United Therapeutics Corporation (UTHR) recently announced that it has finished enrolling patients for its phase III study with a sustained release oral formulation of treprostinil diethanolamine (UT-15C).
The 16-week, multi-center, international, double-blind, randomized, placebo-controlled FREEDOM-C2 study will evaluate oral treprostinil as an add-on therapy in pulmonary arterial hypertension (PAH) patients who are receiving an endothelin receptor antagonist and/or a phosphodiesterase-5 inhibitor.
Oral treprostinil is currently in another phase III study (FREEDOM-M) which is evaluating the candidate as a monotherapy for treatment for PAH. While preliminary results from the FREEDOM-M study are due in June 2011, results from the FREEDOM-C2 study are expected in September 2011. The successful development of this formulation could add significant upside to the company’s existing business.
United Therapeutics expects to file for approval in 2012. We currently model the launch of the oral formulation in the 2013-2014 timeframe. The company is also evaluating the efficacy of oral treprostinil in reducing the frequency and severity of digital ulcers associated with scleroderma. Preliminary results from a phase II study should be out in the first half of 2011.
United Therapeutics has a varied range of therapies available for the treatment of PAH. The company’s lead product is Remodulin, an injectable formulation of treprostinil, indicated for the treatment of PAH in patients with New York Heart Association (NYHA) Class II-IV symptoms. Remodulin is approved for both subcutaneous (SC) and intravenous (IV) use.
United Therapeutics received approval for an inhaled version of treprostinil, which is being marketed under the trade name Tyvaso. In May 2009, United Therapeutics received US Food and Drug Administration (FDA) approval to market Adcirca [tadalafil; sold by Eli Lilly (LLY) as Cialis for erectile dysfunction] for the treatment of PAH.
Neutral on United Therapeutics
We currently have a Neutral recommendation on United Therapeutics. We believe the company’s PAH product portfolio will drive strong top-and bottom-line growth. Going forward, we expect investor focus to remain on the successful commercialization of Adcirca and Tyvaso. The next major catalyst for United Therapeutics would be positive results from ongoing studies for the development of oral Remodulin.
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