New Drug Application for Inhaled Treprostinil Submitted to the U.S. Food and Drug Administration

SILVER SPRING, Md., June 30 /PRNewswire-FirstCall/ -- United
Therapeutics Corporation (Nasdaq: UTHR) and its wholly-owned subsidiary,
Lung Rx, Inc., announced today the submission of a New Drug Application
(NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval
of an inhaled formulation of treprostinil (ITRE) for the treatment of
pulmonary arterial hypertension (PAH), a chronic, life-threatening disease.
The submission starts a 60-day period during which the FDA will examine the
application for completeness. If the FDA accepts the ITRE NDA for review,
then it is expected to be subject to the standard 10- to 12-month review
period before an action letter is issued.

"We believe that an inhaled formulation of treprostinil will be a very
desirable option for PAH patients," said Martine Rothblatt, Ph.D., United
Therapeutics' Chairman and Chief Executive Officer. "The completion of the
NDA filing is a huge milestone in United Therapeutics' quest to develop as
many formulations of treprostinil as possible to create better, more
convenient therapies to treat the debilitating effects of PAH along the
full spectrum of the disease."

The ITRE NDA is principally supported by data from the TRIUMPH-1 Phase
III clinical trial.

About TRIUMPH-1

TRIUMPH-1 (TReprostinil Sodium Inhalation Used in the Management of
Pulmonary Arterial Hypertension), was a randomized, double-blind, placebo-
controlled trial of patients with PAH. ITRE is prepared once per day and
administered in four daily inhalation sessions using the NEBU-TEC
Optineb(TM) ultrasonic nebulizer, with each inhalation session taking
approximately 1-2 minutes.

The TRIUMPH-1 clinical trial is one of the first pivotal trials to
assess the incremental benefit of an add-on therapy in PAH patients who are
already receiving an approved background therapy. The study population
consisted of 235 patients who were optimized on an approved oral therapy
for PAH, either bosentan (Tracleer(R)), an endothelin receptor antagonist,
or sildenafil (Revatio(R)), a phosphodiesterase-5 inhibitor. The majority
of patients were New York Heart Association (NYHA) Class III (~98%) of
varied etiologies, including idiopathic or familial PAH (~60%), collagen
vascular disease associated PAH (~30%), and PAH associated with HIV,
anorexigens or other associated conditions (~10%).

The primary efficacy endpoint of the TRIUMPH-1 clinical trial was the
change in six-minute walk (6MW) distance at 12 weeks measured at peak
exposure, defined by the trial protocol as 10-60 minutes after
administration of ITRE relative to baseline. Analysis of the TRIUMPH-1
clinical trial results confirmed an improvement in median 6MW distance of
approximately 20 meters (p<0.0005 at peak exposure, Hodges-Lehmann estimate
and non-parametric analysis of covariance in accordance with the trial's
pre-specified statistical analysis plan), in patients receiving ITRE as
compared to patients receiving only background therapy. In addition, the
6MW distance at week 12 relative to baseline at trough exposure was also
significantly improved, with an estimated treatment effect of approximately
14 meters (p<0.007). Secondary endpoints related to quality of life and
change in NT pro-BNP, a plasma biomarker of cardiac function, were also
significantly improved in the ITRE group as compared to the group receiving
only background therapy (p<0.05). Other secondary efficacy measures,
including change in Borg Dyspnea Score (shortness of breath test), NYHA
functional class, signs and symptoms score, and time to clinical worsening,
were not significantly different between the ITRE and background therapy
only groups. Safety findings were typically those associated with the
well-known vasodilatory side effects of prostacyclin and its analogs (e.g.,
headache, nausea, dizziness, flushing) and those commonly associated with
the inhalation route of administration (e.g., cough and throat irritation).
These side effects were mostly mild or moderate in severity and were not
dose-limiting in the majority of patients treated with ITRE.

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.

About Lung Rx

Lung Rx is a biotechnology company focused on unmet medical needs in
pulmonary medicine and pulmonary delivery of innovative therapeutic
products.

Forward-looking Statements

Statements included in this press release that are not historical in
nature are "forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward-looking statements
include our expectation that the ITRE NDA will be subject to a 10- to
12-month review period and our belief that ITRE will be a desirable option
for PAH patients once it has been approved for marketing. These
forward-looking statements are subject to certain risks and uncertainties,
such as those described in our periodic reports filed with the Securities
and Exchange Commission, which could cause actual results to differ
materially from anticipated results. These risks and uncertainties include,
among others, the failure of ITRE and the nebulizers used to administer
ITRE to receive regulatory approvals on the schedule expected; the
uncertainties of launching a new product on a global scale following
receipt of regulatory approvals, if received, due to misestimates of the
time and resources required to do so, or for other reasons; the failure of
ITRE to receive favorable pricing or reimbursement; the possible
inaccuracies of our analysis with respect to the TRIUMPH-1 preliminary
trial results and market opportunity; and the inability of ourselves and
our suppliers to manufacture ITRE and the nebulizers used to administer the
drug in accordance with all applicable regulatory requirements and in
sufficient quantity to support patient demand. Consequently, such
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. We claim the protection of the safe harbor
contained in the Private Securities Litigation Reform Act of 1995 for
forward- looking statements. We are providing this information as of June
30, 2008, 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]

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