By Business Wire, September 20, 2013, 08:15:00 AM EDT
ImmunoGen, Inc. Announces Positive Regulatory Decisions for Roche's Kadcyla® in the European Union and Japan
- CHMP has issued a positive opinion for Kadcyla, with the European
Commission decision expected by the end of 2013.
- The Japanese MHLW has approved Kadcyla for marketing in Japan,
which triggers a $5 million milestone payment to ImmunoGen.
- Kadcyla comprises Roche's trastuzumab antibody and ImmunoGen's ADC
WALTHAM, Mass.--(BUSINESS WIRE)--
ImmunoGen, Inc. (Nasdaq:IMGN), a biotechnology company that develops
novel anticancer therapeutics using its antibody-drug conjugate (ADC)
technology, today announced positive decisions for Kadcyla (trastuzumab
emtansine, formerly T-DM1) in both the European Union (EU) and Japan,
the two largest pharmaceutical markets after the US. Kadcyla was
approved for marketing in the US earlier this year.
The EU's Committee for Medicinal Products for Human Use (CHMP) has
recommended approval of Kadcyla for the treatment of adults with
HER2-positive, inoperable locally advanced or metastatic breast cancer
who previously received trastuzumab and a taxane, separately or in
combination. This decision is based on the findings in the EMILIA Phase
III trial. A decision by the European Commission is expected by year
end. An approval decision would trigger a $5 million milestone payment
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved
Kadcyla for the treatment of inoperable or recurrent HER2-positive
breast cancer based on results from a Japanese Phase II trial and the
EMILIA Phase III trial. This event triggers a $5 million milestone
payment to ImmunoGen.
"These positive decisions are important steps toward Kadcyla becoming
available for patients in the EU and Japan," commented Dan Junius,
President and CEO.
The EMILIA trial assessed Kadcyla compared to standard therapy for the
treatment of patients with HER2-positive metastatic breast cancer who
had previously received Herceptin® (trastuzumab) and a
taxane. Kadcyla demonstrated a significant improvement in overall
survival and in progression-free survival, and fewer patients
experienced severe adverse events, compared to standard therapy.
Kadcyla consists of Roche's trastuzumab antibody and ImmunoGen's DM1
cytotoxic agent. The DM1 is attached to the antibody using one of
ImmunoGen's linkers. Roche has global development and commercialization
rights for Kadcyla; ImmunoGen is entitled to receive specified milestone
payments and royalties on product sales.
Roche is conducting a number of studies assessing Kadcyla for potential
additional uses. These include for the first-line treatment of
HER2-positive metastatic breast cancer, for early stage HER2-positive
breast cancer and for advanced HER2-positive gastric cancer.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company's
ADC technology uses a tumor-targeting engineered antibody to deliver one
of ImmunoGen's highly potent cancer-cell killing agents specifically to
tumor cells. The most advanced compound with ImmunoGen's ADC technology
is Roche's Kadcyla, which is marketed in the US by Genentech. ImmunoGen
has four wholly owned clinical-stage product candidates, with additional
compounds in the clinic through its partnerships with Amgen, Bayer
HealthCare, Biotest and Sanofi. More information about the Company can
be found at www.immunogen.com.
Kadcyla® and Herceptin® are registered trademarks
of Genentech, Inc., a member of the Roche Group.
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 risks related to regulatory decisions, their timings and
results. A review of these risks can be found in ImmunoGen's Annual
Report on Form 10-K for the fiscal year ended June 30, 2013 and other
reports filed with the Securities and Exchange Commission.
Source: ImmunoGen, Inc.