-----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, LmwhaI5RhcFE/EPVgc9G8aqVaS52kVWHGsG0KOLJX+Ybbou9oih0Ou+j3uYn79Hk ActFDXIijMDqSEMq4fYaoA== 0001104659-08-064202.txt : 20081015 0001104659-08-064202.hdr.sgml : 20081015 20081015114458 ACCESSION NUMBER: 0001104659-08-064202 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20081014 ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20081015 DATE AS OF CHANGE: 20081015 FILER: COMPANY DATA: COMPANY CONFORMED NAME: IMMUNOGEN INC CENTRAL INDEX KEY: 0000855654 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 042726691 STATE OF INCORPORATION: MA FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-17999 FILM NUMBER: 081124333 BUSINESS ADDRESS: STREET 1: 128 SIDNEY ST CITY: CAMBRIDGE STATE: MA ZIP: 02139 BUSINESS PHONE: 6179952506 MAIL ADDRESS: STREET 1: 128 SIDNEY ST CITY: CAMBRIDGE STATE: MA ZIP: 02139 8-K 1 a08-26175_18k.htm 8-K

 

 

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): October 14, 2008

 

ImmunoGen, Inc.

(Exact name of registrant as specified in its charter)

 

Massachusetts

 

0-17999

 

04-2726691

(State or other
jurisdiction of
incorporation)

 

(Commission File
Number)

 

(IRS Employer
Identification No.)

 

830 Winter Street, Waltham, MA 02451

(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (781) 895-0600

 

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 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 7.01 — REGULATION FD DISCLOSURE

 

On October 14, 2008 Genentech, Inc. disclosed new information after market close related to trastuzumab-DM1 (T-DM1), which comprises ImmunoGen’s DM1 cell-killing agent linked to Genentech’s anti-HER2 antibody, trastuzumab. T-DM1 is in development by Genentech for the treatment of HER2-positive metastatic breast cancer (HER2+ mbc).

 

Genentech disclosed that the company plans to initiate a Phase III trial in the first half of 2009 to evaluate T-DM1 as a second-line treatment for HER2+ mbc (i.e., Genentech made the Phase III “go” decision). Patients in this trial will be randomized to treatment either with T-DM1, given as a single agent, or with capecitabine plus lapatinib, and the trial is to have progression-free survival as its primary endpoint.

 

T-DM1 is being developed under a licensing agreement that enables Genentech to use ImmunoGen’s maytansinoid TAP technology with anti-HER2 antibodies. Under this agreement, ImmunoGen is entitled to earn a milestone payment from Genentech with the start of patient dosing in a Phase III trial. Anticipated achievement of this milestone payment was reflected in ImmunoGen’s financial guidance provided on August 7, 2008 for its fiscal year ending June 30, 2009.

 

Genentech also disclosed that patient dosing began during the quarter ended September 30, 2008 in both its Phase II trial evaluating T-DM1 as a third-line treatment for HER+ mbc and in its Phase II trial assessing T-DM1 as a first-line treatment for HER2+ mbc. Should the third-line study yield compelling data, Genentech plans to discuss an accelerated approval path with the FDA.

 

Additionally, Genentech disclosed that the company expects to present data from the study evaluating T-DM1 as a “second-line plus” treatment for HER2+ mbc at the San Antonio Breast Cancer Symposium in December 2008, and that it plans to initiate a Phase Ib study in the first half of 2009 to assess T-DM1 given in combination with its pertuzumab compound.

 

 

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.

 

 

 

ImmunoGen, Inc.

 

(Registrant)

 

 

Date: October 15, 2008

/s/ Daniel M. Junius

 

 

 

Daniel M. Junius

 

President and Chief Operating Officer

 

2

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