ImmunoGen, Inc. Announces Orphan Drug Designation Granted to IMGN901 for Treatment of Merkel Cell Carcinoma by US FDA and EU COMP
WALTHAM, Mass., Mar 08, 2010 (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 http://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.
SOURCE: ImmunoGen, Inc.
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