0001144204-11-051766.txt : 20110908 0001144204-11-051766.hdr.sgml : 20110908 20110908123859 ACCESSION NUMBER: 0001144204-11-051766 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20110903 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20110908 DATE AS OF CHANGE: 20110908 FILER: COMPANY DATA: COMPANY CONFORMED NAME: HEMISPHERX BIOPHARMA INC CENTRAL INDEX KEY: 0000946644 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 520845822 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-13441 FILM NUMBER: 111080234 BUSINESS ADDRESS: STREET 1: 1617 JFK BLVD #660 STREET 2: ONE PENN CENTER CITY: PHILADELPHIA STATE: PA ZIP: 19104 BUSINESS PHONE: 2159880080 MAIL ADDRESS: STREET 1: 1617 JFK BLVD STREET 2: ONE PENN CENTER CITY: PHILADELPHIA STATE: PA ZIP: 19103 8-K 1 v234394_8k.htm FORM 8-K Unassociated Document
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)
September 3, 2011

HEMISPHERX BIOPHARMA, INC.
(Exact name of registrant as specified in its charter)
    
Delaware
0-27072
52-0845822
(state or other juris-
(Commission
(I.R.S. Employer
diction of incorporation)
File Number)
(Identification No.)
 
1617 JFK Boulevard, Philadelphia, Pennsylvania
19103
(Address of principal executive offices)
(Zip Code)

Registrant's telephone number, including area code: (215) 988-0080

(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 (see General Instruction A.2. below):

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 
 

 

Section 1 – Registrant’s Business and Operations

Item 1.01 Entry into a Material Definitive Agreement.

On September 3, 2011, we executed a new agreement with Armada Health Care, LLC ("Armada") for sales and marketing of Alferon N Injection®, our Federal Drug Administration-approved natural interferon, in the U.S.  In this Agreement, we will manufacture and supply Alferon N Injection® to physicians and patients through Armada's national network of specialty pharmacies.   Armada will also provide us with start up and ongoing sales and marketing support. The Agreement ends on August 14, 2012. Either party may terminate the Agreement at any time for any reason on not less than 60-days’ prior written notice.

Pursuant to a related agreement with Specialty Distributor, Bio Ridge Pharma, LLC (”BRP”), an Armada authorized Distributor and Wholesaler, BRP will warehouse, ship, and distribute Alferon N Injection® on an exclusive basis for sales in the U.S. and its Territories. The Agreement ends on August 14, 2012, but can be extended upon the mutual agreement of the parties.  Either party may terminate the Agreement at any time for any reason on not less than 60-days’ prior written notice.

A copy of the press release related to these agreements, dated September 6, 2011 is attached as Exhibit 99.1 to this Current Report on Form 8-K.
 
Item 9.01.  Financial Statements and Exhibits.

(c) Exhibits:
 
 
99.1 
Press Release dated September 6, 2011.
 
 
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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.
 
 
HEMISPHERX BIOPHARMA, INC.
       
September 8, 2011
By:
/s/ William A. Carter
 
   
William A. Carter M.D.,
 
   
Chief Executive Officer
 
 
 
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EX-99.1 2 v234394_ex99-1.htm EXHIBIT 99.1 Unassociated Document
Exhibit 99.1


Company/Investor Contact:
Dianne Will
Hemispherx Biopharma, Inc.
518-398-6222
ir@hemispherx.net

Hemispherx Biopharma Enters Into a Strategic Alliance with Armada Health Care
For Alferon N Injection®
….Coincides with Scale-Up of Manufacturing Capacity

Philadelphia, PA, September 6, 2011: Hemispherx Biopharma, Inc. (NYSE Amex: HEB) (the “Company” or “Hemispherx”), announced that the Company has entered into a new agreement with Armada Health Care, LLC (“Armada”) (www.armadahealthcare.com) for the sales/marketing of Alferon N Injection®, its Federal Drug Administration approved natural interferon, in the U.S.  Under this Agreement, the Company will manufacture and supply Alferon N Injection® to physicians and patients through Armada’s national network of specialty pharmacies.  Specialty Distributor, BioRidge Pharma, LLC (”BRP”) will warehouse, ship, and distribute Alferon N Injection® on an exclusive basis for U.S. sales.  Armada will also provide start up and ongoing sales and marketing support to the Company.

Brian Burke, Vice President of Sales and Marketing at Armada, said “We are very pleased to have completed our discussions with Hemispherx and are excited to start preparing for the planned launch of Alferon N Injection®.  As the only natural interferon approved in the U.S., we think Alferon N Injection® has great potential in our market”.

Mr. Wayne Springate, Senior Vice President of Operations for Hemispherx, stated “This agreement with Armada is especially timely.  We are upgrading our manufacturing facility in New Brunswick, New Jersey, to include a high volume, state-of- the-art bioreactor for the manufacture of Alferon N Injection®.  We hope this will allow us to supply greater volumes of product to the market.  We are also establishing an in-house team to support Armada and to establish other sales channels for Alferon N Injection®, educate physicians and patients with the expectation to eventually drive sales in a growing and sustainable manner in the U.S., as well as in Europe, Latin America and Asia where we are actively seeking partners”.

About Armada Health Care (Armada)
Armada has built the nation’s largest specialty pharmacy group contracting organization for comprehensive and cost effective access to the nation’s $100 billion specialty pharmacy industry. Armada offers specialty pharmacy providers, pharma/biotech manufacturers, national health plan payers and wholesale distributors a specialty pharmacy channel management solution through customized patient programs, prescription-data-management services and other unique purchasing agreements on specialty pharmacy products purchased and dispensed within this market.

 
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About Hemispherx Biopharma

Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx’s flagship products include Alferon N Injection® (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen® and Alferon® LDO. Ampligen® is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx’s platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net.

Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company’s filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen® and Alferon® LDO) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company’s judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. The planning, completion, results or submission of clinical trials do not imply that any study product will ever be approved commercially for the studied or other treatment indications. The scale-up of Alferon N manufacturing could be delayed by various critical steps including those involved in construction, GMP compliance, formulation, packaging and labeling, as well as potential issues related to 3rd party vendors including without limitation various “fill and finish” procedures.

 
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