Kadcyla® sales off to strong start. Decision on
European Union, TH3RESA Phase III data presentation expected by Roche in 2H2013.
- ImmunoGen progress with its proprietary pipeline includes advancement of third wholly owned product candidate for solid tumors, IMGN289, to active IND and presentation of first clinical data with IMGN853. Company remains on track to complete enrollment in IMGN901 NORTH Phase II trial in 2013 and to make key next-step decisions in mid-2014.
- ImmunoGen advancement of its wholly owned compounds to clinical proof of concept well supported by the Company's solid financial position and many cash-generating partnerships.
"We are starting to see the first commercial rewards from our many years
of scientific innovation," commented
Product Pipeline Update
Kadcyla is an approved product that utilizes the Company's TAP
technology. It is being developed and commercialized by Roche under an
agreement with ImmunoGen. ImmunoGen receives and recognizes royalties
on Kadcyla sales one quarter after the sales are reported by Roche.
FDAmarketing approval in the US on February 22, 2013for the treatment of people with HER2-positive metastatic breast cancer (BC) who had received prior treatment with Herceptin® (trastuzumab) and a taxane. Roche reported "strong uptake" of Kadcyla in the US, with year-to-date sales of 82 million CHF(approximately $87 million) through June 30, 2013.
Kadcyla was approved in
Switzerlandin May 2013, and Roche reported sales through June 30of 1 MM CHF. Roche expects a decision about approval in the EU in 2H2013. A marketing application is also under review in Japan.
Roche is assessing Kadcyla in a number of additional indications, including for first-line treatment of HER2-positive metastatic BC (MARIANNE trial), for uses in early stage HER2-positive BC (including the KATHERINE trial), and for the treatment of advanced HER2-positive stomach cancer (GATSBY trial). The progression-free survival (PFS) endpoint of TH3RESA has been met, and Roche intends to submit these data for presentation at the ESMO annual meeting
Sept. 27-Oct. 1, 2013. Roche expects results from MARIANNE in late 2014 and to apply for first-line treatment of HER2-positive metastatic BC and for treatment of advanced HER2-positive gastric cancer in 2015.
IMGN901 is ImmunoGen's lead wholly owned product candidate and is
being evaluated for first-line treatment of small-cell lung cancer
(SCLC). Its target, CD56, is found on a variety of cancers, including
SCLC, other tumors of neuroendocrine origin, and multiple myeloma.
The Company's NORTH Phase II trial is designed to assess whether the addition of IMGN901 to standard of care etoposide/carboplatin (E/C) provides a meaningful benefit over E/C alone as first-line treatment for newly diagnosed, extensive disease SCLC. The primary endpoint is progression-free survival (PFS), with objective response rate and overall survival (OS) among the secondary endpoints. Current first-line therapy for this cancer has a median PFS of 5-5.5 months and OS of 9-11 months.
ImmunoGen expects to complete patient enrollment this quarter and to have the data needed to make next-step decisions for the compound by mid-2014. The Company expects NORTH clinical data will be reported at one or more medical conferences in 2014.
IMGN853 is a potential new therapy for ovarian, endometrial, and
adenocarcinoma lung cancers, as well as other cancers that overexpress
its folate receptor α (FRα) target. This TAP compound is also wholly
owned by ImmunoGen.
The first IMGN853 clinical data were reported at the ASCO annual meeting in
June 2013. They were from the dose-escalation part of the Phase I trial underway, which is designed to establish the IMGN853 dose for the expansion phase of the trial. Dose levels ranging from 0.15 to 7.0 mg/kg had been evaluated, and at the time of data cut-off for presentation, the 5.0 mg/kg dose was being further explored. Evidence of activity was reported in patients with strong FRα expression who had received IMGN853 at doses of 3.3 mg/kg or above.
ImmunoGen expects to start the expansion phase of this trial later this year, and to report updated findings from it in disease-specific populations in mid-2014.
IMGN289 is ImmunoGen's third wholly owned TAP compound for solid tumor
indications, and is a potential new treatment for EGFR-positive
cancers, including most squamous cell lung and head and neck cancers.
In preclinical testing, IMGN289 was found to be highly active against cancer cells resistant to EGFR inhibiting agents − including tyrosine kinase inhibitors (TKIs) — as well as those responsive to EGFR inhibition. This is attributed to the ability of IMGN289 to kill cancer cells directly with its potent cytotoxic component as well as through EGFR inhibition. The IMGN289 Investigational New Drug (IND) application is now active and ImmunoGen expects to begin its clinical testing by the end of 2013.
IMGN529 is ImmunoGen's lead wholly owned TAP compound for
hematological malignancies. It is a potential treatment for
CD37-positive non-Hodgkin's lymphoma (NHL) and chronic lymphocytic
leukemia (CLL), and is currently in Phase I testing for
- In addition to Kadcyla, six other TAP compounds and a CD38-targeting therapeutic antibody are in clinical testing through ImmunoGen's collaborative partnerships, with additional compounds progressing preclinically.
Fiscal Year 2013 Financial Results
For the Company's fiscal year ended
Revenues in FY2013 were
Operating expenses in FY2013 were
ImmunoGen had approximately
Financial Guidance for FY 2014
For its fiscal year ending
"Kadcyla sales in the US are off to a good start, and we believe it will
become a very successful global product — one that makes an important
difference for many patients," commented
Conference Call Information
ImmunoGen is holding a conference call today at
Kadcyla® and Herceptin® are
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 revenues,
operating expenses, net loss, cash used in operations and capital
expenditures in its 2014 fiscal year; its cash and marketable securities
|SELECTED FINANCIAL INFORMATION|
|(in thousands, except per share amounts)|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||194,960||$||160,938|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Long-term portion of deferred revenue and other long-term liabilities||72,576||80,164|
|Total liabilities and shareholders' equity||$||213,596||$||180,308|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended||Fiscal Year Ended|
|License and milestone fees||$||855||$||950||$||24,227||$||9,161|
|Research and development support||2,203||1,184||7,873||4,517|
|Clinical materials revenue||181||818||2,843||2,679|
|Research and development||20,399||19,539||87,073||69,192|
|General and administrative||5,373||5,726||21,471||20,422|
|Total operating expenses||25,772||25,265||108,544||89,614|
|Loss from operations||(21,941||)||(22,313||)||(73,009||)||(73,257||)|
|Other income (expense), net||66||(101||)||198||(62||)|
|Net loss per common share, basic and diluted||$||(0.26||)||$||(0.29||)||$||(0.87||)||$||(0.95||)|
|Weighted average common shares outstanding, basic and diluted||84,554||77,416||84,063||76,814|
Executive Director, Investor Relations and Corporate Communications
The Yates Network
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