On June 24, 2008, the FDA's Cardiovascular and Renal Drug Advisory Committee met to discuss ultrasound contrast agents. Specifically, the committee met to discuss safety considerations in the development of new agents for approval.
Although Acusphere's (ACUS) Imagify was not specifically discussed at the meeting, we find it encouraging that the guidelines put forth by the FDA on what is necessary to gain approval for future contrast agents, including a large, randomized clinical program effectively powered to detect significant safety concerns, all seem to have been put in place and accomplished with the RAMP-1 and RAMP-2 program.
We note that between RAMP-1 (n=321) and RAMP-2 (n=377), along with over 300 patients in earlier-stage testing, Imagify has been studied in over 1000 patients. During the phase III (randomized) RAMP program, Imagify was well-tolerated with the majority of adverse effects (AEs) reported being mild in intensity, transient, and resolved without residual effects. Therefore, given the FDA's paramount focus on patient safety following what occurred with Definity and Optison last year, we think Imagify should have smooth sailing in this regard.
However, perhaps the most interesting comment made by the Advisory Committee came from the panel's chairperson, Dr. William R. Hiatt who stated, '...(They) would like to see a better (ultrasound) image lead to a better outcome...and that doesn't have to be lower mortality, but a better strategy...' Dr. Hiatt went on to note that the better strategy could be better utilization of cardiac catheterization.
This essentially means the panel sees utility in an ultrasound contrast agent that would lead to greater control over use of angioplasty. In short, only using angioplasty when it is absolutely necessary (i.e. less unnecessary angioplasty). In our view, this is exactly what Acusphere showed with its RAMP-1 and RAMP-2 program.
In RAMP-1, a noted 'less sick' population, the data demonstrated statistically superior (p<0.006) Specificity. Meaning, readers were better able to call a healthy patient healthy using Imagify, and thus send less patients onto an unnecessary angioplasty. In RAMP-2, a noted 'more sick' population, the data demonstrated a statistically superior (p<0.002) Sensitivity. Meaning, readers were better able to identify a patient in need of further diagnostic testing (angioplasty). Both trials demonstrated non-inferior Accuracy to nuclear stress.
The Imagify New Drug Application (NDA) was accepted by the FDA earlier today. We continue to be optimistic on Acusphere and see $5 as our long-term price target.
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