ImmunoGen, Inc. Announces Favorable Update Provided by Roche Related to Its Trastuzumab-DM1 Regulatory Plans
April 15 2010 - 12:01AM
Business Wire
ImmunoGen, Inc. (Nasdaq:
IMGN), 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 www.immunogen.com.
This press release includes forward-looking statements. For
these statements, ImmunoGen claims the protection of the safe
harbor for forward-looking statements provided by the Private
Securities Litigation Reform Act of 1995. It should be noted that
there are risks and uncertainties related to the development of
novel anticancer products, including T-DM1, including risks related
to regulatory submissions and outcomes. A review of these risks can
be found in ImmunoGen’s Annual Report on Form 10-K for the fiscal
year ended June 30, 2009 and other reports filed with the
Securities and Exchange Commission.
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