Drug Profile
`
`NVP DPP 728
`
`Alternative Names: DPP 728
`
`Latest Information Update: 14 May 2002
`
`At a glance
`At a glance
`
`• Originator Novartis
`• Class Antihyperglycaemics; Nitriles; Pyrrolidines; Small molecules
`• Mechanism of Action CD26 antigen inhibitors
`
`• Orphan Drug Status
`
`Orphan designation is assigned by a regulatory body to encourage companies to develop
`drugs for rare diseases.
`
`No
`• On Fast track
`
`Fast track status is assigned by the US FDA so therapies with the potential to address
`unmet needs can move faster through development.
`
`No
`• New Molecular Entity Yes
`
`Highest Development Phases
`
`• Discontinued Type 2 diabetes mellitus
`
`Most Recent Events
`
`• 14 May 2002 A clinical study has been added to the pharmacodynamics section
`• 04 Dec 2001 Discontinued - Phase-II for Type-2 diabetes mellitus in USA (PO)
`• 05 Apr 2001 A preclinical study has been added to the Diabetes pharmacodynamics section
`
`http://adisinsight.springer.com/drugs/800012640
`
`AstraZeneca Exhibit 2086
`Mylan v. AstraZeneca
`IPR2015-01340
`
`Page 1 of 16
`
`
`
`NVP DPP 728
`
`Alternative Names: DPP 728
`
`Latest Information Update: 14 May 2002
`
`At a glance
`At a glance
`
`• Originator Novartis
`• Class Antihyperglycaemics; Nitriles; Pyrrolidines; Small molecules
`• Mechanism of Action CD26 antigen inhibitors
`
`• Orphan Drug Status
`
`Orphan designation is assigned by a regulatory body to encourage companies to develop
`drugs for rare diseases.
`
`No
`• On Fast track
`
`Fast track status is assigned by the US FDA so therapies with the potential to address
`unmet needs can move faster through development.
`
`No
`• New Molecular Entity Yes
`
`Highest Development Phases
`
`• Discontinued Type 2 diabetes mellitus
`
`Most Recent Events
`
`• 14 May 2002 A clinical study has been added to the pharmacodynamics section
`• 04 Dec 2001 Discontinued - Phase-II for Type-2 diabetes mellitus in USA (PO)
`• 05 Apr 2001 A preclinical study has been added to the Diabetes pharmacodynamics section
`
`http://adisinsight.springer.com/drugs/800012640
`
`AstraZeneca Exhibit 2086
`Mylan v. AstraZeneca
`IPR2015-01340
`
`Page 1 of 16
`
`
`
`Drug Profile
`
`P 3298
`
`Alternative Names: P-32-98; P32/98
`
`Latest Information Update: 22 Feb 2008
`
`At a glance
`At a glance
`
`• Originator Probiodrug
`• Class Antihyperglycaemics; Thiazolidines
`• Mechanism of Action CD26 antigen inhibitors
`
`• Orphan Drug Status
`
`Orphan designation is assigned by a regulatory body to encourage companies to develop
`drugs for rare diseases.
`
`No
`• On Fast track
`
`Fast track status is assigned by the US FDA so therapies with the potential to address
`unmet needs can move faster through development.
`
`No
`• New Molecular Entity Yes
`
`Highest Development Phases
`
`• Discontinued Type 2 diabetes mellitus
`
`Most Recent Events
`
`http://adisinsight.springer.com/drugs/800014308
`
`Page 2 of 16
`
`
`
`• 04 Dec 2002 Probiodrug has granted a non-exclusive licence to Ferring and its sublicensee,
`Ortho-McNeil Pharmaceuticals, for the inhibitors if dipeptidyl peptidase IV for diabetes and
`obesity
`• 06 Apr 2001 Phase-II clinical trials for Type-2 diabetes mellitus in Germany (PO)
`• 20 Feb 2001 A study has been added to the adverse events section
`
`http://adisinsight.springer.com/drugs/800014308
`
`Page 3 of 16
`
`
`
`Drug Profile
`
`Denagliptin
`
`Alternative Names: 823093; GW 823093; GW823093C; Redona
`
`Latest Information Update: 29 May 2015
`
`At a glance
`At a glance
`
`• Originator GlaxoSmithKline
`• Class Antihyperglycaemics; Aromatic amino acids; Pyrrolidines; Small molecules
`• Mechanism of Action Dipeptidyl-peptidase and tripeptidyl-peptidase inhibitors
`
`• Orphan Drug Status
`
`Orphan designation is assigned by a regulatory body to encourage companies to develop
`drugs for rare diseases.
`
`No
`• On Fast track
`
`Fast track status is assigned by the US FDA so therapies with the potential to address
`unmet needs can move faster through development.
`
`No
`• New Molecular Entity Yes
`
`Highest Development Phases
`
`• Discontinued Type 2 diabetes mellitus
`
`http://adisinsight.springer.com/drugs/800020028
`
`Page 4 of 16
`
`
`
`Most Recent Events
`
`• 20 Apr 2015 GlaxoSmithKline withdraws a phase II/III trial in Type-2 diabetes mellitus in USA
`and Finland due to the cancellation of the trial (NCT00387972; EudraCT2006-002157-79)
`• 08 Nov 2006 Suspended - Phase-III for Type-2 diabetes mellitus in United Kingdom (PO)
`• 28 Jul 2006 Phase-II/III clinical trials in Type-2 diabetes mellitus in United Kingdom (PO)
`
`http://adisinsight.springer.com/drugs/800020028
`
`Page 5 of 16
`
`
`
`Drug Profile
`
`Dutogliptin
`
`Alternative Names: Dutogliptin tartrate; PHX-1149; PHX1149T; REC-01
`
`Latest Information Update: 02 Dec 2015
`
`At a glance
`At a glance
`
`• Originator Phenomix Corporation
`• Class Antihyperglycaemics; Pyrrolidines; Small molecules
`• Mechanism of Action CD26 antigen inhibitors
`
`• Orphan Drug Status
`
`Orphan designation is assigned by a regulatory body to encourage companies to develop
`drugs for rare diseases.
`
`No
`• On Fast track
`
`Fast track status is assigned by the US FDA so therapies with the potential to address
`unmet needs can move faster through development.
`
`No
`• New Molecular Entity Yes
`• Available For Licensing Yes - Type 2 diabetes mellitus
`
`Highest Development Phases
`
`• Phase I Myocardial infarction
`• Discontinued Type 2 diabetes mellitus
`
`Most Recent Events
`
`http://adisinsight.springer.com/drugs/800024092
`
`Page 6 of 16
`
`
`
`• 25 Nov 2015 Dutogliptin is in phase I trial for Myocardial infarction in Austria
`• 11 Nov 2015 Recardio plans a phase II trial for Myocardial infarction in Austria
`• 09 Mar 2015 Phase-I clinical trials in Myocardial infarction (In volunteers) in Austria
`(Parenteral)
`
`http://adisinsight.springer.com/drugs/800024092
`
`Page 7 of 16
`
`
`
`Drug Profile
`
`Research programme: CD26 antigen
`antagonists - Point Therapeutics
`
`Alternative Names: PT-630
`
`Latest Information Update: 14 Feb 2008
`
`At a glance
`At a glance
`
`• Originator Tufts University
`• Developer DARA BioSciences
`• Class Pyrrolidines; Small molecules
`• Mechanism of Action CD26 antigen inhibitors
`
`• Orphan Drug Status
`
`Orphan designation is assigned by a regulatory body to encourage companies to develop
`drugs for rare diseases.
`
`No
`• On Fast track
`
`Fast track status is assigned by the US FDA so therapies with the potential to address
`unmet needs can move faster through development.
`
`No
`• New Molecular Entity Yes
`
`http://adisinsight.springer.com/drugs/800022168
`
`Page 8 of 16
`
`
`
`Highest Development Phases
`
`• Suspended Type 2 diabetes mellitus
`
`Most Recent Events
`
`• 12 Feb 2008 Point Therapeutics has been acquired and merged into DARA Biosciences
`• 10 Nov 2006 Suspended - Preclinical for Type-2 diabetes mellitus in USA (unspecified route)
`• 09 Mar 2006 Preclinical data from a media release have been added to the Diabetes
`pharmacodynamics section
`
`http://adisinsight.springer.com/drugs/800022168
`
`Page 9 of 16
`
`
`
`Drug Profile
`
`AMG 222
`
`Alternative Names: ALS 2-0426
`
`Latest Information Update: 02 Dec 2015
`At a glance
`At a glance
`
`• Originator Alantos Pharmaceuticals
`• Developer Amgen
`• Class Antihyperglycaemics; Small molecules
`• Mechanism of Action CD26 antigen inhibitors
`
`• Orphan Drug Status
`
`Orphan designation is assigned by a regulatory body to encourage companies to develop
`drugs for rare diseases.
`
`No
`• On Fast track
`
`Fast track status is assigned by the US FDA so therapies with the potential to address
`unmet needs can move faster through development.
`
`No
`• New Molecular Entity Yes
`
`Highest Development Phases
`
`• Discontinued Type 2 diabetes mellitus
`
`Most Recent Events
`
`• 17 Jul 2007 Alantos has been acquired by Amgen
`• 07 Jun 2007 Phase-II clinical trials in Type-2 diabetes mellitus in USA (PO)
`• 26 Oct 2006 ALS 20426 has been licensed to Servier worldwide (except for the US)
`
`http://adisinsight.springer.com/drugs/800022304
`
`Page 10 of 16
`
`
`
`Drug Profile
`
`PSN 9301
`
`Alternative Names: P 9301; P93/01; PSN9301
`
`Latest Information Update: 04 Jul 2011
`At a glance
`At a glance
`
`• Originator Probiodrug
`• Developer Prosidion
`• Class Antihyperglycaemics; Small molecules
`• Mechanism of Action CD26 antigen inhibitors
`
`• Orphan Drug Status
`
`Orphan designation is assigned by a regulatory body to encourage companies to develop
`drugs for rare diseases.
`
`No
`• On Fast track
`
`Fast track status is assigned by the US FDA so therapies with the potential to address
`unmet needs can move faster through development.
`
`No
`• New Molecular Entity Yes
`
`Highest Development Phases
`
`• Discontinued Type 2 diabetes mellitus
`
`Most Recent Events
`
`• 30 Nov 2007 Discontinued - Phase-II for Type-2 diabetes mellitus in Germany (PO)
`• 10 Sep 2007 Clinical data added to the drug interactions section
`• 18 Jan 2006 (OSI) Prosidion is the diabetes and obesity business unit of OSI Pharmaceuticals
`
`http://adisinsight.springer.com/drugs/800019065
`
`Page 11 of 16
`
`
`
`Drug Profile
`
`R 1438
`
`Latest Information Update: 19 Oct 2006
`At a glance
`At a glance
`
`• Originator Roche
`• Class Antihyperglycaemics
`• Mechanism of Action CD26 antigen inhibitors
`
`• Orphan Drug Status
`
`Orphan designation is assigned by a regulatory body to encourage companies to develop
`drugs for rare diseases.
`
`No
`• On Fast track
`
`Fast track status is assigned by the US FDA so therapies with the potential to address
`unmet needs can move faster through development.
`
`No
`• New Molecular Entity Yes
`
`Highest Development Phases
`
`• Discontinued Type 2 diabetes mellitus
`
`Most Recent Events
`
`• 19 Oct 2006 Discontinued - Phase-II for Type-2 diabetes mellitus in Europe (unspecified route)
`• 30 Jun 2005 Phase-II clinical trials in Type-2 diabetes mellitus in Europe (unspecified route)
`• 26 May 2003 Phase-I clinical trials in Type-2 diabetes mellitus in Europe (unspecified route)
`
`http://adisinsight.springer.com/drugs/800018193
`
`Page 12 of 16
`
`
`
`Drug Profile
`
`TA 6666
`
`Alternative Names: TA-6666
`
`Latest Information Update: 02 Dec 2015
`At a glance
`At a glance
`
`• Originator Tanabe Seiyaku
`• Developer Mitsubishi Tanabe Pharma Corporation
`• Class Antihyperglycaemics
`• Mechanism of Action CD26 antigen inhibitors
`
`• Orphan Drug Status
`
`Orphan designation is assigned by a regulatory body to encourage companies to develop
`drugs for rare diseases.
`
`No
`• On Fast track
`
`Fast track status is assigned by the US FDA so therapies with the potential to address
`unmet needs can move faster through development.
`
`No
`• New Molecular Entity Yes
`
`Highest Development Phases
`
`• Discontinued Type 2 diabetes mellitus
`
`Most Recent Events
`
`• 12 May 2010 Discontinued - Phase-I for Type-2 diabetes mellitus in Japan (PO)
`• 12 May 2010 Discontinued - Phase-II for Type-2 diabetes mellitus in USA (PO)
`• 01 Oct 2007 Mitsubishi Pharma Corporation has merged with Tanabe Seiyaku to form
`Mitsubishi Tanabe Pharma Corporation
`
`http://adisinsight.springer.com/drugs/800020875
`
`Page 13 of 16
`
`
`
`Drug Profile
`
`TS 021
`
`Alternative Names: TS-021
`
`Latest Information Update: 25 Jul 2007
`At a glance
`At a glance
`
`• Originator Taisho Pharmaceutical
`• Class Antihyperglycaemics
`• Mechanism of Action CD26 antigen inhibitors
`
`• Orphan Drug Status
`
`Orphan designation is assigned by a regulatory body to encourage companies to develop
`drugs for rare diseases.
`
`No
`• On Fast track
`
`Fast track status is assigned by the US FDA so therapies with the potential to address
`unmet needs can move faster through development.
`
`No
`• New Molecular Entity Yes
`
`Highest Development Phases
`
`• Discontinued Type 2 diabetes mellitus
`
`Most Recent Events
`
`• 15 May 2007 Discontinued - Phase-I for Type-2 diabetes mellitus in USA (PO)
`• 15 May 2007 Discontinued - Phase-I for Type-2 diabetes mellitus in Japan (PO)
`• 07 Aug 2006 Phase-I clinical trials in Type-2 diabetes mellitus in USA (PO)
`
`http://adisinsight.springer.com/drugs/800021798
`
`Page 14 of 16
`
`
`
`Drug Profile
`
`SSR 162329
`
`Latest Information Update: 18 Jul 2007
`At a glance
`At a glance
`
`• Originator sanofi-aventis
`• Class
`• Mechanism of Action CD26 antigen inhibitors
`
`• Orphan Drug Status
`
`Orphan designation is assigned by a regulatory body to encourage companies to develop
`drugs for rare diseases.
`
`No
`• On Fast track
`
`Fast track status is assigned by the US FDA so therapies with the potential to address
`unmet needs can move faster through development.
`
`No
`• New Molecular Entity Yes
`
`Highest Development Phases
`
`• Discontinued Type 2 diabetes mellitus
`
`Most Recent Events
`
`• 18 Jul 2007 Discontinued - Preclinical for Type-2 diabetes mellitus in France (unspecified route)
`• 26 Aug 2004 Aventis has merged with Sanofi-Synthelabo to form Sanofi-Aventis
`• 08 Sep 2003 Preclinical trials in Type-2 diabetes mellitus in France (unspecified route)
`
`http://adisinsight.springer.com/drugs/800019580
`
`Page 15 of 16
`
`
`
`Drug Profile
`
`SYR 619
`
`Alternative Names: SYR619
`
`Latest Information Update: 15 May 2007
`At a glance
`At a glance
`
`• Originator Takeda San Diego
`• Class Antihyperglycaemics
`• Mechanism of Action CD26 antigen inhibitors
`
`• Orphan Drug Status
`
`Orphan designation is assigned by a regulatory body to encourage companies to develop
`drugs for rare diseases.
`
`No
`• On Fast track
`
`Fast track status is assigned by the US FDA so therapies with the potential to address
`unmet needs can move faster through development.
`
`No
`• New Molecular Entity Yes
`
`Highest Development Phases
`
`• Discontinued Type 2 diabetes mellitus
`
`Most Recent Events
`
`• 11 May 2007 Discontinued - Preclinical for Type-2 diabetes mellitus in USA (unspecified route)
`• 25 Jul 2005 Takeda and PPD have entered into an agreement providing Takeda with the
`development and marketing rigths to all DPP IV inhibitors that were previouslly granted to PPD
`by Syrrx (now Takeda San Diego)
`• 01 Mar 2005 Syrrx has been acquired by Takeda and renamed Takeda San Diego
`
`http://adisinsight.springer.com/drugs/800021904
`
`Page 16 of 16
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