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Merck at ASCO 2007: New Data Demonstrate the Value of UFT as an,Important Treatment Option for Patients With Metastatic Colorectal,Cancer

CHICAGO/DARMSTADT, Germany, June 4, 2007 – Data presented today at this year’s American Society of Clinical Oncology (ASCO) meeting in Chicago show that a novel combination regimen based on Merck KGaA’s oral 5-fluorouracil (5-FU) therapy UFT (tegafur–uracil) plus leucovorin (LV) has shown an excellent response rate in the first-line treatment of metastatic colorectal cancer (mCRC).

In the SCOUT study (Study of CPT-11 with Oxaliplatin combined with UFT plus leucovorin Therapy), the feasibility of UFT plus LV with alternating irinotecan and oxaliplatin was investigated in a phase I/II open-label trial in patients with mCRC (n=45). The objective response rate was 66% and, at a median follow-up of 14.9 months, the median time to progression was 8.7 months and the overall survival was 16.8 months Neurotoxicity and alopecia were minimal and there were no cases of hand–foot syndrome reported in this study.

Study author, Dr. Hamid Y. Sheikh of the Christie Hospital in Manchester, UK, commented: “Our findings point to the potential of this regimen in the first-line management of patients with metastatic colorectal cancer. In our opinion, UFT is an effective alternative to 5-FU in this disease.”

In a second study presented at ASCO, the first-line combination of UFT with LV plus irinotecan and Merck KGaA’s targeted monoclonal antibody therapy cetuximab (Erbitux®) was investigated in 61 patients with metastatic colorectal cancer (mCRC). The overall response rate was 47% in 53 evaluable patients, which was considered “attractive” by the authors alongside its acceptable safety profile. It is comparable with the response rate achieved with Erbitux combined with the intravenous 5-FU-based FOLFIRI regimen.(1) This combination regimen, termed CETUFTIRI, represents the first teaming of UFT and Erbitux (cetuximab) and is expected to be studied mor e extensively in the future.

More than 370,000 people develop colorectal cancer in Europe each year, accounting for 13% of the total cancer burden and around 200,000 deaths.(2) Approximately 25% of patients present with metastatic disease and their prognosis is poor;(3) five-year survival rates for patients with mCRC are as low as 5%.(4)

About UFT
UFT has marketing authorizations in more than 50 countries. In the majority of these countries, UFT is registered in combination with folinic acid (leucovorin, LV) as a first-line treatment for metastatic colorectal cancer (mCRC). In some countries, UFT is also approved as a treatment for other tumors. In Japan, for example, UFT is approved for the treatment of a variety of cancer types, including tumors of the colon/rectum, lung, breast, stomach, head and neck, liver, gallbladder, bile duct, pancreas, bladder, prostate, and cervix. Since 1984, more than 30 million cancer patients have been treated with UFT.(5)

Merck KGaA, Darmstadt, Germany, has an ongoing commitment to the advancement of oncology treatments and is currently investigating novel therapies in highly targeted areas. In 2005, Merck KGaA acquired the rights for UFT® (tegafur–uracil), an oral chemotherapy administered with leucovorin for the first-line treatment of metastatic colorectal cancer, from Taiho.

Merck KGaA also licensed the right to market Erbitux® (cetuximab), a first-in-class and highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR), outside the US and Canada from ImClone Systems Incorporated of New York in 1998. In Japan, Merck KGaA has co-exclusive marketing rights with ImClone Systems. Erbitux is being investigated principally in colorectal cancer, squamous cell carcinoma of the head and neck and non-small cell lung cancer.

Merck KGaA is also investigating other cancer treatments, including the use of Stimuvax® (formerly referred to as BLP25 Liposom e Vaccine) in the treatment of non-small cell lung cancer. The vaccine was granted fast-track status in September 2004 by the FDA. Merck obtained the exclusive worldwide licensing rights from Biomira Inc. of Edmonton, Alberta, Canada, with the exception of Canada, where the companies share rights.


References
1. Peeters M, et al. Eur J Cancer Suppl 2005; 3: 188 (Abstract 664).
2. Parkin DM, et al. CA Cancer J Clin 2005; 55: 72–108.
3. GLOBOCAN. http://www-dep.iarc.fr/
4. Argiris A, et al. Cancer 2004; 101: 2222–2229.
5. Hospital Pharmacy Europe, March/April 2006.


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Merck is a global pharmaceutical and chemical company with sales of EUR 6.3 billion in 2006, a history that began in 1668, and a future shaped by 35,091 employees in 62 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

Contact: Phyllis Carter Phone: +49 (0) 6151 72-7144


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