Ik haal de topic nog even naar voren voor dat het in een oeverloze discussie eindigt.
May 15, 2012.
Santarus' CEO Presents at Bank of America Merrill Lynch 2012 Health Care Conference.
Biotech team at Bank of America Merrill Lynch. Our next presenting company is Santarus, and it’s my pleasure to introduce Executive Vice President of R&D, Wendell Wierenga.
..............I mentioned that we have a recombinant C1 inhibitor in development, this particular product has already enjoyed two big pre-clinical studies, I’ll show you the data in just a moment. But our discussion with the FDA, our partner Pharming was required to do a third phase pre-clinical trial looking at the lower dose of this particular recombinant protein. This is clearly based on the treatment for hereditary angioedema, and (inaudible) associated with them, and this Phase III clinical trial done under [Pharming], and we’ll be completing enrollment here in the third quarter of this year. The product is already on the market in Europe under the trademark Ruconest sold by Swedish Orphan Biovitrum.
The data was quite compelling in terms of time to begin the relief of symptoms in both of the clinical trials that were part of the original discussion with the FDA. However, as I noted, the FDA wanted more patients at the lower dose, which is the 50 units per kilogram, and so that is the focus of the current trial involving 75 patients.
If the patient (inaudible) that this would be part of the BLA filing at the end of this year, early next year, that’s what our partner Pharming is saying at present time. And we’re working with them in terms of anticipating then the potential launch of this particular product after approval in the time frame of late 2013, assuming everything goes on track.
The opportunity we believe is significant in this area because this will be the first and only recombinant product for replacement treatment in patients with acute angioedema. And in fact, while there are two class of derived products on the market, the FDA has already agreed that recombinant products are safer and in fat manner enjoy your working designation and as we know from the sourcing of this we can in fact generate significant amounts of this particular protein for not only this particular indication, but thinking of other indications down the road. The treatment paradigm here is moving significantly into the area of acute treatment with self-administration and we will also have that as part of our label in our filings with the agency.
Natuurlijk met dank aan Jurps.