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ANP - ANTISENSE THERAPEUTICS LIMITED


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anyone watching this mob, they have a lot of cash in the bank and trials continuing ... will be a long term hold, but they are going after some big targets .... bioshares also gave them a big tick as an improver this year after being oversold in 2004. opinions/brickbats?

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ANP could come under significant selling pressure today because an MS drug made by Biogen and Elan Corp. was yesterday removed from sale because it caused the death of one patient and caused a serious disease in the central nervous system of another patient.

 

The removal of sale of the Biogen/Elan MS drug is very significant for ANP because the protien targeted by the Biogen/Elan drug is the same protein (VLA-4) being targeted by ANP's lead MS compound. Indeed, ANP have pinned their hopes for success on the back of the success of the Biogen/Elan drug. See ANP's 26 November 2004 ASX release (attached to this post).

 

In light of these new safety concerns, the results of ANP's phase I and IIa trials might now be treated as suspect by regulatory authorities. ANP may be forced to abandon the present IIb trials and conduct further safety trials. At the very least, ANP's phase IIb is likely to be put on hold until it is clear what precisely is causing death in the Biogen/Elan drug.

 

Further funding for ANP will be impossible without a satisfactory resolution of this issue. If it emerges that the very targeting of the VLA-4 protein itself is a cause of death in some patients, ANP will have to abandon its MS trials completely and would struggle to continue as a going concern.

 

Read the following link for more information on the Biogen drug:

http://www.nytimes.com/aponline/business/A...artner=homepage

3nvrdqq7vp4kn.pdf

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Hi Ousia,

 

VLA-4 , also known as integrin alpha 4, is part of a ubiquitous family of naturally occurring and crucial biological molecules involved in intercellular communication.

 

To me, it is ambitious to attempt to specifically target neutralisation in a limited physiological environment. I would have concerns re: development of autoimmune sequelae. Such projects would not get my money.

 

As others say, do you own research because I could be mistaken.

 

Regards,

 

Gum Nut

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In reply to: ousia on Tuesday 01/03/05 06:51am

Further to my earlier post, I notice that the NYTimes link is not working. Here is the article:

 

Makers Suspend Sale of M.S. Drug After Death

By THE ASSOCIATED PRESS

 

Published: February 28, 2005

 

Filed at 3:42 p.m. ET

 

BOSTON (AP) -- The makers of Tysabri, a new drug used to treat multiple sclerosis, announced Monday they are voluntarily suspending sales of the drug after one patient died and another developed a serious disease of the central nervous system.

 

Stocks of both Biogen Idec Inc. and Elan Corp. tumbled, while shares of ther makers of rival MS drugs rose.

 

The biotechnology companies said in a news release that they have suspended supplying and marketing the drug Tysabri and advised doctors to suspend prescribing the medication. The companies also have stopped using the drug in clinical trials.

 

The companies said the decision to withdraw the drug came after recent reports of two cases of serious effects among patients who used it along with an earlier Biogen Idec MS drug, called Avonex, in clinical trials. In one case, the person died, while in another, the person developed a suspected case of progressive multifocal leukoencephalopathy, a rare and frequently fatal disease of the central nervous system.

 

Both patients had taken Tysabri for more than two years in combination with Avonex, the companies said.

 

``Our ongoing commitment to MS patients has led us to take these steps,'' said Dr. Burt Adelman, executive vice president of Development at Cambridge-based Biogen Idec. ``Because we believe in the promising therapeutic benefit of Tysabri, we are working to evaluate this situation thoroughly and expeditiously. While we work through this matter, we must place patient safety above all other considerations.''

 

The Food and Drug Administration approved Tysabri, which was called Antegren during clinical trials, in an accelerated process after a late-stage study showed that it reduced MS relapses by 66 percent compared with a placebo.

 

About 5,000 patients have received intravenous infusions of Tysabri since the drug's approval in November, Biogen executives said during a conference call with industry analysts and reporters.

 

Elan chief executive Kelly Martin told reporters in Ireland, where the company is based, that the drug has been withdrawn as a precaution and that the companies hoped to resume marketing of Tysabri later this year.

 

The companies said they withdrew the medication after consulting with the U.S. Food and Drug Administration.

 

The U.S. Food and Drug Administration issued a public health advisory after consulting with Biogen and Elan in the decision to withdraw the medication from the market.

 

Dr. Steven Galson, acting director of FDA's Center for Drug Evaluation and Research, said in a statement that the regulatory agency ``continues to believe Tysabri offers great hope to MS patients.''

 

``We are working with leading experts and regulatory agencies to responsibly investigate these events and to develop the appropriate path forward,'' said Dr. Lars Ekman, executive vice president and president of research and development at Elan. ``Our primary concern is for the safety of patients.''

 

Biogen shares fell $29.46, or nearly 44 percent, to $37.82 in afternoon trading on the Nasdaq Stock Market, while Elan shares sank $18.37, or more than 68 percent, to $8.53 on the New York Stock Exchange. Those are the lowest prices for both stocks since 2003.

 

But the U.S. shares of rival MS drugmakers Schering AG rose $1.75, or 2.5 percent, to $72.85 and Serono SA jumped $2.76, or nearly 18 percent, to $18.30 in afternoon trading on the NYSE.

 

Tysabri was expected to be a big seller for the companies, and sales of Elan shares surged in October amid published reports in Ireland that Biogen could mount a friendly takeover bid for the Irish company. Elan, once Ireland's highest-flying company and a darling of international investors, subsequently issued a statement saying it was not in talks with Biogen about a merger or business combination.

 

Tysabri -- which also is known by the generic name natalizumab -- has been designed principally to slow the progression of disabilities related to multiple sclerosis, but Elan and Biogen had previously said they believed it could also help sufferers of the gastrointestinal ailment Crohn's disease and rheumatoid arthritis.

 

In December, the companies announced they were starting a head-to-head study comparing Tysabri with another MS drug called Rebif. That study was to enroll 1,000 patients.

 

On Feb. 17, the companies announced favorable Tysabri trial results indicating success in slowing MS in patients who had relapsed, with a 42 percent reduction in the risk of the disability progressing compared with patients who took a placebo.

 

------

 

Associated Press reporter Shawn Pogatchnik contributed to this report from Dublin, Ireland.

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There is a minor error in my earlier post re IIb (should read IIa). Here is a corrected version:

 

ANP could come under significant selling pressure today because an MS drug made by Biogen and Elan Corp. was yesterday removed from sale because it caused the death of one patient and caused a serious disease in the central nervous system of another patient.

 

The removal of sale of the Biogen/Elan MS drug is very significant for ANP because the protien targeted by the Biogen/Elan drug is the same protein (VLA-4) being targeted by ANP's lead MS compound. Indeed, ANP have pinned their hopes for success on the back of the success of the Biogen/Elan drug. See ANP's 26 November 2004 ASX release.

 

In light of these new safety concerns, the results of ANP's phase I trials might now be treated as suspect by regulatory authorities. ANP may be forced to abandon the present IIa trials and conduct more comprehensive safety trials. At the very least, ANP's MS trials are likely to be put on hold until it is clear what precisely is causing death in the Biogen/Elan drug.

 

Further funding for ANP will be impossible without a satisfactory resolution of this issue. If it emerges that the very targeting/neutralisation of the VLA-4 protein itself is a cause of death/neurological disease in some patients, ANP will have to abandon its MS trials completely and would struggle to continue as a going concern.

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ousia,

 

a great example of how sensible/informative posting and information sharing helps the community .... thanks for your timely warning. i had a buy order that would have been hit and already underwater. you've saved me some dollars today.

 

cheers

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