The Right Chemistry

BIOTECHNOLOGY company Alchemia is set to receive a boost in revenues next year once a drug that prevents blood clots after surgery is approved by the Food and Drug Administration (FDA) in the US.

CEO Peter Smith says the expected review time from the FDA would be six to nine months for the anti-thrombotic drug Generic Fondaparinux.

“We’ve got an agreement with Indian company Dr. Reddy’s and they will be marketing our product Generic Fondaparinux in the States. We’re expecting it to be on the market by the end of the year, which would generate revenue that we expect to get in the first half of 2010,” says Smith.

“One of our great goals is to have a self sustainable source of revenue and we are very rapidly approaching that point. We project US$30million to US$40million per year from Generic Fondaparinux, so we’ll have the resources to develop other programs.”

The product was originally made by a company called Sanofi in France, and is now produced by GlaxoSmithKline (GSK) under the name Arixtra, but Smith says Alchemia’s production method is more efficient.

“It took us less time to develop the synthesis of the product than the original — the important thing is that we can make it and no one else can make it apart from GSK and us, period,” says Smith.

“The cool thing is that there’s not much competition. If you have a dozen or so on the market then prices collapse, but if you’ve got the sole generic then there’s much less price pressure.”

With projected revenues from the US the bio-tech group will have more resources towards studies into a method of drug delivery to bowel cancer patients.

“We’ve developed a cancer product HA-irinotecan but we don’t have the money now for that. It’s a drug used for bowel cancer which was worth around a billion dollars before the patents expired and we combine this with our delivery technology to get more of the drug transported to the tumour. This way we’re killing more cancer cells but not making it more toxic.”

In a phase two study it was shown that Alchemia’s product more than doubled the effectiveness of the drug in terms of how long it took before patients relapsed.

For the control group, the relapse time was 2.4 months whereas with Alchemia’s product it took 5.2 months.

“A few months may not seem like a big thing, but it matters for these patients when their health is rapidly deteriorating,” says Smith.

Alchemia will focus heavily on the oncology (cancer) side of the business this year. Smith urges the State Government to continue to support biotechnology research.

“Hopefully we’ll see more support from the State Government – (Peter) Beattie gave a lot of support, but so far we’re yet to see as much from Premier Anna Bligh. We don’t want to see companies going away from Queensland for lack of grants and support.

“The two major hubs for our kind of research are Melbourne and Brisbane, and the attraction here is that there are high quality universities on our doorstep. We have strong ties with Griffith University, the University of Queensland, and a large number of other groups, with access to cutting edge technology.”

Smith points out that the real deficit to be overcome for his industry is the distance from major markets overseas, but is hoping to get a phase three cancer trial across Europe and the US mid-year, and is looking for ways to finance the study.