FDA Again Rejects United Therapeutics’ NDA for Pulmonary Arterial Hypertension ER Tablet

Andrew Klips |

United Therapeutics Corp. (UTHR) said Monday that it has received a second complete response letter from the U.S. Food and Drug Administration failing to approve United’s new drug application for treprostinil diolamine extended-release tablets as a treatment for pulmonary arterial hypertension, or PAH.

The Silver Spring, Maryland-based biotech wrote in a corporate statement that it intends to immediately request an “end of review” meeting with the FDA to discuss the rejection.

"We remain confident that oral treprostinil will play an important role in treating PAH and we are committed to working collaboratively with the FDA to accomplish this goal in the most timely and appropriate manner,” said Dr. Martine Rothblatt, chairman and chief executive of United Therapeutics, in Tuesday’s statement.

United surprised in February by re-filing the NDA submission with the FDA after an initial rejection in October 2012.

Some may remember Dr. Rothblatt for her distinguished career involved in many successful endeavors, including the Human Genome Project and as the founder of Sirius Satellite Radio in 1990, now Sirius XM Radio (SIRI).

On February 26, United Therapeutics reported that fourth-quarter revenues grew 25 percent to $243.8 million compared to the year earlier quarter, topping Wall Street predictions of $233 million. Net income more than doubled from the year earlier quarter to $1.65 per share, outpacing analyst expectations of EPS of $1.25.

Net income for the full year totaled $304.4 million, or $5.84 per share, on revenue of $916 million.

Meanwhile, United reaffirmed its 2013 full-year revenue guidance, expecting revenues within a range of 5 percent above or below $1 billion for the year.

Revenues for the company are primarily comprised of United’s pulmonary arterial hypertension drug franchise. In 2012, sales of injectable Remodulin rose 6.5 percent compared to 2011 to $458 million. Sales of inhalant Tyvaso rose 35 percent to $325.6 million, while the company’s oral drug Adcirca had sales increase 74 percent year-over-year to $122.5 million.

In the past year, shares of UTHR are up by about 28 percent, closing Friday at $60.95.

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure, please go to: http://www.equities.com/disclaimer

Companies

Symbol Name Price Change % Volume
GLAD Gladstone Capital Corporation 8.67 0.16 1.88 340,238
SIRI Sirius XM Holdings Inc. 4.54 -0.01 -0.11 24,422,142
UTHR United Therapeutics Corporation 131.69 -0.18 -0.14 400,878

Comments

Emerging Growth

Taranis Resources Inc.

Taranis Resources Inc is an exploration stage company. The Company along with its subsidiaries is engaged in the acquisition and exploration of mineral properties. Its projects include Thor Property in…

Private Markets

8tracks

Our mission is to be the best place for people who care about music to create and discover thoughtfully curated playlists. In essence, 8tracks is a platform for online mixtapes.

Dropbox, Inc.

Dropbox is a service that allows their users to bring all photos, docs, and videos anywhere, and share them easily. Any file saved to Dropbox will automatically save to all…