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`DOCUMENTS CONSIDERED BY RANDALL M. ZUSMAN, M.D.
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`DOC. NO.
`1
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`DOCUMENT DESCRIPTION
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`U.S. Patent No. 7,932,268 (Rader)
`
`U.S. Patent No. 8,618,135 (Rader)
`
`Certified U.S. Patent No. 7,932,268 File History
`
`U.S. Patent No. 8,618,135 File History
`
`Certified U.S. Provisional Patent Application No. 60/550,915
`
`“Bayer/PPD Implitapide Development Follows Zetia Model As
`Statin Add-On,” The Pink Sheet, 66(7):17 (February 16, 2004)
`
`Stein Presentation re Microsomal Triglygeride Transfer Protein
`(MTP) Inhibitor (implitapide) program (2004)
`
`PPD Webpage Screenshot: PPD To Hold Analyst Day on
`February 5, 2004 (1/15/04)
`
`Chandler et al., “CP-346086: an MTP inhibitor that lowers
`plasma cholesterol and triglycerides in experimental animals
`and in humans,” Journal of Lipid Research, 44:1887-1901
`(2003)
`
`Chang et al., “Microsomal triglyceride transfer protein (MTP)
`inhibitors: Discovery of clinically active inhibitors using high-
`throughput screening and parallel synthesis paradigms,”
`Current Opinion in Drug Discovery & Development, 5(4):562-
`570 (2002)
`
`Shiomi & Ito, “MTP inhibitor decreases plasma cholesterol
`levels in LDL receptor-deficient WHHL rabbits by lowering
`the VLDL secretion,” European Journal of Pharmacology,
`431:127-131 (2001)
`
`Wetterau et al., “An MTP Inhibitor that Normalizes
`Atherogenic Lipoprotein Levels in WHHL Rabbits,” Science,
`282:751-754 (1998)
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`1
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`CFAD Ex. 1028 (1 of 3)
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`
`
`Petition for Inter Partes Review of USPN 7,932,268
`
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`DOC. NO.
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`DOCUMENT DESCRIPTION
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`14
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`15
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`16
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`17
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`18
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`Goldberg, “Clinical Trial Experience with Extended-Release
`Niacin (Niaspan): Dose-Escalation Study,” American Journal
`of Cardiology, 82(12A):35U-38U (1998)
`
`Davidson, “Combination Therapy for Dyslipidemia: Safety and
`Regulatory Considerations,” American Journal of Cardiology,
`90(10B):50K-60K (2002)
`
`Goldberg et al., “Multiple-Dose Efficacy and Safety of an
`Extended-Release Form of Niacin in the Management of
`Hyperlipidemia,” American Journal of Cardiology, 85:1100-
`1105 (2000)
`
`Edwards & Moore, “Statins in hypercholesterolaemia: A dose-
`specific meta-analysis of lipid changes in randomized, double
`blind trials,” BMC Family Practice, 4:18 (2003)
`
`Guay, “Update on Fenofibrate,” Cardiovascular Drug Reviews,
`20(4):281-302 (2002)
`
`Physicians’ Desk Reference (2003)
`
`“Third Report of the National Cholesterol Education Program
`(NCEP) Expert Panel on Detection, Evaluation and Treatment
`of High Blood Cholesterol in Adults(Adult Treatment Panel
`III) Final Report,” Circulation, 106:3143-3421 (2002)
`
`FDA Approves Zetia – first new class to treat cholesterol since
`statins introduced, (October 28, 2002), (available at
`http://www.drugs.com/news/fda-approves-zetia-first-new-
`class-cholesterol-since-statins-introduced-3164.html)
`
`Physicians’ Desk Reference (2004)
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`2
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`CFAD Ex. 1028 (2 of 3)
`
`
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`Petition for Inter Partes Review of USPN 7,932,268
`
`
`DOC. NO.
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`DOCUMENT DESCRIPTION
`
`Affidavit of Christopher Butler, Office Manager, Internet
`Archive, authenticating Internet Archive URLs (June 12, 2015)
`(attaching as Ex. A:
`PPD News Releases(2004/02/13) (available at
`https://web.archive.org/web/20040213233245/http://www.ppdi.
`com/PPD_U6.htm?ID=126662);
`PPD News & IR Presentations(2003/12/12) (available at
`https://web.archive.org/web/20031212193444/http://ppdi.com/
`PPD_6_12.htm);
`PPD News & IR Presentations (2004/06/04) (available at
`https://web.archive.org/web/20040604203252/http://www.ppdi.
`com/PPD_6_12.htm)).
`
`Affidavit of Christopher Butler, Office Manager, Internet
`Archive, authenticating Internet Archive URLs (June 16, 2015)
`(attaching as Ex. A:
`PPD News & IR Presentations (2004/04/15) (available at
`https://web.archive.org/web/20040415065142/http://ppdi.com/
`PPD_6_12.htm)).
`
`Margaret A. McDowell et al., “Anthropometric Reference Data
`for Children and Adults: U.S. Population, 1999-2002,” CDC
`Advance Data from Vital & Health Stats., 361 (2005).
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`24
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`3
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`CFAD Ex. 1028 (3 of 3)
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