ImClone/Merck/Bristol-Myers: Erbitux Set for Breakthrough in Japan
Posted on: Friday, 13 June 2008, 06:00 CDT
Erbitux has received backing from a review committee of the Ministry of Health, Labor and Welfare's Advisory Food and Drugs Sanitation Council for the treatment of its lead indication, colorectal cancer. Erbitux's launch in Japan will undoubtedly further boost sales and strengthen its global success in the colorectal cancer market.
The anti-epidermal growth factor receptor (EGFR) IgG1 monoclonal antibody Erbitux (cetuximab) has received a positive opinion from a review committee of the Ministry of Health, Labor and Welfare's Advisory Food and Drugs Sanitation Council for the treatment of inoperable advanced or recurrent colorectal cancer (CRC). Erbitux is the first anti-EGFR monoclonal antibody to be submitted for approval in Japan.
Erbitux is marketed by Bristol-Myers Squibb and ImClone Systems in the US, and Merck KGaA outside the US. In Japan, Merck and Bristol-Myers Squibb will jointly market the drug. Once launched, Merck will receive 50% and ImClone and Bristol-Myers will receive 25% each of the profit or loss from sales of Erbitux in Japan.
Erbitux became the first monoclonal antibody to be approved in CRC. It was approved in the US in February 2004 and the EU in June 2004, for use in combination with Camptosar (irinotecan; Pfizer) in advanced CRC and as a monotherapy in patients who cannot tolerate Camptosar-based chemotherapy. In September 2007, Merck filed for approval in the EU for first-line metastatic CRC and in May 2008, the CHMP issued a positive opinion for this Erbitux line-extension. Erbitux is also approved in the US and EU for the treatment of head and neck cancer in combination with radiotherapy for locally advanced disease or as monotherapy for recurrent or metastatic disease following failure of platinum-based therapy.
The seven major pharmaceutical markets (US, Japan, France, Germany, Italy, Spain and the UK) have a high incidence of CRC and it has been estimated that by 2010, incidence will rise by a further 14% in these countries. In Japan, CRC affects over 90,000 people annually, making it the second most common cancer after gastric cancer. Around a quarter of patients diagnosed with CRC present with metastatic disease, when surgery is no longer an option.
Japanese approval of Erbitux for inoperable/recurrent CRC may put pressure on Genentech/Roche/Chugai's anti-vascular endothelial growth factor (VEGF) antibody Avastin (bevacizumab) which was approved in June 2007 for the same indication. On the other hand, Erbitux's potentially steeper price tag compared to Avastin may inhibit its uptake as a CRC therapy. Either way, having already received market authorization for CRC in over 65 countries worldwide, Erbitux's entry into the Japanese market is likely to be well-received given the high unmet needs in this indication.
Source: Datamonitor
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