ChemGenex's omacetaxine wins orphan drug status

ChemGenex Pharmaceuticals' lead program--omacetaxine--has won the FDA's orphan drug designation for the treatment of Myelodysplastic Syndromes. While a coup for the company, Australia's Herald Sun has raised analysts' concerns regarding the developer's burn rate.

According to a research note from ABN Amro Morgans, ChemGenex will need to raise more money at the end of 2009 if it doesn't find a partner. Analysts report that the company is spending $4.6 million a quarter. CEO Greg Collier, though, brushed aside any financial concerns, saying the company has the cash it needs to complete trials in the first of five indications for the drug and is on track to file for an approval by the FDA in the middle of the year.

"Whilst expansion into MDS is integral to realizing the full commercial potential of omacetaxine, we remain focused on our primary objective of seeking regulatory approval for the drug in CML patients with the T315I mutation," Collier said in a release. "The enrollment target for our registration-directed clinical trial for omacetaxine was achieved on schedule in December, and we remain on track to complete the rolling NDA submission to the FDA in mid 2009."

- check out the report from the Herald Sun
- read the ChemGenex release

Related Articles:
ChemGenex restructures, focuses on cancer drugs (Nov 2007)
ChemGenex gains fast track (Nov 2006)
ChemGenex gains orphan status for cancer drug (Mar 2006)