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.

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