INTERVIEW WITH DAVID FULLER, CHIEF MEDICAL OFFICER, ARANA THERAPEUTICS LIMITED (AAH)

“Arana Announces Key Anti-Inflammatory Drug Milestone”

http://www.brr.com.au/event/50455

THURSDAY, AUGUST 28, 2008, 4:30 PM.

            BRR    Welcome to Boardroom Radio. Today I’m joined by Dr. David Fuller, the Chief Medical Officer at Arana Therapeutics. David, thank you very much for joining

10                    us today.

            AAH     James, it’s a pleasure to be here.

            BRR    Now, today, some exciting news. You’ve announced the key milestone for your lead product ART621. Could you start by explaining what that is and

15                    what this means for Arana?

            AAH     Thanks, James. Well today we’ve announced that we have completed the patient recruitment into our psoriasis trial for our anti-inflammatory drug ART621. So with recruitment complete we now know when the trial will finish.  We’re now expecting that in the early 2009 time frame, around January next

20                    year, we’ll know several important pieces of information about ART621. We’ll have information on the product safety, we’ll have information on the product’s pharmacokinetics, we’ll also have some preliminary efficacy data, we’ll also have information on the immunogenicity of the product, and that’s important for biologics. So immunogenicity has been -- the body actually

25                    attacks the drug, so we’re expecting and hoping that ART621 will have low immunogenicity. And we’ll have information on that for the first time in around January.

            BRR    Now, David, could I ask you to briefly explain what ART621 is and what is it

30                    targeting?

            AAH     Sure. ART621 is a biological anti-TNF molecule using (inaudible) (0:01:31) technology called domain antibodies. Those antibodies are directed against TNF. Now, TNF is a protein in the body that causes inflammation. And it’s known to cause and be involved in diseases like rheumatoid arthritis,

35                    psoriasis, Crohn’s disease. There are several marketed products, which are against TNF. Those products have been highly successful, but also, those products do have limitations and so, there’s a demand for new products like ART621 to treat these major inflammatory diseases.

40        BRR    And, David, I also understand you’re preparing an IND for your lead compound ART621. What is the significance of this and what new trials will this allow you to do?

            AAH     Sure. An IND means an investigational new drug application, and it’s done with the American regulatory agency called the Food and Drug

45                    Administration. By us filing an IND, it’s actually the first step towards around our filing a new drug application, eventually. So it’s very significant step because it means we’re on the regulatory path to potential approval. The other significant part of having an IND filed is that we can now -- under the IND, once it’s been opened -- we can then commence trials in the USA. So we are currently planning to commence a new trial in rheumatoid arthritis for ART621. We’re hoping to keep that trial off towards the very end of this year and that trial will then recruit in various countries including the USA. So the IND opens the door for us into the US and that’s very significant.

5

            BRR    David, there is a lot of activity here and it seems that Arana is obviously very keen to progress ART621’s development as quickly as possible.

            AAH     Yes, James. Well I think, ART621 is now a phase II compound in psoriasis, and it’s heading towards being a phase II compound in rheumatoid arthritis

10                    and this is a stage of our products development where a lot of activities take off. So it’s certainly encouraging for Arana as a biotechnology company to be at this stage. It’s an exciting phase. The TNF market overall is a multibillion dollar market. I think, in 2007, it was close to a $13-billion market. We estimate that by 2012 the market size will be close to 20 billion. So obviously,

15                    keen to rapidly progress ART621 so it can take a share. Assuming ART621 is approved so we can take a share of this important and valuable market.

            BRR    Well, David, we certainly appreciate you taking the time to give us an update on the latest progress at Arana and some very exciting news within that. And

20                    we look forward to following the progress of Arana and indeed ART621 in the future.

            AAH     Thanks very much, James. It’s been a pleasure.

INTERVIEW CONCLUDED

Contact brr@brr.com.au for more information

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