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` UNITED STATES PATENT AND TRADEMARK OFFICE
` ________________________________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ______________________________
` PAR PHARMACEUTICAL, INC.,
` Petitioner
` V.
` NOVARTIS AG
` Patent Owner
` _________________________
` Case IPR2016-01479
` U.S. Patent No. 9,006,224
`
` DEPOSITION of MATTHEW H. KULKE, M.D.
` Boston, Massachusetts
` July 12, 2017
`
`
` Reported by: Dana Welch, CSR, RPR, CRR, CRC
` Job No: 125680
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`Ex. 1070-0001
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`
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` ________________________________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ______________________________
` PAR PHARMACEUTICAL, INC.,
` Petitioner
` V.
` NOVARTIS AG
` Patent Owner
` _________________________
` Case IPR2016-01479
` U.S. Patent No. 9,006,224
`
` DEPOSITION of MATTHEW H. KULKE, M.D.
` Boston, Massachusetts
` July 12, 2017
`
`
` Reported by: Dana Welch, CSR, RPR, CRR, CRC
` Job No: 125680
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`Ex. 1070-0001
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`Page 2
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` July 12, 2017
` 10:54 a.m.
`
` Deposition of MATTHEW H. KULKE, M.D., held
` at the offices of McCarter & English, LLP, 265
` Franklin St., Boston, Massachusetts 2110, before
` Dana Welch, Certified Shorthand Reporter,
` Registered Professional Reporter, Certified
` Realtime Reporter, and Notary Public of the
` Commonwealth of Massachusetts.
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`Ex. 1070-0002
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`Page 3
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` APPEARANCES:
` For the Petitioner:
` LATHAM & WATKINS
` BY: BRENDA DANEK, ESQ.
` 330 North Wabash Avenue
` Chicago, IL 60611
`
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`
`
` For the Patent Owner:
` FITZPATRICK CELLA HARPER & SCINTO
` BY: CHARLOTTE JACOBSEN, ESQ.
` LAURA FISHWICK, ESQ.
` 1290 Avenue of the Americas
` New York, NY 10104
`
`
`
` Appearing by telephone conference:
` Tyler Liu, Esq.
` Argentum Pharmaceuticals
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`Ex. 1070-0003
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` KULKE
` P R O C E E D I N G S 10:53
` MATTHEW KULKE, M.D., sworn 10:54
` EXAMINATION 10:54
`BY MS. DANEK: 10:54
` Q. Good morning, Dr. Kulke. 10:55
` A. Good morning. 10:55
` Q. My name is Brenda Danek and I'm 10:55
`representing the petitioner in this case, Par 10:55
`Pharmaceutical. 10:55
` I believe that you've testified before in 10:55
`legal proceedings as an expert witness; is that 10:55
`right? 10:55
` A. Yes, I have. 10:55
` Q. And, in fact, in matters, proceedings 10:55
`related to the '224 patent? 10:55
` A. Yes, I have. 10:55
` Q. So I assume that you're generally familiar 10:55
`with the procedure of a deposition, but I just want 10:55
`to go over a couple of ground rules. So you 10:55
`understand that you're under oath today? 10:55
` A. I do. 10:55
` Q. And that your testimony here is as though 10:55
`you were testifying live before a judicial 10:55
`tribunal? 10:55
`
`Ex. 1070-0004
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` A. Yes. 10:55
` Q. So I'll be asking a series of questions, 10:55
`and your counsel will be -- may make some 10:55
`objections. And do you understand that you are to 10:55
`answer my question unless specifically instructed 10:55
`by your counsel not to answer the question? 10:55
` A. I do. 10:55
` Q. And you understand that the court reporter 10:55
`will be recording everything that is said today? 10:55
` A. I do. 10:55
` Q. And so it's really important that only one 10:55
`person is speaking at a time. So I will endeavor 10:55
`to wait until you complete your answer before 10:56
`asking new questions. If you will also try to wait 10:56
`until I complete my questions before starting your 10:56
`answer. 10:56
` Is that okay? 10:56
` A. That's perfectly fine. 10:56
` Q. Is there -- if there's any part of one of 10:56
`my questions that you don't understand, I would ask 10:56
`that you ask me to clarify it. 10:56
` Is that okay? 10:56
` A. Yes. 10:56
` Q. And if you don't ask me to clarify my 10:56
`
`Ex. 1070-0005
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` KULKE
`question, I will assume that you understood the 10:56
`question. 10:56
` Is that fair? 10:56
` A. That's fair. 10:56
` Q. Is there any reason that you cannot 10:56
`provide truthful testimony here today? 10:56
` A. No, not at all. 10:56
` Q. And, Dr. Kulke, have you testified 10:56
`previously in IPR proceedings? 10:56
` A. In patent proceedings? 10:56
` Q. In -- I'm sorry -- in proceedings before 10:56
`the patent appeals board in an inter partes review? 10:56
` A. I testified in a case involving sunitinib 10:56
`in the past. 10:56
` Q. Before the patent office? 10:56
` A. It was in Delaware. 10:56
` Q. Okay. So I think there's been -- this is 10:57
`where we get the court reporter confused with that. 10:57
` My question is, has your previous 10:57
`experience been solely involved in district court 10:57
`litigation before a federal district court judge? 10:57
` A. I can't -- I can't say. 10:57
` Q. Okay. 10:57
` A. I testified in Delaware, and the specifics 10:57
`
`Ex. 1070-0006
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` KULKE
`of the court, I can't say. 10:57
` Q. Okay. Well -- 10:57
` MS. JACOBSEN: Sorry. Excuse me. Did 10:57
`somebody join? Did someone dial in? 10:57
` MR. LIU: Yes. My name is Tyler, last 10:57
`name L-i-u. 10:57
` MS. JACOBSEN: And where are you calling 10:57
`in from? 10:57
` MR. LIU: Argentum Pharmaceuticals. I'm 10:58
`in-house counsel at Argentum Pharmaceuticals, 10:58
`A-r-g-e-n-t-u-m. 10:58
` MS. JACOBSEN: And Tyler, you will just be 10:58
`listening; is that correct? You don't plan on 10:58
`participating in the deposition? 10:58
` MR. LIU: No, I do not. I'm not 10:58
`participating. I'm just listening in. 10:58
` MR. JACOBSEN: Okay. 10:58
`BY MS. DANEK: 10:58
` Q. Dr. Kulke, this is a slightly different 10:58
`proceedings than maybe you have previously 10:58
`testified before. This is before the patent office 10:58
`and not a federal district court judge. Your 10:58
`testimony here today is public and will be filed 10:58
`with the patent office and accessible to anyone who 10:58
`
`Ex. 1070-0007
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`Page 8
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` KULKE
`is interested in the proceedings. 10:58
` Is that okay? 10:58
` A. That's fine. 10:59
` Q. Dr. Kulke, you've been involved in a 10:59
`number of clinical trials; is that right? 10:59
` A. Yes, I have. 10:59
` Q. Okay. And before you is a copy of your 10:59
`CV, if you want to take a look at it. It's 10:59
`Exhibit 2042. Is this the CV that you submitted 10:59
`when you submitted your declaration in support of 10:59
`Novartis' patent owner response? 10:59
` A. Yes, it is. 10:59
` Q. Okay. Is this an accurate representation 10:59
`of your experience? 10:59
` A. To the best of my knowledge, yes. 10:59
` Q. Okay. Is there anything material that you 10:59
`think is missing from this since the date it was 10:59
`prepared on February 1st, 2017? 10:59
` A. There conceivably could be minor 10:59
`additions; for example, publications after 10:59
`February of 2017; but otherwise, it looks fine. 10:59
` Q. Okay. And I believe you have a listing of 11:00
`your clinical trials, or at least some portion of 11:00
`them, perhaps not after February 2017, starting at 11:00
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`Ex. 1070-0008
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`Page 9
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` KULKE
`page 4 of Exhibit 2042; is that correct? 11:00
` A. Yes, that's correct. 11:00
` Q. And I want to just take a look at a couple 11:00
`of them. 11:00
` A. Sure. 11:00
` Q. So you have here listed from 1999 to 11:00
`2001 -- do you see that entry? 11:00
` A. Yes. 11:00
` Q. That you were a principal investigator in 11:00
`a Phase 2 study of gemcitabine in patients with 11:00
`advanced neuroendocrine tumors; is that correct? 11:00
` A. That's correct. 11:00
` Q. Okay. And did this study enroll patients 11:00
`with both carcinoid and PNET? 11:00
` A. To my knowledge, it did. 11:00
` Q. And then in 2001 to 2003, at the bottom of 11:00
`the page, you were a principal investigator for 11:00
`Pharmacia and Upjohn in a Phase 2 study of 11:00
`irinotecan and cisplatin in patients with advanced 11:01
`neuroendocrine tumors; is that right? 11:01
` A. Yes. 11:01
` Q. And did this study enroll patients with 11:01
`both carcinoid and PNET? 11:01
` A. I would have to look at the study to 11:01
`
`Ex. 1070-0009
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` KULKE
`remind myself. 11:01
` Q. Do you have any recollection that it would 11:01
`have enrolled patients with only carcinoid or only 11:01
`PNET? 11:01
` A. I'd have to look at the study. 11:01
` Q. Okay. On the next page you have -- well, 11:01
`let me ask you this. I should clarify. So I used 11:01
`the abbreviation PNET, and we understand that -- or 11:01
`you understand that PNET means pancreatic 11:01
`neuroendocrine tumors? 11:01
` A. Yes, I do. 11:01
` Q. So if I use that, there will be no 11:01
`misunderstanding? 11:01
` A. That's fine. 11:01
` Q. And what is your understanding of the term 11:01
`"advanced neuroendocrine tumors"? 11:01
` MS. JACOBSEN: Objection to form. 11:02
` A. I have addressed that in my report -- 11:02
` Q. Okay. 11:02
` A. -- specifically. And I -- 11:02
` Do you happen to know where I address that 11:02
`in my report specifically? I would welcome that. 11:02
` Q. My question, I guess, is, Dr. Kulke, when 11:02
`you use the term "neuroendocrine tumors," do you 11:02
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`Ex. 1070-0010
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` KULKE
`typically mean to include both carcinoid and PNET? 11:02
` A. Yes, I do. 11:02
` Q. Okay. Okay. And Dr. Kulke, on page 5 of 11:02
`your 2042 -- of Exhibit 2042 there is -- going back 11:02
`to your CV, sorry -- page 5. Are you with me? 11:02
` A. Yeah. 11:03
` Q. And at the top of the page you were 11:03
`involved in a study from 2001 to 2003 as a 11:03
`principal investigator for Entremed in a Phase 2 11:03
`study of the safety and efficacy of recombinant 11:03
`human endostatin in patients with advanced 11:03
`neuroendocrine tumors; is that correct? 11:03
` A. That's correct. 11:03
` Q. And in 2002 to 2004, you were involved in 11:03
`a study as a principal investigator for Celgene in 11:03
`a Phase 2 study of temozolomide and thalidomide in 11:03
`patients with metastatic neuroendocrine tumors; is 11:03
`that correct? 11:03
` A. That's correct. 11:03
` Q. And in 2003 to 2004, you were a principal 11:03
`investigator for Sugen in a Phase 2 study of the 11:03
`efficacy and safety of SU011248 in patients with 11:03
`advanced unresectable neuroendocrine tumor; is that 11:04
`correct? 11:04
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`Ex. 1070-0011
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` A. That's correct. 11:04
` Q. And then at the bottom of the page you 11:04
`were involved in a study from 2004 to 2005, as a 11:04
`principal investigator for Genentech in a Phase 2 11:04
`study of temozolomide and bevacizumab -- 11:04
` A. Bevacizumab. 11:04
` Q. Bevacizumab? 11:04
` A. Yeah. 11:04
` Q. -- in patients with advanced 11:04
`neuroendocrine tumors; is that correct? 11:04
` A. That's correct. 11:04
` Q. In these studies, do you recall if prior 11:04
`treatment with cytotoxic chemotherapy was an 11:04
`exclusion criteria? 11:04
` A. I would have to go back and look at the 11:04
`study specifically. 11:04
` Q. Do you have any recollection of any study 11:04
`that you have run or been involved in that had an 11:04
`exclusion criteria in looking at treatments for 11:04
`advanced neuroendocrine tumors that had prior 11:04
`treatment with cytotoxic chemotherapy as an 11:05
`exclusion criteria? 11:05
` MS. JACOBSEN: Objection to form. 11:05
` A. I would have to go back and review the 11:05
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`Ex. 1070-0012
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`study specifically. 11:05
` Q. All right. Well, let's take a look at one 11:05
`of the studies that you were involved in enrolling 11:05
`patients before November 2005. 11:05
` MS. DANEK: I will mark this as 11:05
`Exhibit 1066. 11:05
` (Exhibit 1066, Journal of Clinical 11:05
`Oncology, July 10, 2008, Activity of Sunitinib in 11:05
`Patients with Advanced Neuroendocrine Tumors, 11:06
`marked for identification.) 11:06
` MS. JACOBSEN: And I just -- rather than 11:06
`take time now and review this and state my 11:06
`objections, I'll take a look at it in the next 11:06
`break and make sure that I have whatever objections 11:06
`I need to preserve on the record, if that's okay. 11:06
` MS. DANEK: Yep. No problem. 11:06
` Q. Dr. Kulke, I've handed you a copy of an 11:06
`exhibit that's marked 1066 that is a journal 11:06
`article from the Journal of Clinical Oncology. It 11:06
`is titled "Activity of Sunitinib in Patients With 11:06
`Advanced Neuroendocrine Tumors." You were listed 11:06
`as a first author on this exhibit. 11:06
` Do you recognize this paper? 11:06
` A. Yes, I do. 11:06
`
`Ex. 1070-0013
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` Q. And is this a paper that you authored? 11:06
` A. Yes, it is. 11:07
` Q. And then looking back at your list of 11:07
`clinical studies in your CV, which is Exhibit 2042, 11:07
`is this a -- is the study that is discussed in 11:07
`Exhibit 1066, one of the studies that you've listed 11:07
`on your CV? 11:07
` A. Yes, it is. 11:07
` Q. Is it the study that is identified as 11:07
`enrolling from 2003 to 2004 as the principal 11:07
`investigator for a Phase 2 study on the efficacy 11:07
`and safety of SU011248? 11:07
` A. Yes. 11:07
` MS. JACOBSEN: Objection to form. 11:07
` A. That is the same study. 11:07
` Q. Okay. So this study was enrolling 11:07
`patients and performed in 2003 to 2004? 11:07
` A. Let me look at the manuscript. 11:07
` Q. Yes. 11:08
` I will direct your attention to the second 11:08
`page of the manuscript under the heading "Patients 11:08
`and Methods" and the subheading "Patients." 11:08
` A. Yes. 11:08
` Q. Does that refresh your recollection? 11:08
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`Ex. 1070-0014
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` A. It does. 11:08
` So in the manuscript, patients were 11:08
`enrolled at eight centers in the United States 11:08
`between March 2003 and November 2005. 11:08
` Q. Okay. And then this is -- in this paper 11:08
`you report the results of the study in which you 11:08
`administered the compound sunitinib to patients 11:08
`with advanced neuroendocrine tumors? 11:08
` A. That's correct. 11:08
` Q. Okay. And sunitinib is not a cytotoxic 11:08
`chemotherapy; is that right? 11:08
` A. Correct. Sunitinib would be considered 11:08
`what we were referring to as molecularly targeted 11:08
`therapy. 11:09
` Q. And so molecularly targeted therapies are 11:09
`sometimes -- I believe they're referred to as 11:09
`"targeted therapies" -- are a different category of 11:09
`therapy than cytotoxic chemotherapy? 11:09
` MS. JACOBSEN: Objection to form. 11:09
` A. I think the terms are not particularly 11:09
`specific. But I would agree that in general, 11:09
`sunitinib would be considered in the category of 11:09
`molecularly targeted therapy. It's not cytotoxic 11:09
`chemotherapy. 11:09
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`Ex. 1070-0015
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` Q. Okay. And you were a principal 11:09
`investigator on this? 11:09
` A. Yes, I was. 11:09
` Q. Were you involved in the study design? 11:09
` A. Yes, I was. 11:09
` Q. And this is identified as a Phase 2 study, 11:09
`I believe; is that correct? 11:09
` A. That's correct. 11:09
` Q. What does it mean to be a Phase 2 study? 11:09
` MS. JACOBSEN: Objection to form. 11:09
` Q. Let me ask a more specific question -- 11:10
` A. Sure. 11:10
` Q. -- if that's helpful. 11:10
` MS. JACOBSEN: Well, okay. I mean, take 11:10
`whatever time you need to review the reference, 11:10
`Dr. Kulke. 11:10
` Q. My question was not specific to the 11:10
`reference. It was your understanding as a clinical 11:10
`investigator what a Phase 2 study is. So let's ask 11:10
`a more specific question. 11:10
` So are Phase 2 studies intended to assess 11:10
`efficacy of a treatment protocol? 11:10
` MS. JACOBSEN: Objection to form. 11:10
` A. The objective of studies is generally very 11:10
`
`Ex. 1070-0016
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`clearly stated in terms of with the objectives. 11:11
`And the objective of this Phase 2 study was to 11:11
`assess the response rate associated with sunitinib 11:11
`when used to treat neuroendocrine tumors. 11:11
` Q. Is response rate a measure of efficacy? 11:11
` MS. JACOBSEN: Objection to form. 11:11
` A. Response rate refers to the number of 11:11
`patients that experience tumor shrinkage, which 11:11
`would be an indication of activity. 11:11
` Q. Would response rate not indicate efficacy 11:11
`of a drug or treatment protocol? 11:11
` MS. JACOBSEN: Objection to form. 11:11
` A. It depends on how you would define 11:11
`efficacy. 11:12
` Q. How do you define efficacy? 11:12
` A. It completely depends on the context. 11:12
` Q. Okay. Well, let's put it in the context 11:12
`of your Phase 2 study here. 11:12
` How would you define efficacy in the 11:12
`context of administering sunitinib to patients with 11:12
`advanced neuroendocrine tumors? 11:12
` MS. JACOBSEN: Objection to form. 11:12
` A. It's a vague -- it's a vague question that 11:12
`doesn't quite make sense to me. 11:13
`
`Ex. 1070-0017
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` Q. Okay. What context do you need in order 11:13
`to provide an answer on how you define efficacy? 11:13
` A. I need a more specific question. 11:13
` Q. And what specifics do you think are 11:13
`missing from the question? 11:13
` A. I mean, we can tell you that the study 11:13
`indicated that sunitinib was associated with 11:13
`antitumor activity in that it resulted in tumor 11:13
`shrinkage in a certain number of patients with 11:13
`pancreatic neuroendocrine tumors. So that's what 11:13
`it -- that's what it showed. 11:13
` Q. And antitumor activity, is that limited to 11:13
`tumor shrinkage? 11:13
` MS. JACOBSEN: Objection to form. 11:14
` A. Antitumor activity would include tumor 11:14
`shrinkage or a drug stopping growth of the tumor 11:14
`that would otherwise be growing. 11:14
` Q. Is that referred to as achieving stable 11:14
`disease? 11:14
` MS. JACOBSEN: Objection to form. 11:14
` A. Stable disease can be an indicator of 11:14
`antitumor activity, but, again, it depends on the 11:14
`context. 11:14
` Q. Okay. 11:14
`
`Ex. 1070-0018
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` A. And not all stable disease in clinical 11:14
`trials indicates that a drug is active. 11:14
` Q. Okay. Thank you. 11:14
` You indicated that you were involved in 11:14
`the study design of this Phase 2 study of sunitinib 11:15
`in patients with advanced neuroendocrine tumors. 11:15
`Were you involved in the decision to design a 11:15
`Phase 2 study for sunitinib? 11:15
` A. Yes, I was. 11:15
` Q. Okay. And not seeking any confidential 11:15
`information, but what -- was the decision to move 11:15
`to a Phase 2 study based on data that was available 11:15
`about the antitumor activity of sunitinib? 11:15
` MS. JACOBSEN: Objection to form. 11:15
` Dr. Kulke, you should be careful not to 11:15
`reveal confidential information from another party 11:16
`or company. 11:16
` A. Could you restate the question? 11:16
` Q. Sure. 11:16
` And, again, I'm not seeking any specifics 11:16
`or confidential information. Maybe it might be 11:16
`easier if I direct you to a portion of your 11:16
`manuscript. 11:16
` On the second page of the document, 11:16
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`Ex. 1070-0019
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`page 3404, you see in the text above the table on 11:16
`the left-hand side, there in the middle of that 11:17
`paragraph it says, "In a Phase 1 trial of 11:17
`sunitinib, antitumor activity was reported in 11:17
`patients with renal cell carcinoma and GI stromal 11:17
`tumors, GIST, and in 1 of 4 patients with 11:17
`neuroendocrine tumors." 11:17
` Do you see that? 11:17
` A. I do. 11:17
` Q. Did the Phase 1 trial results of sunitinib 11:17
`that are reported here influence the decision to 11:17
`move to a Phase 2 trial in the study of sunitinib 11:17
`in patients with advanced neuroendocrine tumors? 11:17
` MS. JACOBSEN: Objection to form. 11:17
` A. The fact that there had been a patient in 11:17
`the Phase 1 trial that had experienced tumor 11:17
`shrinkage was one factor contributing to the 11:17
`interest in pursuing a Phase 2 study. 11:17
` Q. Okay. Now, just to investigate a little 11:17
`bit more of the characteristics of the study 11:18
`population that are outlined in Table 1, here you 11:18
`report that patients -- a certain number of 11:18
`patients had previous systemic therapy. That is 11:18
`the last line in Table 1. 11:18
`
`Ex. 1070-0020
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` Do you see that? 11:18
` A. I do. 11:18
` Q. And does previous systemic therapy include 11:18
`previous cytotoxic chemotherapy? 11:18
` A. Previous systemic therapy would include 11:18
`previous cytotoxic chemotherapy. 11:18
` Q. And in this Phase 2 study that you 11:18
`designed, you enrolled 18 patients or 43.9 percent 11:18
`of patients with carcinoids that had previous 11:18
`cytotoxic chemotherapy? 11:18
` MS. JACOBSEN: Objection to form. 11:18
` Q. Dr. Kulke, if it helps, I'm just looking 11:19
`at the last line of Table 1. Feel free, of course, 11:19
`to -- 11:19
` A. I do. I see that. 11:19
` So we don't know if all the previous 11:20
`systemic therapy was cytotoxic chemotherapy. It 11:20
`could have been other types of systemic therapy. 11:20
` Q. What other types of systemic therapies 11:20
`would patients with carcinoid tumors have been 11:20
`prescribed? 11:20
` A. One example would be interferon. 11:20
` Q. Was cytotoxic chemotherapy one of the more 11:20
`common systemic therapies that was addressed -- 11:20
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`Ex. 1070-0021
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`that was administered to patients with carcinoid 11:20
`tumors? 11:20
` MS. JACOBSEN: Objection to form. 11:20
` A. It was administered to those patients. It 11:20
`would, again, depend on the context. 11:20
` Q. Right. 11:20
` And you also report that previous systemic 11:20
`therapy -- 11:20
` MS. DANEK: Strike that. Let me start 11:21
`over. 11:21
` Q. You also report that 40 patients with 11:21
`pancreatic neuroendocrine tumors or 60.6 percent of 11:21
`the PNET patients enrolled had previous systemic 11:21
`therapy; is that correct? 11:21
` A. That is correct. 11:21
` Q. Okay. And you identify in the left-hand 11:21
`column of page 3405 that treatment with prior 11:21
`chemotherapy embolization or radiotherapy was 11:21
`permitted; is that correct? 11:21
` A. That's correct. 11:21
` Q. So specifically you did enroll patients 11:21
`that had previously been treated with chemotherapy? 11:21
` MS. JACOBSEN: Objection to form. 11:21
` A. This was an eligibility criterion, but it 11:21
`
`Ex. 1070-0022
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`does not tell us whether patients were treated with 11:21
`prior chemotherapy. 11:21
` Q. Is it your recollection that the 18 11:21
`carcinoid patients and 40 pancreatic neuroendocrine 11:21
`tumor patients were all previously treated with 11:22
`interferon? 11:22
` MS. JACOBSEN: Objection to form. 11:22
` A. I do not recall the specifics of what the 11:22
`previous treatments were. 11:22
` Q. Looking at the patient characteristics in 11:22
`Table 1, there were 43.9 percent of the carcinoid 11:22
`patients had previous systemic therapy, but 11:22
`60.6 percent of the PNET patients had previous 11:22
`systemic therapy. 11:22
` Do you see that? 11:22
` A. I do. 11:22
` Q. Why would 50 percent more patients with 11:22
`PNETs have failed previous systemic therapies as 11:23
`compared to carcinoid patients? 11:23
` MS. JACOBSEN: Objection to form. 11:23
` A. So I would want to be specific in the 11:23
`eligibility criteria. Treatment with prior 11:23
`chemotherapy was permitted. It did not require 11:23
`failure, at least from what I'm looking in the 11:23
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`Ex. 1070-0023
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`eligibility criteria. 11:23
` Q. Okay.
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