-Quarterly Conference Call Today at 8:00 am ET-
Sales development in the US, a positive CHMP opinion for the European
Union, and approvals and/or launches in additional countries,
including approval in Japan.
Roche reported Kadcyla sales year-to-date September 30, 2013 were 152
million CHF in the US and 4 million CHF ex-US (in total, approximately
$168 million). ImmunoGen receives and recognizes royalties on Kadcyla
sales the quarter after the quarter in which Roche records the sales.
Positive results from the TH3RESA trial were presented at the 2013
European Cancer Congress.
Roche reported its plans to conduct a pivotal trial assessing Kadcyla
for neoadjuvant use in early stage HER2-positive breast cancer. It
expects to start this trial in 2Q2014 and for the pCR (pathological
complete response) data to be available in late 2015.
Roche continues to expect results from its first-line MARIANNE trial
in 2014. It expects to apply in 2015 for marketing approval of Kadcyla
for first-line treatment of HER2-positive metastatic breast cancer
with MARIANNE data and for treatment of advanced HER2-positive gastric
cancer with GATSBY data.
WALTHAM, Mass.--(BUSINESS WIRE)--
Inc. (Nasdaq: IMGN), a biotechnology
company that develops novel anticancer therapeutics using its
antibody-drug conjugate (ADC) technology, today reported financial
results for the three-month period ended September 30, 2013 – the first
quarter of the Company’s 2014 fiscal year. ImmunoGen also provided an
update on Kadcyla®, the Company’s wholly owned product
candidates, other partner programs and the latest additions to its
industry-leading ADC technology portfolio.
“Kadcyla is already making a difference for many patients in the US, and
the number of countries in which it is available internationally is
increasing rapidly,” commented Daniel Junius, President and CEO. “We
believe its lead indication provides a meaningful market opportunity for
Kadcyla, with many additional indications in development by Roche.”
Mr. Junius continued, “Achievements with our wholly owned clinical-stage
product candidates include completion of patient enrollment in our NORTH
Phase II trial with IMGN901, which keeps us on track to make next-step
decisions for this product candidate by mid-2014. We are making progress
with IMGN853 and expect to report disease-specific Phase I data mid next
year. In 2014, we also expect to report the first clinical findings with
IMGN529 and potentially the first data with our newest clinical-stage
compound, our EGFR-targeting IMGN289. These different product candidates
reflect many enhancements we have made to our ADC technology portfolio
in recent years, and our presentations at the recent AACR-NCI-EORTC
conference underscore our ongoing commitment to leadership in the ADC
Kadcyla (ado-trastuzumab emtansine)
Kadcyla utilizes ImmunoGen’s ADC technology with Roche’s Herceptin®
(trastuzumab) antibody and is being developed and commercialized by
Roche under an agreement with ImmunoGen. Recent developments include: