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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ----------------------------------X
` AMERIGEN PHARMACEUTICALS LIMITED
` AND ARGENTUM PHARMACEUTICALS, LLC,
`
` Petitioners,
`
` vs.
`
` JANSSEN ONCOLOGY, INC.,
`
` Patent Owner.
`
` Case IPR2016-00286
` Patent No. 8,822,438 B2
` ----------------------------------X
`
` DEPOSITION OF RICHARD AUCHUS, M.D., Ph.D.
`
` New York, New York
`
` Thursday, December 15, 2016
`
` 9:15 a.m.
`
` Reported by:
`
` Jennifer Ocampo-Guzman, CRR, CLR
`
` JOB NO. 17732
`
`Amerigen Exhibit 1188
`Amerigen v. Janssen IPR2016-00286
`
`TransPerfect Legal Solutions
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`
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ----------------------------------X
` AMERIGEN PHARMACEUTICALS LIMITED
` AND ARGENTUM PHARMACEUTICALS, LLC,
`
` Petitioners,
`
` vs.
`
` JANSSEN ONCOLOGY, INC.,
`
` Patent Owner.
`
` Case IPR2016-00286
` Patent No. 8,822,438 B2
` ----------------------------------X
`
` DEPOSITION OF RICHARD AUCHUS, M.D., Ph.D.
`
` New York, New York
`
` Thursday, December 15, 2016
`
` 9:15 a.m.
`
` Reported by:
`
` Jennifer Ocampo-Guzman, CRR, CLR
`
` JOB NO. 17732
`
`Amerigen Exhibit 1188
`Amerigen v. Janssen IPR2016-00286
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
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` December 15, 2016
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` 9:15 a.m.
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`
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` Deposition of RICHARD AUCHUS,
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` M.D., Ph.D., held at the offices of
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` Sidley Austin, LLP, 787 Seventh Avenue,
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` New York, New York, pursuant to notice,
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` before Jennifer Ocampo-Guzman, a
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` Certified Real-Time Shorthand Reporter
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` and Notary Public of the State of New
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` York.
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` A P P E A R A N C E S:
`
`
`
` MCNEELY, HARE, WAR LLP
`
` Attorneys for Petitioner
`
` 12 Roszel Road, Suite C104
`
` Princeton, New Jersey 08540
`
` (347) 400-1154
`
` BY: GABRIELA MATERASSI, ESQ.
`
` materassi@miplaw.com
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` WILLIAM D. HARE, ESQ.
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` bill@miplaw.com
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`
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` SIDLEY AUSTIN LLP
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` Attorneys for Patent Owner
`
` 787 Seventh Avenue
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` New York, New York 10019
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` (212) 839-5300
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` BY: BINDU DONOVAN, ESQ.
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` bdonovan@sidley.com
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` ALYSSA B. MONSEN, ESQ.
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` amonsen@sidley.com
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` APPEARANCES (Continued):
`
`
`
` FINNEGAN HENDERSON FARABOW
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` GARRETT & DUNNER LLP
`
` Attorneys for BTG
`
` 16 Old Bailey
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` London EC4M 7EG
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` United Kingdom
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` +44 (0)20 7864 2800
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` BY: ANTHONY C. TRIDICO, Ph.D.
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` anthony.tridico@finnegan.com
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`
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` ALSO PRESENT:
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`
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` TIM TRACY (Johnson & Johnson)
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` TONY DOLAN (BTG)
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` R I C H A R D J. A U C H U S, called as
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` a witness, having been duly sworn, was
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` examined and testified as follows:
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` EXAMINATION BY
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` MS. MATERASSI:
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` Q. Good morning, doctor. My name is
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` Gabriela Materassi and I represent petitioner
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` Amerigen Pharmaceuticals Ltd. in this
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` proceeding.
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` My first question for you is, do
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` you understand why you're here today?
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` A. Yes, I do.
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` Q. And what is your understanding of
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` why you're here today?
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` MS. DONOVAN: And I will just
`
` caution the witness not to disclose any
`
` attorney/client privileged
`
` communications. You may answer the
`
` question generally.
`
` A. To discuss my declaration.
`
` Q. Very good. So first exhibit that I
`
` am going to hand has been, will be marked AMG
`
` 1082?
`
` (AMG Exhibit 1082, Petitioners'
`
` Notice of Deposition of Richard Auchus,
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` M.D., Ph.D., marked for identification,
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` this date.)
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` Q. Just handing that to you, sir.
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` MS. MATERASSI: Sorry.
`
` Q. You can take a look at AMG-1082 and
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` confirm for me whether or not this is your
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` deposition notice for this deposition today.
`
` A. Yes.
`
` Q. Now, you've already alluded to your
`
` declaration, so in connection with this
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` proceeding before the Patent Board of Trials
`
` and Appeals, you submitted a declaration
`
` regarding the validity of U.S. Patent number
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` 8,822,438; is that correct?
`
` A. Yes.
`
` Q. And so we're going to hand you AMG
`
` 1001, previously marked AMG 1001, and I'm
`
` going to ask you to confirm whether or not
`
` this is the patent that you were asked to
`
` submit a declaration with respect to.
`
` A. Sorry, you said that you are
`
` handing me AMG, so you are marking this --
`
` Q. Okay. So here is what we are going
`
` to be doing. AMG 1001 that number is down
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` here.
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` A. Irrespective of what is up here.
`
` Q. Here is the number of the patent.
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` A. Correct.
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` Q. So what I asked, I hope, was to
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` confirm whether or not this document, which
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` has been labeled previously Amerigen 1001, is
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` the patent that you submitted a declaration
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` in connection with.
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` A. So it appears to be a copy of the
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` patent, yes.
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` Q. Okay. Very good.
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` MS. DONOVAN: If I may just
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` interject, the witness has been provided
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` with Janssen Exhibit 2040 which is a
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` copy of his declaration. And you're
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` welcome to look at it, if you wish to,
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` to confirm it's the same as what has
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` been submitted, but I can represent to
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` you that it is.
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` MS. MATERASSI: But you can
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` represent to us that that is a copy of
`
` the declaration, so we can proceed on
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` the basis of your representation.
`
` Q. So for purposes of this proceeding
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` today, is it okay with you and will you
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` understand what I'm referencing to, if I use
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` the abbreviation "the '438 patent" when I
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` refer to the patent at issue in this
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` proceeding?
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` A. Yes, that's fine.
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` Q. Okay. Very good.
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` So for today, I'm going to ask you
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` some questions today in connection with your
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` written testimony on behalf of the patent
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` owner in this proceeding, and what I'm going
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` to be doing in particular is I'm going to be
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` cross-examining you regarding your written
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` testimony in this case.
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` So first let me go over briefly the
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` ground rules for the deposition. Maybe my
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` first question before I do that is to ask you
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` whether you've ever been deposed before in
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` any proceeding.
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` A. No, I have not.
`
` Q. Okay, so I will go slowly.
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` Do you understand, sir, doctor,
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` that when you answer my questions, your
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` answer must be full, complete and truthful,
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` because you are under oath?
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` A. Yes, I do.
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` Q. Do you understand that you are to
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` respond to my questions, regardless of your
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` counsel's stated objection, unless your
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` counsel expressly instructs you not to
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` respond?
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` A. Yes, I do.
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` Q. Okay. Now if for any reason you do
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` not understand a question, and that may
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` happen more than once, do you understand that
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` you should raise the issue of your lack of
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` understanding before answering that question?
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` A. Yes, I do.
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` Q. Okay. Please let me know whether
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` you need to take a break, and we will try to
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` accommodate you as soon as possible. The
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` only request that petitioner makes from our
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` end is, if we are in the middle of a question
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` and you have not responded to that question,
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` if you can respond to the question before we
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` go on to the break.
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` Is that all right with you?
`
` A. I understand that, yes.
`
` Q. Okay. Doctor, can you state your
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` full name for the record, please?
`
` A. Richard Joseph Auchus.
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` Q. Can you state for the record your
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` residential address?
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` A. I life at 525 Green Road in Ann
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` Arbor, Michigan.
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` Q. Very nice place.
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` Dr. Auchus, can you tell me if you
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` are on any medication today that might affect
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` your testimony?
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` A. No.
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` Q. Are you suffering from any malady
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` that might affect your testimony today?
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` A. No.
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` Q. Do you understand that you are not
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` to confer or consult with your counsel
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` regarding any questions that I will ask you
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` or any of your responses to any questions
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` that I will ask you today, during any time in
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` which you have a break from the deposition?
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` A. Yes, I do.
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` Q. Okay. Am I correct that you are
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` here on behalf of Janssen?
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` A. Yes, I am.
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` Q. Can we agree to use the shorthand
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` Janssen, when referring to the patent owner
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` in this proceeding?
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` A. Yes.
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` Q. Can you identify your counsel for
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` me?
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` A. My counsel is sitting to my left.
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` Q. Okay. And that's --
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` A. Bindu Donovan.
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` MS. DONOVAN: I will state for the
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` record my name is Bindu Donovan. I'm
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` with Sidley Austin. Also with me today
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` is Ms. Monsen, who is also with Sidley
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` Austin, Alyssa Monsen, and we're here on
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` behalf of Janssen in this proceeding.
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` MS. MATERASSI: Okay.
`
` Q. How long after you were first
`
` approached, doctor, by Janssen did you agree
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` to testify on behalf of Janssen in this
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` proceeding?
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` MS. DONOVAN: Object to the form of
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` the question.
`
` A. I do not recall.
`
` Q. Okay. Do you recall when you were
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` first approached by Janssen about anything in
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` connection with this proceeding?
`
` A. Not exactly.
`
` Q. Okay.
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` A. Yeah, it was at least a year ago, I
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` can tell you that much.
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` Q. Okay. Doctor, are you being
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` compensated for your testimony in this
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` proceeding?
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` A. Yes, I am.
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` Q. Can you describe the terms of your
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` compensation?
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` A. So paragraph 2, my declaration,
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` says I'm being compensated at a customary
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` rate of $350 per hour.
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` Q. And is that the rate that you are
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` being compensated at?
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` A. Yes.
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` Q. Have you ever served as an expert
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` witness in any other proceeding?
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` A. Yes, yes.
`
` Q. Okay. Can you describe briefly the
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` nature of those proceedings in which you
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` served as an expert testimony -- an expert
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` witness?
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` A. So one of these was a court martial
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` when I was in the military, regarding a
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` doping case; and the other was a binding
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` arbitration, also about a doping case.
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` Q. How long were you in the military,
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` doctor?
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` A. Four years.
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` Q. Which branch?
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` A. Air force.
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` Q. So was my father-in-law, similar
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` track.
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` With respect to your deposition
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` here today, how much time did you spend
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` preparing for today's deposition?
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` MS. DONOVAN: And I'll caution the
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` witness not to disclose any specific
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` attorney/client privileged
`
` communications. You may answer the
`
` question very generally.
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` A. I would have to add up. I can't
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` really give you an exact answer without
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` taking some time to make an estimate.
`
` Q. So let me ask you, was it more than
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` 10 hours?
`
` A. Yes.
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` Q. Was it more than 20?
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` A. Probably, yes, but -- yes, close to
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` --
`
` Q. More than 30?
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` A. Probably not.
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` Q. So is it fair to say between 20 and
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` 30 hours?
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` A. I think that's a good
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` approximation.
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` Q. Okay. How much of that between 20
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` and 30 hours approximately of time that you,
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` that you spent preparing for today's
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` deposition did you spend preparing on your
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` own?
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` A. Maybe a quarter of that time.
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` Q. Okay. So the remaining
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` three-quarters of the time, roughly, was with
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` counsel?
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` MS. DONOVAN: Object to form.
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` A. Most, so some of that time was with
`
` counsel, yes.
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` Q. So if we can go back, and if I can
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` ask you again, just to clarify for the
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` record, from that between 20 and 30 hours
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` that you testified earlier, approximately,
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` you spent preparing for today's deposition,
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` approximately how many hours, I guess, did
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` you spend preparing for today's deposition on
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` your own?
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` A. So I will make an estimate of about
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` eight hours.
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` Q. Okay.
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` Did you speak with or consult with
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` anyone at Janssen, in the course of preparing
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` for your deposition today?
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` MS. DONOVAN: I object to the form
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` of the question, and I also caution the
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` witness not to disclose any
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` attorney/client privileged
`
` communications.
`
` You may answer the question
`
` generally.
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` A. Can you restate that, please?
`
` Q. Yes. Did you speak with or consult
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` with anyone at Janssen, in the course of
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` preparing for your deposition today?
`
` MS. DONOVAN: I object to the form
`
` of the question.
`
` A. I don't recall. I honestly am not
`
` sure the, connection to some of the other
`
` parties. I did not seek out any people from
`
` Janssen, let's put it that way.
`
` Q. Okay. That's a slightly different
`
` answer to my question.
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` Did anyone from Janssen seek you
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`Page 16
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` out?
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` A. No.
`
` Q. Did you and someone or anyone at
`
` Janssen communicate regarding your deposition
`
` today, before your deposition today?
`
` MS. DONOVAN: I object to the form
`
` of the question.
`
` A. So, okay, if they did, I didn't
`
` know that they were associated with Janssen.
`
` So I'm not aware of somebody from Janssen
`
` seeking me out.
`
` Q. What about someone from BTG, are
`
` you aware or did you speak with or consult
`
` with anyone from BTG?
`
` A. So what is BTG?
`
` Q. So BTG is one of the real parties,
`
` one of the real parties in terms of the
`
` patent owner. And I guess from your response
`
` you don't know who BTG is --
`
` A. No, no.
`
` Q. -- so it's unlikely that you
`
` knowingly consulted or spoke with anyone from
`
` the BTG.
`
` What about Cougar, did you speak
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` with anyone from Cougar?
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` MS. DONOVAN: I object to the form
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` of the question. And just, Gabriela,
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` for the record, are you asking in the
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` context of preparation for his
`
` deposition?
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` Q. So this is all in the context of
`
` the preparation for today's deposition.
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` MS. DONOVAN: So again I caution
`
` the witness to not disclose any
`
` attorney/client privileged
`
` communications you may answer the
`
` question generally, if you understand
`
` it.
`
` And maybe, Gabriela, if you could
`
` just repeat the question.
`
` MS. MATERASSI: Here's the thing,
`
` counselor. If Dr. Auchus does not
`
` understand the question, I would prefer,
`
` strongly prefer that Dr. Auchus himself
`
` let me know that he does not understand
`
` the question.
`
` A. So it is my understanding that
`
` Cougar doesn't exist anymore. And I may be
`
` incorrect about that, and I don't understand
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` how I could consult with someone from a
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` company that no longer exists.
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` Q. What became of Cougar, if you snow?
`
` MS. DONOVAN: Object to the form of
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` the question.
`
` A. My understanding it was acquired.
`
` Q. So by Johnson & Johnson, correct?
`
` A. Correct.
`
` Q. Did you speak with or consult with
`
` anyone at Johnson & Johnson --
`
` A. No.
`
` Q. -- in the course of preparing for
`
` your deposition today?
`
` A. No.
`
` Q. Can you generally describe what, if
`
` any, documents you reviewed before coming to
`
` this deposition?
`
` MS. DONOVAN: I object to the form
`
` of the question, and I also object on
`
` the grounds of the attorney/client
`
` privilege.
`
` MS. MATERASSI: So here is an
`
` issue, Ms. Donovan. There is a
`
` veritable mountain of case law that
`
` supports the position that we
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` petitioners are taking in this
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` deposition, and all the preceding
`
` depositions, that questions with respect
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` to what categories of documents the
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` witness consulted and even in particular
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` which documents the witness consulted
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` are not attorney work product. And so
`
` we can cite several cases and we can
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` take this up separately with the board.
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` For today, we very, very strongly
`
` feel the case law is unequivocal as to
`
` whether or not Dr. Auchus can respond to
`
` what categories of documents he
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` reviewed. If you feel differently, we
`
` can certainly approach the board about
`
` that right now.
`
` MS. DONOVAN: Ms. Materassi, I'm
`
` going to preserve and maintain my
`
` objection.
`
` Let me explain to you what we are
`
` willing to do here, and I actually
`
` disagree with you. His preparation for
`
` this deposition is subject to the
`
` attorney/client privilege, the documents
`
` --
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` MS. MATERASSI: Here is the
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` problem --
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` MS. DONOVAN: I don't want to argue
`
` with you. Let me finish my objection.
`
` Let me finish my objection.
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` MS. MATERASSI: We will take this
`
` up before the board.
`
` MS. DONOVAN: I told you we are
`
` going to figure out a procedure, okay?
`
` Now let me finish my objection. Let me
`
` make my objection.
`
` MS. MATERASSI: How long is your
`
` objection going to be, counselor?
`
` MS. DONOVAN: It's going to be as
`
` long as yours, so let me finish my
`
` objection. Okay.
`
` Now we believe that his preparation
`
` is subject to the attorney/client
`
` privilege. You may put a document in
`
` front of him and ask him if he had seen
`
` it before, and he will answer yes or no.
`
` But other than that, I am not going to
`
` let you ask any questions about what
`
` happened and what documents he was shown
`
` during the course of his preparation,
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` okay.
`
` Q. Well, here is the question that I
`
` can ask you -- and we are going to see if
`
` counselor has an unusual and perhaps unique
`
` interpretation of attorney work product.
`
` Did you independently review any
`
` documents, including any literature, in the
`
` course of preparing for your deposition?
`
` MS. DONOVAN: You may answer that
`
` yes or no.
`
` Q. Independently of counsel.
`
` A. No.
`
` Q. So all of the documents that you
`
` reviewed in preparation for your deposition
`
` today were documents that you reviewed
`
` because counsel selected them and showed them
`
` to you for your review; is that correct?
`
` MS. DONOVAN: Object to the form of
`
` the question. I caution the witness not
`
` to disclose privileged communications.
`
` Q. You can answer the question,
`
` doctor.
`
` MS. DONOVAN: You can answer
`
` generally, doctor.
`
` A. Some of those documents I had known
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` about previously and --
`
` Q. So my question wasn't that. My
`
` question was, in the course of preparing for
`
` your deposition today, did -- were all of the
`
` documents that you reviewed documents that
`
` were selected and provided to you for your
`
` review by counsel?
`
` A. I would say yes.
`
` Q. Did you review testimony from any
`
` of the other witnesses for Janssen in this
`
` proceeding?
`
` A. No.
`
` Q. Did you review the testimony of Dr.
`
` Scott Serels?
`
` A. Yes.
`
` Q. Did you review any of the
`
` references cited by Dr. Serels in his
`
` deposition -- in his declaration, rather?
`
` A. Yes.
`
` Q. So separate question is, did you
`
` review Dr. McDuff's declaration?
`
` A. No.
`
` Q. Do you know who Dr. McDuff is?
`
` A. No.
`
` Q. Do you have any notes with you here
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` today?
`
` A. No.
`
` Q. And I think you said before you had
`
` never been deposed before, correct?
`
` A. Correct.
`
` Q. Have you ever testified at trial?
`
` A. Minor trials, traffic violations.
`
` Q. But not in your capacity as an
`
` expert?
`
` A. No.
`
` Q. Have you ever been involved in a
`
` case outside of this that involved an opinion
`
` pertaining to the validity of a patent claim?
`
` A. No.
`
` Q. Can you go over briefly your
`
` educational background, doctor?
`
` A. So undergraduate in chemistry at
`
` MIT; MD and Ph.D. in pharmacology at
`
` Washington University; internal medicine
`
` residency training at the University of Iowa;
`
` and then fellowship training at Wilford Hall
`
` U.S.A.F. Medical Center in the University of
`
` Texas, San Antonio. And then I did
`
` postdoctoral work at the University of
`
` California, San Francisco.
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` Q. What did you receive your Ph.D. in?
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` A. Pharmacology.
`
` Q. What was your thesis or
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` dissertation topic for your Ph.D.?
`
` A. It was making and studying
`
` inhibitors of estrogen biosynthesis.
`
` Q. Dr. Auchus, have you participated
`
` any phase I clinical trials?
`
` MS. DONOVAN: I object to the form
`
` of the question.
`
` A. How -- I would ask you to explain
`
` what "participation" means.
`
` Q. Have you participated as a clinical
`
` investigator --
`
` A. Yes.
`
` MS. DONOVAN: Just allow me to
`
` object.
`
` THE WITNESS: Sorry.
`
` Q. -- in phase I trials?
`
` MS. DONOVAN: I object to the form
`
` of the question.
`
` You may answer.
`
` A. Yes, I have.
`
` Q. Do you understand what the term
`
` "clinical investigator" means, in the context
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` of phase I clinical trials?
`
` A. I interpret that as enrolling
`
` patients and being responsible for the
`
` conduct of the trial.
`
` Q. So that's very good. That was the
`
` meaning I had in mind as well.
`
` So if I can ask you, have you ever
`
` participated as a clinical investigator in
`
` any phase I trials of abiraterone?
`
` A. Yes, I have.
`
` Q. Can you describe briefly which
`
` trials you participated as a clinical
`
` investigate for abiraterone?
`
` A. So it was a study of patients with
`
` 21-hydroxylase deficiency, and it was a
`
` six-dose dose escalation phase I trial.
`
` Q. And we will get into this in a
`
` little more detail, I promise you, in a
`
` little bit. But 21-hydroxylase deficiency,
`
` is that a form of what is generally referred
`
` as congenital adrenal hyperplasia?
`
` A. Yes, it is.
`
` Q. Had you ever participated in any
`
` phase II clinical trials, as a clinical
`
` investigator?
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` MS. DONOVAN: I object to the form
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`Page 26
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` of the question.
`
` You may answer.
`
` A. Yes, I have.
`
` Q. Okay. Can you describe which drugs
`
` you have participated as a clinical -- excuse
`
` me, as a clinical investigator in a phase II
`
` trial?
`
` A. So that would be a drug called
`
` ATR-101, which is also for 21-hydroxylase
`
` deficiency.
`
` Q. Any others?
`
` A. I think that's the only one that's
`
` phase II.
`
` Q. And what about with respect to
`
` phase III, have you ever participated as a
`
` clinical investigator in any phase III
`
` trials?
`
` MS. DONOVAN: Object to the form of
`
` the question.
`
` A. Yes, I have.
`
` Q. Can you describe which drugs were
`
` involved in those phase III trials that you
`
` participated in as a clinical investigator?
`
` MS. DONOVAN: Object to form.
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` A. So one was mifepristone for
`
` Cushing's disease. Then there was a
`
` pasireotide, P-A-S-I-R-O -- sorry, excuse me.
`
` P-A-S-I-R-E-O-T-I-D-E, for both Cushing's
`
` disease and acromegaly.
`
` There is osilodrostat, O-S-O -- no,
`
` sorry. O-S-I-L-O-D-R-O-S-T-A-T, for
`
` Cushing's Disease. Levoketoconazole for
`
` Cushing's Disease, and that's it.
`
` Q. Is Cushing's Disease, what is
`
` Cushing's Disease? I'm sorry, I'll ask you
`
` that.
`
` A. It is a condition where a patient
`
` makes too much cortisol.
`
` Q. Doctor, do you have an
`
` understanding of what the objectives
`
` generally of a phase I clinical trial are?
`
` MS. DONOVAN: I object to the form
`
` of the question. And outside the scope
`
` of the direct testimony and declaration.
`
` A. I have a general understanding.
`
` Q. And what is your general
`
` understanding of what those objectives of a
`
` phase I clinical trial are?
`
` A. To determine dose-limiting
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` toxicity.
`
` Q. Anything else?
`
` A. That's the major objective that I'm
`
` aware of. People do try to add other things,
`
` but that's the major, by definition, the
`
` major objective.
`
` Q. Now, with respect to phase II
`
` trials, do you have an understanding of what
`
` the objectives generally of a phase II
`
` clinical trial are?
`
` MS. DONOVAN: Object to the form of
`
` the question.
`
` A. I'm -- I do have a general
`
` understanding, yes.
`
` Q. Okay. What is that general
`
` understanding of what the objective of a
`
` phase II clinical trial is?
`
` A. To demonstrate efficacy.
`
` Q. Now, with respect to phase III
`
` clinical trials, do you have an understanding
`
` of the objectives generally of a phase III
`
` clinical trial?
`
` MS. DONOVAN: Objection to form.
`
` A. Yes, I do.
`
` Q. Okay. Can you explain what your
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` understanding is of the objectives generally
`
` of a phase III clinical trial?
`
` MS. DONOVAN: Same objection.
`
` A. So I would say in three words,
`
` safety, efficacy and registration.
`
` Q. And so can you explain what you
`
` mean by "registration"?
`
` A. To obtain FDA approval.
`
` Q. And I think you testified earlier
`
` that you have worked as a clinical
`
` investigator in phase III clinical trials,
`
` correct?
`
` A. Correct.
`
` Q. So for the drugs that were involved
`
` in those phase III clinical trials where you
`
` participated as a clinical investigator, do
`
` you know whether or not those drugs
`
` ultimately received approval from FDA for any
`
` indication?
`
` A. Yes, they did.
`
` Q. Which drugs received approval from
`
` the FDA?
`
` A. Mifepristone and pasireotide.
`
` Q. What was the approved indication
`
` for mif --
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`25
`
` A. Mifepristone.
`
` Q. Yes.
`
` A. For treatment of Cushing's Disease
`
` with glucose intolerance or diabetes.
`
` Q. Was that drug approved alone or in
`
` combination with another drug agent?
`
` A. It was approved alone.
`
` Q. And with respect to the second
`
` drug --
`
` A. Pasireotide?
`
` Q. Yes.
`
` -- what was the approved
`
` indication?
`
` A. There's two indications. One is
`
` for Cushing's disease, and the other is for
`
` acromegaly.
`
` Q. And again, was that drug approved
`
` alone or in combination with another drug
`
` agent for these indications?
`
` A. These were approved alone.
`
` Q. And you testified earlier that the,
`
` that you did participate as a clinical
`
` investigator in at least one clinical trial
`
` for abiraterone, correct?
`
` MS. DONOVAN: Object to the form of
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`30
`
`
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`Page 31
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`19
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`20
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`21
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`22
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`23
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`24
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`25
`
` the question.
`
` Q. So the patients in that clinical
`
` trial that you participated in for
`
` abiraterone were not patients with prostate
`
` cancer, correct?
`
` A. That's correct.
`
` Q. Were they male?
`
` A. No, they were not.
`
` Q. They were female by default, I
`
` guess.
`
` A. Depends if you're asking sex or
`
` gender.
`
` Q. Exactly. I knew you were going to
`
` say that, speaking to a specialist.
`
` So you have your own copy, counsel
`
` has represented you have your own copy of the
`
` declaration that you had s
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