News Releases

December 6, 2002

The World's First Totally Synthesized Anthracycline Carcinostatic Launch of Calsed Anticancer Antibiotic

Sumitomo Pharmaceuticals Co., Ltd. today launched the ethical drug Calsed. Discovered and developed by the Company, it is the world's first anthracycline anticancer antibiotic produced by purely synthetic technology. Using amrubicin HCI (generic name) as the chief ingredient, the injectable freeze-dried preparation is indicated for and effective against both non-small cell lung cancer and small cell lung cancer.

Anthracycline carcinostatics are powerful anticancer antibiotics, widely used to treat malignant lymphoma, leukemia, and breast cancer etc. Several anthracycline preparations are commercially available now, but all are fermentation products or semi-synthesized from fermentation products. Sumitomo Pharmaceuticals, using totally synthetic process, challenged to the development of new anthracycline compounds with a chemical structure conventional fermentation methods could not produce, and that effort led to the discovery of amrubicin HCI.

In a pre-clinical study, amrubicin HCI showed a better anti-tumor effect than conventional anthracycline drugs. Although adverse reactions, such as bone marrow depression, were observed in clinical trials, as with other carcinostatics, the compound showed effective performance against non-small cell lung cancer and small cell lung cancer, with success rates*1 of 23.1% and 75.8%, respectively. Given these results, the Company in April 2002 obtained a manufacturing license for the drug, which was launched upon NHI drug price listing on December 6, 2002.

Lung cancer can be roughly classified as small cell lung cancer and non-small cell lung cancer. The number of new patients is estimated at some 75,500 annually, and the number of deaths the highest among all types of cancer, at over 50,000 annually. These figures are expected to grow. Remedies include surgery, radiation therapy, and chemotherapy using carcinostatics, with chemotherapy being the primary choice where the disease is in an advanced stage. Since the 5-year survival rate show some 20% and patients have an unfavorable prognosis, better treatment such as the development of new carcinostatics is longed for.

Showing a higher efficacy than comparable drugs, Calsed was granted a useful price incentive (category 2) when it was put on the NHI drug price list, and is thus expected to be a new option for lung cancer remedies. The Company plans to make it one of the standard lung cancer remedies by promoting its proper use and building of its clinical evidence*2.

*1 Success rate: Percentage of cases where cancer has been reduced by over 50% or eradicated
*2 Evidence: Scientifically-evaluated clinical trial records