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Biotech / Medical : Regeneron Pharmaceuticals -- Ignore unavailable to you. Want to Upgrade?

To: mopgcw who wrote (890)	10/17/2003 1:03:46 AM
From: mopgcw	Respond to of 3559

Final Event Transcript of REGN conference call pt 2 Sapna Srivstava, ThinkEquity Partners - Analyst [41] -------------------------------------------------------------------------------- Hi, just two quick questions. First was -- did you notice a (indiscernible) -- I apologize, I missed the first part of your conference call, so I apologize if this was discussed before -- that any improvements in the solman tender joint(ph) counts, and secondly, just after the first Trap to go into Phase 2, can we draw any broad implications for the other Traps to go into the clinic in terms of safety? -------------------------------------------------------------------------------- Leonard Schleifer, Regeneron - President, CEO [42] -------------------------------------------------------------------------------- Yes, we haven't discussed the further details of the data, and we can't go beyond that at this point because we sort of agreed with our partner what we are. And we're not going to talk about it in terms of precluding the presentation in the future. But I can tell you the ACR scores should be reflective of the components. As far as your question, the second part of your question had to do with safety and how this -- the implications for other traps. Obviously, the most important thing here from other trap point of view is that we have confirmed that we've got a drug that behaves very well in patients in terms of its long half-life and the absence of any immunogenicity. And so that's very encouraging to allow us to move aggressively forward in our other programs -- which we are doing for the VEGF Trap. Obviously, we are prevented from the IL-4/13 Trap on our own. -------------------------------------------------------------------------------- Sapna Srivstava, ThinkEquity Partners - Analyst [43] -------------------------------------------------------------------------------- Thank you. -------------------------------------------------------------------------------- Operator [44] -------------------------------------------------------------------------------- William Flattery, Deerfield Partners. -------------------------------------------------------------------------------- William Flattery, Deerfield Partners - Analyst [45] -------------------------------------------------------------------------------- A couple of questions following up on immunogenicity. The reported less than 5 percent was at the 12-week time frame, is that correct? -------------------------------------------------------------------------------- Leonard Schleifer, Regeneron - President, CEO [46] -------------------------------------------------------------------------------- Yes, that is correct. -------------------------------------------------------------------------------- William Flattery, Deerfield Partners - Analyst [47] -------------------------------------------------------------------------------- Is there any correlation at all between dose and the degree of antibodies that are observed so that 25 is less than 100 dose? -------------------------------------------------------------------------------- Leonard Schleifer, Regeneron - President, CEO [48] -------------------------------------------------------------------------------- No, there is really, I think, only two or three patients that had any evidence of positive antibodies, so there's no dose response. If you compare this to other biologics -- once again, it's hard to compare because people do make the comparisons and the FDA obviously warns against them. But this level of immunogenicity is low. And it's perfectly in line, and we're very, very pleased with it. -------------------------------------------------------------------------------- William Flattery, Deerfield Partners - Analyst [49] -------------------------------------------------------------------------------- It sounds like it's (indiscernible) fairly background. And did you do any other -- did you make any attempt to characterize the effe-tope (ph) in which the antibodies were binding against for those two cases? -------------------------------------------------------------------------------- Leonard Schleifer, Regeneron - President, CEO [50] -------------------------------------------------------------------------------- No, we have not. -------------------------------------------------------------------------------- Operator [51] -------------------------------------------------------------------------------- Michael King, Banc of America Securities -------------------------------------------------------------------------------- Michael King, Banc of America Securities - Analyst [52] -------------------------------------------------------------------------------- Hi. Just a couple of things. On the 50 milligram dose, Len, any comments about why you sort of got that dip in the -- -------------------------------------------------------------------------------- Leonard Schleifer, Regeneron - President, CEO [53] -------------------------------------------------------------------------------- Yes, if you look at the confidence intervals around these kinds of measurements, particularly at the minimally-effective end of a dose response, this is exactly the kind of effect you can see and misinterpret. I think you have to take the data in the aggregate and look at the most precise measurements such as C-reactive proteins and you see there was a very reasonable dose response without any saturation in the clearest effect at the highest dose. So I would caution people not to overread into these clinical scores in small numbers of patients. -------------------------------------------------------------------------------- Michael King, Banc of America Securities - Analyst [54] -------------------------------------------------------------------------------- Okay. And just in terms of formulation, is it accurate that the 100 mg dose was given as two injections? -------------------------------------------------------------------------------- Leonard Schleifer, Regeneron - President, CEO [55] -------------------------------------------------------------------------------- Yes, it was. We're working on -- and they have all -- there was nothing (indiscernible) about that. All of them were give the same way -- as multiple injections. But we're working on, obviously, and we have made progress on higher concentrations for future studies. -------------------------------------------------------------------------------- Michael King, Banc of America Securities - Analyst [56] -------------------------------------------------------------------------------- And was there burning at the highest -- at the 100 milligram dose? -------------------------------------------------------------------------------- Leonard Schleifer, Regeneron - President, CEO [57] -------------------------------------------------------------------------------- Yes, there was burning actually in the placebo as well, and it wasn't that much different across the dose groups in terms of the burning. And we don't think that it's got to do -- that's not limiting. We think that may have to do with the formulation which we have already modified. And I think that we should be in pretty good shape on that. -------------------------------------------------------------------------------- Michael King, Banc of America Securities - Analyst [58] -------------------------------------------------------------------------------- And just in terms of antibodies, did you find -- is there any background rate? Were there in the placebo group at all or was it zero? -------------------------------------------------------------------------------- Leonard Schleifer, Regeneron - President, CEO [59] -------------------------------------------------------------------------------- When you did screening assay (ph) -- the way this is done, you do a screening assay. And what you find, is several patients in each of the dose groups is exactly the same number in the placebo. And then what happens is those three or four positives in placebo in each of the others, goes away when you do a secondary assay. Because your trouble is that you do have patients who have rheumatoid factor -- anti- (indiscernible) -- and what you find is that in placebo and in patients, even at baseline you can pick up a positive, and that's why you have a two-system assay. -------------------------------------------------------------------------------- Michael King, Banc of America Securities - Analyst [60] -------------------------------------------------------------------------------- Okay, thanks. -------------------------------------------------------------------------------- Operator [61] -------------------------------------------------------------------------------- (OPERATOR INSTRUCTIONS) Jim Birchenough, Lehman Brothers. -------------------------------------------------------------------------------- Jim Birchenough, Lehman Brothers - Analyst [62] -------------------------------------------------------------------------------- Hi, guys. Just two follow-up questions. On the antibodies, would you characterize the tighters as low? I mean, what were the levels of antibodies in those patients and was there any trend in terms of tighters? -------------------------------------------------------------------------------- Merdad Parsey, Regeneron - Director of Immunology [63] -------------------------------------------------------------------------------- , Leo, you want to cover that? -------------------------------------------------------------------------------- Leonard Schleifer, Regeneron - President, CEO [64] -------------------------------------------------------------------------------- Yes, the antibody response was, in general, in a few patients that had a response very low and just barely above the limit of 5 patients. -------------------------------------------------------------------------------- Jim Birchenough, Lehman Brothers - Analyst [65] -------------------------------------------------------------------------------- And then -- just a broader question, Len, can you remind us what we should expect in terms of upcoming milestones for the company -- not only for IL-1 Trap but for the VEGF Trap and for Axokine? Leonard Schleifer Sure. I think what you're going to see is, as we have said, we're moving forward with the development of AXOKINE. The FDA had given us a very favorable read on our data in terms of showing a favorable risk-benefit results from our Phase III. So we will -- we are in the process of planning those studies. We will give you some information on what they're going to be. They should start next year. The VEGF Trap program, as you know, is partnered with Aventis, and there's a lot of activity in that area. And we will be updating you in all aspects of that, including our aggressive program that we have already announced with Aventis to move forward in parallel -- not only in multiple cancers but in eye diseases -- and not just by one (indiscernible) administration, multiple rods (ph). I think you're going to see very aggressive program unfold in that arena. And the IL-4/13 is just sort of finishing up a small Phase I. We will have the results to you probably early next year on that -- hoping to advance that, as well, next year. So there is a lot going on, and there is quite a bit going on in the laboratory as well. -------------------------------------------------------------------------------- Jim Birchenough, Lehman Brothers - Analyst [66] -------------------------------------------------------------------------------- Is there any data for AXOKINE in terms of the on-off studies that we should expect by year end or say early '04? -------------------------------------------------------------------------------- Leonard Schleifer, Regeneron - President, CEO [67] -------------------------------------------------------------------------------- No, I don't think we're going to see those until sometime in the middle of next year. But (indiscernible) I think as we have previously communicated to the market, given that the effect size in the AXOKINE study was small, our power to see much there has really been diminished. So, we're not going to be able to tell too much when the overall weight-loss results was such a small one. -------------------------------------------------------------------------------- Jim Birchenough, Lehman Brothers - Analyst [68] -------------------------------------------------------------------------------- Okay, great. Thanks for taking my questions. -------------------------------------------------------------------------------- Operator [69] -------------------------------------------------------------------------------- Larry Rifkin, Cumberland Associates. -------------------------------------------------------------------------------- Larry Rifkin, Cumberland Associates - Analyst [70] -------------------------------------------------------------------------------- Yes, hi, more of an accounting question. What is the current cash on hand pro-forma the most recent strategic alliance deals? -------------------------------------------------------------------------------- Leonard Schleifer, Regeneron - President, CEO [71] -------------------------------------------------------------------------------- Murray, can you handle that? (Multiple Speakers) -------------------------------------------------------------------------------- Murray Goldberg, Regeneron - CFO, Senior Vice President Finance and Administration [72] -------------------------------------------------------------------------------- We have said that we expect that by the end of the year to finish with approximately $350 million. (indiscernible) able to hear that line? -------------------------------------------------------------------------------- Larry Rifkin, Cumberland Associates - Analyst [73] -------------------------------------------------------------------------------- Yes, thank you very much. -------------------------------------------------------------------------------- Operator [74] -------------------------------------------------------------------------------- Chris Tanaka, ITRRS. -------------------------------------------------------------------------------- Chris Tanaka, ITRRS - Analyst [75] -------------------------------------------------------------------------------- (indiscernible) I wanted to ask a question regarding the lost-observation carried-forward design on the study. First of all, how many patients had missing observations, and then secondly, how many -- what percentage of the overall data points were non-refuted (ph) from the (indiscernible)? -------------------------------------------------------------------------------- Leonard Schleifer, Regeneron - President, CEO [76] -------------------------------------------------------------------------------- I think about 75 percent of the patients completed the study, so therefore 75 percent -- at least of the end-point data -- is actual non-refuted data. So you can figure about 25 percent. So I think we've done some sensitivity analysis here, and it's not driving the results and the data -- is that correct? -------------------------------------------------------------------------------- Merdad Parsey, Regeneron - Director of Immunology [77] -------------------------------------------------------------------------------- And I think the key thing to remember is anyone who withdrew from the study for either that there disease was worsening -- was actually treated as a non-responder. So their last observation was actually set to an ACR of 0. So, if anything, it will underestimate the effect (indiscernible). -------------------------------------------------------------------------------- Leonard Schleifer, Regeneron - President, CEO [78] -------------------------------------------------------------------------------- So, we have looked at it both ways. I don't think there's much effect of the imputation (ph). -------------------------------------------------------------------------------- Chris Tanaka, ITRRS - Analyst [79] -------------------------------------------------------------------------------- Thank you. -------------------------------------------------------------------------------- Operator [80] -------------------------------------------------------------------------------- Michael King, Banc of America Securities. -------------------------------------------------------------------------------- Michael King, Banc of America Securities - Analyst [81] -------------------------------------------------------------------------------- Hi, I just wanted to know -- in the press release, you talked about embarking on other clinical development plans. Can we get a sense of what kind of indications you would be talking about there? -------------------------------------------------------------------------------- Leonard Schleifer, Regeneron - President, CEO [82] -------------------------------------------------------------------------------- Yes, we have a long list of them. We don't want to telegraph this until the partnership has decided. But, as you can imagine, IL-1 is important in a lot of different diseases. And it's quite a big laundry list. What we're trying to do is figure out where we can find the best clinical effect and the best market opportunity. We should have more information for that to you as well once the partnership can make a decision. -------------------------------------------------------------------------------- Michael King, Banc of America Securities - Analyst [83] -------------------------------------------------------------------------------- Okay. -------------------------------------------------------------------------------- Operator [84] -------------------------------------------------------------------------------- Jim Birchenough, Lehman Brothers. -------------------------------------------------------------------------------- Jim Birchenough, Lehman Brothers - Analyst [85] -------------------------------------------------------------------------------- Hi, guys, sorry. Just one last question. Just following-up on Larry's question on the cash on hand. Are we going to get an update at some point in terms of anticipated cash burn going forward into next year? -------------------------------------------------------------------------------- Leonard Schleifer, Regeneron - President, CEO [86] -------------------------------------------------------------------------------- Yes, you will. -------------------------------------------------------------------------------- Jim Birchenough, Lehman Brothers - Analyst [87] -------------------------------------------------------------------------------- Any general sense of how that will compare to the burn this year? -------------------------------------------------------------------------------- Leonard Schleifer, Regeneron - President, CEO [88] -------------------------------------------------------------------------------- We're not going to try to anticipate what that's going to look like? Obviously there is a lot of things going on -- beginning with the AXOKINE trials and the other trials that are underway. So, that's what we have to put all that together, and when we have a good idea of what the burn will be in 2004, we will certainly share it with you. -------------------------------------------------------------------------------- Jim Birchenough, Lehman Brothers - Analyst [89] -------------------------------------------------------------------------------- Okay, thanks: -------------------------------------------------------------------------------- Leonard Schleifer, Regeneron - President, CEO [90] -------------------------------------------------------------------------------- We are still comfortable with the end-of-year cash projection of 160 million. -------------------------------------------------------------------------------- Operator [91] -------------------------------------------------------------------------------- There are no further questions. I would now like to turn the call back over to Mr. Poole. -------------------------------------------------------------------------------- Charles Poole, Regeneron - Vice President, Investor Relations [92] -------------------------------------------------------------------------------- Thank you, Tony. Before we close, I would like to turn it to Len just for one closing statement. -------------------------------------------------------------------------------- Leonard Schleifer, Regeneron - President, CEO [93] -------------------------------------------------------------------------------- Thanks, Charles, and thanks everybody for participating. I think that the data we released this morning demonstrating that the drug has a nice safety profile that you can tell in the Phase II study. There was absence of any concerns about immugenicity -- and we think convincing evidence that the drug is active. And I think that one has to remember this is a Phase II study -- relatively small groups and that when you take the data in aggregate, it is encouraging. We would like to do better at higher doses to make it even more competitive (indiscernible) but we think we have done pretty well in this Phase II study. So you can look forward for the partnership to get together and figure out what the next steps are. And we will let you know that as soon as that decision is made. Thanks again, and that concludes our conference call. -------------------------------------------------------------------------------- Charles Poole, Regeneron - Vice President, Investor Relations [94] -------------------------------------------------------------------------------- Thank you for joining us this morning. Remember that the audio portion and the slides will be available on the website archived for the next 30 days. And if you have any questions from the audio webcast, you can e-mail them. There's a site on our web site that will allow you to send questions, and we will get back to you as quickly as possible with an answer. Thank you.

To: mopgcw who wrote (890)	10/17/2003 10:06:38 AM
From: nigel bates	Read Replies (1) \| Respond to of 3559

Thanks for the transcript. This bit doesn't sound too impressive to me (Would "we rushed into the trials, which as a result were seriously compromised" be a reasonable translation ?): ...I don't think we have any evidence that we've reached the MTD. So I think we've made substantial progress in the -- really, truly remarkable progress in terms of the production side of this. So I think we can go significantly higher. I just don't know what the appropriate -- how high we should go. We're going to have to discuss this with Novartis and figure this out. -------------------------------------------------------------------------------- Jim Birchenough, Lehman Brothers - Analyst [33] -------------------------------------------------------------------------------- Can I ask, how far have you dosed-up in Phase I, so we might have a sense of where you could go? -------------------------------------------------------------------------------- Leonard Schleifer, Regeneron - President, CEO [34] -------------------------------------------------------------------------------- Yes, I think we have dosed to 100 in Phase I, and we dosed obviously to 100 in this study without any evidence. And we've got toxicology studies that cover substantially higher doses. So I think we can go higher. We just have to figure out what the right strategy is...