FDA Approves TYVASO (Treprostinil) Inhalation Solution for the Treatment of Pulmonary...

FDA Approves TYVASO (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 /PRNewswire-FirstCall/ -- 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
TYVASO 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. TYVASO
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 TYVASO 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 TYVASO. "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 (>= 10%) seen
with TYVASO in the placebo controlled clinical 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 a.m. Eastern Time. The teleconference is accessible by dialing
1-877-852-6576, with international callers dialing 1-719-325-4788. A
rebroadcast of the teleconference will be available for one week and can be
accessed by dialing 1-888-203-1112, with international callers dialing
1-719-457-0820, and using conference code: 4416949.

This teleconference is also being webcast and can be accessed via United
Therapeutics' website at http://ir.unither.com/events.cfm.

About TYVASO
TYVASO 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 inhibitor.

Important Safety Information for TYVASO

TYVASO is a prostacyclin vasodilator indicated for the treatment of pulmonary
arterial hypertension (WHO Group I) in patients with NYHA Class III symptoms,
to increase walk distance. TYVASO is intended for oral inhalation only.
TYVASO is approved for use only with the TYVASO Inhalation System. The safety
and efficacy of TYVASO 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. TYVASO 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
forward-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-Q 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

Andrew Fisher of United Therapeutics Corporation, +1-202-483-7000,
Afisher@unither.com