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7 years ago
UPDATE 1-ImmunoGen lung cancer drug gets FDA orphan status
August 18, 2010 / 5:41 PM / 7 years ago

UPDATE 1-ImmunoGen lung cancer drug gets FDA orphan status

2 Min Read

* Also gets positive opinion from EU agency

* Shares up as much as 5 pct

Aug 18 (Reuters) - Biotechnology firm ImmunoGen Inc (IMGN.O) said its experimental treatment for small-cell lung cancer has been granted orphan drug designation by the U.S. health regulator.

ImmunoGen said it also received a positive opinion from European regulators on granting orphan status to the drug, lorvotuzumab mertansine, formerly known as IMGN901.

In the United States, orphan drug designation is granted to drugs that treat a condition affecting less than 200,000 Americans. The status also grants the drugmaker marketing exclusivity of seven years upon approval.

The drug, which is currently in mid-stage trials, already has orphan drug designation for the treatment of Merkel cell carcinoma, a type of skin cancer, from both the U.S. and European regulators.

The company has six other cancer drugs in the pipeline, of which the most advanced candidate -- trastuzumab-DM1 -- is in late-stage trials. It is being developed for the treatment of metastatic breast cancer in collaboration with Roche's ROG.VX Genentech unit.

Shares of the Waltham, Massachusetts-based company were up 3 percent to $9.32 in afternoon trade on Nasdaq. The shares, which have risen 29 percent over the past six months, touched a high of $9.50 earlier in the session. (Reporting by Esha Dey in Bangalore)

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