Marketing applications submitted for trastuzumab emtansine (T-DM1)
in the US and
- Meaningful clinical data expected to be reported in coming year — for ImmunoGen compounds, T-DM1, and other partner compounds.
- ImmunoGen well positioned to advance its wholly owned compounds at least through proof-of-concept.
"In the past few months, the results from the T-DM1 Phase III EMILIA
trial have been used as the basis for Roche's marketing submissions,
reported in oral presentations at ASCO and ESMO, and published in the
Product Pipeline Update
T-DM1, in global development by Roche:
Marketing applications submitted for lead indication — In August,
Roche applied for marketing approval in the US and
Europeof T-DM1 for the treatment of HER2+ metastatic breast cancer (BC) in patients who had previously received Herceptin®. T-DM1 was found to significantly improve both overall survival and progression-free survival compared to standard-of-care in the EMILIA Phase III trial and was associated with fewer Grade 3 or greater (severe) adverse events.
- Progress in Phase III trial, MARIANNE, for first-line treatment of HER2+ metastatic BC — Patient enrollment was completed this spring, and Roche now expects data from this trial in late 2013/early 2014, which is earlier than originally projected.
- Registration trials in early stage HER2+ BC on track to start in 2013 — Roche plans to evaluate T-DM1 for neoadjuvant use, for adjuvant use and for treatment of residual invasive disease following surgery.
- Assessment for metastatic HER2+ gastric cancer underway — Roche has initiated a trial assessing T-DM1 for second-line treatment of this disease and expects to apply for marketing approval for this use in 2015.
- Marketing applications submitted for lead indication — In August, Roche applied for marketing approval in the US and
IMGN901, ImmunoGen's lead wholly owned compound:
- Patient enrollment progressing in NORTH trial —Thirty-three sites across four countries are now participating in this randomized Phase II trial assessing IMGN901 as part of a combination regimen for first-line treatment of small-cell lung cancer. The Company expects to report the first findings from this Phase II assessment in the second half of 2013. Findings from its dose-finding Phase I assessment were reported at medical meetings in September and October.
Multiple myeloma data to be presented at
American Society of Hematology(ASH) annual meeting— Data from the Phase I trial assessing IMGN901 as part of a combination regimen for this cancer will be reported in an oral presentation at the ASH annual meeting in December.
IMGN853, ImmunoGen's wholly owned folate receptor α (FOLR)-targeting
- Patient enrollment in the Phase I trial is underway at several sites in the US.
- ImmunoGen expects to report the first clinical data with IMGN853 in 2013.
IMGN529, ImmunoGen's wholly owned TAP compound for non-Hodgkin's
- The study protocol was successfully amended to allow use of single-patient cohorts during dose escalation.
- Patient enrollment is underway at an expanding number of clinical centers.
- ImmunoGen expects to report the first clinical data with IMGN529 in 2013.
Other clinical-stage compounds — In addition to T-DM1, seven other
compounds are in clinical testing through ImmunoGen's collaborative
- The Company expects clinical data to be reported for most, if not all, of these compounds in 2013.
Financial Results and Guidance
ImmunoGen reported a net loss of
Operating expenses for 1Q FY2013 were
ImmunoGen had approximately
ImmunoGen's financial guidance remains unchanged from that issued in
"We believe that approval and launch of T-DM1 will begin a new era in
the treatment of HER2+ cancer," commented
Conference Call Information
ImmunoGen is holding a conference call today at
Herceptin® is a registered trademark of
This press release includes forward-looking statements based on
management's current expectations. These statements include, but are not
limited to, ImmunoGen's expectations related to: the Company's net loss,
cash used in operations and capital expenditures in its 2013 fiscal
year; its cash and marketable securities as of
|SELECTED FINANCIAL INFORMATION|
|(in thousands, except per share amounts)|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||233,614||$||160,938|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Long-term portion of deferred revenue and other long-term liabilities||79,928||80,164|
|Total liabilities and shareholders' equity||$||252,668||$||180,308|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended|
|Research and development support||$||1,377||$||1,068|
|License and milestone fees||933||1,187|
|Clinical materials reimbursement||1,781||281|
|Research and development||23,700||17,161|
|General and administrative||5,639||4,841|
|Total operating expenses||29,339||22,002|
|Loss from operations||(25,248)||(19,466)|
|Other income (expense), net||56||(17)|
|Net loss per common share, basic and diluted||$||(0.30)||$||(0.26)|
|Weighted average common shares outstanding, basic and diluted||83,350||76,364|
Executive Director, Investor Relations and Corporate Communications
The Yates Network
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