Analysts had expected MGDF
to generate annual sales of about $200 million.
than 400 patients given MGDF
except for two cases of potentially
The most significant results of the study, involving 51 patients with newly diagnosed inoperable lung cancer, were that MGDF lowered the duration and severity of platelet depletion due to chemotherapy.
In addition, the median platelet count for all the MGDF patients was 70 percent higher than the placebo group following chemotherapy.
MGDF was first administered to humans in the United States by researchers at the UCLA cancer center.
MGDF is produced by the body naturally to stimulate the production of blood platelets in bone marrow.
MGDF also is manufactured by Kirin Pharmaceutical Division in Tokyo.
Among 38 MGDF patients, the researchers documented a median low platelet count of 188,000 per cubic millimeter -- a 70 percent increase over the median low count of 111,000/cmm measured among the unexposed patients.
Still more important to the researchers was the finding that platelet counts in the MGDF patients returned to normal within 14 days -- a significantly more rapid recovery than the 21 days or longer measured among patients receiving placebo.
The development of MGDF represents a potentially important addition to the armamentarium for managing patients receiving myelosuppressive chemotherapy,'' said Laurence A.
At the same time, orally active TER199 offers the opportunity to provide the possible benefits of MGDF
and TPO for platelet growth and the treatment of thrombocytopenia.
We're confident that successful clinical development of MGDF
will enable Amgen to build upon our strong franchise in blood growth factors gained by developing EPOGEN (R) (Epoetin alfa) to stimulate production of red blood cells and NEUPOGEN (R) (Filgrastim) to stimulate production of white blood cells,'' said Gordon Binder, chairman and chief executive officer.