Biotech Values

[iwfal]

ARISE results as cribbed from a reliable Yahoo poster:

-- Secondary "hard" endpoint -- In a composite of "hard" atherosclerotic
endpoints, composed of cardiovascular death, resuscitated cardiac arrest,
myocardial infarction (heart attack) and stroke, AGI-1067 achieved a
meaningful relative risk reduction of 19 percent (p=0.028). A subgroup
analysis indicated that this result was consistent across important sub-
populations such as: patients with and without diabetes, and men and women.
Furthermore, this result was irrespective of whether patients' baseline
cholesterol (LDL and HDL) levels were above or below target.

-- Diabetes parameters -- Patients in ARISE taking AGI-1067 were 64
percent less likely to develop new onset diabetes (p < 0.0001). In patients
with diabetes, AGI-1067 improved glycemic control as measured by reductions
in HbA1c of 0.5 percent at 12 months (p < 0.0001). These patients had a
mean baseline HbA1c of 7.2 percent.

-- Safety and tolerability -- The most common side effect seen with AGI-
1067 was diarrhea-related; however, it did not frequently result in patient
discontinuation (3.3 percent vs. 0.3 percent). There was a small increase
in the number of patients with abnormal liver function tests as measured by
changes in a combination of liver enzymes and bilirubin (0.2 percent vs.
0.1 percent).

I was wrong on hard events being stronger than 20% (with offsetting effects for revasc) but right on glycemic control. Note that the glycemic control numbers of 0.5% don't look huge compared to other diabetes drugs but all the diabetes trials I've seen have much larger control results the higher the baseline values - and 7.2% is a very low number for baseline. My guess is this is approximately as good as the best in class - e.g. Actos. Also note that Actos got 'only' a 16% reduction in events in their (longer) trial.

Clark