FDA panel backs new indication for US Bioscience's
Marketletter via NewsEdge Corporation : US Bioscience's cancer therapeutic Ethyol (amifostine for injection) has received a positive US Food and Drug Administration panel recommendation for use of the drug to reduce the incidence and severity of post-operative radiation-induced xerostomia in patients undergoing radiation for head and neck cancer. This is the first drug to be recommended for approval in this indication, according to the company, which saw its shares boosted 5% on the news.
Ethyol has been available in the USA since 1996, but analysts note that sales could increase by more than 25% this year if it is approved for this extended indication, with potential annual sales of $100 million. Dawn Blessing of SG Cowen & Co noted that a label extension would be significant for the company as radiation patients may require higher doses of the drug than chemotherapy patients, which is good news in terms of sales.
David Maris of Bear Stearns noted that Ethyol is a good niche product and additional indications will be a boost to the company. Mr Maris expects US sales of Ethyol to reach $41.6 million in 1999, up from $32.5 million in 1998.
The panel recommendation was based on data from a Phase III open-label trial which enrolled approximately 300 head and neck cancer patients. At the end of the treatment period, 51% of Ethyol receivers had experienced moderate or severe xerostomia versus 78% of patients treated with radiation alone, with a 35% reduction in the incidence of severe xerostomia overall. Approximately one year following conclusion of the trial, 57% of the radiation monotherapy group were experiencing persistant severe xerostomia, compared to 34% of patients in the Ethyol arm. Adverse events included nausea, vomiting and hypotension.
Ethyol is marketed in the USA by Alza Corp and co-promoted by US Bioscience.
Meantime, Alza says that it has submitted a New Drug Application to the US regulatory agency for Viadur (leuprolide acetate implant), which is designed to provide a once-yearly dosing regimen of leuprolide for the palliative treatment of advanced prostate cancer. If approved, Viadur will be the first product on the market to incorporate the company's DUROS implant technology and the first to provide 12-month testosterone suppression with a single treatment.