Extract from the Register of European Patents

About this file: EP1965823

EP1965823 - METHODS FOR ADMINISTERING HYPOGLYCEMIC AGENTS [Right-click to bookmark this link]
StatusThe patent has been granted
Status updated on  03.10.2018
Database last updated on 09.12.2019
Most recent event   Tooltip10.05.2019Opposition withdrawnpublished on 12.06.2019  [2019/24]
Applicant(s)For all designated states
GlaxoSmithKline LLC
251 Little Falls Drive
Wilmington, DE 19808 / US
[2019/02]
Former [2018/52]For all designated states
GlaxoSmithKline LLC
Corporation Service Company
2711 Centerville Road
Suite 400
Wilmington DE 19808 / US
Former [2017/40]For all designated states
GlaxoSmithKline LLC
251 Little Falls Drive
Wilmington, DE 19808 / US
Former [2016/20]For all designated states
GlaxoSmithKline LLC
Corporation Service Company
2711 Centerville Road
Suite 400
Wilmington DE 19808 / US
Former [2014/15]For all designated states
GlaxoSmithKline LLC
Corporation Service Company
2711 Centreville Road
Suite 400
Wilmington, Delaware 19808 / US
Former [2010/09]For all designated states
GlaxoSmithKline LLC
One Franklin Plaza 200 North 16th Street
Philadelphia, PA 19102 / US
Former [2008/37]For all designated states
SmithKline Beecham Corporation
One Franklin Plaza P.O. Box 7929
Philadelphia, PA 19101 / US
Inventor(s)01 / BUSH, Mark A.
Research Triangle Park
Five Moore Drive
Durham, NC 27709 / US
02 / O'NEILL, Mary Colleen
440 Davis Court
San Francisco, CA 94111 / US
 [2016/20]
Former [2008/37]01 / BUSH, Mark A.
Research Triangle Park Five Moore Drive
Durham, NC 27709 / US
02 / O'NEILL, Mary Colleen
440 Davis Court
San Francisco, CA 94111 / US
Representative(s)Hitchcock, Lucy Rose
GlaxoSmithKline
Global Patents (CN925.1)
980 Great West Road
Brentford, Middlesex TW8 9GS / GB
[2016/20]
Former [2008/37]Hitchcock, Lucy Rose
GlaxoSmithKline 980 Great West Road
Brentford, Middlesex TW8 9GS / GB
Application number, filing date06839697.703.11.2006
[2008/37]
WO2006US60508
Priority number, dateUS20050733920P04.11.2005         Original published format: US 733920 P
US20050742600P06.12.2005         Original published format: US 742600 P
[2008/37]
Filing languageEN
Procedural languageEN
PublicationType: A2  Application without search report
No.:WO2007056681
Date:18.05.2007
Language:EN
[2007/20]
Type: A2 Application without search report 
No.:EP1965823
Date:10.09.2008
Language:EN
The application has been published by WIPO in one of the EPO official languages on 18.05.2007
[2008/37]
Type: B1 Patent specification 
No.:EP1965823
Date:18.05.2016
Language:EN
[2016/20]
Search report(s)International search report - published on:US10.04.2008
(Supplementary) European search report - dispatched on:EP05.07.2010
ClassificationInternational:A61K38/00, C07K1/00
[2008/37]
Designated contracting statesAT,   BE,   BG,   CH,   CY,   CZ,   DE,   DK,   EE,   ES,   FI,   FR,   GB,   GR,   HU,   IE,   IS,   IT,   LI,   LT,   LU,   LV,   MC,   NL,   PL,   PT,   RO,   SE,   SI,   SK,   TR [2016/20]
Former [2008/37]AT,  BE,  BG,  CH,  CY,  CZ,  DE,  DK,  EE,  ES,  FI,  FR,  GB,  GR,  HU,  IE,  IS,  IT,  LI,  LT,  LU,  LV,  MC,  NL,  PL,  PT,  RO,  SE,  SI,  SK,  TR 
Extension statesHR04.06.2008
TitleGerman:VERFAHREN ZUR VERABREICHUNG VON HYPOGLYKÄMISCHEN MITTELN[2008/37]
English:METHODS FOR ADMINISTERING HYPOGLYCEMIC AGENTS[2008/37]
French:PROCEDES D'ADMINISTRATION D'AGENTS HYPOGLYCEMIQUES[2008/37]
Entry into regional phase04.06.2008National basic fee paid 
04.06.2008Search fee paid 
04.06.2008Designation fee(s) paid 
04.06.2008Examination fee paid 
Examination procedure04.06.2008Examination requested  [2008/37]
31.01.2011Amendment by applicant (claims and/or description)
06.07.2012Despatch of a communication from the examining division (Time limit: M06)
18.12.2012Reply to a communication from the examining division
16.01.2013Despatch of a communication from the examining division (Time limit: M04)
16.05.2013Reply to a communication from the examining division
15.07.2013Despatch of a communication from the examining division (Time limit: M06)
16.12.2013Reply to a communication from the examining division
04.07.2014Despatch of a communication from the examining division (Time limit: M04)
05.11.2014Reply to a communication from the examining division
11.11.2014Observations by third parties
16.12.2014Despatch of a communication from the examining division (Time limit: M06)
12.06.2015Reply to a communication from the examining division
24.09.2015Despatch of a communication from the examining division (Time limit: M04)
26.01.2016Reply to a communication from the examining division
03.03.2016Communication of intention to grant the patent
08.04.2016Fee for grant paid
08.04.2016Fee for publishing/printing paid
08.04.2016Receipt of the translation of the claim(s)
Divisional application(s)EP16167794.3  / EP3095456
The date of the Examining Division's first communication in respect of the earliest application for which a communication has been issued is  06.07.2012
Opposition(s)Opponent(s)01  16.02.2017  02.05.2019  WITHDRAWN
Novo Nordisk A/S
Novo Allé
2880 Bagsvaerd / DK
Opponent's representative
Potter Clarkson
The Belgrave Centre
Talbot Street
Nottingham NG1 5GG / GB
 02  16.02.2017  22.02.2017  ADMISSIBLE
Sanofi
54 Rue La Boétie
75008 Paris / FR
Opponent's representative
Zwicker, Jörk
ZSP Patentanwälte PartG mbB
Hansastraße 32
80686 München / DE
 03  17.02.2017  22.02.2017  ADMISSIBLE
Generics [UK] Limited
Station Close
Potters Bar
Hertfordshire EN6 1TL / GB
Opponent's representative
Elkington and Fife LLP
Prospect House
8 Pembroke Road
Sevenoaks, Kent TN13 1XR / GB
 04  20.02.2017  23.02.2017  ADMISSIBLE
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, IN 46285 / US
Opponent's representative
Ingham, Stephen Howard
Eli Lilly and Company Ltd
European Patent Operations
Lilly Research Centre
Erl Wood Manor, Sunninghill Road
Windlesham, Surrey, GU20 6PH / GB
 [N/P]
Former [2019/24]
Opponent(s)01  16.02.2017  02.05.2019  WITHDRAWN
Novo Nordisk A/S
Novo Allé
2880 Bagsvaerd / DK
Opponent's representative
Potter Clarkson
The Belgrave Centre
Talbot Street
Nottingham NG1 5GG / GB
 02  16.02.2017  22.02.2017  ADMISSIBLE
Sanofi
54 Rue La Boétie
75008 Paris / FR
Opponent's representative
Zwicker, Jörk
ZSP Patentanwälte PartG mbB
Hansastraße 32
80686 München / DE
 03  17.02.2017  22.02.2017  ADMISSIBLE
Generics [UK] Limited
Station Close
Potters Bar
Hertfordshire EN6 1TL / GB
Opponent's representative
Elkington and Fife LLP
Prospect House
8 Pembroke Road
Sevenoaks, Kent TN13 1XR / GB
 04  20.02.2017  23.02.2017  ADMISSIBLE
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, IN 46285 / US
Opponent's representative
Ingham, Stephen Howard
Eli Lilly and Company Ltd
European Patent Operations
Lilly Research Centre
Erl Wood Manor, Sunninghill Road
Windlesham, Surrey, GU20 6PH / GB
Former [2018/52]
Opponent(s)01  16.02.2017  22.02.2017  ADMISSIBLE
Novo Nordisk A/S
Novo Allé
2880 Bagsvaerd / DK
Opponent's representative
Potter Clarkson LLP
The Belgrave Centre
Talbot Street
Nottingham NG1 5GG / GB
 02  16.02.2017  22.02.2017  ADMISSIBLE
Sanofi
54 Rue La Boétie
75008 Paris / FR
Opponent's representative
Zwicker, Jörk
ZSP Patentanwälte PartG mbB
Hansastraße 32
80686 München / DE
 03  17.02.2017  22.02.2017  ADMISSIBLE
Generics [UK] Limited
Station Close
Potters Bar
Hertfordshire EN6 1TL / GB
Opponent's representative
Elkington & Fife LLP
Prospect House
8 Pembroke Road
Sevenoaks, Kent TN13 1XR / GB
 04  20.02.2017  23.02.2017  ADMISSIBLE
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, IN 46285 / US
Opponent's representative
Ingham, Stephen Howard
Eli Lilly and Company Ltd
European Patent Operations
Lilly Research Centre
Erl Wood Manor, Sunninghill Road
Windlesham, Surrey, GU20 6PH / GB
Former [2017/13]
Opponent(s)01  16.02.2017  22.02.2017  ADMISSIBLE
Novo Nordisk A/S
Novo Allé
2880 Bagsvaerd / DK
Opponent's representative
Potter Clarkson LLP
The Belgrave Centre
Talbot Street
Nottingham NG1 5GG / GB
 02  16.02.2017  22.02.2017  ADMISSIBLE
Sanofi
54 Rue La Boétie
75008 Paris / FR
Opponent's representative
Zwicker, Jörk
ZSP Patentanwälte PartG mbB
Radlkoferstrasse 2
81373 München / DE
 03  17.02.2017  22.02.2017  ADMISSIBLE
Generics [UK] Limited
Station Close
Potters Bar
Hertfordshire EN6 1TL / GB
Opponent's representative
Cooke, Richard Spencer
Elkington and Fife LLP
Patents Department
3-4 Holborn Circus
London EC1N 2HA / GB
 04  20.02.2017  23.02.2017  ADMISSIBLE
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, IN 46285 / US
Opponent's representative
Ingham, Stephen H.
Eli Lilly and Company Ltd
European Patent Operations
Lilly Research Centre
Erl Wood Manor, Sunninghill Road
Windlesham, Surrey, GU20 6PH / GB
27.03.2017Invitation to proprietor to file observations on the notice of opposition
27.07.2017Reply of patent proprietor to notice(s) of opposition
09.05.2018Date of oral proceedings
04.10.2018Despatch of minutes of oral proceedings
04.10.2018Despatch of communication that the patent will be revoked
Appeal following opposition16.11.2018Appeal received No.  T2749/18
11.02.2019Statement of grounds filed
Fees paidRenewal fee
07.11.2008Renewal fee patent year 03
06.11.2009Renewal fee patent year 04
22.10.2010Renewal fee patent year 05
07.11.2011Renewal fee patent year 06
07.11.2012Renewal fee patent year 07
07.11.2013Renewal fee patent year 08
07.11.2014Renewal fee patent year 09
06.11.2015Renewal fee patent year 10
Documents cited:Search[X]US5545618  (BUCKLEY DOUGLAS I [US] ET AL) [X] 1-34 * column 13, paragraph l - column 14, line 28 * * claim 12 * * example 1 *;
 [X]EP1408050  (SHANGHAI HUA YI BIO TECH LAB [CN]) [X] 1-34 * paragraph [0005] * * paragraph [0018] * * figures 9-11 * * page 15; examples 15, 16 *;
 [X]  - "Human albumin/GLP-1(7-36(A8G)) fusion protein, SEQ ID NO:611.", Geneseq, (20040311), Database accession no. ADH21814, URL: EBI, XP002587051 [X] 1-34 * from US2005/0054570 (see ISR), see Table 2, page 31 (Fusion 139) and [579] *
 [X]  - "Glucagon like peptide 1 (7-37) analogue Gly8.", Geneseq, (19970415), Database accession no. AAW03873, URL: EBI, XP002587052 [X] 1-34 * compound . *
 [X]  - "Human insulinotropic GLP-1(7-36) analogue polypeptide, Gly8-GLP-1(7-36).", Geneseq, (20041021), Database accession no. ADR00560, URL: EBI, XP002587053 [X] 1-34 * compound . *
 [A]  - Caffrey RM, Seley JJ, "How to take your best shot", (20041101), Diabetes Health - Investigate, Inform, Inspire, URL: http://www.diabeteshealth.com/read/2004/11/01/4128/how-to-take-your-best-shot/, (20100614), XP002587054 [A] 1-34 * paragraph "2. Needle Gauge"; page 2 *
International search[X]US2005054570  (ROSEN CRAIG A [US], et al)
ExaminationWO2004060920
 WO2005058958
 WO03099314
 US5728074
 WO2005077042
 WO0246227
 US7452996
    - MILLER MARIA A ET AL, "Low viscosity highly concentrated injectable nonaqueous suspensions of lysozyme microparticles.", LANGMUIR : THE ACS JOURNAL OF SURFACES AND COLLOIDS 19 JAN 2010 LNKD- PUBMED:19803503, (20100119), vol. 26, no. 2, ISSN 1520-5827, pages 1067 - 1074, XP055070251

DOI:   http://dx.doi.org/10.1021/la9023426
    - EMSA ASSESSMENT FOR EZPERAN(TM), "Eperzan", EUROPEAN MEDICINES AGENCY, SCIENCE MEDICINES HEALTH, London, UK, (20140123), pages 1 - 124
    - FDA LABEL FOR TANZEUM(TM), (201404), pages 1 - 56
    - FDA LABEL FOR TRULICITY(TM), (201409), pages 1 - 19
    - ELI LILLY, ELI LILLY AND COMPANY INVESTMENT COMMUNITY MEETING OCTOBER 3, 2013, page 124
    - COMMITEE FOR MEDICAL PRODUCTS FOR HUMAN USE (CHMP), EUROPEAN MEDICINES AGENCY, (20140925), pages 1 - 2
    - HARDER HELLE ET AL, "The effect of liraglutide, a long-acting glucagon-like peptide 1 derivative, on glycemic control, body composition, and 24-h energy expenditure in patients with type 2 diabetes.", DIABETES CARE AUG 2004, (200408), vol. 27, no. 8, ISSN 0149-5992, pages 1915 - 1921, XP055085996

DOI:   http://dx.doi.org/10.2337/diacare.27.8.1915
    - ENCYCLOPEDIA OF FAMILIY HEALTH, (20041101), pages 1 - 5
    - CAROL ET AL., "Photo Atlas of Medication Administration", LIPPINCOTT'S PHOTO ATLAS OF OF MEDICATION ADMINISTRATION, pages 1 - 4
by applicantUS2005054570
 US5545618
 EP1408050
 WO03060071
 WO03059934
 WO2005003296
 WO2005077042
    - MEIER ET AL., "Glucagon-Like Peptide 1 and Gastric Inhibitory Polypeptide Potential Applications in Type 2 Diabetes Mellitus", BIODRUGS, (2003), vol. 17, no. 2, pages 93 - 102
    - "Posttranslational Protein Modifications: Perspectives and Prospects", WOLD, F., POSTTRANSLATIONAL COVALENT MODIFICATION OF PROTEINS, ACADEMIC PRESS, (1983), pages 1 - 12
    - SEIFTER ET AL., "Analysis for protein modifications and nonprotein cofactors", METH. ENZYMOL., (1990), vol. 182, pages 626 - 646
    - RATTAN ET AL., "Protein Synthesis: Posttranslational Modifications and Aging", ANN NY ACAD SCI, (1992), vol. 663, pages 48 - 62
otherWO2004060920
 WO2005058958
 WO03099314
    - "EPERZAN (INTERNATIONAL NON-PROPRIETARY NAME: ALBIGLUTIDE); PROCEDURE NO. EMEA/H/C/002735/0000", ASSESSMENT REPORT EMA, (20140123), pages 1 - 124, XP055184490
    - FOOD AND DRUG ADMINISTRATION, "TANZEUM", FDA LABEL, (2014), pages 1 - 56, XP055184518
    - ELI LILLY AND COMPANY, "TRULICITY", FDA LABEL, (2014), pages 1 - 19, XP055184535
    - ELI LILLY AND COMPANY, "INVESTMENT COMMUNITY MEETING", SHAREHOLDER PRESENTATION LILLY, (20131003), pages 1 - 24, XP003035212
    - EMA, "SUMMARY OF OPINION (INITIAL AUTHORISATION); TRULICITY", EMA CHMP OPINION (EMA/CHMP/524609/2014), (20140925), XP055184574
    - HARDER H. ET AL., "THE EFFECT OF LIRAGLUTIDE, A LONG-ACTING GLUCAGON-LIKE PEPTIDE 1 DERIVATIVE, ON GLYCEMIC CONTROL, BODY COMPOSITION, AND 24-H ENERGY EXPENDITURE IN PATIENTS WITH TYPE 2 DIABETES", DIABETES CARE, (200408), vol. 27, no. 8, pages 1915 - 1921, XP055085996

DOI:   http://dx.doi.org/10.2337/diacare.27.8.1915
    - "INJECTIONS", YOUNGSON R.M. ET AL., ENCYCLOPEDIA OF FAMILY HEALTH, 3RD ED., MARSHALL CAVENDISH, (2005), pages 955 - 956, XP003035213
    - TAYLOR C. ET AL., LIPPINCOTT'S PHOTO ATLAS OF MEDICATION ADMINISTRATION, LIPPINCOTT WILLIAMS & WILKINS, (2004), pages 6 - 7, XP003035214
OppositionUS2005054570
 US5545618
 EP1408050
 WO2004060920
 WO2005058958
 WO03099314
 US5728074
 WO2005077042
 WO0246227
 US7452966
 WO2004069314
 WO9300948
 WO2005000892
 WO2007056681
 US4313439
 US2004019326
 EP0882468
 WO2006131730
 WO2006124529
 WO2004057959
    - CAFFREY et al., "How to take your best shot", Diabetes Health, (20041101), URL: http://www.diabeteshealth.com/read/2004/11/01/4128/how-to-take-your-best-shot/, XP002587054
    - MILLER et al., "Low viscosity highly concentrated injectable nonaqueous suspensions of lysozyme microparticles", Languir, (20100119), vol. 26, no. 2, pages 1067 - 1074, XP055070251

DOI:   http://dx.doi.org/10.1021/la9023426
    - EUROPEAN MEDICINES AGENCY, "EPERZAN (INTERNATIONAL NON-PROPRIETARY NAME: ALBIGLUTIDE); PROCEDURE NO. EMEA/H/C/002735/0000", ASSESSMENT REPORT EMA, (20140123), pages 1 - 124, XP055184490
    - FOOD AND DRUG ADMINISTRATION, "Tanzeum", FDA label, pages 1 - 56, XP055184518
    - ELI LILLY AND COMPANY, "Trulicity", FDA label, (20140000), pages 1 - 19, XP055184535
    - ELI LILLY AND COMPANY, "INVESTMENT COMMUNITY MEETING", Shareholder presentation Lilly, (20131003), pages 1 - 24, XP003035212
    - EMA, "SUMMARY OF OPINION (INITIAL AUTHORISATION); TRULICITY", EMA CHMP OPINION (EMA/CHMP/524609/2014), (20140925), XP055184574
    - HARDER et al., "THE EFFECT OF LIRAGLUTIDE, A LONG-ACTING GLUCAGON-LIKE PEPTIDE 1 DERIVATIVE, ON GLYCEMIC CONTROL, BODY COMPOSITION, AND 24-H ENERGY EXPENDITURE IN PATIENTS WITH TYPE 2 DIABETES", Diabetes Care, (20040800), vol. 27, no. 8, pages 1915 - 1921, XP055085996

DOI:   http://dx.doi.org/10.2337/diacare.27.8.1915
    - DAVID B. JACOBY et al., Encyclopedia of Family Health. 3rd ed., Marshall Cavendish, (20041101), pages 955 - 956, XP055356814
    - "Administering Medication", CAROL TAYLOR et al., Lippincott's Photo Atlas of Medication Administration, Lippincott Williams, & Wilkins, (20040000), pages 6 - 7, XP055356818
    - "Needle gauge comparison chart", Wikipedia, the free encyclopedia, (20160208), pages 1 - 4, XP002754019
    - DC TANFORD et al., "The Viscosity of Aqueous Solutions of Bovine Serum Albumin between pH 4.3 and 10.5.", J. Phys. Chem., (19560200), vol. 60, no. 2, pages 225 - 231, XP055356828

DOI:   http://dx.doi.org/10.1021/j150536a020
    - J T YANG et al., "Conformation of beta- endorphin and beta-lipotropin: formation of helical structure in methanol and sodium dodecyl sulfate solutions", Proc Natl Acad Sci USA., vol. 74, no. 8, (19770800), pages 3235 - 3238, (19770800), XP055356802

DOI:   http://dx.doi.org/10.1073/pnas.74.8.3235
    - "Insulin Signal Transduction Pathway", Wikipedia, the free encyclopedia, (20161209), pages 1 - 5, URL: https://en.wikipedia.org/wiki/Insulin_signal_transduction_pathway, XP055356842
    - J. PFITZNER, "Poiseuille and his law", Anaesthesia, (19760000), vol. 31, pages 273 - 275, XP055356849

DOI:   http://dx.doi.org/10.1111/j.1365-2044.1976.tb11804.x
    - NOIROT et al., "Contraintes techniques du remplissage vasculaire rapide", Ann Fr Anesth Réanim, (19900000), vol. 9, no. 5, pages 433 - 442, XP055356856
    - MILLER et al., "Low viscosity highly concentrated injectable nonaqueous suspensions of lysozyme microparticles", Langmuir, (20100119), vol. 26, no. 2, pages 1067 - 1074, XP055070251

DOI:   http://dx.doi.org/10.1021/la9023426
    - SCHWARTZ et al., "A multicenter, open-label, randomized, two-period crossovertrial comparing glycemic control, satisfaction, and preference achieved with a 31 gauge x 6 mm needle versus a 29 gauge x 12.7 mm needle in obese patients with diabetes mellitus", Clinical Therapeutics, (20041010), vol. 26, no. 10, pages 1663 - 1678, XP004682056

DOI:   http://dx.doi.org/10.1016/j.clinthera.2004.10.007
    - CAFFREY et al., "How to take your best shot", Diabetes Health, (20041101), URL: www.diabeteshealth.com, XP002587054
    - DEGN et al., "One week's treatment with the long-acting glucagon-like peptide 1 derivative liraglutide (NN2211) markedly improves 24-h glycemia and alpha- and beta-cell function and reduces endogenous glucose release in patients with type 2 diabetes", Diabetes, (20040500), vol. 53, no. 5, pages 1187 - 1194, XP002512806

DOI:   http://dx.doi.org/10.2337/diabetes.53.5.1187
    - HARDER et al., "The Effect of Liraglutide, a Long-Acting Glucagon-Like Peptide 1 Derivative, on Glycemic Control, Body Composition, and 24-h Energy Expenditure in Patients With Type 2 Diabetes", Diabetes Care, (20040800), vol. 27, no. 8, pages 1915 - 1912, XP055085996

DOI:   http://dx.doi.org/10.2337/diacare.27.8.1915
    - BAGGIO et al., "A Recombinant Human Glucagon-Like Peptide (GLP)-1-Albumin Protein {Albugon) Mimics Peptidergic Activation of GLP-1 Receptor-Dependent Pathways Coupled With Satiety, Gastrointestinal Motility, and Glucose Homeostasis", Diabetes, (20040900), vol. 53, pages 2492 - 2500, XP003004469

DOI:   http://dx.doi.org/10.2337/diabetes.53.9.2492
    - "The novo nordisk history of insulin devices", Novo Nordisk, (20140800), URL: https://www.novonordisk.com/content/dam/Denmark/HQ/media/documents/Devices_heritage_infographic.pdf, XP055356908
    - EMA, "Assessment report for Eperzan (International non-proprietary name: albiglutide); Procedure No. EMEA/H/C/002735/0000", EMA assessment report for Ezperan, (20140123), pages 1 - 124, URL: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002735/WC500165119.pdf, XP055184490
    - BSI, "Stainless steel needle tubing for the manufacture of medical Devices", European Standard EN ISO 9626, (19950700), XP003029843
    - GINSBERG J., "Mixing Pens and the Future of Diabetes Drugs", Diabetes Sciences and Technology, (20150000), vol. 9, no. 4, pages 822 - 823, XP055356880

DOI:   http://dx.doi.org/10.1177/1932296815585873
    - "Human albumin/GLP-1 (7-36(A8G)) fusion protein, SEQ ID NO :611.", EBI, (20040311), Database accession no. ADH21814, XP002587051
    - "Glucagon like peptide 1 (7-37) analogue Gly8.", EBI, (19970415), Database accession no. AAW03873, XP002587052
    - "Human insulinotropic GLP-1 (7-36 ) analogue polypeptide, Gly8-GLP-1 (7-36).", EBI, (20041021), Database accession no. ADR00560, XP002587053
    - CAFFREY RM et al., "How to take your best shot", Diabetes Health - Investigate, Inform, Inspire;, (20041101), URL: http://www.diabeteshealth.com/read/ 2004/11/01 /4128/how- to-take-your-best-shot, (20100614), XP002587054
    - MILLER MARIA A et al., "Low viscosity highly concentrated injectable nonaqueous suspensions of lysozyme microparticles.", LANGMUIR: THE ACS JOURNAL OF SURFACES AND COLLOIDS, (20100119), vol. 26, no. 2, ISSN 1520-5827, pages 1067 - 1074, XP055070251

DOI:   http://dx.doi.org/10.1021/la9023426
    - "EPERZAN (INTERNATIONAL NON-PROPRIETARY NAME: ALBIGLUTIDE); PROCEDURE NO. EMEA/H/C/002735/0000", EUROPEAN MEDICINES AGENCY, SCIENCE MEDICINES HEALTH, London, UK, (20140123), pages 1 - 124, XP055184490
    - FOOD AND DRUG ADMINISTRATION, "TANZEUM", FDA LABEL, (20140400), pages 1 - 56, XP055184518
    - ELI LILLY AND COMPANY, "TRULICITY", FDA LABEL, (20140900), pages 1 - 19, XP055184535
    - ELI LILLY AND COMPANY, "INVESTMENT COMMUNITY MEETING", SHAREHOLDER PRESENTATION LILLY, (20131003), pages 1 - 24, XP003035212
    - EMA, "SUMMARY OF OPINION (INITIAL AUTHORISATION); TRULICITY", EMA CHMP OPINION (EMA/CHMP/524609/2014, (20140925), pages 1 - 2, XP055184574
    - HARDER HELLE et al., "The effect of liraglutide, a long-acting glucagon- like peptide 1 derivative, on glycemic control, body composition, and 24-h energy expenditure in patients with type 2 diabetes.", DIABETES CARE, (20040800), vol. 27, no. 8, ISSN 0149-5992, pages 1915 - 1921, XP055085996

DOI:   http://dx.doi.org/10.2337/diacare.27.8.1915
    - "Injections", Jacoby D. B. et al, ENCYCLOPEDIA OF FAMILIY HEALTH. 3rd ed., Marshall Cavendish, (20041101), pages 955 - 956, XP055356814
    - CAROL et al., "Photo Atlas of Medication Administration", LIPPINCOTT'S PHOTO ATLAS OF OF MEDICATION ADMINISTRATION, (20080000), pages 6 - 7, XP055356818
    - Stonehouse A. et al, "Exenatide Once-Weekly Clinical Development: Safety and Efficacy Across a Range of Background Therapies", Diabetes Technology and Therapeutics, (20111000), vol. 13, no. 10, pages 1063 - 1069, XP055356769

DOI:   http://dx.doi.org/10.1089/dia.2011.0076
    - Jens Juul Holst, "The Physiology of Glucagon-like Peptide 1", Physiol Rev, (20071000), vol. 87, no. 4, pages 1409 - 1439, XP002699671

DOI:   http://dx.doi.org/10.​1152/​physrev.​00034.​2006
    - HARDER, H. et al., "THE EFFECT OF LIRAGLUTIDE, A LONG-ACTING GLUCAGON-LIKE PEPTIDE 1 DERIVATIVE, ON GLYCEMIC CONTROL, BODY COMPOSITION, AND 24-H ENERGY EXPENDITURE IN PATIENTS WITH TYPE 2 DIABETES", Diabetes Care, (20040800), vol. 27, no. 8, pages 1915 - 1921, XP055085996

DOI:   http://dx.doi.org/10.2337/diacare.27.8.1915
    - SCHWARTZ, S. et al., "A multicenter, open-label, randomized, two-period crossovertrial comparing glycemic control, satisfaction, and preference achieved with a 31 gauge x 6 mm needle versus a 29 gauge x 12.7 mm needle in obese patients with diabetes mellitus", Clinical Therapeutics, (20041000), vol. 26, no. 10, pages 1663 - 1678, XP004682056

DOI:   http://dx.doi.org/10.1016/j.clinthera.2004.10.007
    - SHIRE, S.J. et al., "Challenges in the development of high protein concentration formulations", J. Pharma. Sciences, (20040600), vol. 93, no. 6, pages 1390 - 1402, XP009108986

DOI:   http://dx.doi.org/10.1002/jps.20079
    - LIU, J et al., "Reversible self-association increases the viscosity of a concentrated monoclonal antibody in aqueous solution", J. Pharma. Sciences, (20050900), vol. 94, no. 9, pages 1928 - 1940, XP002475004

DOI:   http://dx.doi.org/10.1002/jps.20347
    - "Needle gauge comparison chart", Wikipedia, the free encyclopedia, (20160208), pages 1 - 4, URL: https://en.wikipedia.org/wiki/Needle_gauge_comparison_chart, XP002754019
    - GNANALINGHAM M.G. et al., "Accuracy and reproducibility of low dose insulin administration using pen-injectors and syringes", Arch. Dis. Child, (19980700), vol. 79, no. 1, page 59, XP055356734

DOI:   http://dx.doi.org/10.1136/adc.79.1.59
    - ConjuChem, "Phase I/II Preliminary Results Clinical Trail data publication by ConjuChem", Thonsom Reuters, (20161209), pages 1 - 5, XP055356738
    - MILLER, M.A. et al., "Low viscosity highly concentrated injectable nonaqueous suspensions of lysozyme microparticles", Langmuir, (20100119), vol. 26, no. 2, pages 1067 - 1074, XP055070251

DOI:   http://dx.doi.org/10.1021/la9023426
    - GONCALVES, A. D. et al., "The effect of protein concentration on the viscosity of a recombinant albumin solution formulationt", RSC Advances, (20160000), vol. 6, no. 18, pages 15143 - 15154, XP055356758

DOI:   http://dx.doi.org/10.1039/C5RA21068B