ImmonoGen Drug Gets Orphan Status – Analyst Blog

ImmunoGen Inc. (IMGN) recently announced that the US Food and Drug Administration (FDA) granted orphan drug status to the company’s small-cell lung cancer (SCLC) candidate, lorvotuzumab mertansine. The drug was earlier called IMGN901.

 

ImmunoGen said that it also has a positive opinion from the European Medicines Agency (EMA) Committee for lorvotuzumab mertansine. A final decision from the European Commission (EC) regarding the orphan drug status for the SCLC indication in the EU should be out shortly.

 

Lorvotuzumab mertansine has orphan drug status in the United States and the European Union (EU) for the treatment of Merkel cell carcinoma, which is a kind of skin cancer.

 

Orphan drug designation is granted in the US only to drugs that treat a disease affecting less than 200,000 people in the country. As one of the benefits of this status, lorvotuzumab mertansine on being granted marketing approval will have seven years of market exclusivity along with receiving certain financial help to support the drug’s development for SCLC.

 

In the EU, orphan drug status is given to drugs, which have the potential to treat life-threatening or chronically debilitating conditions that affect fewer than five in 10,000 people. Once the EC approves lorvotuzumab mertansine for marketing in the EU for SCLC, the drug will have ten years of marketing exclusivity along with some financial incentives.

 

We currently have a Neutral recommendation on ImmunoGen, which is supported by a Zacks #3 Rank (short-term Hold rating). ImmunoGen has several compounds in development for the treatment of various types of cancer. Trastuzumab-DM1 being studied for advanced breast cancer is the only one for which a marketing approval application has been filed in the US. ImmunoGen has an agreement with Roche Holding Ltd. (RHHBY) for the development of trastuzumab-DM1.

 

We view the granting of orphan drug status to lorvotuzumab mertansine by the FDA as a positive given the fact that ImmunoGen is presently running at a loss. We believe the approval of trastuzumab-DM1 and lorvotuzumab mertansine will help the company turn the tide.