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Affymax, Inc. (AFFY)
Lazard Capital Markets Healthcare Conference
November 14, 2012 1:00 PM ET
John Orwin – CEO
Meredith Cheng – Lazard Capital Markets
Meredith Cheng – Lazard Capital Markets
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Thank you very much and welcome. It’s a great pleasure to be here this afternoon and to provide an update on Affymax and the launch of our products OMONTYS. I should point out that we will be making forward-looking statements and our results may vary from projections that we may make and I would recommend that you look to our latest 10-Q on file for a complete discussion of our risk factors.
So this is actually the safety information of OMONTYS which comes along with actually having an approved product. So it’s actually better to have than not to have I suppose. OMONTYS was approved back in late March for the treatment chronic kidney disease in adult patients who are on dialysis in order to correct their anemia and as you’ll see, the label is very similar as are the warning for OMONTYS as exists for other ESAs including Aranesp. Here is a shot of the product itself. It represents the first one’s monthly ESA available in the United States. The market for ESA and dialysis has been primarily Epogen which is a 13 times a month product and again approved for treatment of anemia and this chronic kidney disease patients on dialysis.
So, first one once monthly product launch in the second quarter. We compete in a large market. it’s a little greater than $2 billion net in the US and we believed and I think it’s been affirmed in the marketplace that there was a strong desire to have therapeutic alternative to Epogen and Aranesp to the existing ESAs particularly in the dialysis setting which had up until we launched earlier this year than for all intents and purposes a monopoly market for over two decades. So we’re about four months into the launch and we’re happy to report on some terrific progress that we've made. Fresenius which is the largest dialysis provider in the US has undertaken a fairly large scale conversion. They've converted over 10,000 patients at this point and we have a supply agreement in place with them and we’ll be working toward a long term supply agreement. We announced last week on our earnings call that we signed two additional medium sized dialysis organizations or MDOs bringing the total to four out of the existing six, so roughly two things of the available business on the MOD side.
And then we've also achieve a meaningful penetration into the smaller and independent dialysis organizations as well which among them make up about 15% or $300 million of the total market.
As I'll describe in a bit, we have a very strong strategic alliance with Takeda Pharmaceuticals who have responsibility for OMONTYS ex-US and with whom we have collaboration and a profit split inside the United States. We also reported $100 million in cash and investments at the end of the third quarter.
So to begin with, OMONTYS is a differentiated product. It does bind to and stimulate the erythropoietin receptors in the way that conventional cell derived ESA such as Epogen do. But is a synthetic peptide based ESA. So non-cell derived. And in fact has no shared structural homology with either endogenous erythropoietin or the recombinant ESAs.
Safety and efficacy were demonstrated in a very large Phase III program in dialysis and particular two large randomized mutually supportive controlled trials. The evaluation was done for efficacy on the basis of non-inferiority looking at hemoglobin stability and control and each of those studies was independently powered for efficacy and met its primary and secondary endpoints.
Safety was evaluated on the basis of a blinded independently and judicated (ph) comprehensive cardiovascular safety analysis and were really the first product in this category to have done that evaluation and the safety analysis was a pool analysis across the two studies in dialysis as well as two studies in pre-dialysis again, meeting the primary and secondary endpoints for safety in this large analysis which included over 2,500 patients.
So as mentioned before, we’re approved for chronic kidney disease patients on dialysis but it’s important to point out that the label we were granted includes both maintenance patients, patients who can be switched from EPO as well as so called incident patients or patients who are new to dialysis. Its counter-indicated and uncontrolled hypertensive patients and patients with serious allergic reactions as is the case for other ESAs. As mentioned before, the pox warnings were all very similar.
The package insert also includes a conversion table, there is a nonlinear dose conversion from EPO to Amicus, but it’s actually very straight forward using the table that's included in the package insert. And that information allows you to correct dose either patients who are new to dialysis or patients who providers might be switching from Epogen. And then the product is also stable at room temperature for up to 30 days when its unused which actually is quite helpful to the dialysis centers themselves, the competitor products needing to be keep refrigerated.