Shares of United Therapeutics Corporation (UTHR - Analyst Report) surged 27.5% in the past one week after the U.S. Food and Drug Administration (FDA) approved the oral use of Remodulin (treprostinil).
The oral formulation has been approved under the brand name – Orenitram for the treatment of pulmonary arterial hypertension (PAH) patients (in WHO Group I) to improve exercise capacity. We note that Remodulin is already approved for both subcutaneous (SC) and intravenous (IV) use.
The news comes as a relief for United Therapeutics as the FDA had previously issued two complete response letters (CRLs) to the company’s new drug application (NDA) for Orenitram and a final decision was expected by Feb 16, 2014.
The first CRL was issued in Oct 2012. In Jan 2013, United Therapeutics resubmitted its NDA to address the concerns raised in FDA’s CRL. However, the company suffered a setback when the FDA issued a second CRL in Mar 2013.
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 Orenitram, and the failure to show a statistically significant effect on 6MWD in the two FREEDOM-C studies.
Thereafter, United Therapeutics 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.
United Therapeutics resubmitted its NDA, which was accepted by the FDA in Sep 2013. Hence, the approval comes as a major relief for United Therapeutics after suffering two setbacks.
However, United Therapeutics is facing a patent challenge for Remodulin injection. Novartis’ (NVS - Analyst 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). Better-ranked stocks include Questcor Pharmaceuticals and Jazz Pharmaceuticals (JAZZ - Analyst Report) . Both carry a Zacks Rank #1 (Strong Buy).