g‘eiUnited
`fiETherapeutics
`
`FDA Approves TWASO (Treprostinil) Inhalation Solution for the Treatment of Pulmonary
`Arterial Hypertension
`
`--Conference Call to be Held at 9:00 a.m. Eastern Time, July 31, 2009
`
`SILVER SPRING, Md., July 30, 2009 fPRNewswire—FirstCall via COMTEX News Network;" -- United Therapeutics Corporation
`(Nasdaq: UTHR) announced today that the United States Food and Drug Administration (FDA) has approved TYVASO
`(treprostinil) Inhalation Solution for the treatment of pulmonary arterial hypertension (PAH) using the TWASO Inhalation
`System (which includes the Optineb-ir device and accessories}. TYVASO is indicated to increase walk distance in patients with
`NYHA Class III symptoms associated with WHO Group I PAH, which includes multiple etiologies such as idiopathic and familial
`PAH as well as PAH associated with scleroderma and congenital heart disease.
`
`"We are thrilled to have a fourth approval from the FDA for treatment of this serious cardio-pulmonary condition," said Martine
`Rothblatt, Ph.D.. United Therapeutics‘ Chairman and Chief Executive Officer. "I want to specially recognize Drs. Werner Seeger
`of Germany and Lew Rubin of the United States for their critical pioneering efforts in making this new therapy possible.
`TWASO epitomizes the hopes and dreams we had in forming this company."
`
`In connection with the TYVASO approval. United Therapeutics has agreed to Post-Marketing Commitments (PMC) to modify
`certain aspects of the TYVASO Inhalation System, perform a usability analysis and collect pharmacokinetic data to verify
`expected dosing with the modified device. "We are well underway with the modifications to the TWASO Inhalation System," said
`Roger Jeffs, Ph.D., United Therapeutics' President and Chief Operating Officer. "And we think these modifications will make the
`device more patient-friendly. In the meantime, patients will use the current version of the device.” We have committed to
`complete the PMC no later than October 31, 2010.
`
`Additionally, United Therapeutics has agreed to a Post-Marketing Requirement (PMR) to conduct a long-term observational
`study to evaluate the risk of oropharyngeal and pulmonary toxicities among patients using TWASO. "We welcome the
`opportunity to gather further information on TYVASO's safety," continued Dr. Jeffs. We have committed to complete the PMR
`no later than December 15, 2013.
`
`In the TRIUMPH-1 randomized, double-blind, 12-week placebo-controlled clinical trial, patients taking TYVASO in four daily
`inhalation sessions achieved a 20-meter improvement in six-minute walk distance over those taking placebo (p<0.0005}. The
`safety and effectiveness in patients with underlying lung disease has not been established. The most common side effects (3-:
`10%) seen with TYVASO in the placebo controlled clinicat study were cough. headache. nausea. dizziness. flushing, throat
`irritation, pharyngolaryngeal pain and diarrhea.
`
`United Therapeutics plans to launch TYVASO in conjunction with its wholly-owned subsidiary, Lung Rx, Inc., in the United
`States at the beginning of September 2009.
`
`Conference Call
`
`United Therapeutics will host a half hour teleconference on July 31, 2009. at 9:00 am. Eastern Time. The teleconference is
`accessible by dialing LBW-85245576, with international caiiers dialing 1-719-325-4788. A rebroadcast of the teleconference
`will be available for one week and can be accessed by diaiing 1-888-203-1112. with international callers dialing 1419-45?-
`0820, and using conference code: 4416949.
`
`This teleconference is also being webcast and can be accessed via United Therapeutics' website at
`httpvgirunithercomgeventscfm.
`
`About TYVASO
`
`TWASO is an inhaled medicine used to treat PAH, a life-threatening disease that constricts the flow of blood through the
`pulmonary vasculature. TYVASO contains the same active ingredient (treprostinil) as REMODULIN (treprostinil sodium}
`Injection, which is also approved for the treatment of PAH. TYVASO is marketed by United Therapeutics and its wholly—owned
`subsidiary, Lung Rx, Inc.
`
`Nearly all clinical experience has been on a background of an endothelin receptor antagonist or a phosphodiesterase type 5
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`inhibitor.
`
`Important Safety Information for TYVASO
`
`TYVASO is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (WHO Group E) in patients
`with NYHA Class III symptoms, to increase walk distance. TYVASO is intended for oral inhalation only. TWASO is approved for
`use only with the TYVASO Inhalation System. The safety and efficacy of TWASO have not been established in patients with
`significant underlying lung disease (such as asthma or chronic obstructive pulmonary disease). Patients with acute pulmonary
`infections should be carefully monitored to detect any worsening of lung disease and any loss of drug effect. In patients with
`low systemic arterial pressure. TYVASO may cause symptomatic hypotension. TWASO may also increase the risk of bleeding.
`particularly in patients receiving anticoagulants. The concomitant use of TYVASO with diuretics, antihypertensives or other
`vasodilators may increase the risk of systemic hypotension. Hepatic or renal insufficiency may increase exposure and decrease
`the tolerability of TYVASO. The most common side effects (>= 10%) seen with TYVASO in the placebo controlled clinical study
`were cough. headache, nausea. dizziness, flushing. throat irritation. pharyngolaryngeal pain and diarrhea. Please see the
`TYVASO full prescribing information or patient information for further details.
`
`About United Therapeutics
`
`United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of unique
`products to address the unmet medical needs of patients with chronic and life-threatening cardiovascular and infectious
`diseases and cancer.
`
`Forward-looking Statements
`
`Statements included in this press release concerning. among others. the benefits of TYVASO for patients. our future activities
`to improve the TYVASO Inhalation System and its usability. our conducting a post-marketing usability analysis of the modified
`TYVASO Inhalation System device. the timing of completing the usability analysis. our conducting a post-marketing
`observational study of TYVASO. the timing of completing the observational study. and our plans to commercialize TYVASO in
`the United States are "forward-looking statements" within the meaning of the safe harbor contained in the Private Securities
`Litigation Reform Act of 1995. These fonivard-looking statements are qualified by the cautionary statements, cautionary
`language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission,
`including our most recent Annual Report on Form 10-K. Quarterly Reports on Form 10-0 and current reports on Form 8-K,
`which could cause actual results to differ materially from anticipated results. We are providing this information as of July 31,
`2009, and assume no obligation to update or revise the information contained in this press release whether as a result of new
`information, future events or any other reason. [uthr-g]
`
`REMODULIN is a registered trademark of United Therapeutics Corporation.
`
`TYVASO is a trademark of United Therapeutics Corporation.
`
`Optineb( )is a registered trademark of NEBU-TEC GmbH.
`
`SOURCE United Therapeutics Corporation
`
`http : //www. unither .Com
`
`Copyright (C) 2009 PR Newswire. All rights reserved
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