Amgen’s Extended-Release Neupogen Trials Going Well

Amgen Inc. in Thousand Oaks, the world’s biggest biotechnology company, said that trials of an extended-release version of its blockbuster cancer drug Neupogen are proceeding well and that it hopes to seek approval of the product by mid-2001.

The drug, dubbed SD-01, is in a Phase 3 study, the final stage of clinical trials required by the Food and Drug Administration before it will consider approval of an experimental treatment.

SD-01 is one of four Amgen drug candidates, including two experimental drugs that have already been submitted for FDA review, that the company has said could win approval over the next two to three years.

Neupogen and SD-01 both work to boost white blood cell counts in cancer patients receiving chemotherapy, which attacks the body’s immune system as it fights tumors. Although Neupogen is designed to be given daily, some patients do not get the full benefit of the treatment because they can’t get to the doctor on weekends or miss appointments for other reasons.

Amgen designed extended-release SD-01, which stays in the body for eight to 10 days, to address that problem.