Replies to post #3873 on Biotech Values

[DewDiligence]

Re AGIX:

>> I guess we'll have to see what the final cart II data show to see if they cherry picked in this interim analysis… I think the bottom line for agix is the arise-events trial will be the new binary event and a HUGE one at that. Unless they agree to merge in the interim. <<

If we accept the premise that the interim data reported last week were immature and unfit for public consumption, one explanation for AGIX’s seemingly odd behavior is that they received a buyout or partnership offer contingent on a peek at the interim data.

Of course, AGIX could have shown the data to a suitor privately, under a non-disclosure agreement. Perhaps AGIX went public to invite a sweetened offer from another suitor.

Or maybe suitors and partners had nothing to do with AGIX’s actions. Nissen and Tardif themselves might have pushed for an early data release in order to bask in the klieg lights. Alternatively, AGIX might have jumped the gun on the pedestrian motive that the company had promised investors a data update during the third quarter and the third quarter was coming to a close.

One thing is for certain: this is going to be a fun one to watch.

[DewDiligence]

>> I think the bottom line for agix is the arise-events trial will be the new binary event and a HUGE one at that. <<

Is ARISE really a binary event? I can think of more than two outcomes (ordered from best to worst):

1. ARISE shows a statistically significant lower incidence of heart attacks and other cardiovascular SAE’s for AGI-1067 relative to placebo.

2. As above but a close miss instead of a hit (p>.05 and <.10).

3. No benefit in reducing SAE’s but a statistically significant reduction in plaque volume on an intent-to-treat basis (i.e. no cherry picking of data).

4. As in #3, but a close miss instead of a hit.

5. No benefit in either a reduction of SAE’s or plaque volume. Nevertheless, AGIX continues development of AGI-1067, perhaps reverting to the original indication of reducing restenosis in stent patients.

6. AGIX nixes the entire AGI-1067 program.

--
If you are going to conduct a backgammon type of analysis on the various outcomes, it looks like you have more than two dice sequences to consider :-)

[DewDiligence]

AGIX attempts to tweak pivotal trial:

[No doubt there will be a range of opinions on the changes described here. In my view, when a company requests the FDA to alter the terms of an SPA, it’s not a good sign.]

http://biz.yahoo.com/prnews/050103/sfm053_1.html

AtheroGenics Provides Update on AGI-1067 Clinical Program

ATLANTA, Jan. 3 /PRNewswire-FirstCall/ -- AtheroGenics, Inc. (Nasdaq: AGIX - News), a pharmaceutical company focused on the treatment of chronic inflammatory diseases, today provided an update on its AGI-1067 clinical program for the treatment of atherosclerosis in patients with coronary artery disease. The drug is currently being tested in a pivotal Phase III clinical trial, called ARISE, at leading cardiovascular research centers throughout the United States, Canada, the United Kingdom and South Africa.

AtheroGenics has submitted to the U.S. Food and Drug Administration (FDA) proposed amendments to the ARISE clinical trial protocol designed to enhance the trial as well as to accelerate the current pace of the trial. Subject to approval by the FDA in a manner that would not adversely affect the Special Protocol Assessment for AGI-1067, AtheroGenics intends to increase patient enrollment in ARISE to a target of 6,000 patients from the current target of 4,000 patients, thus providing an estimated fifty percent increase to 10,000 patient-years of exposure during the course of the trial. At the current rate of enrollment, the company estimates that the trial would achieve full patient enrollment by mid-2005. Given the increased size and longer duration of the trial, the Company has also proposed to eliminate the minimum 12 month follow-up period for subjects.

In addition, AtheroGenics has proposed a decrease in the target number of clinical events from 1,160 to approximately 1,000. This revised target number will continue to yield greater than 95 percent statistical power to detect a 20 percent difference in clinical events between the study arms. AtheroGenics expects that, with the above changes, the trial should be completed by the end of the first quarter of 2006. AtheroGenics plans to file a New Drug Application (NDA) with the FDA as soon as possible after the trial is completed and results are analyzed.

"We believe that these proposed changes will greatly enhance the overall quality of the ARISE Study by increasing the size and power of the safety database" said Rob Scott, M.D., Senior Vice President of Clinical Development and Regulatory Affairs and Chief Medical Officer at AtheroGenics. "In addition, the statistical power of the efficacy database of 1,000 events remains superior when compared to other contemporary studies sponsored by the largest pharmaceutical companies."

Regarding partnership activities, AtheroGenics' plan continues to be to enter into a strategic partnership with a major pharmaceutical company to complete the development and commercialization of AGI-1067. Consistent with previous statements, the Company's strategy remains focused on the quality and not the timing of a partnership. As part of this process, AtheroGenics is reviewing with prospective partners the previously announced results of the CART-2 clinical trial and the progress in the ARISE clinical trial. Additionally, a complete publication of the results of the CART-2 study, including a full analysis of efficacy and safety data, is expected later this year.
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