throbber
Filed on behalf of: Abraxis Bioscience, LLC
`Filed: November 8, 2017
`
`
`UPDATED EXHIBIT LIST – IPR2017-01103
`
`
`Description
`EX
`2001 Declaration of Nicholas A. Peppas, Sc.D.
`In Support of Patent Owner’s Preliminary Response
`2002 Frye, D. K., Taxane Chemotherapy–Advances in Treatment for Breast
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`2003 Paclitaxel (Taxol®) Formulation and Prodrugs: The Chemistry and
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`2004 Gelderblom et al., Cremophor EL: the drawbacks and advantages of
`vehicle selection for drug formulation. Eur J Cancer 2001; 37:1590–1598
`2005 Desai et al., US 5,916,596, “Protein Stabilized Pharmacologically Active
`Agents, Methods for the Preparation Thereof and Methods for the Use
`Thereof” (issued Jun. 29,1999)
`2006 FDA News. “Phase III Trial of Tocosol Paclitaxel Does Not Meet Primary
`Endpoint” (published 2017)
`2007 Paz-Ares et al., Phase III trial comparing paclitaxel poliglumex vs
`docetaxel in the second-line treatment of non-small-cell lung cancer. Brit J
`Cancer. 2008; 98:1608–1613
`2008 Langer et al., Phase III Trial Comparing Paclitaxel Poliglumex (CT-2103,
`PPX) in Combination with Carboplatin Versus Standard Paclitaxel and
`Carboplatin in the Treatment of PS 2 Patients with Chemotherapy-Naïve
`Advanced Non-small Cell Lung Cancer. J Thorac Oncol. 2008; 3:623–630
`2009 Hamaguchi et al., NK105, a paclitaxel-incorporating micellar nanoparticle
`formulation, can extend in vivo antitumour activity and reduce the
`neurotoxicity of paclitaxel, Brit J Cancer. 2005; 92:1240–1246
`2010 FirstWord Pharma, “Results of Phase III study of NK105, a novel
`macromolecular micelle encapsulating an anticancer drug” (created July
`12, 2016)
`2011 Full Prescribing Information, Abraxane® , revised July 2015
`2012 Schnitzer et al., Albondin-mediated Capillary Permeability to Albumin. J
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`2013 Schnitzer J.E., gp60 is an albumin-binding glycoprotein expressed by
`continuous endothelium involved in albumin transcytosis. Am J Physiol.
`
`

`

`2014
`
`2019
`
`Filed on behalf of: Abraxis Bioscience, LLC
`Filed: November 8, 2017
`1992; 262:H246–H254
`John et al., Quantitative analysis of albumin uptake and transport in the rat
`microvessel endothelial monolayer. Am J Physiol-Lung C. 2003;
`284:L187–L196
`2015 Laino, C., June 3, 2009, “Abraxane Beats Standard Breast Cancer
`Treatment” www.webmd.com/breast-cancer/news/20090609/breast-
`cancer-drug-abraxane-is-effective
`2016 Blum et al., Phase II Study of Weekly Albumin-Bound Paclitaxel for
`Patients with Metastatic Breast Cancer Heavily Pretreated with Taxanes.
`Clin Breast Cancer. 2007; 7(11):850–856
`2017 Gradishar et al., Phase III Trial of Nanoparticle Albumin-Bound Paclitaxel
`Compared with Polyethylated Castor Oil-Based Paclitaxel in Women with
`Breast Cancer. J Clin Oncol. 2005; 23(31):7794–7803
`2018 Zhang et al., Nab-Paclitaxel is an Active Drug in Preclinical Model of
`Pediatric Solid Tumors. Clin Cancer Res. 2013; 19(21):5972–5983
`Irizarry et al., Cremophor EL-containing paclitaxel-induced anaphylaxis: a
`call to action. Community Oncology. 2009; 6(3):132–134
`2020 Rajeshkumar et al., Superior Therapeutic Efficacy of nab-Paclitaxel over
`Cremophor-based paclitaxel in locally advanced and metastatic models of
`human pancreatic cancer. Brit J Cancer. 2016; 115:442–453
`2021 Wani, et al., Plant antitumor agents. VI. The isolation and structure of
`taxol, a novel antileukemic and antitumor agent from Taxus brevifolia. J
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`2022
`Intentionally Left Blank
`2023 Chromatographic Techniques for the Characterization of Proteins: Physical
`Methods to Characterize Pharmaceutical Proteins, Springer Science and
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`2024 Girard et al., Separation of Human Serum Albumin Components by RP-
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`2025 The Application of HPLC for Proteins, High Performance Liquid
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`Sons, Chichester, UK, 1996, 411–467
`2026 Sparreboom et al., Determination of paclitaxel in human plasma using
`single solvent extraction prior to isocratic reversed-phase high-
`
`

`

`2032
`
`Filed on behalf of: Abraxis Bioscience, LLC
`Filed: November 8, 2017
`performance liquid chromatography with ultraviolet detection. J.
`Chromatogr B. 1998; 705:159–164
`2027 Martin et al., Assay of paclitaxel (Taxol) in plasma and urine by high-
`performance liquid chromatography. J. Chromatogr B. 1998; 709:281–288
`2028 Tian et al., Degradation of Paclitaxel and Related Compounds in Aqueous
`Solutions I: Epimerization. J Pharm Sci. 2008; 97(3):1224–1235
`2029 Tian et al., Degradation of Paclitaxel and Related Compounds in Aqueous
`Solutions II: Nonepimerization Degradation Under Neutral to Basic pH
`Conditions. J Pharm Sci. 2008; 97(8):3100–3108
`2030 Tian et al., Degradation of Paclitaxel and Related Compounds in Aqueous
`Solutions III: Degradation Under Acidic pH Conditions and Overall
`Kinetics. J Pharm Sci. 2010; 99(3):1288–1298
`2031 Pillai et al., Pharmaceutical Glass Interactions: A Review of Possibilities. J
`Pharm Sci & Res. 2016; Vol. 8(2):103–111
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`http://blogs.sciencemag.org/pipeline/archives/2008/08/29/sticky_container
`s_vanishing_drugs (August 29, 2008)
`2033 Mani et al., Delivery of paclitaxel from cobalt–chromium alloy surfaces
`without polymeric carriers. Biomaterials. 2010; 31(20):5372–5384
`2034 Green et al., Measurement of paclitaxel and its metabolites in human
`plasma using liquid chromatography/ion trap mass spectrometry with a
`sonic spray ionization interface. Rapid Commun Mass Sp. 2006;
`20(14):2183–2189
`2035 Heldman et al., Paclitaxel Stent Coating Inhibits Neointimal Hyperplasia
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`103:2289–2295
`2036 Fukazawa et al., Reduction of non-specific adsorption of drugs to plastic
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`2037 Hunz et al., Plasma And Tissue Pharmacokinetics Of Epirubicin And
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`668
`2038 Pfeifer et al., Precipitation of paclitaxel during infusion by pump. Am J
`Hosp Pharm. 1993; 50:2518–2521
`
`

`

`Filed on behalf of: Abraxis Bioscience, LLC
`Filed: November 8, 2017
`2039 Xu et al., Stability of paclitaxel in 5% dextrose injection or 0.9% sodium
`chloride injection at 4, 22, or 32 °C. Am J Hosp Pharm. 1994;51:3058–
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`2042 Lee et al., Hydrotropic solubilization of paclitaxel: analysis of chemical
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`2043 Feng, et al., Effects of emulsifiers on the controlled release of paclitaxel
`(Taxol®) from nanospheres of biodegradable polymers. J Control Release.
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`2045 Fogh-Andersen et al., Ionic Binding, Net Charge, and Donnan Effect of
`Human Serum Albumin as a Function of pH. Clin Chem. 1993; 39(1):48–
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`2046 Curnis et al., Improving Chemotherapeutic Drug Penetration in Tumors by
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`2048
`Intentionally Left Blank
`2049
`Intentionally Left Blank
`2050 Ziller et al., Control of Crystal Growth in Drug Suspension: 1) Design of a
`Control Unit and Application to Acteaminophen Suspensions). Drug Dev
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`2051 USP Monograph, Paclitaxel. 30(40):1279
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`2052 Garnett et al., The effects of serum and human albumin on calcium
`hydroxyapatite crystal growth. Biochem J. 1990; 266:863–868
`
`

`

`Filed on behalf of: Abraxis Bioscience, LLC
`Filed: November 8, 2017
`2053 Kommanaboyina et al., Trends in Stability Testing, with Emphasis on
`Stability During Distribution and Storage. Drug Dev Ind Pharm. 1999;
`25(7):857–868
`2054 Surapaneni et al., Designing Paclitaxel Drug Delivery Systems Aimed at
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`2055 Flynn, G.L., Solubility Concepts and Their Applications to the
`Formulation of Pharmaceutical Systems: Part I. Theoretical Foundations.
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`2056 Pyo et al., Preparation and Dissolution Profiles of the Amorphous,
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`Albumins: Binding Isotherms, Optical Rotatory Dispersion, Viscosity,
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`1971; 10(22):4005–4015
`2058 U.S. Application No. 12/910,693, Notice of Allowance (mailed Dec. 27,
`2011)
`2059 Diaz et al., Molecular Recognition of Taxol by Microtubules. J Biol Chem.
`2002; 275(34):26265–26276
`2060 Chen et al., Albumin-bound nanoparticle (nab) paclitaxel exhibits
`enhanced paclitaxel tissue distribution and tumor penetration. Cancer
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`2061 Evangelio et al., Fluorescent Taxoids as Probes of the Microtubule
`Cytoskeleton. Cell Motil Cytoskel. 1998; 39:73–90
`2062 U.S. Application No. 12/758,413, Notice of Allowance (mailed Feb. 23,
`2011)
`2063 Declaration of Lisamarie LoGiudice
`2064 Declaration of Andrew S. Chalson in Support of Patent Owner’s
`Unopposed Motion for Pro Hac Vice Admission
`2065 Declaration of Daniel C. Wiesner in Support of Patent Owner’s
`Unopposed Motion for Pro Hac Vice Admission
`
`

`

`
`
`CERTIFICATE OF SERVICE
`The undersigned certifies that on the date indicated below a copy of the
`
`foregoing UPDATED EXHIBIT LIST was served electronically by filing this
`
`document through the PTAB E2E System, as well as by e-mailing copies to the
`
`following counsel of record for Petitioner Actavis LLC:
`
`Lead Counsel
`Samuel S. Park, Reg. No. 59,656
`WINSTON & STRAWN LLP
`35 W. Wacker Drive
`Chicago, IL 60601
`312-558-7931
`AbraxaneIPR@winston.com
`
`
`Date: November 8, 2017
`
`
`
`Backup Counsel
`George C. Lombardi
`Charles B. Klein
`Kevin E. Warner
`Eimeric Reig-Plessis
`WINSTON & STRAWN LLP
`35 W. Wacker Drive
`Chicago, IL 60601
`312-558-7931
`AbraxaneIPR@winston.com
`
`
`
`
`
`/Lisamarie LoGiudice, Ph.D./
`Lisamarie LoGiudice, Ph.D. (Reg. No.
`71,047)
`JONES DAY
`250 Vesey Street
`New York, NY 10281-1047
`Telephone: 212-326-3939
`Facsimile: 212-755-7306
`
`Counsel for Patent Holder
`Abraxis Bioscience, LLC
`
`

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