Amgen Inc. has filed its first FDA marketing application inmore than a year, seeking to extend indications for itsNeupogen granulocyte colony stimulating factor to treat severechronic neutropenia, including congenital, acquired or cyclicalneutropenias.
Neupogen, a white blood cell stimulator, was approved inFebruary 1991 to prevent infection as an adjunct tochemotherapy. The Thousand Oaks, Calif., company(NASDAQ:AMGN) had previously stated that its next productswould be added indications for the drug.
Spokeswoman Kimberley Dorsey on Friday said the companydoesn't project market figures, but the patient population forsevere chronic neutropenia is small.
Amgen had $232 million in worldwide Neupogen sales in 1991.Based on February sales figures, Vector Securities InternationalInc. analyst Peter Drake last month estimated that U.S. sales forthe first quarter of 1992 would be $73 million, with worldwidesales of $91 million.
Neupogen is in Phase III trials for bone marrow transplants,treatment of febrile neutropenia for cancer chemotherapy, andmyelodisplastic syndrome. MDS is a group of blood celldisorders characterized by abnormal development of the bonemarrow and chronically low counts of any of the blood celltypes.
Amgen has completed Phase I/II trials of the drug in AIDSpatients receiving AZT and is developing a protocol for PhaseIII trials. Neupogen is in Phase I or I/II trials for a variety ofinfectious diseases.
The next drug in Amgen's pipeline will be either stem cellfactor or platelet-derived growth factor, Dorsey told BioWorld.Stem cell factor is in Phase I trials in the cancer setting. PDGF isin Phase II trials for wound healing in bedsores.
Amgen shares rose 50 cents on Friday to $60.
-- Karen Bernstein BioWorld Staff
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