United Therapeutics Corporation (UTHR) recently announced that its new drug application (:NDA) for oral treprostinil was accepted for review by the US Food and Drug Administration (:FDA). The company is looking to get oral treprostinil approved for the treatment of pulmonary arterial hypertension (:PAH). The FDA is scheduled to respond on the NDA for oral treprostinil by October 27, 2012.
United Therapeutics had applied for US approval of oral treprostinil in late December 2011. Remodulin (treprostinil), United Therapeutics’ lead product, is currently approved for both subcutaneous (:SC) and intravenous (:IV) use in the US.
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) Revatio and Gilead's (GILD) Letairis.
Neutral on United Therapeutics
We currently have a Neutral recommendation on United Therapeutics. We believe the company is well-positioned to gain share in the PAH market. Remodulin continues to look very strong in both the IV and SC forms.
With the approval of Adcirca and Tyvaso, the company 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. However, we are not too bullish on the company’s chances of gaining US approval for oral treprostinil, given the mixed data on the candidate. Moreover, the company’s weak late-stage pipeline concerns us.
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