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Biotech / Medical : Elan Corporation, plc (ELN) -- Ignore unavailable to you. Want to Upgrade?


To: William Partmann who wrote (423)7/26/1999 10:03:00 AM
From: William Partmann  Respond to of 10345
 
Elan to Develop Antegren for the Chronic Treatment of Multiple Sclerosis
DUBLIN, Ireland, July 26 /PRNewswire/ -- Elan Corporation, plc (NYSE: ELN - news; ''Elan'') today announced preliminary results of a Phase II clinical study evaluating Antegren® (natalizumab), a humanized monoclonal antibody, in the treatment of acute exacerbation in patients with multiple sclerosis (''MS''). The results are consistent with results observed in an earlier multiple-dose Phase II study indicating the potential utility of Antegren for chronic treatment of patients with MS, but do not support continued effort in the acute therapeutic program.

The study measured existing and new gadolinium enhancing lesions by magnetic resonance imaging (''MRI'') at baseline and then at Weeks 1, 3 and 14. To date, only MRI data through week three have been analyzed. There was a trend in favor of Antegren treatment for the proportion of patients with an improvement in existing gadolinium enhancing lesion counts. Similar results were also noted in the analysis of new gadolinium enhancing lesions. These preliminary data are consistent with the earlier multiple-dose study that showed a similar trend after four weeks of Antegren treatment. Both studies suggest that Antegren may have a beneficial effect in suppressing new lesion formation if administered chronically.

In this acute study, patients were treated with a single dose of Antegren within 96 hours of the onset of their MS exacerbation. The clinical effect of Antegren was measured by the Kurtzke Expanded Disability Status Scale (EDSS) at baseline, 72 hours and then at Weeks 1, 2, 3, 4, 6, 8 and 14. To date, only data from the first four weeks have been analyzed. The primary endpoint was a change in EDSS from baseline to week one and no statistically significant change was observed.

''Unlike the animal models where activity is shown within one week, data from the human clinical studies to date suggests that Antegren takes three to four weeks to reach therapeutic effect,'' said Donal Geaney, Chairman and CEO of Elan. ''These results, along with the results from the multiple-dosing study, support the initiation of chronic studies to investigate the potential of Antegren to slow the progression of MS. We will now focus our development resources in this area and plan to initiate Phase II chronic studies this quarter. Antegren is also in Phase II studies for the treatment of inflammatory bowel disease.''

The development of Antegren is being funded in part by Axogen Limited, a Bermuda corporation that develops therapeutic products for persons with neurological disorders. American Depositary Shares of Axogen trade on the American Stock Exchange and the outstanding common shares of Axogen are subject to a purchase option held by Elan, which expires on December 31, 2001.



To: William Partmann who wrote (423)7/26/1999 1:35:00 PM
From: Lance Bredvold  Read Replies (2) | Respond to of 10345
 
Reading this press release and making an effort to get my arms around Elan as an operating company leads me to a vision of Elan as a sort of venture capital firm. Though I have never seen at close hand the types of firms that Elan makes all these deals with, I am imagining graduates in biotechnological firms having a bright idea to start their own company based on some esoteric specialty and succeeding in getting it going, probably hiring some more people and leasing a building on one of the beltlines of the world. Then they get some papers published and run out of money. Now they need somebody to add to their resources, probably both in terms of related expertise (like delivery) and money and perhaps credibility, but the owner does not want to give up his baby. So Elan buys a bunch of stock which has been authorized but not issued (but why far over the market price?) and gets some options (I guess that's to compensate for paying over the market price for the stock) and probably some exclusivity to the possible product of this subsidiary. But why do they buy stock in Targeted Genetics which then uses the money for one specific subsidiary company?
I read the case about Fuisz and was embarrassed by the things Elan was alleged to have done. I imagine those are detrimental to Elans ability to form this type of relationship and that the bigger companies need to have a good reputation in dealing with these smaller companies. But when I try to look at the bigger picture, that case was probably based on Dr. Fuisz feeling he was not being treated a importantly has he thought he should be. From Elan's perspective it was one small deal in very busy day's and perhaps they were not a quick as they should have been in returning calls and such, but there were a lot of other things to be done. I'll bet there are a lot of prima donnas in the relationships Elan tries to form.

I suppose all I really am doing here is developing a view of Elan, and no response is necessary unless my thinking generates some new thinking in others or if I am viewing this business wrongly--and like the blind man with the elephant, it is just one small view of the whole company.

Sincerely, L.