Oct. 20, 2009 (Business Wire) -- Acusphere, Inc. (ACUS.PK) today issued the following letter to shareholders:
Dear Fellow Shareholders:
As I have done in the past, I want to use this letter to provide Acusphere shareholders with a review of the Company’s progress in 2009 and our plans as we move forward in the coming months. While we are very disappointed about the significant delay associated with the need for another clinical trial for our lead product candidate, Imagify™, we have not lost sight of the fact that Imagify remains the leader in myocardial perfusion assessment with ultrasound, an important investigational area, continues to show promise in addressing a potential $2 billion market that is growing, and has compelling competitive advantages over the standard of care, nuclear stress testing. We continue to believe strongly in Imagify’s potential for the condition proposed, and we are committed to doing whatever we can to realize that opportunity.
So far this year, we have taken steps to fund operations necessary to obtain feedback from the U.S. Food & Drug Administration (FDA) in the complete response letter to our New Drug Application (NDA) – raising over $30 million during the last two years without selling additional equity that would dilute our existing shareholders. Upon receiving FDA’s feedback, we restructured our partnership agreements to regain worldwide rights to our Imagify intellectual property and reduced our burn rate dramatically, which has given us needed time to explore potential additional partnerships that could provide the financing necessary for the new clinical trial required for FDA approval of Imagify. Obviously these tasks were much more difficult in the economic environment this year, but we are pleased with our progress to date as I will share with you momentarily.
Imagify Is the Leader in Myocardial Perfusion Assessment with Ultrasound
Ultrasound is one of the least expensive and most convenient ways to image the body, but ultrasound alone is not capable of assessing myocardial perfusion (e.g. blood flow in the heart muscle). The ability to evaluate perfusion in the heart muscle allows for early detection of coronary artery disease – the leading cause of death in the U.S. and many other parts of the world. We believe that Imagify, if approved, has the potential to improve the ability of heart stress ultrasound tests (stress ultrasound) to compete with the nuclear stress test, an inconvenient and expensive standard for assessing perfusion today. More than 10 million nuclear stress tests and stress ultrasounds are performed each year in the U.S., providing Acusphere with a market potential of more than $2 billion per year for Imagify in the U.S. alone. Our Imagify Phase 3 clinical program was designed to demonstrate that the efficacy of Imagify with ultrasound is non-inferior, or equivalent, to nuclear stress. We have evaluated Imagify in more than 1,000 patients thus far and believe that it is well tolerated, with a safety profile similar to other drugs used in this patient population.
Regulatory Requirements for FDA Approval of Imagify
By way of background, in December 2008, the Cardiovascular and Renal Drugs Advisory Committee advised the FDA that additional information should be obtained before approving Imagify for commercial use. In February 2009, we oversaw FDA’s successful pre-approval inspection (PAI) of our manufacturing facility and received a complete response letter from the FDA providing feedback on our NDA. In this letter, FDA affirmed the Advisory Committee meeting conclusion, that there were deficiencies in our NDA and another clinical trial comparing the performance of stress ultrasound without Imagify to stress ultrasound with Imagify would be required for approval. We believe that this kind of trial should have a high probability of success. It is well documented in the scientific literature that nuclear stress has higher sensitivity than stress ultrasound alone. Sensitivity is the detection of disease when it is present and is the efficacy parameter that cardiologists and the FDA care most about in the moderate risk patient population in which Imagify is intended to be used. Since we believe our existing Phase 3 data support that Imagify with ultrasound has sensitivity equivalent to nuclear stress, and since nuclear stress is known to have better sensitivity than stress ultrasound without an imaging agent, then we believe Imagify with stress ultrasound would be expected to have better sensitivity than stress ultrasound alone.
At the same time, the probability of success of the new trial, as well as the cost and time required for completion, will be influenced by the specifics of the trial design, which has not yet been negotiated with FDA. As a point of reference, our earlier Phase 3 trials, RAMP-1 and RAMP-2, involved about 320 and 460 patients respectively, incurred costs of approximately $12 and $17 million respectively and required about 24 and 30 months for completion respectively. We will have a better idea of the cost and timing of the next trial once we have negotiated the trial design with FDA. We expect reaching agreement with FDA on the specifics of the trial design will require 6-9 months. We have identified a number of clinical research organizations (CROs) with expertise in myocardial perfusion assessment with ultrasound that could help us with the clinical trial design and FDA discussions.
