Pathology Industry: Shire Plc – Product Pipeline Review – H2 2011

• Publication date: April 2013
• Report size: 253 pages

The report includes data on current developmental pipeline, complete with latest updates, and features on discontinued and dormant projects. This report is built using data and information sourced from Global Industries Direct’s proprietary databases, Shire Plc’s corporate website, SEC filings, investor presentations and featured press releases, both from Shire Plc and market -specific third party sources, put together by Global Indus...

The report includes data on current developmental pipeline, complete with latest updates, and features on discontinued and dormant projects.

This report is built using data and information sourced from Global Industries Direct’s proprietary databases, Shire Plc’s corporate website, SEC filings, investor presentations and featured press releases, both from Shire Plc and market -specific third party sources, put together by Global Industries Direct’s team.

Scope of the Research

- Shire Plc - Brief Shire Plc overview including business description, key information and facts, and its locations and subsidiaries.
- Review of current pipeline of Shire Plc human therapeutic division.
- Detailed Analysis of pipeline therapeutics across various therapy areas.
- Coverage of current pipeline molecules in various stages of drug development, including the combination treatment modalities, across the globe.
- Product profiles for late stage and clinical stage products of Shire Plc with complete description of the product’s developmental history, mechanism of action, therapeutic class, target and major milestones.
- Recent updates of the Shire Plc’s pipeline in the last quarter.
- Key discontinued and dormant projects.
- Latest news and deals relating to the products.

Why Should You Get This Report?

- Evaluate Shire Plc’s strategic position with total access to detailed data on its product pipeline.
- Assess the growth opportunities of Shire Plc in its therapy areas of focus.
- Identify new drug targets and therapeutic classes in the Shire Plc’s Research and Development portfolio and develop key strategic initiatives to reinforce pipeline in those areas.
- Exploit in-licensing opportunities by identifying windows of opportunity to fill portfolio gaps.
- Exploit collaboration and partnership opportunities with Shire Plc.
- Avoid Intellectual Property Rights related issues.
- Explore the dormant and discontinued projects of Shire Plc and identify potential opportunities in those areas.

Global Electronic Component And Semiconductor Industry

Table of Contents
Data table of Contents 2
List of Tables 10
List of Figures 13
Shire Plc Snapshot 14
Shire Plc Overview 14
Key Information 14
Key Facts 14
Shire Plc – Research and Development Overview 15
Key Therapeutic Areas 15
Shire Plc – Pipeline Review 19
Pipeline Products by Stage of Development 19
Shire Plc – Pipeline Products Glance 20
Shire Plc – Pipeline Products Glance 20
Shire Plc – Late Stage Pipeline 20
Phase III Products/Combination Treatment Modalities 20
Shire Plc Clinical Stage Pipeline Products 21
Phase II Products/Combination Treatment Modalities 21
Phase I Products/Combination Treatment Modalities 22
Shire Plc–Early Stage Pipeline Products 23
Pre-Clinical Products/Combination Treatment Modalities 23
Discovery Products/Combination Treatment Modalities 24
Shire Plc – Drug Profiles 25
ACE-031 25
Product Description 25
Mechanism of Action 25
Bradykinin B1 Receptor Antagonist 26
Product Description 26
Mechanism of Action 26
R&D Progress 26
Drug for Gastrointestinal & CNS 27
Product Description 27
Mechanism of Action 27
R&D Progress 27
HGT 1110 28
Product Description 28
Mechanism of Action 28
R&D Progress 28
HGT 2310 29
Product Description 29
Mechanism of Action 29
R&D Progress 29
HGT-1410 31
Product Description 31
Mechanism of Action 31
R&D Progress 31
HGT-2610 32
Product Description 32
Mechanism of Action 32
R&D Progress 32
Intuniv + Amphetamine 33
Product Description 33
Mechanism of Action 33
R&D Progress 33
Intuniv + Daytrana 35
Product Description 35
Mechanism of Action 35
R&D Progress 35
JPE 1375 37
Product Description 37
Mechanism of Action 37
R&D Progress 37
JSM 10292 38
Product Description 38
Mechanism of Action 38
R&D Progress 38
JSM 8757 39
Product Description 39
Mechanism of Action 39
R&D Progress 39
JSM-7717 40
Product Description 40
Mechanism of Action 40
R&D Progress 40
Juvista 41
Product Description 41
Mechanism of Action 41
R&D Progress 41
Lialda 42
Product Description 42
Mechanism of Action 42
R&D Progress 42
Library 1 43
Product Description 43
Mechanism of Action 43
R&D Progress 43
M0004 44
Product Description 44
Mechanism of Action 44
R&D Progress 44
M0012 45
Product Description 45
Mechanism of Action 45
R&D Progress 45
M0014 46
Product Description 46
Mechanism of Action 46
R&D Progress 46
Resolor 47
Product Description 47
Mechanism of Action 47
R&D Progress 47
SPD 535 49
Product Description 49
Mechanism of Action 49
R&D Progress 49
SPD 556 50
Product Description 50
Mechanism of Action 50
R&D Progress 50
SPD 557 51
Product Description 51
Mechanism of Action 51
R&D Progress 51
Vyvanse 52
Product Description 52
Mechanism of Action 52
R&D Progress 52
Shire Plc – Pipeline Analysis 53
Shire Plc – Pipeline Products by Therapeutic Class 53
Shire Plc - Pipeline Products By Target 55
Shire Plc – Pipeline Products by Route of Administration 57
Shire Plc – Pipeline Products by Molecule Type 58
Shire Plc – Recent Pipeline Updates 59
Shire Plc - Dormant Projects 63
Shire Plc - Discontinued Pipeline Products 65
Discontinued Pipeline Product Profiles 65
NRP290 65
SPD 452 65
SPD 453 66
SPD756 66
Ampalex 66
Firazyr 66
Metazym 67
SPD 427 67
SPD 493 67
SPD491 67
Shire Plc – Firms Statement 68
Shire Plc – Operations and Subsidiaries 70
Head Office 70
Other Locations & Subsidiaries 70
Shire Plc - Key Manufacturing Facilities 72
Recent Developments 73
April 28, 2011: Shire Reports Positive Results From Signal Finding Study Of Investigative Use Of Vyvanse Capsules As Adjunctive Treatment In Predominant Negative Symptom Schizophrenia 79
February 28, 2011: Shire Files Complete Response To FDA’s Not Approvable Letter For FIRAZYR For Treatment Of Acute Attacks Of Hereditary Angioedema 81
February 28, 2011: Shire Receives FDA Approval For INTUNIV Extended-Release Tablets For Treating ADHD In Children And Adolescents 82
August 25, 2011: Shire Receives FDA March keting Approval For FIRAZYR For Acute Attacks Of Hereditary Angioedema 89
May 25, 2011: Shire Receives VYVANSE Paragraph IV Notice Letters 91
June 24, 2011: European Authorities Approve New Manufacturing Facility For Shire’s REPLAGAL 95
February 24, 2011: Shire Receives New Paragraph IV Notice Letter From Watson For ADDERALL XR 97
October 23, 2011: New Study Demonstrates Similar Remission Results Between Once-Daily 4g Dose And Twice-Daily 2g Doses Of Mesalazine In Active Ulcerative Colitis 98
June 23, 2011: FDA Panel Recommends Approval And Self-Administration Of FIRAZYR For Treatment Of Acute Attacks Of Hereditary Angioedema 99
March 22, 2011: Shire Announces Positive New Data From FAST-3 Study Of FIRAZYR 102
March 21, 2011: FDA Assigns PDUFA Date For Shire’s FIRAZYR In Acute Attacks Of Hereditary Angioedema 108
March 21, 2011: Shire Presents Data For Replagal In Fabry Disease At 2011 ACMG Annual Meeting 109
March 21, 2011: Shire Presents Data For VPRIV In Gaucher Disease At 2011 ACMG Annual Meeting 109
May 19, 2011: Shire Receives VYVANSE Paragraph IV Notice Letter 112
July 18, 2011: Shire Announces Lialda Approval In US For Maintenance Of Remission Of Ulcerative Colitis 116
September 12, 2011: BioRx Expands Therapy Offering To Patients With Hereditary Angioedema 127
January 10, 2011: Shire Reports Positive Study Results Of Vyvanse In Excessive Daytime Sleepiness Model 130
June 07, 2011: Health Canada Grants MEZAVANT New Expanded Indication For Maintenance Of Remission Of Ulcerative Colitis 138
February 02, 2011: Shire Receives Health Canada Approval For Vyvanse For Treatment Of ADHD In Adolescents And Adults 154
Financial Deals Landscape 162
Shire Plc, Merger and Acquisition Deal Summary 162
Shire Plc, Pharmaceuticals & Healthcare, Merger and Acquisition Deal Details 167
Asset Transactions 167
Shire Takes Over Worldwide Rights To EQUASYM IR And XL From UCB 167
Shire Takes Over METAZYM From Zymenex 169
Advanced BioHealing Takes Over Dermagraft And TransCyte From Smith & Nephew 170
Venture Financing 172
AM-Pharma Secures US$ 39.7 Mln In Series D Financing 172
Prexa Pharmaceuticals Secures An Additional US$ 3.7 Mln In Series B Venture Financing 175
Naurex Secures US$ 18 Mln In Series A Financing Round 176
DBV Technologies Secures US$ 25.5 Mln In Series C Venture Financing Round 178
Advanced BioHealing Secures Additional US$ 4.5 Mln In Series C Round Of Financing 180
Advanced Biohealing Secures US$ 8 Mln In Series B Funding 182
Advanced Biohealing Secures US$ 2.4 Mln In Series A Funding 183
Partnerships 184
Prasco Laboratories Enters Into Distribution Agreement With Shire US Manufacturing 184
ID Business Solutions Enters Into Research Agreement With Shire 185
Shire Enters Into Research Agreement With Santaris Pharma 186
Shire Completes Acquisition Of Advanced BioHealing 253
Shire Takes Over 100% Stake In Movetis 256
Vertex Pharmaceuticals Takes Over ViroChem Pharma 259
Shire Takes Over 98.6% Interest In Jerini 261
Shire Takes Over New River Pharmaceuticals 263
Supernus Pharmaceuticals Takes Over Shire Laboratories 265
Shire Takes Over Transkaryotic Therapies 267
Appendix 269
Methodology 269
Coverage 269
Secondary Research 269
Primary Research 269
Expert Panel Validation 270
Contact Us 270
Disclaimer 270

List of Tables

Shire Plc – Pipeline by Therapy Area and Indication, H2 2011 17
Shire Plc – Pipeline by Stage of Development, H2 2011 19
Shire Plc – Phase III, H2 2011 20
Shire Plc - Phase II, H2 2011 21
Shire Plc - Phase I, H2 2011 22
Shire Plc - Pipeline By Therapeutic Class, H2 2011 54
Shire Plc - Pipeline By Target, H2 2011 56
Shire Plc – Pipeline By Route of Administration, H2 2011 57
Shire Plc – Pipeline By Molecule Type, H2 2011 58
Shire Plc – Recent Pipeline Updates, H2 2011 59
Shire Plc - Dormant Developmental Projects, 2010 63
Shire Plc - Discontinued Pipeline Products, 2010 65
Shire Plc, Subsidiaries 70
Shire Plc, Key Manufacturing Facilities 72
Shire Plc, Merger and Acquisition Deal Summary 162
Shire Takes Over Worldwide Rights To EQUASYM IR And XL From UCB 167
Shire Takes Over METAZYM From Zymenex 169
Advanced BioHealing Takes Over Dermagraft And TransCyte From Smith & Nephew 170
AM-Pharma Secures US$ 39.7 Mln In Series D Financing 172
Prexa Pharmaceuticals Secures An Additional US$ 3.7 Mln In Series B Venture Financing 175
Naurex Secures US$ 18 Mln In Series A Financing Round 176
DBV Technologies Secures US$ 25.5 Mln In Series C Venture Financing Round 178
Advanced BioHealing Secures Additional US$ 4.5 Mln In Series C Round Of Financing 180
Advanced Biohealing Secures US$ 8 Mln In Series B Funding 182
Advanced Biohealing Secures US$ 2.4 Mln In Series A Funding 183
Prasco Laboratories Enters Into Distribution Agreement With Shire US Manufacturing 184
ID Business Solutions Enters Into Research Agreement With Shire 185
Shire Enters Into Research Agreement With Santaris Pharma 186
Shire Enters Into Co-Promotion Agreement With GlaxoSmithKline 188
Advanced BioHealing Concludes a New Deal With Regenesis Biomedical 189
Shire Enters Into Co-Promotion Agreement With TAP Pharmaceutical Products 190
Paladin Labs Expands Distribution Agreement With Shire HGT 191
Samaritan Pharmaceuticals Concludes a new deal With Shire Human Genetic 192
Samaritan Pharmaceuticals Enters Into March keting Agreement With Shire 193
Shire Enters Into Co-Promotion Agreement With Abbott Laboratories 194
New River Pharmaceuticals Enters Into Co-Promotion Agreement With Shire Pharmaceuticals 195
IMPAX Laboratories Enters Into Co-March keting Agreement With Shire For Adderall XR 196
Impax Laboratories Enters Into Co-Promotion Agreement With Shire For Carbatrol 197
Barrier Therapeutics Enters Into Agreement With Shire Pharmaceutical 198
Shire Pharmaceuticals Group Concludes a new deal With New River Pharmaceuticals 199
November en Pharmaceuticals Enters Into Agreement With Shire 201
Shire Concludes a New Deal With January ssen Pharmaceutica 202
QRxPharma Enters Into Co-Development Agreement With Shire Laboratories 203
Shire Enters Into Licensing Agreement With Merck Serono 204
Heptares Therapeutics Enters Into Option Licensing Agreement With Shire For Adenosine A2A 205
RaQualia Pharma Enters Into Licensing Agreement With Shire 206
Shire Enters Into Licensing Agreement With Acceleron Pharma For ACE-031 207
Renovo Amends Licensing Agreement With Shire 209
Shire Enters Into License Agreement With Sandoz 210
Shire Amends Its Agreement With Duramed Pharmaceuticals 211
Mochida Pharmaceutical Concludes a New Deal With Shire Pharmaceuticals 212
Avexa Amends Licensing Agreement With Shire 213
Shire Enters Into Licensing Agreement With Alba Therapeutics 214
Shire Enters Into Licensing Agreement With Amicus Therapeutics 215
November en Pharmaceuticals Enters Into Licenisng Agreement With Shire 217
Shire Enters Into Licensing Agreement With Renovo Group 218
Avexa Amends Licensing Agreement With Shire For April icitabine 219
Shire Enters In An Agreement With Warren Pharmaceuticals 220
Shire Enters Into Agreement With Duramed Pharmaceuticals 221
Shire Enters Into Licensing Agreement With Yissum Research 222
Cellectis Enters Into Licensing Agreement With Shire Pharmaceuticals 223
EpiTan Enters Into Licensing Agreement With Shire 224
Shire Pharmaceuticals Enters Into Licensing Agreement With Transkaryotic Therapies 225
Shire Enters Into Licensing Agreement With Avexa 226
Shire Enters Into Licensing Agreement With AnorMED 227
Structural Genomix Enters Into Licensing Agreement With Shire BioChem 228
Shire Enters Into Licensing Agreement With AnorMED For FOSRENOL 229
Maxim Pharmaceuticals Terminates License Agreement With Shire Biochem 230
AnorMED Enters Into Licensing Agreement With Shire Pharmaceuticals 231
Avexa Completes Private Placement Of US$ 5 Mln 232
Avexa Completes Private Placement Of US$ 3 Mln 234
Shire Completes Private Placement Of US$ 878 Mln 236
Avexa Completes Private Placement Of US$ 9.05 Mln 238
Shire Completes Private Placement Of 2.75% Convertible Bonds For US$ 1,100 Mln 240
November en Pharmaceuticals Completes Acquisition Of World Rights To Daytrana From Shire 241
Laboratorios Almirall Takes Over Portfolio Of Eight Products From Shire 243
Validus Pharmaceuticals Takes Over Bipolar Drug From Shire plc 245
Paladin Takes Over Products From Shire 246
Shire Completes Sale Of Vaccines Business To ID Biomedical 248
Neurochem Takes Over Facility From Shire BioChem 250
D-Pharm Reacquires Rights To DP-VPA From Shire 251
Shire Completes Acquisition Of Advanced BioHealing 253
Shire Takes Over 100% Stake In Movetis 256
Vertex Pharmaceuticals Takes Over ViroChem Pharma 259
Shire Takes Over 98.6% Interest In Jerini 261
Shire Takes Over New River Pharmaceuticals 263
Supernus Pharmaceuticals Takes Over Shire Laboratories 265
Shire Takes Over Transkaryotic Therapies 267

List of Figures

Shire Plc – Pipeline by Therapy Area and Indication, H2 2011 17
Shire Plc – Pipeline by Stage of Development, H2 2011 19
Shire Plc – Pipeline By Therapeutic Class, H2 2011 53
Shire Plc - Pipeline By Target, H2 2011 55
Shire Plc – Pipeline By Route of Administration, H2 2011 57
Shire Plc – Pipeline By Molecule Type, H2 2011 58