The U.S. Food and Drug Administration (FDA) recently accepted United Therapeutics Corporation’s re-submitted new drug application (NDA) for its pulmonary arterial hypertension candidate, oral Remodulin (treprostinil). The FDA said that the resubmission is a complete, class 2 response to the complete response letter (CRL) issued by the agency in Mar 2013.
The Mar 2013 CRL was the second to be issued by the FDA for oral Remodulin. At the time of issuing the first CRL, the FDA had raised questions about the clinical importance of the 6 Minute Walk Distance (6MWD) effect size shown in the FREEDOM-M study, the lack of improvement in time to clinical worsening in all three phase III studies conducted with oral Remodulin, and the failure to show a statistically significant effect on 6MWD in the two FREEDOM-C studies.
United Therapeutics had conducted an end of review meeting with the FDA in early May 2013 to discuss the second CRL. At that meeting, additional analyses and contextual information about combination studies in the field were presented.
With the FDA accepting the resubmission, a response regarding oral Remodulin should be out by Feb 16, 2014.
Remodulin is currently approved for both subcutaneous (SC) and intravenous (IV) use. However, United Therapeutics is facing a patent challenge for Remodulin injection. Novartis’ (NVS - Free Report) generic unit, Sandoz, is seeking approval for its generic version of Remodulin (10 mg/mL). United Therapeutics has filed a patent infringement lawsuit against Sandoz.
United Therapeutics currently carries a Zacks Rank #3 (Hold). Although we believe United Therapeutics’ existing PAH product portfolio will drive strong top- and bottom-line growth, we remain concerned about the generic challenge being faced by Remodulin. Remodulin is a key revenue generator at United Therapeutics. We expect investor focus to remain on the patent infringement case as well as updates on the regulatory path for oral Remodulin.
Currently, companies like Questcor Pharmaceuticals and Gilead Sciences Inc. (GILD - Free Report) look well-positioned. While Questcor is a Zacks Rank #1 (Strong Buy) stock, Gilead is a Zacks Rank #2 (Buy) stock.