Ex. 2007
`
`EX. 2007
`
`Trial Testimony of Dr. John Plachetka
`Trial Testimony of Dr. John Plachetka
`Oct. 12, 2010, Afternoon Session
`Oct. 12, 2010, Afternoon Session
`
`
`
`EX. 2007
`
`Trial Testimony of Dr. John Plachetka
`Trial Testimony of Dr. John Plachetka
`Oct. 12, 2010, Afternoon Session
`Oct. 12, 2010, Afternoon Session
`
`
`
`Case 6:08-cv-00437-LED Document 358 Filed 10/20/10 Page 1 of 159 PageID #: 7407
` 1 IN THE UNITED STATES DISTRICT COURT
` FOR THE EASTERN DISTRICT OF TEXAS
` 2 TYLER DIVISION
`
` 3 POZEN,INC. * Civil Docket No.
` * 6:08-CV-437
` 4 VS. *
` * Tyler, Texas
` 5 PAR PHARMACEUTICALS, INC., * October 12, 2010
` ET AL * 1:20 P.M.
` 6
` TRANSCRIPT OF BENCH TRIAL
` 7 AFTERNOON SESSION
` BEFORE THE HONORABLE LEONARD DAVIS
` 8 UNITED STATES DISTRICT JUDGE
`
` 9 APPEARANCES:
`
` 10 FOR THE PLAINTIFF
`
` 11 MR. WILLEM G. SCHUURMAN
` MS. TRACEY B. DAVIES
` 12 MR. STEPHEN M. HASH
` MS. ERIN A. THOMSON
` 13 VINSON & ELKINS
` 2801 Via Fortuna
` 14 Suite 100
` Austin, TX 78746
` 15
` MS. STEPHANIE LOLLO
` 16 VINSON & ELKINS LLP
` 666 Fifth Ave., 26th Floor
` 17 New York, NY 10103
`
` 18 MR. COLLIN MALONEY
` IRELAND, CARROLL & KELLEY
` 19 6101 S. Broadway, Ste. 500
` Tyler, TX 75703
` 20
` COURT REPORTERS:
` 21 MS. SHEA SLOAN, CSR
` MS. SHELLY HOLMES, CSR
` 22 Official Court Reporters
` 211 West Ferguson, Third Floor
` 23 Tyler, TX 75702
` 903/590-1171
` 24
` (Proceedings recorded by mechanical stenography,
` 25 transcript produced on CAT system.)
`
`
`1
`
`
`
`Case 6:08-cv-00437-LED Document 358 Filed 10/20/10 Page 2 of 159 PageID #: 7408
` 1 FOR THE DEFENDANTS
` 2 MR. MICHAEL E. JONES
` POTTER MINTON P.C.
` 3 110 N. College
` 500 Plaza Tower
` 4 Tyler, TX 75702
`
` 5
` MR. RICHARD J. BERMAN
` 6 MS. JANINE A. CARLAN
` MR. AZIZ BURGY
` 7 MR. TIMOTHY W. BUCKNELL
` MR. JOSHUA T. MORRIS
` 8 MR. TANIEL E. ANDERSON
` ARENT FOX LLP
` 9 1050 Connecticut Ave., N.W.
` Washington, DC 20036
` 10
`
` 11 MR. DERON R. DACUS
` RAMEY & FLOCK
` 12 100 E. Ferguson, Ste. 500
` Tyler, TX 75702
` 13
`
` 14 MR. THOMAS J. PARKER
` MR. ROBERT E. HANLON
` 15 MS. NATALIE C. CLAYTON
` ALSTON & BIRD LLP
` 16 90 Park Ave.
` New York, NY 10016
` 17
`
` 18 MR. CHARLES AINSWORTH
` PARKER, BUNT & AINSWORTH, P.C.
` 19 100 E. Ferguson, Ste. 1114
` Tyler, TX 75702
` 20
`
` 21 MR. PAUL H. KOCHANSKI
` MR. MICHAEL H. TESCHNER
` 22 LERNER, DAVID, LITTENBERG,
` KRUMHOLZ & MENTLIK, LLP
` 23 600 S. Avenue W
` Westfield, NJ 07090-1497
` 24
`
` 25
`
`
`2
`
`
`
`Case 6:08-cv-00437-LED Document 358 Filed 10/20/10 Page 3 of 159 PageID #: 7409
` 1 P R O C E E D I N G S
` 2 COURT SECURITY OFFICER: All rise.
`
` 3 THE COURT: Please be seated.
`
` 4 All right. You may proceed, Mr. Hash.
`
` 5 DR. JOHN PLACHETKA, PLAINTIFF'S WITNESS, SWORN
`
` 6 DIRECT EXAMINATION (CONTINUED)
`
` 7 BY MR. HASH:
`
` 8 Q Dr. Plachetka, when we left we were talking
`
` 9 about the Phase II studies conducted by Pozen. There's
`
` 10 a second study that Pozen conducted; what is that study
`
` 11 referred to as?
`
` 12 A It's referred to as a Phase II study, and also
`
` 13 known as protocol MT400-204.
`
` 14 Q And what was the Phase II study?
`
` 15 A This was a study evaluating four different
`
` 16 treatments in people with migraines, now almost a
`
` 17 thousand patients, approximately 250 per group. They
`
` 18 were given a medicine -- it was a double-blind study --
`
` 19 and asked to treat their next migraine attack, at which
`
` 20 point they were asked to record symptoms in a diary for
`
` 21 the next 24 to 48 hours.
`
` 22 MR. HASH: And could I have PTX565?
`
` 23 Q (By Mr. Hash) And, Dr. Plachetka, in front of
`
` 24 you is PTX566. This is a -- is this a clinical study
`
` 25 report for the Phase II study?
`
`3
`
`
`
`Case 6:08-cv-00437-LED Document 358 Filed 10/20/10 Page 4 of 159 PageID #: 7410
` 1 A Yes, it is.
` 2 MR. HASH: And could I have Slide No. 13?
`
` 3 Q (By Mr. Hash) What were the results of the
`
` 4 Phase II study, Dr. Plachetka?
`
` 5 A Well, it's shown on the slide, the 24-hour
`
` 6 sustained pain-free relief was very much improved with
`
` 7 sumatriptan plus naproxen compared to the other
`
` 8 treatment groups.
`
` 9 Q And so what was the effect that you were
`
` 10 seeing in the patients --
`
` 11 A The effect --
`
` 12 Q -- in the Phase II study?
`
` 13 A Excuse me. The effect was to make them better
`
` 14 longer and provide better relief for them.
`
` 15 Q And to what did you attribute these clinical
`
` 16 improvements?
`
` 17 A I believe this was another evidence of synergy
`
` 18 of the two different mechanisms providing an excellent
`
` 19 clinical result.
`
` 20 Q Have these Phase II study results been
`
` 21 published?
`
` 22 A They have been published.
`
` 23 MR. HASH: Could I have JTX9?
`
` 24 Q (By Mr. Hash) Do you recall where these Phase
`
` 25 II results were published?
`
`4
`
`
`
`Case 6:08-cv-00437-LED Document 358 Filed 10/20/10 Page 5 of 159 PageID #: 7411
` 1 A I believe these data were published in the
` 2 journal Headache.
`
` 3 Q And this is the Smith paper. Is that the
`
` 4 publication of the results of the Phase II study?
`
` 5 A That's correct.
`
` 6 Q After Pozen had the results of the Phase II
`
` 7 study, was Pozen able to license its
`
` 8 sumatriptan/naproxen technology?
`
` 9 A Yes, we were.
`
` 10 Q And to whom did Pozen license the technology?
`
` 11 A To the company now known as GSK.
`
` 12 MR. HASH: Could I have PTX498?
`
` 13 Q (By Mr. Hash) And is this the license between
`
` 14 Pozen and GSK?
`
` 15 A Yes, it is.
`
` 16 Q Why did Pozen choose GSK to license its
`
` 17 technology to?
`
` 18 A Well, they were the most experienced company
`
` 19 in the field of migraine. They had the gold standard of
`
` 20 migraine care on the market in several different dosage
`
` 21 forms. I thought that they would be a wonderful company
`
` 22 to bring a much-improved version to the marketplace.
`
` 23 Q What was the nature of the license of the
`
` 24 sumatriptan/naproxen technology to GSK?
`
` 25 A Well, the license was for the United States
`
`5
`
`
`
`Case 6:08-cv-00437-LED Document 358 Filed 10/20/10 Page 6 of 159 PageID #: 7412
` 1 rights to sell this prescription product. And it
` 2 involved a front payment -- excuse me, it involved an
`
` 3 upfront payment and milestone payments along the way of
`
` 4 the development. If certain things happened, we would
`
` 5 get additional funds and a royalty stream from the net
`
` 6 sales of the product.
`
` 7 Q And what were the royalties on the -- on the
`
` 8 product?
`
` 9 A The royalties started at 5 percent, and the
`
` 10 royalties are currently 18 percent of net sales.
`
` 11 Q Now, you mentioned certain milestone
`
` 12 payments -- and I wanted to go to PTX498 -- were there
`
` 13 multiple milestone payments?
`
` 14 A There were.
`
` 15 MR. HASH: Page 33.
`
` 16 Q (By Mr. Hash) And I was wondering if you could
`
` 17 discuss in particular the second milestone payment
`
` 18 associated with this license.
`
` 19 A We received a $15 million milestone payment
`
` 20 upon the issuance of a certain patent.
`
` 21 Q Okay. And is that the '458 patent that's at
`
` 22 issue in this case?
`
` 23 A I believe so, yes.
`
` 24 Q Okay. So when the '458 patent issued, how
`
` 25 much did GSK pay to Pozen?
`
`6
`
`
`
`Case 6:08-cv-00437-LED Document 358 Filed 10/20/10 Page 7 of 159 PageID #: 7413
` 1 A $15 million.
` 2 Q Now, you're the -- the CEO of a pharmaceutical
`
` 3 company. In your experience, would a major
`
` 4 pharmaceutical company like GSK make a milestone payment
`
` 5 on a patent it viewed to be invalid or unenforceable?
`
` 6 MS. CARLAN: Objection, lack of
`
` 7 foundation, speculation.
`
` 8 THE COURT: Overruled.
`
` 9 A No, I would not.
`
` 10 Q (By Mr. Hash) Not to jump too far ahead,
`
` 11 Dr. Plachetka, but to date, approximately how much in
`
` 12 licensing revenue has Pozen received on the Treximet
`
` 13 product?
`
` 14 A Approaching -- excuse me, approaching $100
`
` 15 million now.
`
` 16 Q After licensing the product, was a further
`
` 17 clinical efficacy study run?
`
` 18 A Yes, several were.
`
` 19 Q Okay. But there was a large study that was
`
` 20 run after the license with GSK; is that right?
`
` 21 A Yes.
`
` 22 Q And how is that study referred to?
`
` 23 A There was a study -- there were two identical
`
` 24 Phase III studies that we call the pivotal trials.
`
` 25 Q And can you explain briefly to the Court what
`
`7
`
`
`
`Case 6:08-cv-00437-LED Document 358 Filed 10/20/10 Page 8 of 159 PageID #: 7414
` 1 that pivotal trial was?
` 2 A Well, this was almost an identical trial in
`
` 3 design to the Phase II trial that was almost a thousand
`
` 4 patients. But now we were including the dose of
`
` 5 Treximet that would eventually become marketed. But it
`
` 6 had four treatment arms. It was a double-blind
`
` 7 placebo-controlled trial. It involved virtually the
`
` 8 same procedures as the Phase II thousand patient trial.
`
` 9 Q And what were the results of that pivotal
`
` 10 trial?
`
` 11 A Again, confirming what we had seen in every
`
` 12 step along the way that putting the two things together
`
` 13 for simultaneous administration provided a much better
`
` 14 response.
`
` 15 Q And to what did you attribute the results of
`
` 16 the pivotal trial?
`
` 17 A Again, I thought that this was additional
`
` 18 evidence of the synergistic value of adding naproxen
`
` 19 sodium to sumatriptan when patients have an acute
`
` 20 migraine attack.
`
` 21 Q Now, we talked a little bit earlier today
`
` 22 about pharmacokinetics. And that's a big word. Could
`
` 23 you explain, just give a lay definition of
`
` 24 pharmacokinetics?
`
` 25 A Pharmacokinetics is the science that studies
`
`8
`
`
`
`Case 6:08-cv-00437-LED Document 358 Filed 10/20/10 Page 9 of 159 PageID #: 7415
` 1 how drugs are handled in the body. And it involves an
` 2 assessment of the absorption of the drug, the metabolism
`
` 3 of the drug, how the drug flows through the body and how
`
` 4 the body excretes the drug.
`
` 5 Q Actually, I apologize, Dr. Plachetka, I jumped
`
` 6 a little bit ahead.
`
` 7 I just wanted to go back, I'm sorry, to the
`
` 8 pivotal study for just one second.
`
` 9 MR. HASH: Could we have JTX76?
`
` 10 Q (By Mr. Hash) And is this the final clinical
`
` 11 study report for the one arm of the pivotal study?
`
` 12 A This is the final clinical study report for
`
` 13 this -- this pivotal study, study 301, yes.
`
` 14 Q Okay.
`
` 15 MR. HASH: And JTX142?
`
` 16 Q (By Mr. Hash) And what is JTX142?
`
` 17 A This is the second pivotal trial, and it's
`
` 18 designated 302.
`
` 19 Q And were these two arms of -- or these two
`
` 20 trials identical?
`
` 21 A Yes, I believe so.
`
` 22 MR. HASH: Could we have JT --
`
` 23 Q (By Mr. Hash) Were the results of the pivotal
`
` 24 trial published?
`
` 25 A They were.
`
`9
`
`
`
`Case 6:08-cv-00437-LED Document 358 Filed 10/20/10 Page 10 of 159 PageID #: 7416
` 1 Q And where were they published?
` 2 A I believe these data were published in the
`
` 3 Journal of the American Medical Association.
`
` 4 Q Is that JAMA?
`
` 5 A Yes, referred to as JAMA.
`
` 6 MR. HASH: Okay. Can we have JTX10?
`
` 7 Q (By Mr. Hash) And this is an article entitled
`
` 8 Sumatriptan/Naproxen for Acute Treatment of Migraine.
`
` 9 Dr. Plachetka, what is this paper?
`
` 10 A This is a summary of the pivotal trial results
`
` 11 from the Treximet Phase II program.
`
` 12 Q Okay. I now want to go back to the
`
` 13 pharmacokinetics.
`
` 14 A Right.
`
` 15 Q Have studies been conducted to assess the
`
` 16 pharmacokinetic profile of Treximet?
`
` 17 A Yes.
`
` 18 Q Have the results of those studies been
`
` 19 published?
`
` 20 A They have.
`
` 21 MR. HASH: Could I have JTX73?
`
` 22 Q (By Mr. Hash) And what is JTX73?
`
` 23 A This is a clinical study report on the
`
` 24 pharmacokinetic study that you mentioned.
`
` 25 Q Okay.
`
`10
`
`
`
`Case 6:08-cv-00437-LED Document 358 Filed 10/20/10 Page 11 of 159 PageID #: 7417
` 1 MR. HASH: And can we have JTX81?
` 2 Q (By Mr. Hash) Do you recognize this,
`
` 3 Dr. Plachetka?
`
` 4 A I do.
`
` 5 Q And what is JTX81?
`
` 6 A This is a summation of those data. And the
`
` 7 title is the distinct pharmacokinetic profile and
`
` 8 safety.
`
` 9 Q What were the results -- was this --
`
` 10 MR. HASH: Strike that.
`
` 11 Q (By Mr. Hash) What were the results of the
`
` 12 pharmacokinetic studies done to assess Treximet?
`
` 13 A Well, they're surprising results. We saw that
`
` 14 the sumatriptan in the blood occurred faster when it was
`
` 15 administered in the Treximet tablet compared to an
`
` 16 Imitrex tablet. We also saw that the naproxen was --
`
` 17 its profile was dramatically alternated in the Treximet
`
` 18 tablet relative to what one would see with a free dose
`
` 19 of naproxen.
`
` 20 Q Were there -- now, Dr. Plachetka, you said
`
` 21 that the -- this pharmacokinetic profile was -- was
`
` 22 unexpected. Have others in the art also recognized that
`
` 23 Treximet's pharmacokinetic profile is unexpected?
`
` 24 A Yes, I believe so.
`
` 25 MR. HASH: Could I have PTX288?
`
`11
`
`
`
`Case 6:08-cv-00437-LED Document 358 Filed 10/20/10 Page 12 of 159 PageID #: 7418
` 1 Q (By Mr. Hash) Dr. Plachetka, do you recognize
` 2 this article?
`
` 3 A I do.
`
` 4 Q And what is this article?
`
` 5 A This is an article talking about the
`
` 6 sumatriptan/naproxen combination for the treatment of
`
` 7 migraine.
`
` 8 Q Okay.
`
` 9 MR. HASH: And could we go to Page 7?
`
` 10 No, no, not that one. The one above.
`
` 11 Not that one, sorry. One more down.
`
` 12 Q (By Mr. Hash) Now, Dr. Plachetka, this -- this
`
` 13 article by Catalina Cleves and Stewart Tepper states:
`
` 14 Sumatriptan and naproxen exert extremely interesting,
`
` 15 unexpected, and likely clinical beneficial
`
` 16 pharmacokinetic effects on each other.
`
` 17 Do you see that?
`
` 18 A Yes.
`
` 19 Q And what's your understanding of what this is
`
` 20 referring to?
`
` 21 A It's referring to the words just below that,
`
` 22 which describe the pharmacokinetic interaction that I
`
` 23 mentioned just a minute ago.
`
` 24 Q Okay. And this wasn't an article that was
`
` 25 written by Pozen?
`
`12
`
`
`
`Case 6:08-cv-00437-LED Document 358 Filed 10/20/10 Page 13 of 159 PageID #: 7419
` 1 A No.
` 2 Q Have clinical studies been done on Treximet to
`
` 3 assess its efficacy in migraineur subpopulations?
`
` 4 A Yes, they have.
`
` 5 Q And what subpopulation has Treximet's efficacy
`
` 6 been assessed in?
`
` 7 A Adolescent migraine sufferers.
`
` 8 Q And are oral triptans considered -- generally
`
` 9 considered to be effective in adolescents?
`
` 10 A Oral triptans generally are considered to be
`
` 11 not effective. And none of them, to my knowledge, are
`
` 12 indicated for complete relief of migraine by the Food
`
` 13 and Drug Administration.
`
` 14 Q What -- and so adolescent studies were
`
` 15 conducted to assess the efficacy of Treximet in
`
` 16 adolescent populations?
`
` 17 A That's correct.
`
` 18 Q And what were the results of those studies?
`
` 19 A Well, they were -- by this time we were
`
` 20 expecting Treximet to provide benefit, but we weren't
`
` 21 certain because, in the adolescent population, nothing
`
` 22 else had worked. The adolescents in question are almost
`
` 23 adult size. These adolescents had an average weight of
`
` 24 approximately 140 pounds. So a typical migraineur in a
`
` 25 study is 180 to 200 pounds.
`
`13
`
`
`
`Case 6:08-cv-00437-LED Document 358 Filed 10/20/10 Page 14 of 159 PageID #: 7420
` 1 Now, normally you'll think that scaling down
` 2 the dose makes a difference. But in this instance, we
`
` 3 tried three separate doses. We tried the adult Treximet
`
` 4 dose, we tried one-third of the adult Treximet dose, and
`
` 5 we tried one-ninth of the adult Treximet dose, and a
`
` 6 placebo.
`
` 7 Q What was the effect of the adult dose of
`
` 8 Treximet in these adolescents?
`
` 9 A It appeared to work as well as the adult dose
`
` 10 worked in adults.
`
` 11 Q And what was the effect of this one-third
`
` 12 dose, this middle dose, in adolescents?
`
` 13 A Surprisingly, this dose also worked as well as
`
` 14 the adult dose.
`
` 15 Q Now, there's a third dose that was also tried;
`
` 16 isn't that correct?
`
` 17 A That's correct.
`
` 18 Q And why was this third dose included in the
`
` 19 study?
`
` 20 A Protocol was designed as a dose-ranging trial.
`
` 21 And typically in dose-ranging trials you'd like to start
`
` 22 with a dose that has no effect. This last dose where we
`
` 23 only gave one-ninth of the adult dose was designated in
`
` 24 the protocol as the no-effect dose because we didn't
`
` 25 expect it was going to work.
`
`14
`
`
`
`Case 6:08-cv-00437-LED Document 358 Filed 10/20/10 Page 15 of 159 PageID #: 7421
` 1 Q Was the FDA involved in assessing this
` 2 protocol?
`
` 3 A Well, they had asked us as a condition of
`
` 4 Treximet approval to conduct this study.
`
` 5 Q And what was their opinion on the -- on this
`
` 6 low dose?
`
` 7 A Well, when we submitted the protocol, they --
`
` 8 this protocol was submitted by Glaxo. And I believe
`
` 9 that they agreed that this would be the no-effect dose.
`
` 10 Q Okay. And what was the effect in adolescents
`
` 11 of administering this no-effect dose?
`
` 12 A It worked as well as the other two doses. And
`
` 13 in some parameters it worked better. And when you
`
` 14 coupled this with the side-effect profile, it was, of
`
` 15 the three doses tested, the superior clinical dose.
`
` 16 Q Okay. Now, you talked about this as a -- as a
`
` 17 no-effect dose. Could you characterize for the Court
`
` 18 what the actual amounts of the two active ingredients in
`
` 19 this no-effect dose amounted to as compared to what was
`
` 20 normally given to adolescent patients?
`
` 21 A Well, as I said, it's approximately one-ninth
`
` 22 of the dose -- of the adult dose of Treximet. But
`
` 23 putting the naproxen dose in perspective, the
`
` 24 over-the-counter dose of naproxen is four times higher
`
` 25 than the dose we used here.
`
`15
`
`
`
`Case 6:08-cv-00437-LED Document 358 Filed 10/20/10 Page 16 of 159 PageID #: 7422
` 1 Q So the over-the-counter dose of naproxen in
` 2 Aleve is four times?
`
` 3 A It's 220 milligrams, and we used 60. So it's
`
` 4 approximately four times.
`
` 5 Q But what's usually recommended as the naproxen
`
` 6 dose to treat migraine?
`
` 7 A Well, it's into the hundreds of milligrams.
`
` 8 In adults it's over 750 milligrams. In children it's
`
` 9 not recommended, to my knowledge, in any of the
`
` 10 publications. But for other uses, naproxen would be
`
` 11 dosed somewhere in the neighborhood of three to five
`
` 12 milligrams per kilogram perhaps.
`
` 13 Q And so what would that equate to in a normal
`
` 14 size adolescent for this study?
`
` 15 A Well, again, it would be in the hundreds of
`
` 16 milligrams.
`
` 17 Q And how does the dose of -- of sumatriptan in
`
` 18 the no-effect dose compare to a standard dose of
`
` 19 Imitrex?
`
` 20 A The lowest effective dose of Imitrex that's on
`
` 21 the market in the United States is 25 milligrams. So
`
` 22 this is well below the lowest effective dose known for
`
` 23 sumatriptan oral.
`
` 24 MR. HASH: Could we have Slide 16?
`
` 25 Q (By Mr. Hash) So you've talked about -- about
`
`16
`
`
`
`Case 6:08-cv-00437-LED Document 358 Filed 10/20/10 Page 17 of 159 PageID #: 7423
` 1 the effects. Could you just summarize for the Court
` 2 this -- this chart?
`
` 3 A Well, the number of sustained pain-free
`
` 4 subjects is dramatically better than the placebo group
`
` 5 in all three treatment groups.
`
` 6 What one would have expected in this type of a
`
` 7 study is an ascending staircase effect where the placebo
`
` 8 dose and the so-called no-effect dose would have the
`
` 9 same number of responders. And then, because it had
`
` 10 worked in adults, we would have expected the same sort
`
` 11 of efficacy perhaps in the high dose. The shocking
`
` 12 thing about this was how well the low dose worked.
`
` 13 Q (By Mr. Hash) Now, Dr. Plachetka, what do you
`
` 14 attribute these unexpected results seen in the
`
` 15 adolescent study to?
`
` 16 A I don't think there's any other explanation
`
` 17 than subtherapeutic doses being administered together
`
` 18 causing therapeutic benefit by a synergistic effect.
`
` 19 MR. HASH: Could I have PTX520? Go up a
`
` 20 little bit, please.
`
` 21 Q (By Mr. Hash) Dr. Plachetka, do you recognize
`
` 22 this document?
`
` 23 A I do.
`
` 24 Q Is this the adolescent study results synopsis
`
` 25 document?
`
`17
`
`
`
`Case 6:08-cv-00437-LED Document 358 Filed 10/20/10 Page 18 of 159 PageID #: 7424
` 1 A It is.
` 2 Q And what is the adolescent study results
`
` 3 synopsis?
`
` 4 A This is -- this was prepared by GSK to
`
` 5 summarize how the study was conducted and the study
`
` 6 results.
`
` 7 MR. HASH: Could I have JTX41? Could we
`
` 8 go to Page 9?
`
` 9 Q (By Mr. Hash) And, Dr. Plachetka, is this the
`
` 10 clinical protocol for the adolescent studies?
`
` 11 A Yes.
`
` 12 MR. HASH: And could I have PTX521?
`
` 13 Q (By Mr. Hash) Do you recognize this document,
`
` 14 Dr. Plachetka?
`
` 15 A Yes.
`
` 16 Q And are these tables that relate the results
`
` 17 of the adolescent study?
`
` 18 A Yes.
`
` 19 Q Have additional clinical studies been
`
` 20 performed to assess the efficacy of Treximet?
`
` 21 A There have been some, yes.
`
` 22 Q And have the results of those studies
`
` 23 confirmed the results that you found in the prior
`
` 24 clinical studies?
`
` 25 A Yes.
`
`18
`
`
`
`Case 6:08-cv-00437-LED Document 358 Filed 10/20/10 Page 19 of 159 PageID #: 7425
` 1 Q Now, let me take you back to when you received
` 2 the results of the pivotal studies. After Pozen
`
` 3 obtained the results from the Phase III studies, was
`
` 4 this data provided to the FDA?
`
` 5 A Yes.
`
` 6 Q And how was the data provided to the FDA?
`
` 7 A We compiled all of the information and
`
` 8 submitted a new drug application.
`
` 9 Q And what -- why was that new drug application
`
` 10 submitted to the FDA?
`
` 11 A Asking for marketing authorization to sell the
`
` 12 drug in the United States.
`
` 13 MR. HASH: Could I have PTX612?
`
` 14 Q (By Mr. Hash) Do you recognize this document,
`
` 15 Dr. Plachetka?
`
` 16 A I do.
`
` 17 Q Is this a copy of the letter submitting the
`
` 18 Treximet NDA to the FDA?
`
` 19 A Yes.
`
` 20 Q And did the FDA agree that Treximet was a safe
`
` 21 and effective migraine treatment?
`
` 22 A Yes, they did.
`
` 23 MR. HASH: Could I have PTX673?
`
` 24 Q (By Mr. Hash) Do you recognize this document,
`
` 25 Dr. Plachetka?
`
`19
`
`
`
`Case 6:08-cv-00437-LED Document 358 Filed 10/20/10 Page 20 of 159 PageID #: 7426
` 1 A I do.
` 2 Q And what is this document?
`
` 3 A This is the NDA approval letter from the FDA.
`
` 4 Q And what does this letter -- what is the
`
` 5 purpose of this letter?
`
` 6 A This is to inform Pozen that the NDA for
`
` 7 Treximet is now approved and that we are able to sell
`
` 8 the drug.
`
` 9 Q What happened after the FDA approved Treximet?
`
` 10 A This product was assigned to Glaxo to market.
`
` 11 And within a few weeks, to the best of my recollection,
`
` 12 Glaxo made this drug available to consumers.
`
` 13 Q And did Treximet have a successful launch?
`
` 14 A Yes.
`
` 15 MR. HASH: Could I have Slide 25?
`
` 16 Q (By Mr. Hash) Can you explain to the Court
`
` 17 what this slide shows?
`
` 18 A This is a slide indicating the weekly
`
` 19 prescription volume. We get this data from a service,
`
` 20 NRx weekly. NRx means new prescriptions. And the line
`
` 21 for Treximet is the solid blue line at the top. And you
`
` 22 can see that the slope of the line is greatest for
`
` 23 Treximet compared to four other products that were
`
` 24 approved at various points in -- in the last ten years
`
` 25 or so.
`
`20
`
`
`
`Case 6:08-cv-00437-LED Document 358 Filed 10/20/10 Page 21 of 159 PageID #: 7427
` 1 Q Dr. Plachetka, is Treximet a better product
` 2 than Imitrex?
`
` 3 A I believe so, yes.
`
` 4 Q Does the FDA agree with that assessment?
`
` 5 A Yes, they do.
`
` 6 Q Does the FDA allow GSK to tell the public that
`
` 7 Treximet is better than Imitrex?
`
` 8 A Yes.
`
` 9 Q Is there another migraine therapy that has
`
` 10 permission from the FDA to claim that it's more
`
` 11 effective than the gold standard, Imitrex?
`
`
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