This analysis evaluates the company’s strategy and key strengths, weaknesses, opportunities and threats, and provides an overview of the company’s historical and forecast financial performance. The report also gives an in-depth analysis of the company’s key prescription pharmaceutical product, and provides a forecast sales performance for this drug.
Features and benefits
* Analysis of United Therapeutics full PAH franchise and how it will compete with other PAH agents from Actelion, GSK, Gilead, Novartis, and Pfizer
* Discussion of the company's strategy, commercial relationships, and forthcoming catalysts
Highlights
United Therapeutics is developing an oral version of treprostinil which is currently before the FDA with a Prescription Drug User Fee Act date of October 27, 2012.
Oral treprostinil met its primary endpoint in a Phase III monotherapy trial, but failed two Phase III combination therapy studies. With disappointing efficacy data and gastrointestinal tolerability issues, Datamonitor believes that approval by the PDUFA is far from certain.
Your key questions answered
* Assess the overall pulmonary arterial hypertension market and how United Therapeutics' drugs fit into the treatment paradigm
* Analyze how the performance of Remodulin, Tyvaso, and Adcirca will shape United Therapeutics' growth prospects
* Understand the risks to approval facing oral treprostinil
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Table Of contents
ABOUT THIS REPORT
PharmaVitae Explorer database
Chapter structure
Sales and product analysis
Financial analysis
Data sourcing
Analyst consensus
Primary research
EXECUTIVE SUMMARY
Company introduction
Recent developments
Corporate relationships
Strategic overview
SWOT analysis
Strengths
Weaknesses
Opportunities
Threats
SALES AND PRODUCT ANALYSIS
Sales overview
Product analysis
Product sales
Pulmonary arterial hypertension background
Remodulin (treprostinil)
Factors affecting the use of Remodulin
Approval of IV formulation in Europe could increase growth slightly
Approval in Japan and China expected
United Therapeutics and Medtronic are developing an implantable infusion pump
Imatinib unlikely to affect the use of existing PAH drugs
Tyvaso (inhaled treprostinil)
Factors affecting the use of Tyvaso
Adcirca (tadalafil)
Factors affecting the use of Adcirca
Oral treprostinil
Oral treprostinil clinical trials
FREEDOM-M trial
FREEDOM-C2 trial
FREEDOM-EV (FREEDOM-C3) trial
Factors affecting the approval of oral treprostinil
Factors affecting the use of oral treprostinil
Oral selexipag could provide competition in 2015
Beraprost-MR
Other non-PAH and early-stage drugs in development
8H9 MAb
IW001
Glycobiology antiviral agents
PLX Cells
Pulmonary tissue replacement and remodeling
FINANCIAL ANALYSIS
Financial performance overview
Operating costs and profit analysis, 2005–11
Operating costs and profit analysis, 2011–17
APPENDIX
Primary research
References
Exchange rates
List Of Tables
Table: United Therapeutics pipeline
Table: United Therapeutics product portfolio overview (sales $m), 2011–17
Table: Overview of currently available treatments for PAH
Table: IV/SC Remodulin sales forecast ($m), 2011–17
Table: Tyvaso sales forecast ($m), 2011–17
Table: Adcirca sales forecast ($m), 2011–17
Table: United Therapeutics operating revenue/cost analysis ($m), 2005–11
Table: United Therapeutics operating revenue/cost analysis ($m), 2011–17
Table: Exchange rates, 2012
List Of Figures
Figure: PharmaVitae Explorer
Figure: United Therapeutics prescription pharmaceutical performance, sales ($m) and growth rate (%), 2011–17
Figure: United Therapeutics product sales ($m), 2011–17
Figure: United Therapeutics operating/cost performance ($m), 2005–17
