IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`COALITION FOR AFFORDABLE DRUGS X LLC,
`Petitioner,
`
`v.
`
`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner.
`
`Case No. IPR2015-01776
`Patent No. 7,582,621
`
`PATENT OWNER’S EXHIBIT LIST
`
`
`
`
`
`
`
`
`
`
`
`
`
` DC: 6086179-1
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`COALITION FOR AFFORDABLE DRUGS X LLC,
`Petitioner,
`
`v.
`
`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner.
`
`Case No. IPR2015-01776
`Patent No. 7,582,621
`
`PATENT OWNER’S EXHIBIT LIST
`
`
`
`
`
`
`
`
`
`
`
`
`
` DC: 6086179-1
`
`
`
`Docket No. 036914.0005-US01
`
`
`LIST OF EXHIBITS
`
`IPR2015-01776
`
`Exhibit
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`Description
`FDA Approved Label for KERYDIN® (Rev. 3/2015)
`Fairchild et al., In Vitro Determination of Uptake, Retention,
`Distribution, Biological Efficacy, and Toxicity of Boronated
`Compounds for Neutron Capture Therapy: A Comparison of
`Porphyrins with Sulfhydryl Boron Hydrides, Cancer Res., vol. 50,
`pp. 4860-65 (1990)
`Charif et al., A Historical Perspective on Onychomycosis,
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`Structural Studies of Enoyl Reductase, Science, vol. 274, pp. 2107-
`10 (1996)
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`http://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=200009P5.PDF
`Lefkovits et al., Direct Thrombin Inhibitors in Cardiovascular
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`Richardson, Clinical Update: Proteasome Inhibitors in
`Hematologic Malignancies, Cancer Treatment Rev., vol. 29, suppl.
`1, pp. 33-39 (2003)
`
`
`
`- 1 -
`
`
`
`Docket No. 036914.0005-US01
`
`
`Exhibit
`
`Description
`
`IPR2015-01776
`
`2012
`
`2013
`
`2014
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`Bross et al., Approval Summary for Bortezomib for injection in the
`Treatment of Multiple Myeloma, Clin. Cancer Res., vol. 10, pp.
`3954-64 (2004)
`Adams, Proteasome Inhibitors as Therapeutic Agents, Expert Opin.
`Ther. Patents, vol. 13, no. 1, pp. 45-57 (2003)
`Dorland’s Illustrated Medical Dictionary, p. 211 (29th ed. 2000)
`Stedman’s Medical Dictionary, p. 204 (27th ed. 2000)
`Random House Webster’s Unabridged Dictionary, p. 209 (2nd ed.
`2001)
`Jordon et al., Boric Acid Poisoning: A Report of a Fatal Adult Case
`from Cutaneous Use. A Critical Evaluation of the Use of This Drug
`in Dermatologic Practice, JAMA Derm, vol. 75, pp. 720-28
`(1957).
`Zhdankin et al., Synthesis and Structure of Benzoxaboroles: Novel
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`More, Pharm. Acta Helvetiae, vol. 74, pp. 79-84 (2000)
`Larsen et al., The Prevalence of Onychomycosis in Patients with
`Psoriasis and Other Skin Diseases, Acta Derm. Venereol., vol 83,
`pp. 206-09 (2003)
`Tatsumi et al., Therapeutic Efficacy of Topically Applied KP-103
`Against Experimental Tinea Unguium in Guinea Pigs in
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`Agents and Chemotherapy, vol. 46, no. 12, pp. 3797-3801 (2002)
`Osborne et al., Antifungal Drug Response in an In Vitro Model of
`Dermatophyte Nail Infection, Med. Mycol., vol. 42, pp. 159-63
`(2004)
`Favre et al., Comparison of In Vitro Activities of 17 Antifungal
`Drugs Against a Panel of 20 Dermatophytes by Using a
`Microdilution Assay, J. Clin. Microbiol., vol. 41, no. 10, pp. 4817-
`19 (2003)
`
`
`
`- 2 -
`
`
`
`Docket No. 036914.0005-US01
`
`
`Exhibit
`
`Description
`
`IPR2015-01776
`
`2024
`
`2025
`
`2026
`
`2027
`
`2028
`2029
`2030
`2031
`
`2032
`
`2033
`
`2034
`2035
`2036
`2037
`
`2038
`
`Sangster, Octanol-Water Partition Coefficients of Simple Organic
`Compounds, J. Phys. Chem. Ref. Data, vol. 18, pp. 1111-1227
`(1989)
`Powers et al., Structure-Based Approach for Binding Site
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`http://archive.epa.gov/pesticides/reregistration/web/pdf/0024fact.pd
`f
`Vander Straten et al., Cutaneous Infections: Dermatophytosis,
`Onychomycosis, and Tinea Versicolor, Infect. Dis. Clinics N. Am.,
`vol. 17, pp. 87-112 (2003)
`(Intentionally Left Blank)
`Curriculum vitae of Mahmoud A. Ghannoum, Ph.D., E.M.B.A.
`Curriculum vitae of Paul J. Reider, Ph.D.
`Curriculum vitae of Howard I. Maibach, M.D., Ph.D.
`Transcript, Deposition of Narasimha Murthy, Ph.D. (May 4, 5, 6,
`and 12, 2016)
`Transcript, Deposition of Stephen B. Kahl, Ph.D. (April 7 and 8,
`2016)
`Declaration of Paul J. Reider, Ph.D.
`Declaration of Mahmoud A. Ghannoum, Ph.D., E.M.B.A.
`Declaration of Majella Lane, Ph.D.
`Declaration of Howard I. Maibach, M.D., Ph.D.
`Fletcher et al., Onychomycosis: The Development of a Clinical
`Diagnostic Aid for Toenail Disease, Part I. Establishing
`Discriminating Historical and Clinical Features, Brit. J. Dermatol.,
`vol. 150, no. 4, pp. 701–05 (2004)
`
`
`
`- 3 -
`
`
`
`Docket No. 036914.0005-US01
`
`
`Exhibit
`
`Description
`
`IPR2015-01776
`
`2039
`
`2040
`
`2041
`
`2042
`
`2043
`
`2044
`
`2045
`
`2046
`
`2047
`
`Kemna & Elewski, A U.S. Epidemiologic Survey of Superficial
`Fungal Diseases, J. Am. Acad. of Dermatol., vol. 35, no. 4, pp.
`539–42 (1996)
`Shivakumar, Repka, & Murthy, Transungual Drug Delivery: an
`Update, J. Drug Del. Sci. Tech., vol. 24, no. 3, pp. 301–10 (2014)
`(Ex. 3 from Murthy Deposition)
`Topical Nail Products and Ungual Drug Delivery (S. Narasimha
`Murthy & Howard I. Maibach eds., 2013) (Ex. 4 from Murthy
`Deposition)
`Koo et al., Synthesis and Comparative Toxicology of a Series of
`Polyhedral Borane Anion-Substituted Tetraphenyl Porphyrins, J.
`Med. Chem., vol. 50, pp. 820–27 (2007)
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`“Preliminary Investigation of Effects on the Environment of Boron,
`Indium, Nickel, Selenium, Vanadium and Their Compounds,”
`EPA-56/2-75-005A (August 1975) available at
`http://nepis.epa.gov/Exe/ZyPDF.cgi/9101277V.PDF?Dockey=9101
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`Van Proosdij-Hartzema, Boriumverbindingen: Verleden, Heden en
`Toekomst, Ned. T. Geneesk., vol. 110, no. 51, pp. 2260–69 (1966)
`with certified English translation
`Elewski et al., Efficacy, Safety and Tolerability of Topical
`Terbinafine Nail Solution in Patients with Mild-to-Moderate
`Toenail Onychomycosis: Results from Three Randomized Studies
`using Double-Blind Vehicle-Controlled and Open-Label Active-
`Controlled Designs, J. Eur. Acad. Derm. & Vener., vol. 27, no. 3,
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`Cecil Textbook of Medicine, (J. Claude Bennett & Fred Plum ed.,
`1996)
`Hay et al., Fungal (onychomycosis) and other Infections Involving
`the Nail Apparatus in Baran and Dawber’s Diseases of the Nails
`and their Management, (R. Baran et al., eds., 2001)
`
`
`
`- 4 -
`
`
`
`Docket No. 036914.0005-US01
`
`
`Exhibit
`
`Description
`
`IPR2015-01776
`
`2048
`
`2049
`
`2050
`
`2051
`
`2052
`
`2053
`
`2054
`
`2055
`
`2056
`
`2057
`
`2058
`
`EPA Correspondence, 1992 Labeling Rev., Amended Biobor Label
`available at
`https://www3.epa.gov/pesticides/chem_search/ppls/065217-00001-
`19920403.pdf
`Ghannoum et al., A Large-Scale North American Study of Fungal
`Isolates From Nails: The Frequency of Onychomycosis, Fungal
`Distribution, and Antifungal Susceptibility Patterns, J. Am. Acad.
`Dermatol., vol. 43, no. 4, pp. 641–48 (2000)
`Segal et al., Treatment of Candida Nail Infection with Terbinafine,
`J. Am. Acad. Dermatol., vol. 35, no. 6, pp. 958–61 (1996)
`Rock et al., Antifungal Agent Inhibits an Aminoacyl-tRNA
`Synthetase by Trapping tRNA in the Editing Site, Science, vol. 316,
`pp. 1759–61 (2007)
`Soloway et al., Penetration of Brain and Brain Tumor by Aromatic
`Compounds as a Function of Molecular Substituents, J. Pharmacol.
`& Exp. Therapeutics, vol. 129, pp. 310–14 (1960)
`Baran et al., Onychomycosis: The Current Approach to Diagnosis
`and Therapy, Martin Dunitz Publishers, London, U.K. (1999)
`Gupchup & Zatz, Structural Characteristics and Permeability
`Properties of the Human Nail: A Review, 50 J. Cosmet. Sci. 363,
`363–85 (Nov./Dec. 1999)
`Elkeeb et al., Tranungual Drug Delviery: Current Status, 384
`Internat. J. Pharm. 1–8 (2010)
`Scher, Onychomycosis: Therapeutic Update, J. Am. Acad. Derm.,
`vol. 40, no. 6 (part 2), pp. S21–S26 (1999)
`Baeza et al., cDNA Representational Difference Analysis Used in
`the Identification of Genes Expressed by Trichophyton rubrum
`During Contact with Keratin, Microbes & Infection, vol. 9, pp.
`1415–21 (2007)
`Hamaguchi et al., Characterization of an Extracellular Keratinase
`from Microsporum canis, Jpn. J. Med. Mycol., vol. 41, no. 4, pp.
`257–62 (2000)
`
`
`
`- 5 -
`
`
`
`Docket No. 036914.0005-US01
`
`
`Exhibit
`
`Description
`
`IPR2015-01776
`
`2059
`
`2060
`
`2061
`
`2062
`
`2063
`
`2064
`
`2065
`
`2066
`
`2067
`
`2068
`
`2069
`
`Foster et al., Epidemiologic Surveillance of Cutaneous Fungal
`Infection in the United States from 1999 to 2002, Am. Acad.
`Dermatol., vol. 50, no. 5, pp. 748–52 (2004)
`Jinna & Finch, Spotlight on Tavaborole for the Treatment of
`Onychomycosis, Drug Des. Devel. Ther., vol. 5, no. 9, pp. 6185–90
`(Nov. 20, 2015)
`Childs-Kean & Jourjy, Antifungal Penetration into the Nail and
`New Topicals for Onychomycosis, Curr. Fungal Infect. Rep., vol.
`10, pp. 24–29 (2016)
`Rosen & Stein Gold, Antifungal Drugs for Onychomycosis:
`Efficacy, Safety, and Mechanisms of Action, Semin. Cutan. Med.
`Surg., vol. 35, no. 3S, pp. S51–S55 (March 2016)
`Poulakos et al., Efinaconazole and Tavaborole: Emerging
`Antifungal Alternatives for the Topical Treatment of
`Onychomycosis, J. Pharm. Pract., advance online publication, doi:
`10.1177/0897190016630904, pp. 1–11 (2016)
`Drake et al., Effect of Onychomycosis on Quality of Life, J. Am.
`Acad. Dermatol., vol. 38, no. 5, Part 1, pp. 702–04 (1998)
`Scher et al., Onychomycosis: Diagnosis and Definition of Cure, J.
`Am. Acad. Dermatol., vol. 56, no. 6, pp. 939–44 (2007)
`Summerbell et al., Onychomycosis, Tinea Pedis and Tinea
`Manuum Caused by Non-Dermatophytic Filamentous Fungi,
`Mycoses, vol. 32, no. 12, pp. 609–19 (1989)
`Ellis et al., Non-Dermatophytes in Onychomycosis of the Toenails,
`Brit. J. Dermatol., vol. 136, pp. 490–93 (1997)
`McGinley et al., Composition and Density of Microflora in the
`Subungual Space of the Hand, J. Clin. Microbiol., vol. 26, no. 5,
`pp. 950–53 (1988)
`Strausbaugh et al., High Frequency of Yeast Carriage on Hands of
`Hospital Personnel, J. Clin. Microbiol., vol. 32, no. 9, pp. 2299–
`300 (1994)
`
`
`
`- 6 -
`
`
`
`Docket No. 036914.0005-US01
`
`
`Exhibit
`
`Description
`
`IPR2015-01776
`
`2070
`
`2071
`
`2072
`
`2073
`
`2074
`
`2075
`
`2076
`
`Elewski, Onychomycosis: Pathogenesis, Diagnosis, and
`Management, Clin. Microbiol. Rev., vol. 11, no. 3, pp. 415–
`29(1998)
`Summerbell, Nondermatophytic Molds Causing Dermatophytosis-
`Like Nail and Skin Infection, in Laboratory Handbook of
`Dermatophytes, Chap. 8, pp. 213–56 (Kane et al. eds. 1997)
`Weitzman & Summerbell, The Dermatophytes, Clin. Microbio.
`Rev., vol. 8, no. 2, pp. 240–59 (1995)
`Gupta et al., Pulse Itraconazole vs. Continuous Terbinafine for the
`Treatment of Dermatophyte Toenail Onychomycosis in Patients
`with Diabetes Mellitus, J. Euro. Acad. Dermatol. & Venerol., vol.
`20, pp. 1188–93 (2006)
`FDA Approved Label for SPORANOX® (Supplement 034, Action
`Date 07/14/2004) available at
`http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/200
`83s034,035ltr.pdf (letter) and
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20083s
`034,035lbl.pdf (label)
`FDA Approved Label for LAMISIL® (Supplement 012, Action
`Date 01/21/2004) available at
`http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/205
`39slr012ltr.pdf (letter) and
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20539sl
`r012_lamisil_lbl.pdf (label)
`FDA Approved Label for Gris-PEG® (Supplement 046, Action
`Date 03/26/2003) available at
`http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/504
`75slr046ltr.pdf (letter) and
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50475sl
`r046_gris-peg_lbl.pdf (label)
`
`
`
`- 7 -
`
`
`
`Docket No. 036914.0005-US01
`
`
`IPR2015-01776
`
`Exhibit
`
`2077
`
`2078
`
`2079
`
`2080
`
`2081
`
`2082
`
`2083
`
`2084
`
`2085
`
`Description
`FDA Approved Label for Penlac®, (Supplement 004, Action Date
`12/03/2004) available at
`http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/210
`22s004ltr.pdf (letter) and
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21022s
`004lbl.pdf (label)
`Naglik et al., Candida albicans Secreted Aspartyl Proteinases in
`Virulence and Pathogenesis, Microbio. & Molecular Bio. Revs.,
`vol. 67, no. 3, pp. 400–28 (2003)
`Hattori et al., Keratinolytic Proteinase Produced by Candida
`albicans, Sabouraudia: J. Med. Vet. Mycology, vol. 22, no. 3, pp.
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`Weary & Canby, Absence of Keratinolytic Activity in Three Strains
`of Candida Albicans, J. Invest. Derm., vol. 46, no. 5, pp. 464–734
`(1966)
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`Causative Agents, Epidemiology and Pathogenesis, J. Dtsch. Derm.
`Ges., vol. 12, no. 3, pp. 188–210 (2014) (including English online
`version on Wiley Online Library)
`Balkis et al., Mechanisms of Fungal Resistance, Drugs, vol. 62(7),
`pp. 1025–40 (2002)
`CLSI, Reference Method for Broth Dilution Antifungal
`Susceptibility Testing of Filamentous Fungi; Approved Standard—
`Second Edition, CLSI document M38-A2 (2008)
`Ghannoum et al., Intra- and Interlaboratory Study for Testing the
`Antifungal Susceptibilities of Dermatophytes, J. Clin. Microbiol.,
`vol. 42, no. 7, pp. 2977–79 (2004)
`Norris et al., Optimal Growth Conditions for the Determination of
`the Antifungal Susceptibility of Three Species of Dermatophytes
`with the Use of a Microdilution Method, J. Am. Acad. Dermatol.,
`vol. 40, no. 6, pp. S9–S13, (1999)
`
`
`
`- 8 -
`
`
`
`Docket No. 036914.0005-US01
`
`
`Exhibit
`
`Description
`
`IPR2015-01776
`
`2086
`
`2087
`
`2088
`
`2089
`
`2090
`
`2091
`
`2092
`
`2093
`
`2094
`
`2095
`
`Jessup et al., Antifungal Susceptibility Testing of Dermatophytes:
`Establishing a Medium for Inducing Conidial Growth and
`Evaluation of Susceptibility of Clinical Isolates, J. Clin. Microbiol.,
`vol. 38, no. 1, pp. 341–44 (2000)
`Kokjohn et al., Evaluation of in vitro Activity of Ciclopirox
`Olamine, Butenafine HCI and Econazole Nitrate Against
`Dermatophytes, Yeasts and Bacteria, Int’l J. Dermatol., vol. 42,
`suppl. 1, pp. 11–17 (2003)
`NCCLS (now CLSI), Reference Method for Broth Dilution
`Antifungal Susceptibility Testing of Yeasts; Approved Standard—
`Second Edition, NCCLS document M27-A2 (2002)
`Mukherjee et al., Combination Treatment of Invasive Fungal
`Infections, Clin. Microbiol. Rev., vol. 18, no. 1, pp. 163–94 (2005)
`Ghannoum & Rice, Antifungal Agents: Mode of Action,
`Mechanisms of Resistance, and Correlation of These Mechanisms
`with Bacterial Resistance, Clin. Microbiol. Rev., vol. 12, no. 4, pp.
`501–17 (1999)
`Gupta et al., Drug Interactions with Itraconazole, Fluconazole, and
`Terbinafine and their Management, J. Am. Acad. Dermatol., vol.
`41, no. 2, pp. 237–49 (1999)
`Gupta & Lyons, The Rise and Fall of Oral Ketoconazole , J.
`Cutaneous Med. & Surgery, vol. 19, no. 4, pp. 352–57 (2015)
`Gull & Trinci, Griseofulvin Inhibits Fungal Mitosis, Nature, vol.
`244, pp. 292–94 (1973)
`Ku et al., Mutation of a Major Keratin Phosphorylation Site
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`Onychomycosis, J. Am. Podiatr. Med. Ass’n, vol. 87, no. 12,
`pp. 571–74 (1997)
`
`
`
`- 9 -
`
`
`
`Docket No. 036914.0005-US01
`
`
`Exhibit
`
`Description
`
`IPR2015-01776
`
`2096
`
`2097
`
`2098
`
`2099
`
`2100
`
`2101
`
`2102
`
`2103
`
`2104
`
`2105
`
`Nguyen & Yu, Voriconazole Against Fluconazole-Susceptible and
`Resistant Candida Isolates: in-vitro Efficacy Compared with that of
`Itraconazole and Ketoconazole, J. Antimicrobial Chemotherapy,
`vol. 42, pp. 253–56 (1998)
`Johnson & Kauffman, Voriconazole: A New Triazole Antifungal
`Agent, Clin. Infect. Dis., vol. 36, no. 5, pp. 630–37 (2003)
`Elewski & Tavakkol, Safety and Tolerability of Oral Antifungal
`Agents in the Treatment of Fungal Nail Disease: a Proven Reality,
`Ther. Clin. Risk Manag., vol. 1, no. 4, pp. 299–306 (2005)
`Center for Drug Evaluation and Research, Guidance for Industry:
`Clinical Development and Labeling of Anti-Infective Drug
`Products (1992) available at
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegula
`toryInformation/Guidances/UCM070975.pdf
`Rodgers & Bassler, Treating Onychomycosis, Am. Fam. Physician,
`vol. 63, no. 4, pp. 663–72 (2001)
`Ghannoum et al., Amorolfine 5% Nail Lacquer Exhibits Potent
`Antifungal Activity Compared to Three Acid-Based Devices
`Indicated for the Treatment of Onychomycosis” An In Vitro Nail
`Penetration Assay, Derm. & Therapy, vol. 6, no. 1, pp. 69–75
`(2016 )
`Declaration of Jennifer Augsburger in Support of Patent Owner’s
`Response
`Fukuoka et al., Genetic Basis for Differential Activities of
`Fluconazole and Voriconazole against Candida krusei,
`Antimicrob. Agents Chemother., vol. 47, no. 4, pp. 1213–19 (2003)
`Orozco et al., Mechanism of Fluconazole Resistance in Candida
`krusei, Antimicrob. Agents Chemother., vol. 42, no. 10, pp. 2645–
`49 (1998)
`Nimura et al., Comparison of In Vitro Antifungal Activities of
`Topical Antimycotics Launched in 1990s in Japan, Int’l J.
`Antimicrob. Agents, vol. 18, pp. 173–78 (2001)
`
`
`
`- 10 -
`
`
`
`Docket No. 036914.0005-US01
`
`
`Exhibit
`
`Description
`
`IPR2015-01776
`
`2106
`
`2107
`
`2108
`
`2109
`
`2110
`
`2111
`
`2112
`
`2113
`
`2114
`
`2115
`
`Ghannoum et al., Terbinafine HCl Nail Solution With and Without
`Nail Penetration Enhancer: Evaluation of Minimum Inhibitory
`Concentration and Minimum Fungicidal Concentrations, (abstract)
`J. Am. Acad. Dermatol., vol. 58, no. 2, suppl. 2, p. AB12 (2008)
`Ghannoum et al., Determination of the Efficacy of Terbinafine
`Hydrochloride Nail Solution in the Topical Treatment of
`Dermatophytosis in a Guinea Pig Model, Mycoses, vol. 52, no.1,
`pp. 35–43 (2009)
`Rex et al., Antifungal Susceptibility Testing, Clin. Microbio. Revs.,
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`19970327.pdf
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`
`
`
`- 11 -
`
`
`
`Docket No. 036914.0005-US01
`
`
`Exhibit
`
`Description
`
`IPR2015-01776
`
`2116
`
`2117
`
`2118
`
`2119
`
`2120
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`2121
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`2122
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`2123
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`2124
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`2125
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`Ophthamol., vol. 86, pp. 1064–65 (2002)
`
`
`
`- 12 -
`
`
`
`Docket No. 036914.0005-US01
`
`
`Exhibit
`
`Description
`
`IPR2015-01776
`
`2128
`
`2129
`
`2130
`
`2131
`
`2132
`
`2133
`
`2134
`
`2135
`
`2136
`
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`(1984)
`
`
`
`- 13 -
`
`
`
`Docket No. 036914.0005-US01
`
`
`Exhibit
`
`Description
`
`IPR2015-01776
`
`2139
`
`2140
`
`2141
`
`2142
`
`2143
`
`2144
`2145
`2146
`
`2147
`
`2148
`
`2149
`
`2150
`
`Whyte et al., Molecular Recognition With Boronic Acids—
`Applications in Chemical Biology, J. Chem. Biol., vol. 6, pp. 161–
`74 (2013)
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`translation
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`02ltr.pdf (letter) and
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021602
`lbl.pdf (label)
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`translation
`Dictionnaire Vidal (Office de Vulgarisation Pharmaceutique,
`Paris, 1964) with certified English translation
`
`
`
`- 14 -
`
`
`
`Docket No. 036914.0005-US01
`
`
`Exhibit
`
`Description
`
`IPR2015-01776
`
`2151
`
`2152
`
`2153
`
`2154
`
`2155
`
`2156
`
`2157
`
`2158
`
`2159
`
`2160
`
`2161
`
`2162
`
`Dictionnaire Vidal (Office de Vulgarisation
`Pharmaceutique, Paris, 1970) with certified English translation
`Vidal, Le Dictionnaire (80th ed., France, 2004) with certified
`English translation
`Boislambert & Wangen, Respecting a New Tranquilizer (Critical
`Study), Nanterre Departmental Center (1960) with certified English
`translation
`Biobor JF Service Bulletin No. 982, Biobor JF Aviation Fuel
`Additive (1992)
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`(AN2690), for the Potential Treatment of Onychomycosis, J. Med.
`Chem., vol. 49, pp. 4447-4450 (2006)
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`Challenges, 141 (Suppl. 56) Brit. J. of Derm. 1, 1–4 (1999)
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`Following Daily Treatment of Ex Vivo Human Fingernails with
`Topical Soliutionss of Tavaborole or Efinaconazole, J. of Drugs in
`Derm. (2016)
`Freedberg et al., Fitzpatrick’s Dermatology in General Medicine,
`McGraw-Hill Co. (6th ed. 2003)
`Rosen et al., Onychomycosis: Epidemiology, Diagnosis, and
`Treatment in a Changing Lanscape, J. of Drugs in Derm., vol. 14,
`no. 3, pp. 223–28 (2015)
`Tom & Kane, Management of Toenail Onychomycosis, Am. J.
`Health-Syst. Pharm,, vol. 56, no. 9, pp. 865-871 (1999)
`
`
`
`- 15 -
`
`
`
`Docket No. 036914.0005-US01
`
`
`Exhibit
`
`Description
`
`IPR2015-01776
`
`2163
`
`2164
`
`2165
`
`2166
`
`2167
`
`2168
`
`2169
`
`2170
`
`2171
`
`2172
`
`Stier et al., Patient Satisfaction with Oral versus Nonoral
`Therapeutic Approaches in Onychomycosis, J. of the Am. Pod.
`Med. Assoc., vol. 91, no. 10, pp. 521–27 (Nov./Dec. 2001)
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`Onychomycosis and the Emergence of Newer Agents, J. of Clin.
`and Aesth. Derm., vol. 7, no. 7, pp. 10–18 (2014)
`Wang & Sun, Human Nail and Its Topical Treatment: Brief Review
`of Current Research and Development of Topical Antifungal Drug
`Delivery for Onychomycosis Treatment, J. of Cosm. Sci., vol. 50,
`no. 1, pp. 71–74 (1999)
`Ameen et al., British Association of Dermatologists' Guidelines for
`the
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`2015 (May 2016)
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`Bodman et al., Topical Treatments for Onychomycosis: A
`Historical Perspective, J. Am. Podiatr. Med. Assoc., vol. 93, no. 2,
`pp. 136–41 (2003)
`
`
`
`- 16 -
`
`
`
`Docket No. 036914.0005-US01
`
`
`Exhibit
`
`Description
`
`IPR2015-01776
`
`2173
`
`2174
`
`2175
`
`2176
`
`2177
`
`2178
`
`2179
`
`2180
`
`2181
`
`FDA Center for Drug Evaluation and Research, Dermatologic and
`Ophthalmic Drugs Advisory Committee Meeting, Nov. 4, 1999
`(Transcript) available at
`http://www.fda.gov/ohrms/dockets/ac/99/transcpt/3564t1.pdf
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`http://www.sec.gov/Archives/edgar/data/1017491/0001144204090
`25204/v148508_10q.htm
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`Program to EFFELL LLC, First in a Series of Asset Sales, Sept. 19,
`2012, http://www.prweb.com/releases/2012/9/prweb9911525.htm
`
`SEC, Watson Pharmaceuticals Reports Earnings Per Share of
`$0.48 for Fourth Quarter 2003, Feb. 5. 2004,
`https://www.sec.gov/Archives/edgar/data/884629/00011046590400
`2780/a04-1963_1ex99d1.htm
`
`SEC, Macrochem Discontinues Research and Product
`Development Activities, Terminates Substantially All Non-
`Management Personnel, Will Seek Buyer for Company or Its
`Assets, Sept. 1, 2005,
`http://www.sec.gov/Archives/edgar/data/743884/00007438840500
`0054/exhibit991.txt
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`Preclinical Data at the 69th Annual Meeting of the AAD in New
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`releases/celtic-pharma-announces-presentation-of-preclinical-data-
`at-the-69th-annual-meeting-of-the-aad-in-new-orleans-
`115474199.html
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`Investigational Drugs, vol. 6, no. 2, pp. 170–77 (2005)
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`Comments of Vivian Liu, NexMed President and CEO, NexMed
`Investor Update Conference Call (July 8, 2009)
`
`
`
`- 17 -
`
`
`
`Docket No. 036914.0005-US01
`
`
`Exhibit
`
`Description
`
`IPR2015-01776
`
`2182
`
`2183
`
`2184
`
`2185
`
`2186
`
`2187
`
`2188
`
`2189
`
`2190
`
`2191
`
`2192
`
`2193
`
`ProQuest LLC, Terbinafine Gel – MediQuest Therapeutics, Adis
`R&D Insight (Mar. 2016)
`ProQuest LLC, Fluconazole Transdermal - Watson
`Pharmaceuticals, Adis R&D Insight (Dec. 2015)
`ProQuest LLC, Terbinafine Topical - Celtic Pharma, Adis R&D
`Insight (May 2015)
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`Onychomycosis: an Update, Expert Opin. Investig. Drugs, vol. 25,
`no. 3, pp. 297-305 (2016)
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`and Differences with Respect to the Stratum Corneum, J. Pharm.
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`Pathological Changes, Curr. Probl. Derm., vol. 9, pp. 102–49
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`Pharmacol., vol. 49, no. 1, pp. 30–34 (1997)
`European Commission Scientific Committee on Consumer
`Products, Opinion on Toluene (April 15, 2008)
`
`
`
`- 18 -
`
`
`
`Docket No. 036914.0005-US01
`
`
`Exhibit
`
`Description
`
`IPR2015-01776
`
`Mertin & Lippold, In Vitro Permeability of the Human Nail and of
`a Keratin Membrane from Bovine Hooves: Penetration of
`Chloramphenicol from Lipophilic Vehicles and from a Nail
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