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Biotech / Medical : Tularik Inc. (TLRK) -- Ignore unavailable to you. Want to Upgrade?

To: mopgcw who wrote (525)	10/19/2003 8:52:27 PM
From: mopgcw	Respond to of 598

TLRK CC part 2: David Witzke, SunTrust - Analyst [8] -------------------------------------------------------------------------------- Okay. Can you confirm they're small molecule candidates and that there's some optimization left on these and I guess who is doing the optimization? -------------------------------------------------------------------------------- David Goeddel, Tularik Inc - Founder and CEO [9] -------------------------------------------------------------------------------- I think that would be for Amgen to answer that question. -------------------------------------------------------------------------------- David Witzke, SunTrust - Analyst [10] -------------------------------------------------------------------------------- Okay. I guess one final if I can. I guess with PPR Gamma being commercially validated I wonder if you received any pushback from potential collaborators regarding using Atopinektin as a marker for glucose lowering and do you need to complete the Phase 2a and demonstrate glucose lowering really before partnering? -------------------------------------------------------------------------------- David Goeddel, Tularik Inc - Founder and CEO [11] -------------------------------------------------------------------------------- I'll let Michael Levy address that question. -------------------------------------------------------------------------------- Michael Levy, Tularik Inc - VP of Development and CMO [12] -------------------------------------------------------------------------------- Hi Dave. So we have got a connecting as a biomarker, [indiscernible]-marker specifically for the Phase 1 trials to confirm the activities. In the Phase 2a trial, which will be commencing shortly we will be using fasting blood glucose as the primary end point, and as we move forward to the registration trials we will be using hemoglobin A1C as the primary end point. So far we've had no push backs from potential partners, in fact quite the opposite. T131 is a very promising molecule and it's generating a lot of interest in the community. -------------------------------------------------------------------------------- David Witzke, SunTrust - Analyst [13] -------------------------------------------------------------------------------- Okay. So as far as an optimal time and if you choose to collaborate, it's just a matter of getting the right terms you'd do it, you know, before the trials are completed. -------------------------------------------------------------------------------- Michael Levy, Tularik Inc - VP of Development and CMO [14] -------------------------------------------------------------------------------- That's correct. -------------------------------------------------------------------------------- David Witzke, SunTrust - Analyst [15] -------------------------------------------------------------------------------- Thank you. -------------------------------------------------------------------------------- Operator [16] -------------------------------------------------------------------------------- Our next question from the line of Tony Forstmann , with Forseman Asset Management. Please go ahead. -------------------------------------------------------------------------------- Tony Forstmann, Forseman Asset Management - Analyst [17] -------------------------------------------------------------------------------- Actually, that sort of answered my question, I guess what I'd ask is you have said that you'd had 2 deals before, 1 deal before the end of the year and 1 deal early next year, is that still accurate? -------------------------------------------------------------------------------- David Goeddel, Tularik Inc - Founder and CEO [18] -------------------------------------------------------------------------------- One factor is that is our goal. We'd like to get a deal by the end of this year and another one during the first half of next year. However, the actual timing isn't completely [indiscernible] driven. I can say we have lots of active discussions in very late stages and multiple opportunities to get a major deal done this year. -------------------------------------------------------------------------------- Tony Forstmann, Forseman Asset Management - Analyst [19] -------------------------------------------------------------------------------- Thank you. -------------------------------------------------------------------------------- Operator [20] -------------------------------------------------------------------------------- Mr. Forseman does that conclude your question? -------------------------------------------------------------------------------- Tony Forstmann, Forseman Asset Management - Analyst [21] -------------------------------------------------------------------------------- Yes. Thank you. -------------------------------------------------------------------------------- Operator [22] -------------------------------------------------------------------------------- Very good sir, and we'll go next to line of Joy Maschau with TCL Partners. Please go ahead with your question. -------------------------------------------------------------------------------- Joy Maschau, TCL Partners - Analyst [23] -------------------------------------------------------------------------------- Yes, just to follow up on the previous question regarding the your goals for the deals. I know that T131 is one of the potential deals, maybe you could outline in terms of priorities which programs you are active on the business development front? -------------------------------------------------------------------------------- David Goeddel, Tularik Inc - Founder and CEO [24] -------------------------------------------------------------------------------- We are having active discussions with a number of them including T131, T47, even T67 and earlier stage research programs, as well as individual compounds we call IND candidates named after the potential of moving into the IND stage in the next year and we are carrying these on simultaneously. -------------------------------------------------------------------------------- Joy Maschau, TCL Partners - Analyst [25] -------------------------------------------------------------------------------- Is there a priority for Tularik in terms of those that you listed? -------------------------------------------------------------------------------- David Goeddel, Tularik Inc - Founder and CEO [26] -------------------------------------------------------------------------------- No, I think you know that any one could move to first priority for the right terms or the right partner. -------------------------------------------------------------------------------- Joy Maschau, TCL Partners - Analyst [27] -------------------------------------------------------------------------------- Right okay, and for T67 what kind of partnership are you looking at? Are you looking at something more ex-US, in US? -------------------------------------------------------------------------------- David Goeddel, Tularik Inc - Founder and CEO [28] -------------------------------------------------------------------------------- If we do one it'll be most likely to be ex-US, but that's not one that we're pushing hard ourselves. There are many interests generated and we've responded to requests for meetings to go over T67. I mean unlike T131 where we realized we will need a partner at some point. -------------------------------------------------------------------------------- Joy Maschau, TCL Partners - Analyst [29] -------------------------------------------------------------------------------- Okay, great. Just lastly, on the long term liabilities can you just remind me what those consist of, the long term obligations? -------------------------------------------------------------------------------- William Rieflin, Tularik Inc - EVP & CFO, Administration [30] -------------------------------------------------------------------------------- The big driver there is the deferred rent on our facilities where we conduct our research and development. -------------------------------------------------------------------------------- Joy Maschau, TCL Partners - Analyst [31] -------------------------------------------------------------------------------- That's how much of the obligation? -------------------------------------------------------------------------------- William Rieflin, Tularik Inc - EVP & CFO, Administration [32] -------------------------------------------------------------------------------- That's a significant piece. It is also our deferred revenues. SAV101(ph.) requires that we spread the revenues under our collaborations and recognize them as the services are provided and then for the technology access piece we split it out over the expected term of the collaborations. -------------------------------------------------------------------------------- Joy Maschau, TCL Partners - Analyst [33] -------------------------------------------------------------------------------- Okay. Thank you very much. -------------------------------------------------------------------------------- Operator [34] -------------------------------------------------------------------------------- If there are any additional questions please press 1 on your touchtone phone. We'll go next to Meg Malloy from Goldman Sachs. Please go ahead. -------------------------------------------------------------------------------- Meg Malloy, Goldman Sachs - Analyst [35] -------------------------------------------------------------------------------- Yes. Good afternoon. Thanks for taking my question. Two quick ones on the clinical side. First on the psoriasis Phase 2a data are you going to be looking at possy(ph) scores in this study? You mention clinical outcomes, I was just wondering if you'd look at those? -------------------------------------------------------------------------------- Michael Levy, Tularik Inc - VP of Development and CMO [36] -------------------------------------------------------------------------------- Hi Meg, Michael Levy here I didn't hear your question. For the primary end points for the Phase 2a study in Psoriasis we will be looking at biological markers again. In addition to that we'll be looking at the [indiscernible] connect profile, the safety profile and we'll be looking at the clinical scores. Yes. -------------------------------------------------------------------------------- Meg Malloy, Goldman Sachs - Analyst [37] -------------------------------------------------------------------------------- So you will include the possy scorers? -------------------------------------------------------------------------------- Michael Levy, Tularik Inc - VP of Development and CMO [38] -------------------------------------------------------------------------------- Yes absolutely. -------------------------------------------------------------------------------- Meg Malloy, Goldman Sachs - Analyst [39] -------------------------------------------------------------------------------- What will be the entry criteria? I know it's Phase 2a. We are not going to look for too much in terms of efficacy, but it's nice to know what the general ground rules might be. -------------------------------------------------------------------------------- Michael Levy, Tularik Inc - VP of Development and CMO [40] -------------------------------------------------------------------------------- Well the major [indiscernible] of these studies we'll be taking mild to moderate psoriatic patients and we'll be looking at fact biopsies for the primary end point. -------------------------------------------------------------------------------- Meg Malloy, Goldman Sachs - Analyst [41] -------------------------------------------------------------------------------- And the entry possy scorers what would the mild to moderate imply? -------------------------------------------------------------------------------- Michael Levy, Tularik Inc - VP of Development and CMO [42] -------------------------------------------------------------------------------- Pardon me? -------------------------------------------------------------------------------- Meg Malloy, Goldman Sachs - Analyst [43] -------------------------------------------------------------------------------- What would that imply in terms of the entry possy scores? -------------------------------------------------------------------------------- Michael Levy, Tularik Inc - VP of Development and CMO [44] -------------------------------------------------------------------------------- I don't have that information at the top of my head. -------------------------------------------------------------------------------- Meg Malloy, Goldman Sachs - Analyst [45] -------------------------------------------------------------------------------- That's Okay. Then on diabetes side, will these patients be on oral hypo-glycemic agents or [indiscernible] glutatones(ph) or will these be patients before they would start other -- -------------------------------------------------------------------------------- Michael Levy, Tularik Inc - VP of Development and CMO [46] -------------------------------------------------------------------------------- In the Phase 2a trial we will be focusing on na‹ve patients who aren't receiving other therapy or have received other therapy in the past and have terminated their therapy for at least 60 days prior to beginning the trial. -------------------------------------------------------------------------------- Meg Malloy, Goldman Sachs - Analyst [47] -------------------------------------------------------------------------------- Will you have HBA1C entry criteria for this? -------------------------------------------------------------------------------- Michael Levy, Tularik Inc - VP of Development and CMO [48] -------------------------------------------------------------------------------- No we won't. We'll be focusing on glucose levels as the main cut off. -------------------------------------------------------------------------------- Meg Malloy, Goldman Sachs - Analyst [49] -------------------------------------------------------------------------------- Okay very good, thanks very much. -------------------------------------------------------------------------------- Michael Levy, Tularik Inc - VP of Development and CMO [50] -------------------------------------------------------------------------------- Welcome. -------------------------------------------------------------------------------- Operator [51] -------------------------------------------------------------------------------- Our next question will be from line of Jennifer McNeilly from Franklin Templeton. Please go ahead. -------------------------------------------------------------------------------- Jennifer McNeilly, Franklin Templeton - Analyst [52] -------------------------------------------------------------------------------- Hi thanks for taking my questions. Are the Phase 1's that you did with T67 in which you dosed up to 250, I forget, have we seen that data or will we see it? -------------------------------------------------------------------------------- Michael Levy, Tularik Inc - VP of Development and CMO [53] -------------------------------------------------------------------------------- No you haven't seen that data yet. There was a small Phase 1 problem because we looked at doses 250mg meter squared and less, just to confirm that 250mg per meter squared was the correct dose to take into Phase 3, and as I mentioned earlier we found that the dose was very well tolerated. -------------------------------------------------------------------------------- Jennifer McNeilly, Franklin Templeton - Analyst [54] -------------------------------------------------------------------------------- How many patients? -------------------------------------------------------------------------------- Michael Levy, Tularik Inc - VP of Development and CMO [55] -------------------------------------------------------------------------------- I believe there are 8 patients in total at that dose level. -------------------------------------------------------------------------------- Jennifer McNeilly, Franklin Templeton - Analyst [56] -------------------------------------------------------------------------------- Okay thanks. -------------------------------------------------------------------------------- Operator [57] -------------------------------------------------------------------------------- Thank you for your question. Dr. Goeddel there are no further questions at this time. Please continue. -------------------------------------------------------------------------------- David Goeddel, Tularik Inc - Founder and CEO [58] -------------------------------------------------------------------------------- Okay. Thank you for joining us today. We look forward to speaking with you again soon. Thanks.