ARANA THERAPEUTICS LIMITED
ART621 Reaches Key Milestone
AAH - Arana Announces Key Anti-Inflammatory Drug Milestone - Dr David Fuller, Chief Medical Officer
Thu, 28 Aug 2008 04:30PM
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Dr David Fuller
Thu, 28 Aug 2008
04:30PM Australia/NSW
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ARANA THERAPEUTICS LIMITED (AAH)
ASX code: AAH
Website: http://www.arana.com
Industry: Pharmaceuticals, Biotechnology & Life Sciences
Principal Activities:
A biopharmaceutical company focused on developing next generation antibody based drugs that will improve the lives of patients with inflammatory diseases and cancer.
Address:
, 37 Epping Road, Level 2,
MACQUARIE PARK
NSW
Phone: 02 8061 9900
Fax: 02 8061 9999
Executives & Directors
Mr Robin Beaumont , Chairman
Mr Gordon Black , Non Exec. Director
Dr Lincoln Chee , Non Exec. Director
Mr Chris Harris , Non Exec. Director, Independent Director
Mr Niall Henderson , CFO
Mr Niall Henderson , Company Secretary
Company Podcasts
Company ASX Announcements
Company ASX announcements can be viewed on the ASX website.
Announcements from the preceding six months are shown below.
Please refer to the relevant stock exchange if any of the above information is incorrect
ARANA THERAPEUTICS LIMITED (AAH) Events
Australia/NSW
ARANA THERAPEUTICS LIMITED (AAH)
| Suspension from Official Quotation at close 02/07/09 | Thu, 2 Jul 2009 |
| Cephalon Takeover Bid | Tue, 30 Jun 2009 |
| Change in substantial holding | Mon, 29 Jun 2009 |
| Form 6021 - Compulsory Acquisition following T/O bid | Thu, 25 Jun 2009 |
| Change in substantial holding | Tue, 23 Jun 2009 |
| Appendix 3B - 2009 Performance Share Plan | Wed, 17 Jun 2009 |
| Cephalon T/O - Increase Consideration/Extension Offer Period | Mon, 15 Jun 2009 |
| Change in substantial holding | Mon, 15 Jun 2009 |
| Cephalon has relevant interest in 90.41% of Shares | Mon, 15 Jun 2009 |
| Change in substantial holding | Thu, 11 Jun 2009 |
Please note: This company appears on this website as a result of its listing on the Australian Securities Exchange. Boardroom Radio does not claim any association with any company listed on this site.
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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