data could be available from the German trial now underway?
Here are a few clues from a Merck KG release:
Thursday January 24, 5:28 am Eastern Time
Germany's Merck sees European Erbitux launch in 2003
FRANKFURT, Jan 24 (Reuters) - Germany's Merck KGaA said Thursday it expects to launch its key cancer drug Erbitux in Europe by the third quarter of 2003 even if the regulatory process is slowed by problems at U.S. partner ImClone Systems.
``We hope to apply to the European Commission in the third quarter of this year, and then it takes about a year for them to review the whole file,'' Merck spokeswoman Phyllis Carter said.
``The main rollout in Europe is still on schedule for the third quarter of next year if all goes as planned,'' she added.
There was still a chance the drug could receive its first European approval in Switzerland in the fourth quarter of this year, as had originally been planned.
Merck had originally expected to win approval for Erbitux in Switzerland shortly after ImClone was due to win U.S. clearance, but now it is not clear whose data will be approved first.
ImClone (NasdaqNM:IMCL - news) shares have fallen sharply since December 28, when the U.S. Food and Drug Administration rejected its application to review Erbitux, saying documentation provided by the company was insufficient to judge the drug.
Merck says Erbitux -- also known a C225 and cetuximab -- remains a promising product under development. The company will complete its own analysis of data on the drug by mid-summer.
Since December 28, Merck shares are down seven percent. On Thursday, they fell 1.5 percent to 38.22 euros compared with a 0.8 percent rise on the European DJ Stoxx health index (^SXDP - news).
Merck has the right to the treatment for head-and-neck and colorectal cancer outside North America. It shares the rights in Japan with ImClone and Bristol-Myers Squibb Co. (NYSE:BMY - news), its sales partner for its key diabetes products.
ImClone had expected to launch Erbitux in May this year but postponed this target to no earlier than the third quarter 2002 after the FDA refused to accept its application for not collecting certain key data.
If they plan to apply in Europe in Q3 of this year, then then the trial must be pretty much complete already.
Peter |
