AI
Tuesday, April 06, 2010 2:40:48 AM
Stealth DD w/POZN #2 ($10.89)…How has the SPA has helped POZN in their chance for approval of Vimovo? The SPA allowed Pozen to address the FDA concern in early 2009!
Pozen has already had their setback with the FDA back in 2008. The PDUFA date almost did not happen after the FDA informed POZN of questions they had regarding the clinical endpoints in their study.
Once they and Pozen reached an agreement (via SPA) on the correct clinical endpoints the Phase III study moved forward to where it is today. The FDA has not had any questions from Pozen since late 2008. Below is an article written in 2008 about the Vimovo setback.
Having the SPA (Special Protocol Assessment) has allowed POZN to have access to the FDA more often than most companies do so that concerns the FDA had could be addressed by POZN before the decision date of April 30th. POZN has met with the FDA several times regarding Vimovo which does not often occur unless your product really fills a void (SPA) and the FDA wants to help you “get it approved.” The meetings with the FDA occurred in:
-2005 regarding their development plans for studies to pursue FDA approval of PN 100 and PN 200.
-In early 2006, POZN submitted an SPA to the FDA for their pivotal Phase 3 clinical trials for PN 200 so that was another opportunity
-In April 2006, POZN announced that they reached an agreement with the FDA on the Phase 3 pivotal clinical trials for PN 200. They had also reached an agreement w/ the FDA on their development program & study design.
-Dec 2008 the FDA informed POZN that it “isn't so sure that "endoscopically confirmed gastric ulcers" are the right endpoint. Back in October the FDA notified Pozen that it's trying to decide if the endpoint is clinically relevant. Showing that a drug changes something in the body isn't good enough for the agency; the FDA wants to know that the change results in a real benefit for patients.”
- In late January 2009, the FDA informed us that it had completed its internal discussions and that there was no change to the previous agreements that gastric ulcer incidence was an acceptable primary endpoint for our clinical programs.
POZN had the SPA with the FDA and that was critical to the point they are at now. They were able address the concern of the FDA by communicating the issue in 2008 and Pozen addressing it in 2009.
”In late January 2009, the FDA informed us that it had completed its internal discussions and that there was no change to the previous agreements that gastric ulcer incidence was an acceptable primary endpoint for our clinical programs. “ (from Pozen 10Q)
I believe that the issues that the FDA had with the approval of PN 200 & 400 were addressed in 2009. Most companies have to wait to hear from the FDA on approval day and oftentimes have not communicated with the FDA at all prior to the decision. This has not been the case with POZN with whom the FDA has been in regular contact with regarding their study enpts & other pertinent data. POZN believes that unless new information about Naproxen becomes available, long-term cardiovascular safety studies will not be required for FDA approval of Vimovo (which contains naproxen).
There have been no issues since and the company presented their breakthrough data at the ACR mtng in late 2009 that was very well received. I believe that there are no further issues that would keep Vimovo from getting approved IMO and that they addressed the FDA concerns in Jan 2009.
Pozen has already had their setback with the FDA back in 2008. The PDUFA date almost did not happen after the FDA informed POZN of questions they had regarding the clinical endpoints in their study.
Once they and Pozen reached an agreement (via SPA) on the correct clinical endpoints the Phase III study moved forward to where it is today. The FDA has not had any questions from Pozen since late 2008. Below is an article written in 2008 about the Vimovo setback.
Having the SPA (Special Protocol Assessment) has allowed POZN to have access to the FDA more often than most companies do so that concerns the FDA had could be addressed by POZN before the decision date of April 30th. POZN has met with the FDA several times regarding Vimovo which does not often occur unless your product really fills a void (SPA) and the FDA wants to help you “get it approved.” The meetings with the FDA occurred in:
-2005 regarding their development plans for studies to pursue FDA approval of PN 100 and PN 200.
-In early 2006, POZN submitted an SPA to the FDA for their pivotal Phase 3 clinical trials for PN 200 so that was another opportunity
-In April 2006, POZN announced that they reached an agreement with the FDA on the Phase 3 pivotal clinical trials for PN 200. They had also reached an agreement w/ the FDA on their development program & study design.
-Dec 2008 the FDA informed POZN that it “isn't so sure that "endoscopically confirmed gastric ulcers" are the right endpoint. Back in October the FDA notified Pozen that it's trying to decide if the endpoint is clinically relevant. Showing that a drug changes something in the body isn't good enough for the agency; the FDA wants to know that the change results in a real benefit for patients.”
- In late January 2009, the FDA informed us that it had completed its internal discussions and that there was no change to the previous agreements that gastric ulcer incidence was an acceptable primary endpoint for our clinical programs.
POZN had the SPA with the FDA and that was critical to the point they are at now. They were able address the concern of the FDA by communicating the issue in 2008 and Pozen addressing it in 2009.
”In late January 2009, the FDA informed us that it had completed its internal discussions and that there was no change to the previous agreements that gastric ulcer incidence was an acceptable primary endpoint for our clinical programs. “ (from Pozen 10Q)
I believe that the issues that the FDA had with the approval of PN 200 & 400 were addressed in 2009. Most companies have to wait to hear from the FDA on approval day and oftentimes have not communicated with the FDA at all prior to the decision. This has not been the case with POZN with whom the FDA has been in regular contact with regarding their study enpts & other pertinent data. POZN believes that unless new information about Naproxen becomes available, long-term cardiovascular safety studies will not be required for FDA approval of Vimovo (which contains naproxen).
There have been no issues since and the company presented their breakthrough data at the ACR mtng in late 2009 that was very well received. I believe that there are no further issues that would keep Vimovo from getting approved IMO and that they addressed the FDA concerns in Jan 2009.
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