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Shire Plc - Product Pipeline Review - 2012

Description:
Shire Plc – Product Pipeline Review – 2012

Summary

Global Market Direct’s pharmaceuticals report, “Shire Plc - Product Pipeline Review - 2012” provides data on the Shire Plc’s research and development focus. The report includes information 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 Markets Direct’s proprietary databases, Shire Plc’s corporate website, SEC filings, investor presentations and featured press releases, both from Shire Plc and industry-specific third party sources, put together by Global Markets Direct’s team.

Scope

- 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.
- Overview 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.

Reasons to buy

- Evaluate Shire Plc’s strategic position with total access to detailed information on its product pipeline.
- Assess the growth potential of Shire Plc in its therapy areas of focus.
- Identify new drug targets and therapeutic classes in the Shire Plc’s R&D 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.

Keywords

Current R&D Portfolio of Shire Plc; Shire Plc - Key Therapeutics; Shire Plc - Pipeline Overview and Promising Molecules; Shire Plc - News; Shire Plc - Latest Updates; Shire Plc - Pipeline; Shire Plc - Discontinued/Dormant Projects
 
Contents:


List of Tables
List of Figures
Shire Plc Snapshot
Shire Plc Overview
Key Information
Key Facts
Shire Plc – Research and Development Overview
Key Therapeutic Areas
Shire Plc – Pipeline Review
Pipeline Products by Stage of Development
Pipeline Products – Monotherapy
Shire Plc – Pipeline Products Glance
Shire Plc – Late Stage Pipeline
Registration Filed Products/Combination Treatment Modalities
Phase III Products/Combination Treatment Modalities
Shire Plc Clinical Stage Pipeline Products
Phase II Products/Combination Treatment Modalities
Phase I Products/Combination Treatment Modalities
Shire Plc – Early Stage Pipeline Products
Pre-Clinical Products/Combination Treatment Modalities
Discovery Products/Combination Treatment Modalities
Shire Plc – Drug Profiles
Bradykinin B1 Receptor Antagonist
Product Description
Mechanism of Action
R&D Progress
Drug for Gastrointestinal & CNS
Product Description
Mechanism of Action
R&D Progress
Firazyr
Product Description
Mechanism of Action
R&D Progress
HGT 1110
Product Description
Mechanism of Action
R&D Progress
HGT 2310
Product Description
Mechanism of Action
R&D Progress
HGT-1410
Product Description
Mechanism of Action
R&D Progress
JSM 8757
Product Description
Mechanism of Action
R&D Progress
JSM-7717
Product Description
Mechanism of Action
R&D Progress
Lialda
Product Description
Mechanism of Action
R&D Progress
Library 1
Product Description
Mechanism of Action
R&D Progress
M0012
Product Description
Mechanism of Action
R&D Progress
M0014
Product Description
Mechanism of Action
R&D Progress
Resolor
Product Description
Mechanism of Action
R&D Progress
SPD 535
Product Description
Mechanism of Action
R&D Progress
SPD 557
Product Description
Mechanism of Action
R&D Progress
Vyvanse
Product Description
Mechanism of Action
R&D Progress
Xagrid
Product Description
Mechanism of Action
R&D Progress
Shire Plc – Pipeline Analysis
Shire Plc – Pipeline Products by Therapeutic Class
Shire Plc – Pipeline Products By Target
Shire Plc – Pipeline Products by Route of Administration
Shire Plc – Pipeline Products By Mechanism of Action
Shire Plc – Recent Pipeline Updates
Shire Plc - Dormant Projects
Shire Plc - Discontinued Pipeline Products
Discontinued Pipeline Product Profiles
NRP290
SPD 452
SPD 453
SPD756
Ampalex
HGT-2610
Metazym
SPD 427
SPD 493
SPD 556
SPD491
Shire Plc – Company Statement
Shire Plc – Locations And Subsidiaries
Head Office
Other Locations & Subsidiaries
Shire Plc - Key Manufacturing Facilities
Shire Plc, Recent Developments
Shire Plc- Press Release
May 23, 2012: Shire Presents Positive Phase III Results Of Lisdexamfetamine Dimesylate In Children And Adolescents With ADHD
May 09, 2012: Watson Pharma Confirms Lialda Patent Challenge
May 04, 2012: Shire To Present Scientific Data On Vyvanse At American Psychiatric Association Annual Meeting
Apr 26, 2012: Shire Reports Positive Top-Line Results From Phase II Study Of Vyvanse In Adults With Binge Eating Disorder
Mar 30, 2012: Shire Announces Top-line Results From Phase III Trial Of SPD476
Mar 14, 2012: Shire Provides Update On US Biologics License Application Filing For REPLAGAL
Mar 08, 2012: Shire Receives European Approval For FOSRENOL To Control Hyperphosphataemia In Chronic Renal Failure Patients
Mar 06, 2012: Shire To Initiate Two Phase IV Clinical Trials To Compare Vyvanse Capsules To Concerta Extended-Release Tablets
Feb 22, 2012: Shire Announces European Approval Of Manufacturing Facility For VPRIV
Feb 07, 2012: Shire Receives FDA Approval For Vyvanse In US For Maintenance Treatment In Adults With ADHD
Jan 05, 2012: Shire’s VENVANSE Receives Marketing Application Acceptance For Review In Europe
Dec 22, 2009: Shire Submits Biologics License Application (BLA) For Replagal With The USFDA
Dec 02, 2009: Shire and Teva Announces To Settle The Litigation Of Supply Of Authorized Generic Version Of ADDERALL XR
Nov 26, 2009: Shire Submits European Marketing Authorization Application (MAA) For Velaglucerase Alfa For The Treatment Of Type 1 Gaucher Disease
Nov 12, 2009: Shire Reports Findings From an Analysis Examining Emotional Lability in Children With ADHD Taking VYVANSE (lisdexamfetamine dimesylate) Capsules CII
Nov 11, 2009: Shire Re-Launches FOCUS, an Online, Personalized Patient Support Program for Adults with ADHD Taking Vyvanse (lisdexamfetamine dimesylate) Capsules CII
Nov 04, 2009: FDA Grants Priority Review For Shire’s Velaglucerase Alfa For Type 1 Gaucher Disease
Oct 28, 2009: Shire Secures European Wide Label Extension for Fosrenol in Chronic Kidney Disease
Oct 26, 2009: FDA Determines VYVANSE was Properly Granted Five-Year Market Exclusivity
Oct 07, 2009: Data from a head-to-head crossover study evaluating FOSRENOL and sevelamer published today
Sep 08, 2009: Shire Plc Updates On Velaglucerase Alfa
Sep 01, 2009: Shire Completes Submission Of NDA For Velaglucerase Alfa For Type 1 Gaucher Disease And Reports Positive Results For Remaining Two Phase iii Trials
Sep 01, 2009: Shire Completes Submission Of NDA For Velaglucerase Alfa For Type 1 Gaucher Disease And Reports Positive Results For Remaining Two Phase III Trials
Aug 03, 2009: Shire's New Gaucher Drug Moves Closer To Market, Following Positive Phase III Trial Results
Jul 27, 2009: Movetis receives positive opinion by the CHMP on European Marketing Authorisation Application for Resolor (prucalopride) for the treatment of Chronic Constipation
Jul 22, 2009: Study Published in Child and Adolescent Psychiatry and Mental Health Demonstrated Once-Daily Vyvanse (lisdexamfetamine dimesylate) CII Provided Significant Improvement of ADHD Symptoms for Children at 13 Hours After Administration
Jul 16, 2009: Shire Receives Fast Track Designation for velaglucerase alfa for Gaucher Disease
Jul 06, 2009: Shire Files A Treatment Protocol For Velaglucerase Alfa For Gaucher Disease
Jul 01, 2009: FDA Approves Labeling Change for VYVANSE (lisdexamfetamine dimesylate) CII to Include Supplementary Clinical Data Supporting Efficacy at 13 Hours Postdose in Children Aged 6 to 12 with ADHD
Jul 01, 2009: Study Showed VYVANSE (lisdexamfetamine dimesylate) CII Provided Significant Efficacy at 14 Hours After Administration in Adults with ADHD in an Adult Simulated Workplace Environment
May 22, 2009: New Study Evaluating the ADHD Medication VYVANSE (lisdexamfetamine dimesylate) CII Demonstrated No Change in the Pharmacokinetic Profile of VYVANSE When Coadministered with Prilosec OTC 40 mg (20 mg X 2), a Commonly Used Proton Pump Inhibitor (PPI)
Apr 02, 2009: Shire files lawsuit against Natco Pharma for infringement of FOSRENOL (lanthanum carbonate) patents
Mar 31, 2009: Shire and GlaxoSmithKline enter agreement to co-promote VYVANSE (lisdexamfetamine dimesylate) CII for the treatment of adults with ADHD
Mar 20, 2009: Shire files lawsuit against Mylan for infringement of FOSRENOL (lanthanum carbonate) patent
Mar 16, 2009: Shire files lawsuit against Barr Laboratories for infringement of FOSRENOL (lanthanum carbonate) patents
Mar 11, 2009: Shire Launches Fosrenol in Japan
Mar 09, 2009: SHIRE PLC - Shire declared FDA Approval of Once-Daily INTUNIV
Feb 09, 2009: Shire Receives FOSRENOL Paragraph IV Notice Letters from Barr Laboratories and Mylan
Financial Deals Landscape
Shire Plc, Deals Summary
Shire Plc, Pharmaceuticals & Healthcare, Deal Details
Asset Transactions
Shire Acquires US Rights Of Resolor From Janssen Pharmaceutica
Shire Acquires Worldwide Rights To EQUASYM IR And XL From UCB
Shire Acquires METAZYM From Zymenex
Advanced BioHealing Acquires Dermagraft And TransCyte From Smith & Nephew
Venture Financing
AM-Pharma Secures $39.7 Million In Series D Financing
Prexa Pharma Secures An Additional $3.7 Million In Series B Venture Financing
Naurex Secures $18 Million In Series A Financing Round
DBV Technologies Secures $25.5 Million In Series C Venture Financing Round
Advanced BioHealing Secures Additional $4.5 Million In Series C Round Of Financing
Movetis Secures $63.74 Million In Series A Financing
Advanced Biohealing Secures $8 Million In Series B Funding
Advanced Biohealing Secures $2.4 Million In Series A Funding
Partnerships
arGEN-X Enters Into Co-Development Agreement With Shire For Therapeutic Antibody
Prasco Labs Enters Into Co-Marketing Agreement With Shire For Carbatrol
Shire Enters Into Co-Development Agreement With Shionogi
Prasco Labs Enters Into Distribution Agreement With Shire US Manufacturing
ID Business Solutions Enters Into Research Agreement With Shire
Quintiles Enters Into Co-Marketing Agreement With Movetis
Shire Enters Into Research Agreement With Santaris Pharma
Shire Enters Into Co-Promotion Agreement With GlaxoSmithKline
Movetis Enters Into Co-Development Agreement With Silicos
EpiTan Enters Into Licensing Agreement With Shire
Shire Pharma Enters Into Licensing Agreement With Transkaryotic Therapies
Shire Enters Into Licensing Agreement With Avexa
Shire Enters Into Licensing Agreement With AnorMED
Structural Genomix Enters Into Licensing Agreement With Shire BioChem
Shire Enters Into Licensing Agreement With AnorMED For FOSRENOL
AnorMED Enters Into Licensing Agreement With Shire Pharma
Equity Offering
Movetis Completes IPO For $127 Million
Avexa Completes Private Placement Of $5 Million
Avexa Completes Private Placement Of $3 Million
Shire Completes Private Placement Of $878 Million
Avexa Completes Private Placement Of $9.05 Million
Debt Offering
Shire Completes Private Placement Of 2.75% Convertible Bonds For $1,100 Million
Asset Transactions
Noven Pharma Completes Acquisition Of Global Rights To Daytrana From Shire
Laboratorios Almirall Acquires Portfolio Of Eight Products From Shire
Validus Pharma Acquires Bipolar Drug From Shire plc
Paladin Acquires Products From Shire
Shire Completes Sale Of Vaccines Business To ID Biomedical
Neurochem Acquires Facility From Shire BioChem
D-Pharm Reacquires Rights To DP-VPA From Shire
Acquisition
Shire To Acquire Pervasis Therapeutics, Developer Of Endothelial Cell-Based Therapies
Shire To Acquire FerroKin BioSciences For Up To $325 Million
Shire Completes Acquisition Of Advanced BioHealing
Shire Acquires 100% Stake In Movetis
Vertex Pharma Acquires ViroChem Pharma
Shire Acquires BioPharma Company Jerini For $557 Million
Shire Acquires New River Pharma
Supernus Pharma Acquires Shire Labs
Shire Acquires Transkaryotic Therapies
Appendix
Methodology
Coverage
Secondary Research
Primary Research
Expert Panel Validation
Contact Us
Disclaimer

List of Tables
Shire Plc, Key Information
Shire Plc, Key Facts
Shire Plc – Pipeline by Indication, 2012
Shire Plc – Pipeline by Stage of Development, 2012
Shire Plc – Monotherapy Products in Pipeline, 2012
Shire Plc – Filed, 2012
Shire Plc – Phase III, 2012
Shire Plc – Phase II, 2012
Shire Plc – Phase I, 2012
Shire Plc – Pre-Clinical, 2012
Shire Plc – Discovery, 2012
Shire Plc – Pipeline By Therapeutic Class, 2012
Shire Plc - Pipeline By Target, 2012
Shire Plc – Pipeline By Route of Administration, 2012
Shire Plc – Pipeline Products By Mechanism of Action, 2012
Shire Plc – Recent Pipeline Updates, 2012
Shire Plc - Dormant Developmental Projects,2012
Shire Plc - Discontinued Pipeline Products, 2012
Shire Plc, Subsidiaries
Shire Plc, Key Manufacturing Facilities
Shire Plc, Deals Summary
Shire Acquires US Rights Of Resolor From Janssen Pharmaceutica
Shire Acquires Worldwide Rights To EQUASYM IR And XL From UCB
Shire Acquires METAZYM From Zymenex
Advanced BioHealing Acquires Dermagraft And TransCyte From Smith & Nephew
AM-Pharma Secures $39.7 Million In Series D Financing
Prexa Pharma Secures An Additional $3.7 Million In Series B Venture Financing
Naurex Secures $18 Million In Series A Financing Round
DBV Technologies Secures $25.5 Million In Series C Venture Financing Round
Advanced BioHealing Secures Additional $4.5 Million In Series C Round Of Financing
Movetis Secures $63.74 Million In Series A Financing
Advanced Biohealing Secures $8 Million In Series B Funding
Advanced Biohealing Secures $2.4 Million In Series A Funding
arGEN-X Enters Into Co-Development Agreement With Shire For Therapeutic Antibody
Prasco Labs Enters Into Co-Marketing Agreement With Shire For Carbatrol
Shire Enters Into Co-Development Agreement With Shionogi
Prasco Labs Enters Into Distribution Agreement With Shire US Manufacturing
ID Business Solutions Enters Into Research Agreement With Shire
Quintiles Enters Into Co-Marketing Agreement With Movetis
Shire Enters Into Research Agreement With Santaris Pharma
Shire Enters Into Co-Promotion Agreement With GlaxoSmithKline
Movetis Enters Into Co-Development Agreement With Silicos
Advanced BioHealing Enters Into An Agreement With Regenesis Biomedical
Shire Enters Into Co-Promotion Agreement With TAP Pharma Products
Paladin Labs Expands Distribution Agreement With Shire HGT
Samaritan Pharma Signs An Agreement With Shire Human Genetic
Samaritan Pharma Enters Into Marketing Agreement With Shire
Shire Enters Into Co-Promotion Agreement With Abbott Labs
New River Pharma Enters Into Co-Promotion Agreement With Shire Pharma
IMPAX Labs Enters Into Co-Marketing Agreement With Shire For Adderall XR
Impax Labs Enters Into Co-Promotion Agreement With Shire For Carbatrol
Barrier Therapeutics Enters Into Agreement With Shire Pharma
Shire Pharma Group Signs An Agreement With New River Pharma
Noven Pharma Enters Into Agreement With Shire
Shire Enters Into An Agreement With Janssen Pharmaceutica
QRxPharma Enters Into Co-Development Agreement With Shire Labs
Shire Enters Into Licensing Agreement With Merck Serono
Shire Exercises Option To License Adenosine A2A From Heptares Therapeutics
Shire Enters Into Licensing Agreement With Sangamo BioSciences For ZFP Therapeutics
RaQualia Pharma Enters Into Licensing Agreement With Shire
Shire Enters Into Licensing Agreement With Acceleron Pharma For ACE-031
Renovo Amends Licensing Agreement With Shire
Shire Enters Into License Agreement With Sandoz
Shire Amends Its Agreement With Duramed Pharma
Mochida Pharma Enters Into An Agreement With Shire Pharma
Avexa Amends Licensing Agreement With Shire
Shire Enters Into Licensing Agreement With Alba Therapeutics
Shire Enters Into Licensing Agreement With Amicus Therapeutics
Noven Pharma Enters Into Licenisng Agreement With Shire
Shire Enters Into Licensing Agreement With Renovo Group
Avexa Amends Licensing Agreement With Shire For Apricitabine
Shire Enters In An Agreement With Warren Pharma
Shire Enters Into Agreement With Duramed Pharma
Shire Enters Into Licensing Agreement With Yissum Research
Cellectis Enters Into Licensing Agreement With Shire Pharma
EpiTan Enters Into Licensing Agreement With Shire
Shire Pharma Enters Into Licensing Agreement With Transkaryotic Therapies
Shire Enters Into Licensing Agreement With Avexa
Shire Enters Into Licensing Agreement With AnorMED
Structural Genomix Enters Into Licensing Agreement With Shire BioChem
Shire Enters Into Licensing Agreement With AnorMED For FOSRENOL
AnorMED Enters Into Licensing Agreement With Shire Pharma
Movetis Completes IPO For $127 Million
Avexa Completes Private Placement Of $5 Million
Avexa Completes Private Placement Of $3 Million
Shire Completes Private Placement Of $878 Million
Avexa Completes Private Placement Of $9.05 Million
Shire Completes Private Placement Of 2.75% Convertible Bonds For $1,100 Million
Noven Pharma Completes Acquisition Of Global Rights To Daytrana From Shire
Laboratorios Almirall Acquires Portfolio Of Eight Products From Shire
Validus Pharma Acquires Bipolar Drug From Shire plc
Paladin Acquires Products From Shire
Shire Completes Sale Of Vaccines Business To ID Biomedical
Neurochem Acquires Facility From Shire BioChem
D-Pharm Reacquires Rights To DP-VPA From Shire
Shire To Acquire Pervasis Therapeutics, Developer Of Endothelial Cell-Based Therapies
Shire To Acquire FerroKin BioSciences For Up To $325 Million
Shire Completes Acquisition Of Advanced BioHealing
Shire Acquires 100% Stake In Movetis
Vertex Pharma Acquires ViroChem Pharma
Shire Acquires BioPharma Company Jerini For $557 Million
Shire Acquires New River Pharma
Supernus Pharma Acquires Shire Labs
Shire Acquires Transkaryotic Therapies

List of Figures
Shire Plc – Pipeline by Indication, 2012
Shire Plc – Pipeline by Stage of Development, 2012
Shire Plc – Monotherapy Products in Pipeline, 2012
Shire Plc – Pipeline By Therapeutic Class, 2012
Shire Plc - Pipeline By Target, 2012
Shire Plc – Pipeline By Route of Administration, 2012
Shire Plc - Pipeline Products By Mechanism of Action, 2012
 
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