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BMS and ImClone Systems expand Erbitux clinical programme

ImClone Systems and BMS expand the terms of their agreement for the co-development and co-promotion of metastasised colorectal cancer drug Erbitux in North America

ImClone Systems and Bristol-Myers Squibb (BMS) have expanded the terms of their agreement for the co-development and co-promotion of metastasised colorectal cancer (m-CRC) drug Erbitux (cetuximab) in North America.

Both firms have agreed to expand the investment in the ongoing clinical development plan for Erbitux by around several hundred million dollars. Development costs, up to a threshold value, will be the responsibility of BMS, while costs in excess of the threshold will be shared by both companies through a pre-determined ratio.

With the increased funding, the companies will add phase II and III clinical trials to explore further the activity of Erbitux in a variety of therapeutic settings and use the findings, if any, to support new registrational opportunities for the drug.

The clinical programme exploring the use of Erbitux in additional tumour types, such as brain, breast, bladder, gastric, lung, pancreas and prostate.

Jim Cornelius, BMS' CEO, said: "We value our partnership with ImClone Systems and this new agreement confirms our strong commitment to oncology patients and the importance of Erbitux to our business."

Carl Icahn, chairman of ImClone System's board, added: "As the new chairman, I am happy that BMS and ImClone Systems have come to this very amicable agreement which I have every hope should benefit greatly both parties."

Erbitux is approved in countries all over the world and can arrest the growth and spread of aggressive tumours and causes cancer cell death. Oncologists say it has produced some of the longest survival rates ever seen in mCRC.

But a draft appraisal issued June 2006 by the UK's National Institute for Health and Clinical Excellence (NICE) said that Erbitux will be turned down for use in the UK on cost-effectiveness grounds. A final decision will be made in November 2007.

ImClone's Q2 FY07 global net sales for Erbitux were USD 319.2m, compared with USD 274.8m in Q2 FY06, or an increase of 16 per cent. International net sales were USD 157.2m, compared with USD 102.5m for Q2 FY06, an increase of 53 per cent.

14th August 2007

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