HA-Irinotecan - a significant advance in the treatment of colorectal cancer

Our lead product candidate is HA-Irinotecan. Irinotecan, which is marketed in major markets by Pfizer as Camptosar, is an off-patent chemotherapy drug widely used in the treatment of metastatic colorectal cancer (mCRC). In a randomized Phase II clinical trial of HA-Irinotecan compared with irinotecan alone, based on 76 patients with mCRC, HA-Irinotecan was able to double the Progression-Free Survival (5.2 months for HA-Irinotecan versus 2.4 months for irinotecan alone) in patients with late stage colorectal cancer. Based on these findings, Alchemia began enrollment for a Phase III clinical trial in November 2011.

In addition to its approved use, published studies suggest that irinotecan may have activity in a range of solid tumours such as those of the breast, pancreas, brain and ovaries. According to reports by Pfizer, sales of Camptosar (proprietary irinotecan, which became generic in 2008) were over $900 million in 2006.

We believe that, to the extent clinical trials confirm HA-Irinotecan's improved efficacy compared with irinotecan alone, HA-Irinotecan has the potential to replace irinotecan in first to third line irinotecan-containing treatment regimens while potentially commanding pricing consistent with proprietary drugs.