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Shailendra Malpure

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DIRECT EXPORT SYSTEMCancer is a leading cause of morbidity and mortality in the developed world and is increasing in the developing world. In Western Europe, 25.4% of all deaths are attributed to cancer. In the Americas, around 18.4% of registered deaths are due to cancer; in the USA the proportion is 22.8% (2003). In 2006, around 1.4 million people in the USA will be diagnosed with cancer and an estimated 564,830 will die from the disease. Of these, 16.7% will be diagnosed with prostate cancer, 15.3% with breast cancer, 12.5% with cancer of the bronchus and lung, and 10.6% with colorectal cancer. The available treatment options for cancer may vary according to the cancer site, disease progression, age and health of the patient. Treatment may include surgery, radiotherapy, chemotherapy and/or hormone therapy. Current therapy regimes typically include a combination of off-patent and patented drugs, a number of which are injectable. Generic companies currently active in the anti-cancer injectables market include Abraxis Pharmaceutical Products (APP), Baxter Healthcare, Bedford Laboratories, Mayne Pharma, Pharmachemie (Teva), Pliva-Lachema, Sandoz, Sicor (Teva), Spectrum Pharmaceuticals and SuperGen. A number of the older reference drugs are no longer marketed by the originator companies, although generics remain available. Among the most recently available generics are mitoxantrone, octreotide and carboplatin. Carboplatin became fully open to generic competition in the US in October 2004, since when the FDA has approved 15 ANDAs for eight companies

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