Question-and-Answer Session
Thank you. The question-and-answer session will be conducted electronically. [Operator Instructions]. And we'll take our first question from Tim Anderson of Sanford C. Bernstein & Co.
Tim Anderson - Sanford C. Bernstein & Co
ORENCIA, that seems to be ramping nicely. Can you describe how that product is being used at present in terms of things like first-line setting versus refractory setting, any sort of off-label use or anything like that? And then can you provide development timelines for the sub key formulation, when could that conceivably make it to market, and also the development timelines for the lupus indication?
Lamberto Andreotti - Executive Vice President and Chief Operating Officer
Yes. Let me? this is Lamberto. So let me summarize where we are with ORENCIA in the U.S. Q2 sales were 87 million and this is 64% above last year. And where we are focused is we're focused on increasing our penetration rate in the biologic night patient population by positioning ORENCIA as the IV biological choice. And focusing patients on the efficacy and durability of response over the time of this product. Now, what we have is we have a share, these are data of Q1 '08, we don't have Q2 yet. And we have a new to biologic patient share of 7.5%, and this is up from where were in Q4, we were at 6.5%. And what we see, we measure a number of things of ORENCIA versus REMICADE, and in all this metrics we are improving our ratios then we're improving our performance, relative performance to [inaudible]. So what we're doing is we're solidifying the use in second and third line and increasing our first line use of the product. You know that recently the FDA has removed the requirement that patients must first fail at least one DMARD before initiating therapy with ORENCIA. And this obviously helped us simplify our metrics to both physicians and patients. The same label change broadened the adult indication and at this point, ORENCIA can be prescribed in old patients with moderate to severe array regardless of prior treatment received. So we have a much wider possibility of using ORENCIA and we have a product that is now supported by more data and a better label. And we are taking advantage of all this.
Elliott Sigal - Executive Vice President, Chief Scientific Officer and President, R&D
Tim this is Elliott Sigal. Your question was regarding our lifecycle management program, which continues very intensely, specifically with regard to subcutaneous formulation. Our pivotal trial has been initiated with regulatory feedback both from the FDA and the CHMP. And we expect to have Phase III data in 2009. The dosing frequency will be once a week and that enrollment is progressing. With regard to development this year, Lamberto mentioned the expansion of the label, which I think is very important. That came with our approval in juvenile rheumatoid arthritis. We recently reported Phase II data that was very exciting in terms of the prevention of the development of rheumatoid arthritis. We support our belief and the science, that we can have an impact in earlier forms of disease. We will have one-year data in early rheumatoid arthritis that is the methotrexate naive population to be presented SCACR [ph]. At that time , we will present the Lupus data, the Phase II exploratory study. This is generalized that is non-Lupus Nephritis. That registrational program in Lupus Nephritis, a two, three program are continued. And we are also continuing our program in ulcerative colitis and Crohn's disease.
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