Below is a summary of updates to the
<font> BioMedReports.com </font> database of over 200 entries included in the
<font> FDA and Clinical Trial Calendars </font> . The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
Below is a summary of press releases from Acusphere, Inc. (OTC:ACUS) from this year, which are available in full directly from the Company's website at
<font> www.Acusphere.com </font> . Based on the most recent press release last week, ACUS expects to have sufficient liquidity to fund operations until the end of 3Q09 due to cost-cutting initiatives.
However, the most recent press release states that discussions with the FDA continue regarding the design of a clinical program to address the FDA's complete response letter (CRL) for Imagify and makes no mention of the amended NDA with a narrower claim referenced in earlier press releases. While previous press releases in February and March mentioned FDA meetings to "discuss alternatives" , an "amended NDA" , and a "narrower claim" for Imagify; the Company's latest press release from 5/19/09 only mentions that discussions continue with the FDA regarding the design of a clinical program to satisfy the issues raised in the CRL by the FDA for Imagify.
Since ACUS no longer mentions the amended NDA for Imagify as part of its discussions with the FDA; there is no definitive timeline for a FDA decision on the NDA until further notice from the Company on the strategy and timeline to satisfy the issues raised by the FDA in the CRL for Imagify. BioMedReports.com contacted the Company in an attempt to receive more clarity on the strategy and timeline for Imagify in early May, but has not received a response as of yet.
"We excluded $17 million associated with the acquisition of Licensed Technology from Acusphere. . . In November 2008, Acusphere became a variable interest entity to which we are the primary beneficiary. As a result we are consolidating that company’s results. Operating expense guidance increased compared to our previous guidance predominantly as a result of VIE accounting for Acusphere inception. Consequently, we will eliminate approximately $50 million of expense as non-control and minority interest."
19-May-2009 : The Company continues to discuss its New Drug Application (NDA) with the FDA for its lead product candidate, Imagify (Perflubutane Polymer Microspheres) for Injectable Suspension, a Perfusion Stress Echo imaging agent targeted for use in detecting coronary artery disease. The Company previously announced that it had received a complete response from the FDA for Imagify in February 2009, FDA's target date under PDUFA guidelines. The response was largely consistent with the feedback received at the Advisory Committee meeting in December 2008, and discussions that continued with FDA in January 2009. In general, FDA's response stated that additional clinical work would be required to support approval. Discussions with FDA continue regarding the design of the clinical program.
31-March-2009 : The Company previously announced that it had received a complete response from the FDA for Imagify. The response was largely consistent with the feedback received at the Advisory Committee meeting on December 10, 2008, and discussions that continued with FDA in January 2009. In general, their response suggested that additional clinical work would be required to support the original broad claim. The Company was also invited by FDA to schedule a meeting to discuss alternatives for moving forward.
11-March-2009 : ACUS announced today that it has received a complete response from the FDA. The response was largely consistent with the feedback received at the Advisory Committee meeting on December 10, 2008, and discussions that continued with FDA in January 2009. In general, their response suggested that additional clinical work would be required to support the original broad claim. As previously announced, The Company also submitted in February 2009 a narrower claim with a potentially improved risk-to-benefit ratio. The Company was also invited by FDA to schedule a meeting to discuss alternatives. The Company is in the process of scheduling the meeting.
17-Feb-2009 : ACUS announced today that it has submitted an amendment to its NDA for Imagify. The NDA was submitted to the FDA in April 2008 and filed in June 2008. If FDA accepts the submitted amendment, the Imagify indication will be limited to subsets of patients undergoing pharmacologic stress techniques. The amended indication is focused on patients where the risk-to-benefit ratio of Imagify is more compelling than the broader indication that was originally filed. Since this is a significant amendment to the NDA for Imagify, it is likely that the FDA will push back the PDUFA target date for their complete response letter from February 28, 2009 to May 31, 2009.
I have removed ACUS from the FDA Calendar of pending decisions after their most recent press release last week until the Company provides more clarity on the strategy and timeline for the Imagify NDA. However, with a market cap of just $15M, cost-cutting initiatives to fund operations until the end of 3Q09, and the CEPH involvement; ACUS is still an attractive stock for the most aggressive and speculative investors and traders in the bio-med space due to the inherent value in its core microsphere drug delivery technology platform rather than an imminent FDA decision for Imagify.
Disclosure: No positions.
$58.34 (05/25/09)
