CIBC are still very positive:
On 8/30, CRME reported that IV vernakalant will be discussed at a
Cardiovascular and Renal Drugs Advisory Committee meeting on Dec 11-12.
Initially, the FDA had scheduled this meeting to discuss a different acute antiarrhythmic agent, likely Solvay's tedisamil, but has now requested that CRME and Astellas participate as well.
We have always viewed a panel meeting as a potential positive, as we believe a panel discussion will highlight IV vernakalant's favorable efficacy and safety profile vs. existing antiarrhythmic agents. Notably, unlike many other antiarrhythmic agents including tedisamil, vernakalant has not been associated with Torsades de Pointes. We believe the clinical data from the pivotal ACT 1 and 3 trials of IV vernakalant, which have already been presented at major medical meetings, have been strong and consistent.
Although the need for a panel meeting will delay the PDUFA date by 90 days to mid-January, CRME and Astellas will now have the opportunity to include the positive efficacy data from the phase III ACT 2 trial in post-operative a-fib in the filing package. Safety data from this trial had already been included in the package. We believe this data will further underpin the consistently high efficacy of the drug.
Despite this delay, we expect a positive outcome from the FDA panel meeting, and subsequent approval of IV vernakalant in mid-January. We also continue to have high expectations for the interim ph.IIb data for oral vernakalant, expected in 4Q07. We remain confident that vernakalant will be a very successful commercial franchise, and would be buyers of CRME on weakness. |
