Germany’s Merck KGaA says it still plans to file for European approval of the oncology agent Erbitux (cetuximab) in head and neck cancer this year, after originator ImClone Systems said it would delay a US filing, needing more time to analyse clinical trial data [[13/04/05c]]. ImClone and US partner Bristol-Myers Squibb had originally hoped to file Erbitux in head and neck cancer in the second quarter of 2005, but say they too still hope to complete the filing before the end of the year.
Merck now looks set to seek approval in the second half of this year for Erbitux, which reeled in 42 million euros during the first quarter in its primary indication of colorectal cancer, up 17% from the previous year. The German company now says Erbitux represents “one of the most successful product launches in oncology in Europe.”
The news came as the company unveiled a strong set of first quarter results, with sales up 8% to 1.4 billion euros and operating result boosted more than 17% to 198 million euros following a strong performance from both its generics, ethicals and consumer healthcare business. Profit after tax was 122 million euros, versus 102 million in the like, year-earlier period. Bernhard Scheuble, Chairman of the Executive Board of Merck KGaA, said: “Merck started the year well and we expect a continuation of the positive developments for the remainder of the year from both the pharmaceuticals and chemicals business sectors. As a result, full-year sales for the Group should have a growth rate in the single-digit range, unless unfavorable currency impacts increase.”