Question-and-Answer Session
Operator
(Operator Instructions) Our first question comes from Mark Schoenebaum of Bear Stearns.
Mark Schoenebaum - Bear Stearns
Okay, hey, thanks for taking my question. Great quarter, maybe I'll just use my question for David. Can you talk about the adult Myozyme trial, can you explain, there has been a lot of confusion about this. Can you explain exactly what the timeline is for that trial?
What protocol amendments, if any have been made? And what if that trial comes out negative? What would happen? How would the FDA respond in your opinion?
David Meeker
Sounds like three questions. But...
Mark Schoenebaum - Bear Stearns
Sorry about that.
David Meeker
So with regard to the timeline, the first, the last patient will be out in the third quarter, that database will be locked in November, and we'll process it and look to release results in the first half of 2008, so that's the timeline.
The confusion may have arisen around the design, it was an adaptive design, which simply meant that the data and safety monitoring board have the ability to look at that data and determine what would be the optimal duration of that trial. In other words they have the ability to elect to continue for a full 18 months, which they did. So that's where we are right now, so the trial will end in this fall.
With regard to possibility, if that trial were negative. This drug works, I think we have enormous confidence that this works both in the pivotal trial that was done in the infantile population, which is the most severe and the anecdotal reports, which are growing around the world. So, I think there's little doubt certainly in our minds, and I would say in the community and both physicians and patients that this is benefiting adult patients.
So, if for whatever, reason this trial were not successful, I think it would be more of an inch of clinical trial design, and we go back to the FDA, and work that through. We will have the ability to follow these patients long-term going forward. So there are a number of different avenues, where we could manage through a result, which may be the result of clinical trial design. But we remain very optimistic that the trial design will be positive.
Mark Schoenebaum - Bear Stearns
Thanks a lot.
Henri Termeer
At this time, David, you can comment that the majority of the patients that are going on treatment of the several hundred on treatment are actually late onset.
David Meeker
Exactly. So there are 60% of the patients that are adult patients at the current time, less than 10% are infantile, under one year of age.
Henri Termeer
Next question?
Operator
Yaron Werber of Smith Barney Citigroup. You may ask your question.
Yaron Werber - Smith Barney Citigroup
Hi, good morning. And thanks for taking my question. I have a question for, Mike. Can you just help us understand a little bit you've shown terrific leverage on the SG&A side. And how should we think about SG&A as a percentage of total revenues?
As it's gone down, as you mentioned by about over 200 basis points, even within the last year. How much lower can that go over time?
Mike Wyzga
So, we're not going to give specific advice, I don't think on individual line items. But I think it is fair to say that, as the LSDs in particular continue to ramp up beginning good deal of leverage on, and again particularly in the sales and marketing area. I will also comment that part of that 26% included a fairly large increase of I believe 30 people, Ian, in the Sepra area.
Sally Curley
20.
Mike Wyzga
20 some odd people in the Sepra area. So we did continue our investment there. That will be leveraged as we go forward as well. Again, I can't give specific numbers on that. But it is a fair comment that we will be leveraging that.
Henri Termeer
Yeah, is this actually quite understandable, and in the case of LSDs, we introduced Myozyme last year and that, obviously, took an investment. To date that sales force is starting to become a factor against real revenues.
Last year we increased our department here in the Synvisc sales effort, both here and abroad, as we took over the responsibilities from Wyeth and others to get Synvisc introduced. These products are now getting leveraged. Clolar is also a recent program that we introduced.
These programs are now starting to get leverage. In the case of bone care we took over Hectorol, a significant sales force, and that's were that would starts to occur. In the case of the very nice growth that we're seeing in genetics, is based on the sales force that has been in place for some time.
In the case of Mozobil, it already goes through an existing sales organization and it may add some marketing people and maybe some sales people across the board in different geographies. But there's material leverage in all of these programs. So and of course the G&A piece itself has a similar kind of feel to it. This infrastructure won't change dramatically as we add these new programs that are with the same points of sale.
And so how you project that? Certainly, I have an objective in the way we run this company to continue to leverage the SG&A component of the P&L. Not to target, because we want to invest in the development of some of these markets in a significant way.
But we have been investing in these markets for a long time, and we ought to be able to see the kind of leverage that we have been seeing over the last 12 months, and in a significant way, we are basing our 20% non-GAAP earnings growth on the fact that we can achieve our sales goals on a global basis while keeping a good check on the SG&A component. Next question?
Operator
Ian Somaiya of Thomas Weisel Partners. You may ask your question.
Ian Somaiya - Thomas Weisel Partners
Thank you, and congratulations on great quarter. I had a question related to your long-term earnings guidance. I was looking at the consensus estimates and they call for roughly 15% growth through 2010; let's assume that number is also valid for growth through 2011, just curious what other areas, we should be focusing on that could support that 5% differential, between our assumptions and yours, are there particular pipeline drugs that you have greater confidence in; what the contribution could be potentially from the share buyback over the next two years; any comments on that?
Henri Termeer
Yeah. I would say that you really have to look for debt differential of only a few percent on the top line, and on the leverage on the SG&A line; the investments required to achieve the kind of growth that we see possible on the top line, is probably less than what on average our indicial consensus projections, and this is not something where we have given much visibility to, its something as I said.
We were conservative about ourselves, and we are now feeling much greater confidence and that's why we are so forceful in indicating the kind of earnings projections non-GAAP earnings projections that we have, so that's where I would look for the differential; and clearly that's where it was the second quarter as well, next question.
Operator
Chris Raymond of Robert Baird and company. You may ask your question.
Chris Raymond - Robert Baird & Co.
Hi thanks, maybe a question for John Butler, sort of wanted to step back on the sort of the renal franchise, with the context of the Renvela sort of setback you saw earlier this quarter, with the once daily formulation.
How important was that once daily formulation, and can you maybe talk a little bit about where you go from here with the three times a day dose. If there is some flexibility there that you might see commercially at least to give the Renvela franchise a potential leg up. Especially, if the Ellipsa product for example ends up having the profile people think it has, thanks.
John Butler
Sure Chris, so we were disappointed in not meeting the primary end point on the once a day trial. Though, we certainly haven't given up on that opportunity, the phosphorous control that you saw in patient's dose once a day was, we got people on average to Kinoki range. Its a matter of understanding, how to move forward with that program, that is still something we would like to, we'd like to give that options to physicians.
Because we think that could be a significant driver and certainly drive patient compliance and better outcomes, we think that the powder formulation even three times a day can expand the patients who can use the product, its one more option for them.
But its important just to step back, and look at what the largest part of the growth that was being driven by Renvela is access to a much bigger market, now the dialysis market in the U.S. is about 350,000 patients. The CKD market patients not on dialysis being seen by the same customers we're calling on nephrologists is over a million patients.
So, having that indication is the biggest driver that Renvela will bring us. So, the once a day dosing certainly, driving compliance is important. We're still working on that but really but really its driving that CKD non-dialysis market opportunity; its hard to comment on the Ellipsa Amgen product profile, since we've seen really no data from it.
But we can see how Renagel's developers established in the market we look at the benefits this product brings beyond phosphorous control particularly for CKD population like lowering LDL, total cholesterol, CRP, etcetera.
Those will become more and more important parts of our message as we move forward, and with the comfort that physicians have with the safety of the product. We think that there is a significant amount of growth when you put all of those factors together even without a once a day dose in our label.
Chris Raymond - Robert Baird & Co.
Thank you.
John Butler
Next question?
Operator
Megan Malloy, Goldman Sachs. You may ask your question.
Meg Malloy - Goldman Sachs
Hi great thanks very much, and I'm hoping you might let me have two quick ones; one is could you elaborate on the database that you have with Renvela in the pre-dialysis setting, I know you have indicated top line results net spec, and then separately. Could you clarify the additional FDA requirements or questions regarding Myozyme scale-up, thanks.
Henri Termeer
Sure, John, the CKD patients not on dialysis data will be presented at ASN, we submitted it there; and I think we probably won't go into further detail until we, until its presented in that forum, and David will comment on the FDA process.
David Meeker
Yeah. So the FDA process is as we've highlighted in the press release and like, this is a standard process, there is a dialogue that goes back and forth, in terms of writing additional data. We are not going to leave specific information as to the data that they've requested. But it is data that we have, we are analyzing that data, and we will be able to submit it within the next couple of months to move this process along.
Meg Malloy - Goldman Sachs
Thank you.
Henri Termeer
Next question?
Operator
Phil Nadeau, Cowen and company, you may ask your question.
Phil Nadeau - Cowen & Co.
Good morning, congratulations on a good quarter; my question is for David, David could you discuss Hunter syndrome in Japan. How many patients have it? What type of pricing do you think you will be able to get? And how will reimbursement work?
Henri Termeer
On Eleprase?
Phil Nadeau - Cowen & Co.
On Eleprase. Yes.
Henri Termeer
All right, the pricing I should just say I'll take this. That those discussions have not yet started with the authorities in Japan, so if you give us a little time to work that out. Then we can comment on it
David?
David Meeker
Yeah, so as I highlighted earlier. So the registration process is moving very quickly, that's the good news and they are highly motivated. I think to approve this product for a patient population in need as I said, we're bullish, at this point. I think we have in the order of in excess of 200 patients in the Asia Pacific region well over 100 of those patients are in Japan.
We would expect, there is currently 15 patients on treatment today. Through a couple of different trial efforts that are facilitating the registration process so again. As with any of these rare diseases we are going to learn a lot more as we go into launch. But those numbers frame a, what we think is a very meaningful opportunity for us. And as Henri said, the pricing will play out in a way that I think will be quite comfortable with.
Phil Nadeau - Cowen & Co.
Okay, in the past. I know you've launched other products in Japan. Has pricing been approximately on par with U.S. and Europe?
David Meeker
Yeah, every product that's a negotiation in all of these countries. It's a dynamic process, we have never gotten a lower price in Japan than we've had elsewhere in the world. So, I would leave it at that.
Phil Nadeau - Cowen & Co.
Okay, and the 100 patients in Asia outside of Japan. How do you access them, do you have to go through independent approval processes in the other nations. Or is there typically some sort of mutual recognition where once...
David Meeker
No, we submit in each one of these countries. And so, you work it through one at a time, the other -- other major drivers here is Taiwan. And Taiwan has a very significant number of patients, its currently approved in Taiwan. And we have a small number of paying patients in Taiwan today, so.
Phil Nadeau - Cowen & Co.
Okay, thank you.
Operator
Geoff Meachum of J.P. Morgan, you may ask your question.
Geoffrey Meachum - J.P. Morgan
Thanks for taking the question, a question of Myozyme; can you mentioned the initial uptake in Japan has been good, can you help us characterize that market a little bit better, is the distribution similar to other regions in terms of late onset versus early?
And then a second part of the question is what currently is the utilization that you're producing Myozyme at, can we run into a situation where you are beyond capacity, as you wait for the decision in the first half of next year.
David Meeker
So going to the Japan side of the equation first. We launch in Japan in June; so these numbers are very early on in the launch. That population is predominantly adults, with your question is the profile likely to can similar to what it is around the world yes; what's the upside potential there are additional patients.
We have a pipeline there of 20-plus patients today, what the long-term potential in Japan is again remains to be seen. But we are very pleased with our start, with regard to the supply issues we have implemented the M tap program, which is the program that allows patients to access the 2000-liter under a protocol structure, here in the United States.
To deal with the fact that, there will be a potential shortage of 160-liter material in the U.S; so yes at our current rate we will not be able to supply the U.S. population with 160-liter material only, but with the 2,000-liter option patients will have the ability to get drugs; it's just a little more laborious to work through the logistics of that program.
Henri Termeer
So let me further the inventory, and the manufacturing position around Myozyme, the two-liter manufacturing process. The large scale manufacturing process has been approved in 28 countries around the world. In fact in every country outstanding United States.
So there is no difficulties to meet supply there. In addition, we are continuously developing further manufacturing capabilities to keep up with future demand. In the U.S., as David says, we will have a temporary moment where we will put patients through special program on the 2,000 material, on one commercial basis, but that will be reached through the early part of next year, as we get approval from the FDA.
So patients will all go on treatment. The fastest growth, as is all of our LSDs, is outside of this country, which is very obvious because there are many more patients outside the United States than in the United States.
So the kind of growth that you saw in the second quarter that we reported is very materially driven for three quarters, driven by outside U.S. sales. But that's a similar kind of profile that we have in other businesses.
Geoffrey Meachum - J.P. Morgan
Thank you.
Henri Termeer
The other thing that you may look at, because the scale-up process with the FDA we would expect at the first half, early part of next year, to be resolved. A similar time, we expect to have resolved the clinical trial, the late onset clinical trial.
So you will in that period, get a bit of a step function around Myozyme, as these clinical trial patients go on treatment and as the patients that are on temporary basis on compassionate use, if you like, 2,000-liter material, transition to commercial material.
David Meeker
A last thing, we have reconfirmed guidance despite the situation in the U.S. so far.
Geoffrey Meachum - J.P. Morgan
Okay. Thanks.
Operator
Geraldine O'Keeffe of Fortis, you may ask your question.
Geraldine O'Keeffe - Fortis Bank
Good morning. And congratulations on the quarter. Just a quick follow-up on the last question of Myozyme, with this 2000-liter facility in place, what kind of a capacity will that give you, particularly with this late onset patient, this ramping up so quickly?
Is there any danger that you could still run out of it in the next few years?
Henri Termeer
We are not expecting to run out of capacity. We have a lot of experience with these things, and we are, because we could have a massive miscalculation of the number of patients that go on treatment, how fast.
But we are expecting very continuous rapid growth around Myozyme and currently we are not expecting to run out of capacity, because we will be able to keep up with it. But it is hard work, I can assure you, that it is not something that automatically happens, and as all of you know, the amount of product needed per patient per year is significantly larger than for the other DOT's.
So, but this is one of the great things that, having developed the capabilities in manufacturing over so many years, that we're able to keep up with this. It's actually quite impressive that we're able to scale and keep up with the significant volume that's required, to make product available to all patients that should come across right now.
So we don't expect to run out and we don't expect to have to constrain the sales at any time, even after the approval by the United States of the 2000-liters. Next question?
Operator
Eric Ende of Merrill Lynch. You may ask your question.
Eric Ende - Merrill Lynch
Thanks. Just digging a little deeper on your 20% growth projection, you had mentioned it was going to come from top line as well as leverage, with respect to the top line, what portion of that would you expect to come from existing drugs versus additional pipeline products.
And then from the operating leverage side, you had already mentioned that there would be a bunch of SG&A leverage, can there also be some R&D leverage, meaning that the percent from revenues will actually come down a bit?
And then just very quickly on the options comment that you made, you said there was a charge of some type, and therefore is it safe to assume that the run rate that you have right now in the second quarter is not a good run rate going forward?
Henri Termeer
Let me answer a few this and then Michael can take some of the other parts of your question. And almost all of the projection that underlies this 20% non-GAAP earnings per share growth rate are coming from products that we currently have, but include products like Renvela and Synvisc-One and Hylastan as well.
Mozobil, we would expect to be approved in this period of time, but it will just be in the very early stage of the introduction. It will start to make a material contribution, we think its extraordinarily exciting program, but only in the latter part of this period.
We would expect it to become launched in 2009, early part of 2009, depending on the regulatory process and it will then increasingly make a contribution in 2010 and 2011. So we are basing our calculations on the products that are currently in the markets and the products that where we have expanded indications that we would expect to be approved in this period. Mike, on the option question?
Mike Wyzga
Sure. Last year, we had a charge of approximately $82 million for the stock options. This year, it is about $72 million. The second quarter tends to be the highest quarter, simply because our option pool is handed out by the board of directors in May.
So what you actually have is you have the new option pool hitting as well as the in conjunction with the old option pool, so you have to expense both of those. The differentiation between the two years, i.e. the 82 going to the 72 that we shifted from 100% just options to a combination of options plus restricted stock, despite again, our growing employee population.
So, that is the difference between the numbers, but Q2 tends to be the highest of all of the quarters, simply because you're expensing both the new pool as well as the old pool.
Eric Ende - Merrill Lynch
Thanks.
Henri Termeer
Next question?
Operator
Shiv Kapoor, Montgomery and Company. You may ask your question.
Shiv Kapoor - Montgomery & Co.
Thanks. I believe you're expecting, at the actual Campath in the first line setting of DCLL, I wanted to ask you what kind of usage growth have you seen in Campath in this setting, in the data at ASH, both in the U.S. and Europe?
And what price increases have you taken on Campath in the past few years?
Henri Termeer
Mark, can you comment on that?
Mark Bamforth
Yeah. So, since the ASH data were presented, and just to remind everyone, these were data from a randomized Phase III study compared Campath head-to-head against Chlorambucil.
Showing Campath was superior across a range of end points to include progression free survival, complete response, overall response and times to overall therapy. And since those data, we've seen a doubling of the share in the first line, but that was off of a very small base.
And so our hope will be that we can continue that trend when we can promote the product directly, in that line of therapy, and I'm sorry, the second question was?
Shiv Kapoor - Montgomery & Co.
Price increases on Campath?
Mark Bamforth
So, there have been two price increases taken over the last 18 months, so one in each of the last two years.
Shiv Kapoor - Montgomery & Co.
Can you give us...?
Mark Bamforth
They were each, in each case, they were below 3%.
Shiv Kapoor - Montgomery & Co.
Okay. Thanks a lot.
Henri Termeer
Next question?
Operator
Adam Walsh of Jefferies, you may ask your question.
Sally Kochnover - Jefferies
Hi, it is actually Sally Kochnover. Thanks for taking my question. Could you comment on the time lines for Campath and MS?
Henri Termeer
Yes, we can. Mark?
Mark Bamforth
So, our expectation is to initiate the two Phase III studies this quarter, with the first patient in, and there are two studies here, one in treatment naive patients, and the second in treatment experienced patients.
Those will be two year studies, that is to say, each patient will be followed over a two two-year period of time, and we would expect to complete enrollment in those studies, by the end of next year. There will be a two-year follow-up period. So we would expect to file in the 2010, 2011 time frame and getting approval shortly thereafter.
Sally Kochnover - Jefferies
Are we still going to see three-year data from the Phase II trial in the second half?
Mark Bamforth
Yes, thank you for that question. So, we will be presenting those data at ECTRIMS. Doctor, Professor Alistair Compston will be receiving the Charcot award, which is given bi-annually in recognition of his work in Campath in multiple growth its in the three-year data will be the center piece of that lecture.
Sally Kochnover - Jefferies
Thank you.
Henri Termeer
Next question?
Operator
Jim Birchenough of Lehman Brothers. You may ask your question.
Jim Birchenough - Lehman Brothers
Yes, hi. Just wanted to ask a question on sustainability of Cerezyme trends from the second quarter onwards. Where are you seeing the growth, in what countries? And what is the incremental opportunity in those countries beyond what you have right now?
And just a related question, I'm just trying to understand your guidance, which seems to suggest flattening of EPS from second quarter levels in the back half of the year and just wondering, given your bullish guidance for continued growth and the 15% price increase we saw on the renal side.
Just wondering if there are one-time items we should be considering in the second half. But the main part of the question is just, understanding where the incremental opportunity from Cerezyme comes from?
Henri Termeer
Okay. We, as you noticed we did increase our guidance for the year, to 335 to 340, which is in excess of 20% growth rate from longer earnings from last year, so we feel this is a very good year. And there is no message whatsoever for the second half in that guidance. The message is, it is a damn good year and we expect it to be sustained going forward.
In terms of Cerezyme, we have been in this field for Gaucher patients since 1991 so, we are now 16 years into this. And the patient accruals over those years have been consistent and they come from throughout the world.
We are addressing patients in I believe now in excess of 90 countries. And it is onesies and twosies on a per country basis. It is not just that we are discovering suddenly a lot of patients in a particular location, because we have been and are everywhere.
It is awareness it is the nature of awareness that is playing here. It is not something you can force. It is something that develops over time. It's something that has surprised us as well over the years.
We've been -- since the last many, many years that I have been on these calls, we are talking to you and saying that this is clearly maturing. As a percentage growth rate, clearly, it is not at the same stage as where Myozyme is today, but the nature of awareness is that patients are coming forward even still in the United States.
As in slow, but at a steady rate over a long period of time, if you have a very large geographic reach, and that is really what is the case here, and that's what is so very powerful.
We have now the same experience with Fabrazyme. We would expect around Myozyme to have a similar experience. These programs provide very long-term growth as patients are being found and being put on therapy.
And it is really the presence in all of those locations and the ability to create awareness and ultimately hopefully through diagnostic mechanisms, the ability to find these patients very early on maybe at birth that will allow us to, that it drives this business.
In terms of newborn screening, which I alluded to there, we are making progress in that regard. We have a number of beta sites. In fact in one, in the case of Myozyme, a Pompe disease in one place in Taiwan, I think we are at least 50% of all births or 100% now, 50% of all births are being screened for Pompe disease, and we are finding babies with this disease.
And it is tremendous, because then we can avoid the kind of complications, deathly complications that this disease can create and we have put these patients on treatment very quickly.
So this is a very different business. And many people have wondered about its longevity and will this continue, including ourselves we have learned about this over the years a great deal and we would expect that in the case of Gaucher disease, we will continue to see new patient identification as we go forward. And when that stops, it is very difficult at this time to predict.
Jim Birchenough - Lehman Brothers
So Henri, to the extent that we keep underestimating the ability of Cerezyme to continue to grow, do you have good data on what the true incidence rate is globally?
Because it seems like new patients coming on globally is driving this and it would seem that you should have some good data on what that incidence is for newly diagnosed Gaucher's patients?
Henri Termeer
We don't have -- the good data comes through many, many, many years of doing newborn screening. That will give you the input data. But I'm a layman. Let me ask David to make a comment.
David Meeker
I think in this area, we're all layman to a certain extent. The predicted prevalence I think would be much larger than the number of patients that are currently on treatment. Now in that number the number that not all of the patients with a mutation will necessarily need treatment, so of course you can't line them up exactly.
But I think the way we approach this disease and what Henri just highlighted is, the number of potential patients in need of treatment is we believe, much larger than the number of patients that is being treated today.
Our ability to access that pool is a function of our global infrastructure. And the only piece I would emphasize on, again on top of what Henri said is that, we treat patients in many places where they can't afford that treatment today or the government is not willing to pay today.
But we are very patient. We are in there. And a big part of this model is we look to create a sustainable health care system, which means that government at some point needs to begin to take responsibility for those patients.
And that model has repeated itself over and over and over again where they start, they fund a center, they then fund a small number of patients and increasingly move to independence.
So we're growing this two ways, we're finding patients and we're also helping the systems move to independence where they can assume full responsibility.
Jim Birchenough - Lehman Brothers
Thanks for taking the question.
Henri Termeer
Next question?
Operator
Sean Wu of Rodman & Renshaw, you may ask your question.
Sean Wu - Rodman & Renshaw
Congratulations on a great quarter. I have a question about Renvela. I know you have high hopes for the pre-dialysis indication, I'm just kind of wondering from what I can recall you only have 40 or 50 patient data. Will this be sufficient for you to move the product from dialysis into pre-dialysis setting?
Henri Termeer
John, can you make a comment?
John Butler
Yes, we certainly discussed our development program with the FDA before we put it forward, so it's our expectation that it will be sufficient.
Sean Wu - Rodman & Renshaw
And another one is because I think it, how many of the patients in pre-dialysis study require this? Because most of the patients have to wait, can be treated in other ways, merely with a some combination of some other readily available option?
John Butler
Well, remember that speaking about phosphate control, dialysis patients can be treated with calcium carbonate as well, but there are consequences to doing that and that's the communication point that is most important.
Now I mentioned, in the U.S. there's 350,000 dialysis patients and over a million pre-dialysis patients. Not all of those million patients have an elevated phosphorous level. That phosphorous does rise later as their kidney failure progresses.
So the first population is that marked hyperphosphatemia that we seek to address, but, as I also mentioned the longer term strategy is really to leverage the other benefits that sevelamer Renvela brings like the LDL lowering, the binding of uremic toxins, etcetera, do more development around those other benefits that sevelamer brings.
And convince physicians that they should be starting this therapy earlier in the disease process, when a patient is diagnosed, and not necessarily when you see a marked hyperphosphatemia.
And we think, in that way, over the long period, you can address that much larger patient population not just a those with a marked hyperphosphatemia. Also that's what allows us to compete most effectively because that product profile is not the product profile of any of the competitors we think are coming down the line.
Sean Wu - Rodman & Renshaw
Finally I have a pricing question. For you to address this much larger indication do you have to price differently? Or do you think you can keep your premium pricing in this indication as well?
Henri Termeer
From a pricing point of view, we will maintain the current pricing around Renagel will carry it through Renvela.
Sean Wu - Rodman & Renshaw
Thank you very much.
Henri Termeer
Next question?
Operator
Aaron Reames of A.G. Edwards. You may ask your question.
Aaron Reames - A.G. Edwards
Thanks and congratulations on the quarter. I just had a quick follow-up question on Myozyme. I know there was around 20 or so patients in Japan that were involved in the compassionate use program and accessing Myozyme that way. Did all of those patients convert over to paying customers in June? Or is that something we should expect to see in the third quarter?
Henri Termeer
David?
David Meeker
Yeah. So, yes, the majority of those patients have all converted and there is an additional pipeline, which will come in play in the third quarter.
Aaron Reames - A.G. Edwards
Okay, and just a question on Mozobil, with having Phase III data from multiple myeloma available in weeks, I was wondering why we shouldn't expect a filing at the end of the year, and if you could just walk us through what has to take place to prepare for the filing, so that can be submitted in I guess in early 2008 time frame?
Henri Termeer
No. I don't have anybody of the regulatory group here, but the P.K. Tenderness here who is in charge of our pharmaceutical group. So, very much involved in making sure that all of the data of both the NHL trial and the myeloma trial come together into the filing, and P.K., any comment in terms of the timing?
P.K. Tenderness
Henri, the only comment I will make, because there are about 22 Phase II studies involved, those studies are being analyzed as we speak, and all of the data is required by the FDA to be submitted in a special format, and that process is going on, and we will be hoping to submit as soon as we can, early next year.
Aaron Reames - A.G. Edwards
Okay, and thank you for taking the questions.
Henri Termeer
Next question?
Operator
Ian Somaiya of Thomas Weisel Partners. You may ask your question.
Ian Somaiya - Thomas Weisel Partners
Sure, just a question on Mozobil, can you just help us characterize the market opportunity there in NHL and multiple myeloma separately?
Henri Termeer
Yeah. What we meant to do is to actually have a special moment once the multiple myeloma trial is done to really focus a call on Mozobil. But, we can make some brief comments right now. It is tough sometimes to talk about these things when are you literally just about to get the data. But Joe, do you have a comment on Mozobil?
Joe Labaki
Yes. I can comment. And I think, the market opportunity we're looking for is for front line mobilization, as we saw in the NHL study, the Mozobil GCSF pharm was superior to the GCSF placebo arm and highly significant so, I think it really shows that this should be a front line drug and I think we have the data now to support that.
We get similar results out of the multiple myeloma study I think, you will be looking at and we expect to be using this as a front line treatment in mobilization for multiple myeloma as well in all patients.
So, you can look at it that way. And then we also look to expand into other transplants as we grow our clinical knowledge of the product and look to other transplants. So, when we look at it, for me and the market, the entire BMT stem cell mobilization market is available to us.
Henri Termeer
And Joe, do you want to make a comment, just very briefly, but because we'll come back to all of you to talk more about the whole commercialization approach around Mozobil, which is extremely exciting and something we would really love to talk about.
But, just make a few comments about the value creation of Mozobil, as it displays itself in NHL, in terms of plasma phoresis and what does it mean in a pure value sense for the patients to have this available to them?
Joe Labaki
Well, I think there are a few ways to look at it and the first one being just that initial mobilization aphoresis sessions. As we saw in the study, we actually decreased the number of days that the patients needed NA phoresis, so that is of high value to the transplant centers when they're trying to getting through a lot of aphoresis chairs and keeping those open for patients to come in.
So, as patients can come in and mobilize reliably to get the number of cells that they need, that is of high value to the institution and NA phoresis center. And also is to the patient as well. It is not a simple and easy procedure to go through. Having GCSF for a week and then getting Mozobil and going in for aphoresis.
So the more you can cut down on those aphoresis sessions for the patients, the better that is for them. So there is definitely value there. Also looking at the number of patients that were able to go on to transplant, if you look at the nonhodgkins data, we had reached that minimum level 47% of the patients on the GCSF placebo and 87% on the Mozobil GCSF arm.
So, that's a large different of patients that are able to go on to transplant and collect the amount of cells that they need to have that procedure available to them. So, for a lot of thee these patients, transplant is a terrific option. It gives them a great response rate and a good quality of life. And if you can't reach the number of cells, you can't go through the transplant.
So, that is of high value to the patient, high value to the institution as well, because you have transplantation, it is a good area for institutions. So if they can treat, get their patients to transplant, that is good for the institution as well. So a lot of value creation within NHL and also I believe coming out of multiple myeloma.
Henri Termeer
Thank you very much, Joe. Next question?
Operator
March Schoenebaum of Bear Stearns. You may ask your question.
Mark Schoenebaum - Bear Stearns
Oh, great. Thanks for taking the follow-up. I appreciate it. Just a clarification from Jeff's question much earlier in the call, I just want to make sure I understand the Myozyme manufacturing issue.
I'm sorry to come back to that, but can you just make sure I understand this, are new patients that are added to the drug in the U.S. right now, are they paying patients? And if they are, at what point in time do you expect those patients to become nonpaying patients because they will be essentially be getting drug from a nonapproved facility?
Henri Termeer
David, do you want to make a comment?
David Meeker
Let me just explain the program where we are at the current time. So, new patients to be eligible for the M tab program need a certain level of severity, in other words these we're prioritizing patients at this time who have either a need for wheelchair assistance or some level of respiratory assistance.
So, that is how new patients come in. If you're a new patient, you're not in that group, as of today, are you in a pool that is waiting. With regard to our current population of patients, we are asking those who are able and willing to shift from the 160-liter material to this M tab 2,000-liter material.
Henri Termeer
So, we essentially are selling out all of the 160 material that we have on a commercial basis, and that we are stretching out, using both the 2000-liter material and the other mechanism in terms of the clinical criteria, as much as possible, the supply. So that, as many patients can benefit that really need the drug in the short term.
And that's what I referred to earlier. We will no doubt, when this situation is controlled in the first half of next year, when the FDA has made the decision to approve the large scale as 28 other countries have already done, you will see a bit of a step function as these patients convert to commercial drug.
Mark Schoenebaum - Bear Stearns
Can you give us any idea of what percentage by the end of the year of U.S. patients are going to be on free drug?
Henri Termeer
It is tough to say. We can't say. It will be as many as we identified that have the clinical need. We will not in any way not treat patients, and if it is many that will be the step function will be that much greater when we get to approval.
Mark Schoenebaum - Bear Stearns
Okay. Thanks.
Operator
Matthew Kanaski of UBS you may ask your question.
Steve Slaughter - UBS
Hi, this is Steve slaughter filling in. Just wondering, if you could give us the diagnostic product sales for the quarter. And secondly, curious as to any changes that might be in the works in terms of the well call relationship. It is our understanding that Sankyo may get an indication for type two diabetes with well call and I'm wondering if there is any impact on the economics of your relationship there if they expand that level.
Henri Termeer
Those are good questions. I at the moment don't quite have the number in my head. Do you, Mike? $30 million?
Mike Wyzga
It's $29.5 million.
Henri Termeer
$29.5 million, Steve.
Steve Slaughter - UBS
That is a 10.5% increase over the last year.
Henri Termeer
That is a 10.5% increase up from last year that. That is the diagnostic products, not diagnostic services that Mara Aspinall commented on. And in terms of well call, you are pointing to something that is clearly very interesting to us, and we are not focused on it. It depends on the approval, and of course, we will have a royalty benefit when the product grows.
But, Sankyo is quite bullish on the possibility to introduce well call in a larger patient population with the added label, the label indication for diabetes. The economics in terms of what we will get will not change from a percentage point of view. But, their sales could very significantly grow as a result of that added label indication. So stay tuned on that.
I would say at this moment it is very interesting, it is an important part of the other category. It is very stable. Sankyo's done a very good job of positioning well call in this country, and we are following that very, very tightly.
Now, of course, many of you may have wondered, what about the rest of the world? And we are working on introducing Cholestagel, we will call it, not well call, in Europe through our own organization later this year. Again, it is too early to talk about many projections there.
It is we are positioning at this moment not against statins, we are positioning it in an area of the market where statins are not helpful to patients. It is almost important area of the market if you look at the very broad-based cholesterol lowering market.
But we think it is interesting, and we will comment again to you once we start to have these structures taking place. We expect that to be probably in the third quarter earnings call in October that we will be ready to talk about this in more specific terms.
We have small organizations being created in most markets at this time. We have in fact off-label sales, or well call sales, if you like, imported sales currently in Europe for these very special indications.
So we are hopeful again that that will be an important product for us, over time. It is early, early days and one of the reasons, we haven't talked about it, is that we would like to talk about things maybe they are a little bit more en route. But great question, Steve, and stay tuned on this cholesterol front.
Steve Slaughter - UBS
Thank you.
Operator
Jim Birchenough of Lehman Brothers. You may ask your question.
Jim Birchenough - Lehman Brothers
Just a quick follow-up question on Mozobil and timelines. Is there any gating factor in terms of FDA requiring longer-term outcomes data beyond the 100 days we've seen already? And if so, when would we see longer-term outcomes data from the trials?
Henri Termeer
P.K. can you make a comment?
P.K. Tenderness
Yeah. We will have a six-month data end of this year, on from Phase III trials.
Jim Birchenough - Lehman Brothers
And is that one of the gating factors for your filing?
P.K. Tenderness
No, with the FDA, we have a special protocol approval that's based on the 100-days data, follow-up data from the two Phase III trials.
Jim Birchenough - Lehman Brothers
And at the six-month point are you looking at success of transplants?
P.K. Tenderness
Yes, we are looking at safety as well as success of transplants, yes.
Jim Birchenough - Lehman Brothers
Thank you.
Operator
Yaron Werber of Smith Barney Citigroup. You may ask your question.
Yaron Werber - Smith Barney Citigroup
Yeah, I have a follow-up question on Synvisc. Can you just give us a little bit of an update on what you're seeing in the market right now in terms of the competitive landscape and is your market share stabilized or what where are you in the process?
And on Synvisc-One, you presented a little bit of data at ULAR and it does seem admittedly as you compare cross studies, that the efficacy is not quite as robust as typical Synvisc and preparation for placebo, when you have met your end point, but it wasn't all that impressive. So could you comment on that and how you see the market ultimately shaping up?
David Meeker
Ann?
Ann Merrifield
Certainly. In the U.S. competitive frame, there are five of us on the market. Synvisc, we estimate our share to be stabilizing around 40% of all treatments. Hygaron (ph) and Sepra shared of that 20% each and Nuflexa and Orthofix split the balance. So we have a clear leadership position and trending upwards and moving upward slightly in the last few months.
So we feel comfortable in a competitive market with the pricing actions taken, with the clinical data we've made available and the pipeline ahead of us that we will stabilize and continue to turn that trend around as we wants them this one.
In terms of the efficacy data the original data on Synvisc classic, as we're calling the three injection product, are many years old and these data are recent. The protocols of the various trials are different. There are no head-to-head comparisons, so it is very difficult to make an efficacy comparison between the two products.
The pain trials as you will learn, or I am learning, as you talk to folks who do many of them are very difficult, and this treatment effect is as significant as what has been seen on Celebrex and some of the other pain-relieving modalities in the OA franchise, OA arena, so we feel comfortable that the treatment effect is significant and it is hard to make a comparison.
Henri Termeer
And next question? Operator, I would leave it to two more questions, because we are a little bit over time.
Operator
At this time, we have no further questions.
Henri Termeer
Wow. I didn't mean to cut anybody off. But if there are other questions, don't hesitate, and I know you won't. Thank you all very much for your participation today. I think they were good questions, questions that really dealt with the kind of growth that we told you at the beginning of this call that we now are expecting, not only this year, but through 2011, based on the kinds of programs that all of us increasingly are becoming familiar with.
So thank you very much for being here today. And we will stay in touch as we move forward.
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