Secondly, it also opens up the ability for our clinical development teams to more aggressively pursue additional development of Cinryze, whether it would be our subcutaneous administration program or other serious conditions of unmet need that could benefit from C1 inhibitor.
I am very proud of the can do attitude of the joint ViroPharma/Sanquin team in achieving the PAS approval. And I am extremely thankful to the patients, physicians, HAEA and many others for their willingness to work with us and work through any challenges that confronted us. I would also like to note the efforts of the FDA’s CBER review team, who also worked together with us in a very professional manner.
So now, let’s move into some of the facts that how this approval impacts the business moving ahead. As we noted earlier, the industrial scale line is capable of producing on a single shift between 100,000 and 110,000 doses annually. We have plans in place to add additional shifts as well as increase in production through various other means.
As it pertains to 2012 specifically, we expect that we’ll be able to produce more than enough doses to not only meet the expected demand for the year, but also all of our clinical needs. We anticipate product produced at risk from our industrial scale manufacturing line to start being available for sale on approximately six weeks.Our first priority is to get all patients back to receiving monthly shipments as opposed to the weekly shipments they have been and are currently receiving. We expect this to occur during the third quarter. In the fourth quarter, we expect our SPs and SDs will be in a position to be begin to rebuild their inventories. Moving on to Cinryze demand; since the launch, we’ve demonstrated a very steady and consistent demand growth every quarter, and the second quarter of 2012 marked yet another very impressive period of growth. During the quarter we added approximately 60 gross new patients on Cinryze therapy, and across the first half of 2012 we have added over 120 gross new patients on the Cinryze therapy. As further evidenced of the tremendous strength of our demand growth, I’ll also add that in July we had the second strongest month of new scripts generated in the past three years. Read the rest of this transcript for free on seekingalpha.com
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