Taxol Competitor From IVAX Nears US Market

NaPro BioTherapeutics and partner IVAX Corp have been successful ingaining a positive recommendation for approval for their version of the anticancer drug paclitaxel from the US Food and Drug Administration's Oncologic Drugs Advisory Committee.

The panel recommended by a unanimous vote that NaPro's Paxene version of the drug should be approved by the FDA for use "after failure of first-line or subsequent systemic chemotherapy for the treatment of advanced AIDS-related Kaposi's sarcoma."

The backing could herald a conflict with the first company to market paclitaxel, Bristol-Myers Squibb. The drug was originally developed by the US National Cancer Institute and was licensed to B-MS, which markets it as Taxol, in 1992. In addition to other indications (ovarian and breast cancer), B-MS also has approval to market Taxol for the second-line therapy of KS, and was granted Orphan Drug status for this indication on August 4. This provides the firm with a seven-year exclusivity from that date for sale of this drug for the KS indication. Taxol's Orphan Drug status clearly limits the circumstances under which the FDA may approve Paxene for KS.