Amgen Entering New Product Cycle

Amgen expects to file license applications in the USA for three new product candidates in the next 12 months, as well as two new indications for Neupogen (filgrastim).

Gordon Binder, chairman and chief executive of the firm, told analysts in New York last week that a Product License Application for Infergen (consensus interferon) for the treatment of hepatitis C would be filed shortly. Amgen has not yet decided whether to outlicense or retain the product. In addition, should positive results be obtained in ongoing clinical trials of stem cell factor in progenitor cell mobilization and brain-derived neurotrophic factor in amyotrophic lateral sclerosis, applications will be filed shortly thereafter.

Neupogen's indications will be extended to include acute myeloid leukemia and HIV infection (it is already approved for the latter in the UK; Marketletter March 18), and plans are afoot to begin Phase III studies of the product in multilobar pneumonia and pneumonia sepsis.