EU Nod for UTHR's Remodulin IV

United Therapeutics Corporation ([url=http://www.zacks.com/stock/quote/uthr]UTHR[/url]) recently received approval in the EU for the intravenous (IV) use of its pulmonary arterial hypertension (PAH) treatment, Remodulin (treprostinil). Approval was granted by the French regulatory agency Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS).

Remodulin is already approved in several European countries, as a subcutaneous (SC) infusion treatment, for idiopathic or heritable PAH in patients classified as New York Heart Association (NYHA) functional class III.

Remodulin sales totaled $403.6 million in 2010, up 21.7%. EU approval for the intravenous formulation should drive sales further. The company is looking to launch Remodulin in new territories including Japan and China. The Japanese market, where approval is expected by late 2013, could bring in incremental sales of about $100 million.

Oral Treprostinil Filed in the US

Meanwhile, United Therapeutics applied for US approval of oral treprostinil for the treatment of PAH. Remodulin, United Therapeutics’ lead product, is currently approved for both subcutaneous (SC) and intravenous (IV) use in the US. Assuming the US Food and Drug Administration (FDA) accepts the filing for the oral formulation, a final response should be out in the second half of 2012.

Data on oral treprostinil has been mixed. In August 2011, United Therapeutics had reported that oral treprostinil failed to meet its primary endpoint in a late stage study (FREEDOM-C2). FREEDOM-C2 was a combination therapy study, which was examining oral treprostinil in combination with PDE-5 inhibitors or endothelin receptor agonists.

However, earlier in June 2011, United Therapeutics had presented positive data from another late stage study (FREEDOM-M) which evaluated oral treprostinil as a monotherapy for PAH. Management hopes to get oral treprostinil approved on the basis of data from the FREEDOM-M trial. Other players in the PAH market include Pfizer's ( PFE - Analyst Report ) Revatio and Gilead's ( GILD - Analyst Report ) Letairis.

Outperform on United Therapeutics

We currently have an Outperform recommendation on United Therapeutics, which carries a Zacks #1 Rank (short-term Strong Buy rating). We believe the company is well-positioned to gain share in the PAH market. Lead product, Remodulin, continues to look very strong in both the IV and SC form. With the approval of Adcirca and Tyvaso, the company now has a varied range of therapies available for the treatment of PAH. We believe the company’s PAH product portfolio will drive strong top-and bottom-line growth.