This may help IMCL a bit tomorrow. Bought some last week as a trade and decided to hold over the weekend.
UPDATE 1-Germany's Merck seeks OK for wider use of Erbitux
Mon Sep 3, 2007 2:48AM EDT
(Adds details, background)
FRANKFURT, Sept 3 (Reuters) - Merck KGaA (MRCG.DE: Quote, Profile, Research) has applied to the European Medicines Agency (EMEA) to broaden the use of its cancer drug Erbitux, the German drugs and chemicals group said on Monday.
Merck said the submission was supported in part by data from its Crystal study that showed the efficacy of Erbitux as a first-line treatment in the treatment of metastatic colorectal cancer (mCRC).
The drug is already approved to treat colorectal cancer in patients who have failed other therapies.
"If approved, using Erbitux as a first-line therapy will provide a much greater hope for cure for these patients," said Wolfgang Wein, senior executive vice president, Oncology, Merck Serono, a unit of Merck.
Merck shares were indicated up 0.5 percent in Frankfurt.
The application will be reviewed by the Committee for Medicinal Products for Human Use (CHMP). If approved, Erbitux can start be used as a first-line therapy from the second half of next year, the company said.
The study showed, when added to current standard irinotecan based chemotherapy in first-line, Erbitux significantly boosted progression-free survival, response and resection rates.
"Erbitux is the only targeted therapy to increase the chance of cure through resection," Merck said.
Merck licensed the drug from ImClone Systems (IMCL.O: Quote, Profile, Research) and has rights for key regions including Europe. Erbitux is ImClone's only marketed drug, which it distributes in the United States along with Bristol-Myers Squibb (BMY.N: Quote, Profile, Research).
Erbitux was first approved for treatment of mCRC after irinotecan failure in Switzerland in Dec. 2003. It was also approved for treatment of mCRC after irinotecan failure in the United States by the Food and Drug Administration (FDA) in February 2004 and was followed by EMEA approval in June 2004.
In Europe, more than 370,000 people develop colorectal cancer every year, accounting for 13 percent of the total cancer burden and around 200,000 deaths. |
