Replies to post #87432 on Biotech Values

[turtlepower]

imgn -

It appears that Roche is not in a hurry to file for 3rd line.

Why do you say that? Assuming you are referring to them speaking to the FDA first, what did you expect them to say when there is no SPA?

ONce T-DM1 is approved, those patients randomized to control arm would be clamoring for it upon disease progression.

Thats an interesting point. However as far as the 2nd line trial goes, it should be done by early '11 and tdm1 if submitted won't be approved till late 2010 which wouldn't leave enough time for a significant number of patients to skew the data against tdm1 for 2nd line.

[mcbio]

IMGN - Roche filing for T-DM1 Approval

http://finance.yahoo.com/news/ImmunoGen-Inc-Announces-bw-3496483266.html?x=0&.v=1

ImmunoGen, Inc. Announces Favorable Update Provided by Roche Related to Its Trastuzumab-DM1 Regulatory Plans

WALTHAM, Mass.--(BUSINESS WIRE)--ImmunoGen, Inc. (Nasdaq: IMGN - News), a biotechnology company that develops targeted anticancer products, today announced that Roche has provided a favorable update related to its plans to apply for marketing approval of trastuzumab-DM1 (T-DM1) in the US.

T-DM1 comprises ImmunoGen’s DM1 cancer-cell killing agent linked to the HER2-targeting antibody, trastuzumab, developed by Genentech, a wholly owned member of the Roche Group. T-DM1 is in global development by the Roche Group under a collaboration agreement between Genentech and ImmunoGen.

In its quarterly release issued earlier today, Roche disclosed that company representatives have had discussions with the US Food and Drug Administration (FDA) and that, based on these discussions, Genentech/Roche plans to submit a marketing application to the FDA in 2010 for use of T-DM1 in the treatment of advanced HER2-positive metastatic breast cancer. This is cancer that has progressed on multiple prior therapies including trastuzumab- and lapatinib-containing regimens for metastatic disease. The basis for this application is to be the positive Phase II data that were presented at the San Antonio Breast Cancer Symposium in December 2009.

“We’re pleased that Roche has provided this update and look forward to the submission of the US marketing application for T-DM1,” commented Daniel Junius, President and CEO.

About ImmunoGen’s Targeted Antibody Payload (TAP) Technology

The Company’s TAP technology uses antibodies to deliver one of ImmunoGen’s proprietary cancer-cell killing agents (e.g., DM1, DM4) specifically to tumors. ImmunoGen developed these agents specifically for targeted delivery to tumor cells. They are 1,000 – 10,000-fold more potent than standard chemotherapeutics and are designed to be attached to antibodies using one of the Company’s engineered linkers. In addition to T-DM1, five other compounds that make use of ImmunoGen’s TAP technology are in clinical testing.

About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer therapeutics using its expertise in cancer biology, monoclonal antibodies and the creation and attachment of potent cell-killing agents. The Company’s TAP technology uses antibodies to deliver one of ImmunoGen’s cancer-cell killing agents specifically to tumor targets. In addition to the Company’s product pipeline, compounds utilizing the TAP technology are in clinical testing through ImmunoGen’s collaborations with Genentech (a wholly owned member of the Roche Group), sanofi-aventis, Biogen Idec and Biotest. The most advanced compound, T-DM1, is in Phase III testing being conducted by Genentech and Roche. Other ImmunoGen collaborative partners include Bayer HealthCare and Amgen. More information about ImmunoGen can be found at http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.immunogen.com%2Fwt%2Fhome%2Fhome&esheet=6249137&lan=en_US&anchor=www.immunogen.com&index=2&md5=1ff47f3c115c9be6d839da261c9add6f