United Therapeutics Announces Receipt Of Complete Response Letter For Oral Treprostinil NDA

  United Therapeutics Announces Receipt Of Complete Response Letter For Oral
                               Treprostinil NDA

Conference Call to be Held at 4:45 p.m. Eastern Time today, October 23, 2012

PR Newswire

SILVER SPRING, Md., Oct. 23, 2012

SILVER SPRING, Md., Oct. 23, 2012 /PRNewswire/ -- United Therapeutics
Corporation (NASDAQ: UTHR) announced today that it received a complete
response letter from the United States Food and Drug Administration (FDA)
declining to approve its new drug application (NDA) for treprostinil
diethanolamine extended release tablets (oral treprostinil) for the treatment
of pulmonary arterial hypertension (PAH).

The FDA letter questioned the clinical importance of the 6 Minute Walk
Distance (6MWD) effect size shown in the FREEDOM-M study, the inability to
demonstrate an improvement in time to clinical worsening in all three Phase
III studies of oral treprostinil, and the inability to demonstrate a
statistically significant effect on 6MWD in the two FREEDOM-C studies as
reasons for being unable to approve the NDA in its current form. The FDA
noted that it was unsure whether an additional clinical study could alter
these impressions, but if United Therapeutics did undertake an additional
study it should consider, among other things, a fixed dose design and more
frequent dosing.

"We will continue using our best efforts to gain approval of oral
treprostinil, and we will focus on doing so within the next four years," said
Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United
Therapeutics. "We will convene with our experts over the next several weeks
to decide which of several paths forward to pursue."

Conference Call Today

On Tuesday, October 23, 2012 at 4:45 p.m. Eastern Time, United Therapeutics
will host a conference call to answer questions related to the FDA's complete
response letter.

The conference call is accessible by dialing 1-877-351-5881, with
international callers dialing 1-970-315-0533. A rebroadcast of the conference
call will be available for two weeks and can be accessed by dialing
1-855-859-2056, with international callers dialing 1-404-537-3406, and using
conference code: 56801607.

This conference call is also being webcast and can be accessed via our website
at http://ir.unither.com/events.cfm.

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 conditions.

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, among
others, statements regarding United Therapeutics' efforts to gain approval of
oral treprostinil, the related timing of those efforts, and actions United
Therapeutics may take in response to the FDA's complete response letter.
These forward-looking statements are subject to certain risks and
uncertainties and 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 October 23, 2012,
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]

SOURCE United Therapeutics Corporation

Website: http://www.unither.com
Contact: Andrew Fisher, +1-202-483-7000, Afisher@unither.com
 
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