Drug Application (NDA) which was August 11, 2004. In November of 2004 Hameln Pharmaceuticals signed an Exclusive License and Supply Agreement for their FDA Approved Ca-DTPA and Zn-DTPA with Akorn, Inc. of Buffalo Grove, IL for the marketing and distribution of both drugs in the United States and Canada.
Due to the urgency of providing Ca-DTPA and Zn-DTPA for the SNS, HHS intends to utilize the Federal Acquisition Regulation (FAR) Subpart 6.3 ? Other than full and open competition, 6.302-1 Only one Responsible Source and No Other Supplies or Services will Satisfy Agency Requirements. The Government intends to enter into a sole source contract with Akorn, Inc of Buffalo Grove, IL. A commercial item award, resulting from a written RFP is anticipated. The anticipated award date is on or about November 15, 2005. This notice of intent is not a request for competitive proposals. Interested parties may identify their interest and capabilities in response to this requirement by submitting a capabilities statement to Darrick A. Early at the e-mail address below by September 29, 2005. The determination by the Government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government.

 


 

Comments to this announcement, referencing synopsis RFP-DHHS-ORDC-DDA-05-10 may be submitted to Darrick A. Early at (202) 205-5668 or in writing to darrick.early@hhs.gov. This proposed acquisition is subject to the availability of funds.
Original Point of Contact
Darrick Early, Contract Specialist, Phone 202-401-3693, Fax 202-690-7412, Email darrick.early@hhs.gov — David Beck, Chief Contracting Officer, Phone 202-205-5639, Fax 202-690-7412, Email david.beck@hhs.gov
Current Point of Contact
Darrick Early, Contract Specialist, Phone 202-205-5668, Fax 202-690-7412, Email darrick.early@hhs.gov — David Beck, Chief Contracting Officer, Phone 202-205-5639, Fax 202-690-7412, Email david.beck@hhs.gov
Place of Performance
     
Address:
  Buffalo Grove, IL
Postal Code:
  60089 
Country:
  US

 

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