Swiss biotechnology group Serono has completed a pivotal Phase III trial evaluating its recombinant human growth hormone (r-hGH) as a therapy for HIV-associated Adipose Redistribution Syndrome (HARS), a condition leading to abnormal fat distribution in the body.
The study was designed to assess whether r-hGH, a human growth hormone produced by recombinant DNA technology, is better than placebo at reducing fat tissue that has accumulated as a result of the HARS. The trial, which enrolled more than 300 patients, met all its pre-specified goals, and so Serono says it plans to file a submission with the US Food and Drug Administration (FDA) in the first half of this year.
“The completion of this important research study of r-hGH in HARS is a strategic milestone for Serono and may lead to an important advance for patients living with this condition, that not only affects their health but also their quality of life,” commented Dr Paul Lammers, Chief Medical Officer at Serono. “The rapid enrollment in the study demonstrates the need for treatment for this rare medical syndrome. We anticipate filing a supplemental New Drug Application (sNDA) in the first half of 2006,” he added.
Serono’s r-hGH products are already approved in the USA for the treatment of pediatric growth hormone deficiency, adult growth hormone deficiency, HIV wasting or cachexia and for the treatment of short bowel syndrome.
The company, which put itself up for sale in November last year, recently received a significant slap on the wrist over its aggressive tactics in getting doctors to prescribe its AIDS wasting treatment, Serostim (somatropin). The group was formally ordered to pay $704 million to settle claims that it offered kickbacks to doctors in return for prescribing the drug, in a ruling that brings to an end a four-year investigation and includes a $137 million criminal fine and a further $567 million to settle civil claims. This is the third-largest penalty ever imposed in the USA for healthcare fraud, according to US Attorney General Alberto Gonzales.
According to media reports, Swiss drugmaker Novartis AG is the favourite to lead bidding for the company, but a number of other pharma giants, including US groups Pfizer and Johnson & Johnson, are considering whether to enter bids for the group.