I thought I would put out the "facts" before the spinning takes place. I believe it was mostly good, but it is important to have timelines and opportunities clearly understood so that attempts to alter the facts don't mislead.
Sales are clearly growing continually. The highlight for me was that they are focusing on stroke and dimentia in the retail setting as well as institutional. The numbers given for the target population are actually quite staggering. The company stated that there are 5M ALZ patients with dimentia and potentially underlying PBA and 5M stroke patients similarly. That is a monstrous population and only underscores how small a percentage of those patients need to have PBA to actually meaningfully increase sales in the US. I am VERY optimistic on that front.
Europe is the end of Q1 calendar 2013 AT THE EARLIEST for the initial recommendation. PLEASE don't spin that...whomever. It could be later if the EMA decides that AVNR's responses to the 180 day questions( which have NOT been completed) require more time and discussion.
Additionally, and more importantly, the whole EMA issue will depend on whether the recommendation allows for a broad label or is limited to ALS and MS only. If it is limited, it is basically worthless and the company will either appeal, or withdraw the application and refile with current updated data including success with stroke and dimentia patients. There is no way to know now what the EMA will do, but that is the nature of what we are waiting to find out in March, if then.
On the clinical front all proceeds as previously understood. Four programs; 3 on AVP 923 and one on AVP786(D DEX). The ONLY data we will receive in calendar 13 is the PK/Phase I data from 786 by the end of the first quarter calendar 13. PLEASE no spinning on near term pain data. That has now been moved behind agitation for ALZ which is first Q calendar 14, and is now first HALF calendar 14. I personally believe that this so because it makes much more sense commercially to slide the ALZ indication into our existing institutional sales force than to try and compete in pain which is a whole new ballgame and highly competitive. The PBA numbers in MS and ALS are just not there, which is why the successful focus on other retail segments which has already yielded results.
Lastly the litigation results are not expected until early 2014.
All in all I am very excited about the sales growth that I anticipate in 2013. D Dex data will hopefully be positive which will extend IP protection until 2030, and HOPEFULLY the EMA follows the FDA in a broad label recommendation. Lots to look for.
good luck to all Longs
Sentiment: Strong Buy
This is a good, relatively even handed summary.
I gathered from the transcript of today's conference call that the reason the pain study has been delayed now to first half of calendar year 2014 is that recruitment has been delayed because there are a lot of studies going on for neuropathic pain and it has been harder than they thought to recruit patients.
The pain market is very large and the chances of success with pain are very good while the chances of success with agitation in dementia are so poor I think one can go so far as to say it is a mistake on Avanir's part to be pursuing a relatively large Phase 2 in agitation in dementia based on the poor basisthey have for doing this study.
All in all, I don't think Avanir should be preferentially investing in the agitation in dementia study versus the MS neuropathic pain study and my guess is they are not.