Ivax Corp. - Taxol NDA -2: Expects To File In
Other Countries Soon
AP-Dow Jones News Service
MIAMI -- Ivax Corp. (IVX) submitted a New Drug Application to
the Food and Drug Administration to market Paxene, its
jointly-developed product with NaPro BioTherapeutics Inc.
(NPRO) for the treatment of AIDS-related Kaposi's sarcoma,
the companies said in a joint press release.
Paxene is Ivax's brand name for its formulation of the
compound paclitaxel, or Taxol.
Ivax said studies have demonstrated the activity of Paxene for
Kaposi's sarcoma, a cancer related to AIDS, and support the
benefits of dosing schedules which differ from those approved
for Taxol.
Ivax said it and NaPro are strategic partners in the
development, maunfacture and marketing of paclitaxel in the
U.S., Europe and other countries.
NaPro provides the bulk active drug substance for Paxene,
while Ivax said it is responsible for the clinical development,
registration and manufacture of the finished product.
Ivax said it expects to seek regulatory approval of Paxene for
Kaposi's sarcoma in other countries in the near future.
In addition, Ivax, a pharmaceuticals company, said it has
completed full-scale clinical trials for Paxene in the treatment
of refractory breast and ovarian cancer, and that these studies
may be the subject of subsequent filings with the FDA and
international health ministries.
NaPro, of Boulder, Colo., develops and manufactures natural
product pharmaceuticals. |
