Alchemia’s CEO, Dr Peter Smith said “The impending commercialization of generic fondaparinux and anticipated revenues in calendar year 2009 will form a strong financial base for Alchemia. This will enable the company to advance its drug targeting and drug discovery technologies to further build a sustainable pipeline of opportunities for future commercialization.”

The company’s report states: “Given the complexity of the synthesis, Alchemia continues to believe that its generic fondaparinux will be the only generic brought to market, restricting competition to two drugs, Alchemia’s fondaparinux and GSK’s Arixtra. Typically, a first generic will take 40-50 percent of the prescription share, and with Alchemia’s fondaparinux expected to be the sole generic, a modest level of price discounting is anticipated.”

Arixtra is the only heparin drug not derived from biological sources as it is a synthetic molecule. Thus, it was not among the recent heparin recall.

Alchemia contends that there are no significant technical hurdles remaining and that generic fondaparinux approval and launch is expected in the first half of 2009, depending on review time at the FDA.

SOURCE: Heparin Recall › Synthetic heparin expected to launch early 2009