Specter of PEARL Studies Makes Omontys Rehab Unlikely
Pooled data from two studies enrolling such patients -- dubbed PEARL-1 and PEARL-2 -- yielded a hazard ratio of 1.32 for a composite safety endpoint that included all-cause mortality, stroke, myocardial infarction, congestive heart failure, unstable angina, and cardiac arrhythmia (95% CI 0.97 to 1.81) with peginesatide relative to darbepoetin alfa (Aranesp), reported Iain C. Macdougall, MD, of King's College Hospital in London, and colleagues.
No such increase in cardiovascular risk was seen in two other trials labeled EMERALD 1 and 2 that used the identical composite safety endpoint but enrolled patients who were on dialysis. See "Omontys Safety Still a Problem for Nondialysis Patients."
An AFFY medical adviser, identified as Dr. Schiller, speaking about the safety profile discrepancies in the two studies, acknowledged that AFFY would not seek FDA approval for Omontys to be used to treat anemia for CKD patients generally, stated: "We do not underestimate this safety signal. It [is] something we need to investigate and find out more about. But at this time, to file for [chronic kidney disease] patients would be suicidal. The FDA probably would not go for it right now," said Dr. Schiller.
Note how ABSOLUTELY NONE of the touters saying to go long dare to mention that the Omontys safety problem was already discovered and reported in the PEARL study! Now AFFY will have to explain the safety profile discrepancy between the PEARL and EMERALD studies to the FDA. AFFY previously dismissed this discrepancy as "inexplicable" and one for which there was "no definitive answer."
I would not go long AFFY even at what looks like a cheap price here. Cheap compared to what? A failed drug. A failed business plan. No revenues. Huge research and legal expenses. A monopoly rival, Epogen, with a proven safety profile standard in the industry. A damaged reputation in the medical community. A book value of $1.78 per share. What a bargain at only $2.65 a share.