-----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, DK7exQ9ftIDL65EHpKOlVFp8dybE7YIm/1fCe8rjpLG0dWyOwTyhk74opS/vdOBw dOf5KEwH1BhTO/LcGL8j5A== 0000908737-06-000858.txt : 20061206 0000908737-06-000858.hdr.sgml : 20061206 20061206164850 ACCESSION NUMBER: 0000908737-06-000858 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20061206 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20061206 DATE AS OF CHANGE: 20061206 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ADVANCED MAGNETICS INC CENTRAL INDEX KEY: 0000792977 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 042742593 STATE OF INCORPORATION: DE FISCAL YEAR END: 0930 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-14732 FILM NUMBER: 061260509 BUSINESS ADDRESS: STREET 1: 125 CAMBRIDGEPARK DRIVE, 6TH FLOOR CITY: CAMBRIDGE STATE: MA ZIP: 02140 BUSINESS PHONE: 6174972070 MAIL ADDRESS: STREET 1: 125 CAMBRIDGEPARK DRIVE, 6TH FLOOR CITY: CAMBRIDGE STATE: MA ZIP: 02140 8-K 1 ami_8k.htm ADVANCED MAGNETICS, INC. 8-K Advanced Magnetics, Inc. 8-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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) December 6, 2006
 
ADVANCED MAGNETICS, INC.
(Exact Name of Registrant as Specified in Its Charter)
 
Delaware
(State or Other Jurisdiction of Incorporation)
 
0-14732
04-2742593
(Commission File Number)
(IRS Employer Identification No.)
   
125 CambridgePark Drive, 6th Floor
 
Cambridge, Massachusetts
02140
(Address of Principal Executive Offices)
(Zip Code)

(617) 498-3300
(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:
 
¨ 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))
 


 

 




Item 8.01. Other Events.

On December 6, 2006, Advanced Magnetics, Inc. issued the press release attached hereto as Exhibit 99.1

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Number Description 
   
99.1 Press release dated December 6, 2006.

 




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 thereunto duly authorized.
 

 
ADVANCED MAGNETICS, INC.
 
 
 
 
By: /s/ Joseph L. Farmer                              
   
Joseph L. Farmer
   
General Counsel and Vice President of
   
Legal Affairs

 
Date: December 6, 2006
 



EXHIBIT INDEX

Number Description 
   
99.1 Press release dated December 6, 2006.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
EX-99.1 2 ex99-1.htm ADVANCED MAGNETICS, INC. 8-K, EXHIBIT 99.1 Advanced Magnetics, Inc. 8-K, Exhibit 99.1
EXHIBIT 99.1

FOR IMMEDIATE RELEASE


Contact:
Lynn Kettleson
 
Clarke Communications Group
lkettleson@clarkecommgroup.com
(978) 463-7952


Advanced Magnetics, Inc. Announces European Partner Files Marketing Authorization Application for Combidex® With EMEA


CAMBRIDGE, MA, (December 6, 2006) -- Advanced Magnetics, Inc. (NASDAQ: AMAG) today announced that its European partner, Guerbet S.A. of France, submitted a marketing authorization application (MAA), the European equivalent of a New Drug Application, for Combidex®, Advanced Magnetics’ investigational functional molecular imaging agent for use in conjunction with magnetic resonance imaging to aid the differentiation of normal from metastatic lymph nodes, to the European Medicines Agency (EMEA).

According to a press release by Guerbet issued on December 4, 2006, the MAA was submitted to the EMEA seeking approval of Combidex under the trade name Sinerem™ as an aid in the differentiation of lymph nodes in patients with pelvic cancers, including prostate, bladder and uterus cancer. Guerbet announced that the MAA will be reviewed by the United Kingdom and Ireland, and subject to approval in Europe, Guerbet stated that it plans to launch the product in Germany and the United Kingdom during the second quarter of 2008. Guerbet also announced that it will file an application for Sinerem in Switzerland before the end of 2006.

Advanced Magnetics and Guerbet are parties to a supply and distribution agreement whereby Advanced Magnetics granted Guerbet an exclusive right to manufacture and sell Combidex in certain countries in the European Union, South America, the Middle East, Southeast Asia, South Africa, Mexico and Eastern Europe. For more information about Guerbet, please go to www.guerbet.com. Sinerem is a trademark of Guerbet S.A. and is registered in France and other jurisdictions.

Combidex is an investigational functional molecular imaging agent consisting of iron oxide nanoparticles for use in conjunction with magnetic resonance imaging, or MRI, to aid in the differentiation of cancerous from normal lymph nodes. We have granted exclusive rights to market and sell Combidex in the United States to Cytogen Corporation.

About Advanced Magnetics
Advanced Magnetics, Inc. is a developer of superparamagnetic iron oxide nanoparticles used in pharmaceutical products. As a leader in our field, we are dedicated to the development and commercialization of our proprietary nanoparticle technology for use in therapeutic iron compounds to treat anemia, as well as novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease. For more information about us, please visit our website at http://www.advancedmagnetics.com, the content of which is not part of this press release.
 
 
 

 
 
This document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and federal securities laws. Any statements contained in this press release that do not describe historical facts, including but not limited to, statements regarding Guerbet’s plans to launch Sinerem™ in certain countries and its plans to seek approval for Sinerem™ in Switzerland are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include the following: (1) the possibility that the EMEA will not accept the MAA for review or will require additional information prior to commencing its review; (2) the possibility that the MAA will not be approved; (3) the possibility that even if approved, Guerbet will not launch the product in Europe as currently planned; (4) the possibility that Guerbet will not file an application for the product in Switzerland as currently planned; (5) uncertainties surrounding Guerbet's ability to market and sell the product; and (6) other risks identified in our Securities and Exchange Commission filings. We caution readers not to place undue reliance on any forward-looking statements which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
 


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