Visibility for Europe's cancer plays

Lessons from ASCO

Visibility for Europe's cancer plays

New cancer compounds from pharmaceutical companies and U.S. biotech companies are nearer to market, but European biotechs now can see the first real bolus of registration efforts on the horizon.

Indeed, about six companies could file a regulatory submission in the 2005-2007 window. PharmaMar S.A. is the notable exception as a CPMP recommendation for its Yondelis ecteinascidin to treat soft tissue sarcomas (STS) could come as early as this summer (see "EU Cancer Windows," A11).

PharmaMar was among several European biotechs that presented clinical results at last week's American Society of Clinical Oncology meeting in Chicago. The company, a subsidiary of Zeltia Group (MSE:ZEL, Madrid, Spain), presented Yondelis data showing that progression-free survival was 19.8% at six months in 189 patients from three pooled "pivotal" Phase II studies in advanced STS (see B21).

Yolendis is a cytotoxic alkaloid derived from a marine organism. PharmaMar submitted the MAA late in 2001. According to the company, if the CPMP opinion is positive, then European approval could follow as early as this fall. Then, depending on pricing negotiations in individual EU countries, Yolendis could be on the market as early as the fourth quarter of 2003 or early next year.

Outside of Europe, Yondelis is being developed by Johnson & Johnson (JNJ, New Brunswick, N.J.), which is planning U.S. Phase III trials on an undisclosed schedule.

One of Europe's most advanced cancer companies, Immuno-Designed Molecules S.A. (Paris, France), did not

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