Serono tests Serostim in HIV lipodystrophy

Swiss biotechnology firm Serono has started a double-blind,placebo-controlled study to evaluate the activity of its human growth hormone Serostim (somatropin for injection) as a potential therapy for HIV-associated adipose redistribution syndrome.

HARS is a subset of abnormal disorders of fat distribution and altered metabolism, often called HIV-related lipodystrophy syndrome, which affect approximately 30% of HIV-infected individuals. Patients with HARS experience abnormal pathological accumulation of visceral adipose tissue, which may be present with or without fat depletion and/or metabolic abnormalities.

Serostim is already approved in the USA for the treatment of cachexia or AIDS wasting, and achieved sales of $137 million in this indication in 2000, approximately the same level as in 1999. Approval of a new indication could inject new life into the drug, which has seen its sales growth dampened by what Serono has described as a tightening in reimbursement for the drug. In the near term, renewed growth is likely to come from its approval in the European Union where, last year, it became the first drug to be awarded orphan status (Marketletter September 18, 2000).