ImmunoGen Inc. ( IMGN ) recently provided an update on its pipeline and maintained its outlook for fiscal year 2013 (ending June 30) at its recently held Analyst & Investor Day.
ImmunoGen stated that its primary focus will be on the advancement of its pipeline. ImmunoGen currently has one approved product along with three wholly owned clinical-stage compounds and seven additional clinical-stage partner compounds.
ImmunoGen's Kadcyla (ado-trastuzumab emtansine or T-DM1) was approved by the US Food and Drug Administration (FDA) for the treatment of patients suffering from HER2-positive metastatic breast cancer (mBC) in February this year.
The company is also expecting the EU approval of Kadcyla in the second half of the calendar year 2013. We note that ImmunoGen has partnered with Roche Holding ( RHHBY ) for Kadcyla.
Pipeline in Focus
The company's three wholly owned clinical-stage compounds include IMGN901, IMGN853 and IMGN529.
IMGN901 is currently in phase II development for the first-line treatment of small-cell lung cancer (SCLC). With patient enrolment being completed for the phase II study, the company should be able to report results from a planned interim analysis on progression free survival (PFS) in the second half of 2013. IMGN901 is also being developed for the treatment of multiple myeloma.
Moreover, ImmunoGen is developing IMGN853 in a phase I study for the treatment of ovarian cancer, with initial data expected in mid-2013. Another candidate, IMGN529 is also being developed in a phase I clinical study for the treatment of non-Hodgkin's lymphoma. The company expects clinical data from the study by year end.
ImmunoGen plans to add IMGN289 to its pipeline this year. The company intends to submit an Investigational New Drug (IND) application for its EGFR-overexpressing solid tumors candidate, IMGN289, in mid-2013. ImmunoGen expects to begin clinical testing for the candidate by the end of 2013.
Fiscal 2013 Outlook Maintained
Apart from providing an update on its pipeline development programs, ImmunoGen also maintained its guidance for fiscal 2013. The company expects net loss of $70-$74 million for the fiscal year 2013. ImmunoGen still expects to exit fiscal 2013 with cash and cash equivalents of $172-$176 million.
We are positive on the FDA approval of Kadcyla since the breast cancer market represents significant commercial potential. We are also impressed by the company's efforts to develop its pipeline.
Moreover ImmunoGen's alliances with big companies like Roche and AstraZeneca ( AZN ) are also encouraging.
ImmunoGen, a biotech stock, presently carries a Zacks Rank #3 (Hold). Comparatively, other biotech stocks such as QLT Inc. ( QLTI ) look better positioned. QLT currently carries a Zacks Rank #1 (Strong Buy).