Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Australia-based Alchemia, a biotechnology company specializing in synthesis and manipulation of carbohydrates, announced on its Web site that it is on target to launch its antithrombotic drug, generic fondaparinux. Generic fondaparinux targets the multi-billion dollar heparin drug market. The company claims fondaparinux has a superior safety and efficacy profile to the market-leading drug Lovenox. Meanwhile, the brand-name fondaparinux drug Arixtra, made by GlaxoSmithKline (GSK) continues to gain market share.

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.

This entry was posted on Wednesday, October 1st, 2008 at 4:03 pm and is filed under News. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.