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Osiris Therapeutics Management Discusses Q2 2012 Results - Earnings Call Transcript

I see that there are many new callers on the line today, so let me start by providing you with a little perspective on how we developed Prochymal.

We were 20 years ago with a mission to responsibly develop and commercialize the stem cell-based therapy to address significant unmet medical needs. In 1992, we began performing the necessary laboratory work to enter human trials with mesenchymal stem cells. After 6 years of bench work, we initiated our first Phase I human clinical trial with MSCs in 1998. Since that time, Osiris has achieved many firsts in the field of stem cells including the first stem cell product to be awarded Fast Track status by the FDA; the first stem cell drug to be granted orphan drug status by FDA and EMA; the first Expanded Access Program to be approved for a stem cell drug, enabling patients all over the world to receive treatment with Prochymal; and finally, with Prochymal becoming the world's first approved stem cell drug and the first drug specifically approved for the management of acute GvHD.

None of these firsts happened because we took a shortcut. In fact, because it was the first stem cell therapy to be reviewed, the standards to which we were held were, in most cases, higher than that of a traditional drug. These accomplishments, instead, are the result of 20 years of hard work and determination.

With approvals in Canada and New Zealand, our work is transitioning into the commercial phase. Essential focus of this effort is ensuring fair but sufficient reimbursement for the product. Given Prochymal's 20-year development history and enormous development costs, premium pricing is appropriate. Fortunately, there are a number of factors that favorably impact reimbursement discussions around Prochymal. GvHD is a rare disease with an inherently limited market. It is an acute disease, meaning that patients typically receive treatment for only 1 to 2 months, unlike the life-long care required for many of the enzyme replacement therapies. It is the only drug approved for GvHD. And lastly, because the disease is most often lethal absent successful intervention, and treatment with Prochymal has been shown to be both clinically and -- clinically meaningful and improve survival.

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