JP Morgan Neutral on United Therapeutics After IV Remodulin Approval

JP Morgan has published a research report on United Therapeutics

after the company announced approval for the treatment of pulmonary arterial hypertension (PAH) with IV Remodulin. In the report, JP Morgan writes, "This morning, United announced that the French regulatory agency, Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS), has approved IV Remodulin for the treatment of pulmonary arterial hypertension (PAH). IV Remodulin will now be available in most EU nations through mutual recognition in the 22 nations for which SC Remodulin is already approved in. Recall, United had been working on approval for quite some time and was optimistic on approval in the EU by YE11. So approval is inline with expectations. We have already accounted for EU sales of IV/SC Remodulin in our model, although our assumptions are modest with ~$76M in 2012, growing to $89M in 2015, which we think is prudent given the economic uncertainty in Europe. United also filed the NDA for oral remodulin in the US slightly ahead of schedule (original guidance was 1Q12), but we remain cautious on ultimate approval given the mixed phase 3 results." JP Morgan maintains its Neutral rating on United Therapeutics, which closed Friday at $46.56.