Ziopharm's Palifosfamide receives orphan designation

NEW YORK Ziopharm Oncology has received orphan drug approval from the Food and Drug Administration for Palifosfamide, for the treatment of soft tissue sarcoma, according to published reports.

Ziopharm will receive seven years of exclusivity of marketing for the drug once it has been approved, as well as an accelerated review process, grant funding, tax benefits, and an exemption from other fees.

Ziopharm’s chief executive Jonathan Lewis said that the drug stands to bring in as much as $400 million in revenues annually in the U.S. alone once it is approved. “Developing drugs for rare diseases is going to become increasingly more important because more and more the way we define diseases is into smaller and smaller subsets,” said Lewis. “In addition, we are looking to develop this for other indications starting with sarcoma.”

The intravenous form of Palifosfamide is currently in phase II studies and the oral form is expected to enter Phase I studies in early 2009.