ImmunoGen, Inc. Announces Orphan Drug Designation Granted to IMGN901 for Treatment of Merkel Cell Carcinoma by US FDA & EU COMP
March 08 2010 - 3:01PM
Business Wire
ImmunoGen, Inc. (Nasdaq:
IMGN), a biotechnology company that develops targeted anticancer
products using its antibody expertise and Targeted Antibody Payload
(TAP) technology, today announced that the US Food and Drug
Administration (FDA) has granted orphan drug designation to its
IMGN901 compound when used for the treatment of Merkel cell
carcinoma (MCC). Through a separate process, the European Union
(EU) Committee for Orphan Medicinal Products (COMP) concurrently
also granted IMGN901 orphan medicinal product designation for the
treatment of MCC.
“IMGN901 has shown promising activity among the small number of
MCC patients treated to date, suggesting this is a potential
registration path for the compound,” commented Daniel Junius,
President and CEO. “Metastatic MCC is a rare and highly aggressive
cancer with no approved treatments today. We are preparing to be
ready to initiate pivotal testing of IMGN901 in MCC in 2011 and
will make the final decision based on expanded clinical experience
and regulatory input. Gaining orphan drug designation for IMGN901
in the US and Europe is an important step in this process.”
Six patients with metastatic MCC had received IMGN901 at the
time of the AACR-NCI-EORTC meeting in November 2009.1 Among these,
two patients had an objective response – including a patient who
has had a sustained complete remission – and a third patient had
clinically meaningful stable disease.
In the US, the Orphan Drug Act is intended to encourage
companies to develop therapies for the treatment of diseases that
affect fewer than 200,000 people in this country. Orphan drug
designation provides ImmunoGen with seven years of market
exclusivity that begins once IMGN901 receives FDA marketing
approval for the treatment of MCC. It also provides certain
financial incentives that can help support the development of
IMGN901 for MCC.
Similarly, in the EU, orphan medicinal product designation is
intended to encourage companies to develop therapies for
life-threatening or chronically debilitating conditions that affect
no more than five in 10,000 people in the EU. Orphan medicinal
product designation provides ImmunoGen with ten years of market
exclusivity that begins once IMGN901 receives European approval for
MCC. It also enables access to certain financial incentives as well
as to protocol assistance.
About IMGN901
IMGN901 is an investigational agent designed to kill cancer
cells that express CD56, a protein. This TAP compound consists of a
CD56-binding antibody with a potent cancer-cell killing agent, DM1,
attached to it using an engineered linker. IMGN901 is wholly owned
by ImmunoGen.
CD56 is expressed on MCC, small-cell lung cancer (SCLC), ovarian
cancer, carcinoid and other solid tumors of neuroendocrine origin,
and IMGN901 is in early clinical testing for the treatment of MCC,
SCLC and ovarian cancer. CD56 also is expressed on multiple myeloma
and certain other hematological malignancies. IMGN901 is in early
clinical testing for the treatment of CD56+ multiple myeloma, both
when used as a single agent and as part of a combination
regimen.
About Merkel Cell Carcinoma (MCC)
MCC is an aggressive neuroendocrine cancer of the skin that
typically occurs on the head/neck, most often in individuals of
European ancestry. There are approximately 2000 new cases of MCC
diagnosed in the US each year.2 The incidence is considered to be
increasing. Medicinal therapy is generally used with patients whose
cancer has recurred following surgery and with patients who have
metastases at the time of diagnosis. Metastatic disease is
associated with a poor outcome, with reported median survival
timeframes of 5 to 9 months.
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, trastuzumab-DM1 (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.
1Woll P. et al., Clinical Experience of IMGN901 (BB-10901,
huN901-DM1) in Patients with Merkel Cell Carcinoma (MCC) (Abstract
#B237), AACR-NCI-EORTC, 2009.
2Based on incidence data from Albores-Saavedra et al., 2009.
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 IMGN901, including risks
related to uncertainties around clinical trials conducted and 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, 2009 and other reports filed with the Securities and
Exchange Commission.
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