·1· · · · Q.· ·You may answer.
`
`·2· · · · A.· ·It cites it because of a small study of
`
`·3· ·short duration.
`
`·4· · · · Q.· ·Because Miner did not use as primary
`
`·5· ·endpoints endoscopically documented gastric ulcers,
`
`·6· ·correct?
`
`·7· · · · A.· ·So, again, if you look at page 6 of the
`
`·8· ·Citizen Petition, HZ168830, it states no endoscopic
`
`·9· ·assessment was performed.
`
`10· · · · Q.· ·Miner was a pH-measuring study, right?
`
`11· · · · A.· ·I think that's what was stated here, and I
`
`12· ·believe that's also what's stated on Exhibit 7,
`
`13· ·which is the Miner publication.· Under "Aim" it
`
`14· ·says, "To evaluate gastric acid suppression of three
`
`15· ·doses of esomeprazole in PN 400 compared with EC
`
`16· ·esomeprazole 20-milligrams.
`
`17· · · · Q.· ·So Miner 2010 did not endoscopically
`
`18· ·document gastric ulcers, correct?
`
`19· · · · A.· ·That's what is stated in the paper, as
`
`20· ·well as in the Citizen Petition.
`
`21· · · · Q.· ·So we're getting close.· So looking here
`
`22· ·again at this paragraph, the first full paragraph on
`
`23· ·HZ16880 of Horizon Citizen Petition, the only data,
`
`24· ·experimental data and the only study here of
`
`25· ·substance is the Miner 2010 study as cited in
`
`[Note, Claim of Confidentiality Withdrawn]
`
`Page 1
`
`Dr. Reddy's Exh. 1066
`
`
`
`·2· · · · A.· ·It cites it because of a small study of
`
`·3· ·short duration.
`
`·4· · · · Q.· ·Because Miner did not use as primary
`
`·5· ·endpoints endoscopically documented gastric ulcers,
`
`·6· ·correct?
`
`·7· · · · A.· ·So, again, if you look at page 6 of the
`
`·8· ·Citizen Petition, HZ168830, it states no endoscopic
`
`·9· ·assessment was performed.
`
`10· · · · Q.· ·Miner was a pH-measuring study, right?
`
`11· · · · A.· ·I think that's what was stated here, and I
`
`12· ·believe that's also what's stated on Exhibit 7,
`
`13· ·which is the Miner publication.· Under "Aim" it
`
`14· ·says, "To evaluate gastric acid suppression of three
`
`15· ·doses of esomeprazole in PN 400 compared with EC
`
`16· ·esomeprazole 20-milligrams.
`
`17· · · · Q.· ·So Miner 2010 did not endoscopically
`
`18· ·document gastric ulcers, correct?
`
`19· · · · A.· ·That's what is stated in the paper, as
`
`20· ·well as in the Citizen Petition.
`
`21· · · · Q.· ·So we're getting close.· So looking here
`
`22· ·again at this paragraph, the first full paragraph on
`
`23· ·HZ16880 of Horizon Citizen Petition, the only data,
`
`24· ·experimental data and the only study here of
`
`25· ·substance is the Miner 2010 study as cited in
`
`[Note, Claim of Confidentiality Withdrawn]
`
`Page 1
`
`Dr. Reddy's Exh. 1066
`
`
`
`·1· ·Footnote 12, correct?
`
`·2· · · · · · ·MR. RODRIGUEZ:· Object to form.
`
`·3· ·BY MR. SHELHOFF:
`
`·4· · · · Q.· ·You may answer.
`
`·5· · · · A.· ·So what we've described was the Miner
`
`·6· ·study, and then we stated that the Miner study was
`
`·7· ·then chosen for VIMOVO to be tested in Phase III
`
`·8· ·gastric protection endoscopy study of six-month
`
`·9· ·treatment duration.
`
`10· · · · Q.· ·Any of the percentages or data or numbers
`
`11· ·mentioned in the first paragraph at page HZ618830
`
`12· ·come from the Miner 2010 study, correct?
`
`13· · · · A.· ·That's what we talked about previously,
`
`14· ·the Table 1 is comparable to Table 3 in the Miner
`
`15· ·study, with the exception of the typographical error
`
`16· ·in the one column.
`
`17· · · · Q.· ·And the Miner study was the product of
`
`18· ·Pozen, correct?· Pozen and -- I should be more --
`
`19· ·the Miner study was the joint product of AstraZeneca
`
`20· ·and Pozen, correct?
`
`21· · · · · · ·MR. RODRIGUEZ:· Object to form.
`
`22· · · · A.· ·Yeah, I can't speak to that.· What I can
`
`23· ·speak to, if you look at the publication, the first
`
`24· ·author is Miner from the Oklahoma Foundation for
`
`25· ·Digestive Research.
`
`[Note, Claim of Confidentiality Withdrawn]
`
`Page 2
`
`Dr. Reddy's Exh. 1066
`
`
`
`·1· · · · · · ·MR. RODRIGUEZ:· Object to form.· Outside
`
`·2· ·the scope.
`
`·3· ·BY MR. SHELHOFF:
`
`·4· · · · Q.· ·Go ahead.
`
`·5· · · · A.· ·Yeah, I don't want to speculate what the
`
`·6· ·term "coordinated" means.· I think the document
`
`·7· ·refers to sequential release.
`
`·8· · · · · · ·MR. RODRIGUEZ:· I'd like to take a short
`
`·9· ·break.
`
`10· · · · · · ·MR. SHELHOFF:· Sure.
`
`11· · · · · · · · · (Recess taken 1:39 p.m. to 2:02 p.m.)
`
`12· ·BY MR. SHELHOFF:
`
`13· · · · Q.· ·I think before the break we stopped at --
`
`14· ·the document reads, open quote, "sequential
`
`15· ·release," close quote.
`
`16· · · · · · ·All right.· So when the document reads
`
`17· ·"sequential release," what does it mean in Horizon's
`
`18· ·Citizen Petition with respect to VIMOVO?
`
`19· · · · A.· ·So can you just show me the page and where
`
`20· ·you're looking at sequential release?
`
`21· · · · Q.· ·If you'll look at page HZ168829, and
`
`22· ·that's page 5, internal page of Horizon's
`
`23· ·petition --
`
`24· · · · A.· ·Okay.
`
`25· · · · Q.· ·-- so here, Section (B)(1), you mention
`
`[Note, Claim of Confidentiality Withdrawn]
`
`Page 3
`
`Dr. Reddy's Exh. 1066
`
`
`
`·1· ·that -- it mentions "sequential release."
`
`·2· · · · · · ·And just to remind you, you can look at
`
`·3· ·the whole petition if you need to answer this
`
`·4· ·question; not only this section, but the whole
`
`·5· ·Horizon Citizen Petition, the whole document.
`
`·6· · · · · · ·And the question is, what does the
`
`·7· ·sequential release mean in Horizon's Citizen
`
`·8· ·Petition with respect to VIMOVO?
`
`·9· · · · A.· ·Yeah.· So just to clarify, it's what's
`
`10· ·described here, is "VIMOVO's sequential delivery
`
`11· ·mechanism," and then what it means is probably --
`
`12· ·well, what it means is described above there in --
`
`13· ·under section 2, "VIMOVO," and the second paragraph
`
`14· ·of that where it states, "VIMOVO is specifically
`
`15· ·formulated to allow esomeprazole, a proton pump
`
`16· ·inhibitor, to achieve its gastroprotective impact
`
`17· ·before naproxen is released into the system."
`
`18· · · · · · ·And then at the last sentence of that
`
`19· ·paragraph it's, "VIMOVO's design is intended to
`
`20· ·produce a sequential delivery of gastroprotective
`
`21· ·esomeprazole before systemic (or local) exposure to
`
`22· ·naproxen."
`
`23· · · · Q.· ·So is VIMOVO specifically formulated to
`
`24· ·allow esomeprazole's release prior to any release of
`
`25· ·naproxen from the enterically coated core of VIMOVO?
`
`[Note, Claim of Confidentiality Withdrawn]
`
`Page 4
`
`Dr. Reddy's Exh. 1066
`
`
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