-----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, Q9PEQO8FbXH9ygk+SedbG7jFlKY4B8lq1/tO0HV4SR5fLmPl4n84x47Mkh/Hj02O AdlgUEX16kaZ0VM+DzDpSA== 0000950133-06-002901.txt : 20060608 0000950133-06-002901.hdr.sgml : 20060608 20060608160856 ACCESSION NUMBER: 0000950133-06-002901 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20060605 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060608 DATE AS OF CHANGE: 20060608 FILER: COMPANY DATA: COMPANY CONFORMED NAME: HUMAN GENOME SCIENCES INC CENTRAL INDEX KEY: 0000901219 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 223178468 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-14169 FILM NUMBER: 06894208 BUSINESS ADDRESS: STREET 1: 14200 SHADY GROVE ROAD CITY: ROCKVILLE STATE: MD ZIP: 20850-3338 BUSINESS PHONE: 3013098504 MAIL ADDRESS: STREET 1: 14200 SHADY GROVE ROAD CITY: ROCKVILLE STATE: MD ZIP: 20850 8-K 1 w22111e8vk.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): June 5, 2006
HUMAN GENOME SCIENCES, INC.
(Exact name of registrant as specified in its charter)
         
Delaware
(State or other jurisdiction
of incorporation)
  000-22962
(Commission
File Number)
  22-3178468
(IRS Employer
Identification No.)
14200 Shady Grove Road, Rockville, Maryland 20850-7464
(Address of principal executive offices)           (ZIP Code)
Registrant’s telephone number, including area code: (301) 309-8504
 
(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:
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 June 5, 2006 we entered into an exclusive worldwide licensing agreement with Novartis for the development and commercialization of Albuferon™, an immunomodulator for the treatment of Hepatitis C.
Pursuant to the licensing agreement we will receive a $45 million up-front payment and are entitled to another $47.5 million when the first Albuferon dose is given to a patient in a Phase 3 clinical trial. We are also entitled to additional clinical development, commercial milestone, and other payments of up to $415 million over the term of the agreement.
The agreement provides that we and Novartis will co-commercialize Albuferon inside the United States and will equally divide (1) U.S. profits relating to Albuferon, (2) U.S. commercialization costs, and (3) clinical development costs. Novartis is responsible for Albuferon commercialization outside of the U.S. and will pay us a royalty on non-U.S. sales. We have the principal responsibility for bulk manufacturing of Albuferon; Novartis is responsible for finished drug product.
A press release discussing our Novartis relationship is attached hereto as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits.
(d)   Exhibits
 
99.1   Press Release dated June 6, 2006 regarding Novartis Agreement
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
         
  HUMAN GENOME SCIENCES, INC.
 
 
  /s/ James H. Davis, Ph.D.    
  Name:   James H. Davis, Ph.D.   
  Title:   Executive Vice President, General Counsel
and Secretary 
 
 
Date: June 8, 2006

 


 

Exhibit Index
     
Exhibit   Description
 
   
99.1
  Press Release dated June 6, 2006 regarding Novartis Agreement

 

EX-99.1 2 w22111exv99w1.htm EXHIBIT 99.1 exv99w1
 

Exhibit 99.1
(HUMAN GENOME LOGO)
FOR IMMEDIATE RELEASE
CONTACTS:
Jerry Parrott
Vice President, Corporate Communications
301-315-2777
Kate de Santis
Director, Investor Relations
301-251-6003
HUMAN GENOME SCIENCES ANNOUNCES COLLABORATION WITH NOVARTIS FOR DEVELOPMENT AND COMMERCIALIZATION OF ALBUFERON™
- HGS to receive development and commercial milestone and other payments of up to $507 million -
- Albuferon™ expected to enter Phase 3 development in chronic hepatitis C in 2006 -
ROCKVILLE, Maryland — June 6, 2006 — Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced an exclusive worldwide licensing agreement with Novartis for the development and commercialization of Albuferon™ (albumin-interferon alpha 2b) for chronic hepatitis C and all other uses.
Under the agreement, HGS and Novartis will co-commercialize Albuferon in the United States, and will share U.S. commercialization costs and U.S. profits equally. Novartis will be responsible for commercialization outside the U.S. and will pay HGS a royalty on those sales. HGS and Novartis will share equally in clinical development costs. HGS will receive an upfront fee of $45 million. Clinical development, commercial milestone and other payments to HGS could total as much as $507.5 million, including $47.5 million when the first patient is dosed in a Phase 3 clinical trial. HGS will have primary responsibility for the bulk manufacture of Albuferon.
“This agreement brings the strengths of a global leader in the pharmaceutical industry to the development and commercialization of Albuferon, a product that could become the best-in-class immunomodulator in treatment regimens for chronic hepatitis C,” said H. Thomas Watkins, President and Chief Executive Officer of Human Genome Sciences.
“Novartis has demonstrated its commitment to leadership in infectious diseases, and we look forward to working closely together to advance Albuferon rapidly to the market. This collaboration is a significant step forward in our company’s progress toward commercialization.”
HGS expects to initiate Phase 3 clinical development of Albuferon by the end of 2006.

1


 

About Albuferon
Clinical studies to date indicate that Albuferon could offer improved dosing in the treatment of chronic hepatitis C, with efficacy and safety at least comparable to the current standard of care, pegylated interferons. These results demonstrate that Albuferon is well tolerated, remains in the blood substantially longer than is reported for recombinant interferon alpha and pegylated interferon alpha, and exhibits robust antiviral activity.
Albuferon is a novel, long-acting form of interferon alpha. It is a Human Genome Sciences drug created using the Company’s proprietary albumin fusion technology. This technology enables scientists to improve the pharmacological properties of therapeutic proteins by fusing the gene that expresses human albumin to the gene that expresses the active protein. Albuferon results from the genetic fusion of human albumin and interferon alpha 2b. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B and a broad range of cancers.
About Hepatitis C
Hepatitis C is an inflammation of the liver caused by the hepatitis C virus. It is the most common chronic blood-borne infection in the developed world. It is estimated that as many as 170 million people worldwide are infected with hepatitis C virus. This includes nearly four million people in the United States. The hepatitis C virus is transmitted primarily through significant or repeated exposures to infected blood. Intravenous drug use and sexual contact with infected persons account for the majority of new hepatitis C infections. When detectable levels of the hepatitis C virus in the blood persist for at least six months, a person is diagnosed as having chronic hepatitis C.
CONFERENCE CALL
HGS management will hold a conference call to discuss this announcement today at 9:00 a.m. Eastern time. Investors may listen to the call by dialing 866/558-6869 or 913/643-4199, passcode 1638413, five to ten minutes before the start of the call. A replay of the conference call will be available for several days by dialing 888/203-1112 or 719/457-0820, passcode 1638413. This conference call also will be webcast. Interested parties who wish to listen to the webcast should visit the Human Genome Sciences website at www.hgsi.com. The archive of the conference call will be available several hours after the conference call and will remain available for several days.

2


 

About Human Genome Sciences
The mission of Human Genome Sciences is to discover, develop, manufacture and market innovative drugs that serve patients with unmet medical needs, with a primary focus on protein and antibody drugs.
For more information about Human Genome Sciences, please visit the Company’s web site at www.hgsi.com. For more information about Albuferon, visit http://www.hgsi.com/products/albuferon.html.
Albuferon, HGS and Human Genome Sciences are trademarks of Human Genome Sciences, Inc.
Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciences’ current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of the Company’s unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, the Company’s ability to develop and commercialize products, its dependence on collaborators for services and revenue, its substantial indebtedness and lease obligations, its changing requirements and costs associated with planned facilities, intense competition, the uncertainty of patent and intellectual property protection, the Company’s dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in the Company’s filings with the Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.
###

3

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-----END PRIVACY-ENHANCED MESSAGE-----