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Right now are human genome sciences' stock.
This stock is up a little more than -- 254%.
The company's experimental drug for lupus is showing promising results from a late stage trial joining us now.
Tom -- the CEO of Human Genome Sciences -- thank you for that hearing about this answer.
Good afternoon it's good to be here what the first question congratulations on the trial study -- the results of first time -- to -- ready this was the first one that went through how fast.
Do you think you can get this drug to market.
Well this this is very encouraging news certainly for the one point five million lupus patients in the US roughly five million worldwide.
The second trial is ongoing and that trial is exactly the same as the one we just on blinded today the second trial is in the US and Western Europe patients.
And we expect to have results -- study in November and the combination of those two trials.
I should provide a very strong package for the FDA and other regulatory agencies to hopefully consider and give us approval to be -- -- make this product available to patients.
One analyst on the street calling medalist this this drug -- a blockbuster.
For your concrete company and also renewing the sentiment that you could be a takeover target can you comment on that.
Focus here is on patients and what this could mean there has not been a new drug approved for lupus patients by the FDA in over fifty years.
And a lot of a late stage trials of -- -- is looking for progress and lupus even last year have failed so.
Certainly were encouraged by the by the market's reaction but the focus here is on what we can do to get this drug further along and get the patients.
It's so desperately need new treatment options.
You know one of the things about lupus and I befriended.
Was afflicted with that 90% of those that -- lupus.
Are women were all of the folks in the trials women thirty -- tests on men as well.
Now that demographics were Mormon women than men for the reason you mentioned that the typically affects women more than men but we had we had some balance in terms of gender and it's it's a very effective drug as a drug we first identified the target for -- 1997.
Began putting the -- of patients in 2001 and so this is.
Not the first time we've we've seen results.
That are encouraging but certainly it's very encouraging to see this magnitude of the fact.
We now -- -- better efficacy in this trial we saw lower use of steroids.
A lot of patients are treated with steroids for lupus now and to be able to.
Potentially offer a drug that can reduce the amount of steroids while offering efficacy is a huge potential benefit we're very excited because.
And worse so so kind of over the top early as far as the placebo patient -- -- A person that got the drug analyst do you think that the FDA will fast track you do are you getting that sense that it's happened many times.
Well it was it's certainly possible we have a need for two trials here that's our agreement with the FDA to trials.
And we would certainly hope that our second trial we certainly expect the second trial based on these results to be positive.
And then we'll submit that full package to the FDA would certainly be looking for fast track.
Status for -- regulatory review but that's certainly after the agency and will will be pushed so well well look look at the earliest they ever alleged got to -- -- slip fault but the government waited earliest convey that the strike at the corner.
Expectation would be that with a good trial result in November we file in the first half of 2010.
And hopefully be on the market by the latter half of 2010.
So -- airline.
And that well -- ways but.
A lot of -- didn't venture I want you you know -- -- -- that it can be a -- process and obviously got a complete the second trials.
We have patients from a phase two study which we and one in 2005 that are still on an extension phase.
Many of those patients have now been on this drug for over four years we were full report those results every six months.
And many of those pages are still getting excellent efficacy -- and has a great safety profile so.
There are some patients that are you being treated we certainly look forward treating a lot more when the drugs available commercially.
You're also working on a therapy for hepatitis and it's kind of the same thing is as the analyst at trial and that is.
You're in that late stage trial process can you update us on that drug -- well.
Absolutely the drug is recall I'll be fair I've had and too late stage trials where -- -- in December and march of this year we saw really strong efficacy.
We're very excited about that drug moving forward that's a big opportunity for us we also have.
An anti bioterrorism.
Drug for anthrax that drug that we are currently supplying for the US government for stocking in the national stockpile.
Supplied about 20000 doses earlier this year.
And so that's an excellent opportunity drug that we hope is never used by any of us but certainly makes all of us can allow all of -- of -- -- little -- Does have a cancer program -- in mid stage development we're very excited about it some earlier stage programs that are also moving forward.
You know Tom I thought headline -- -- this is a classic.
Biotech story and it certainly is Tom -- the CEO of Human Genome Sciences congratulations to you also but hopefully this patients out there thank you sir absolutely.
Thank you very much.
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