Cardiome/SteadyMed's PAH Drug Approved for Review in EU

Cardiome Pharma Corp. CRME announced that the European Medicines Agency (EMA) has approved its request to review Trevyent (treprostinil PatchPump) under the Centralised Authorisation Procedure drug review process.

As per review under this procedure, a single marketing authorization for Trevyent will be valid in 28 EU countries, along with 3 European Economic Area EEA countries.

We note that in Jun 2015, Cardiome Pharma signed a license and supply agreement for Trevyent with SteadyMed Ltd. STDY for commercializing the candidate upon approval in Europe, Canada and the Middle East. Trevyent is being evaluated for the potential treatment of pulmonary arterial hypertension PAH. Trevyent combines SteadyMed's PatchPump technology with treprostinil, a vasodilatory prostacyclin analogue, for the treatment of PAH.

The centralised drug procedure will streamline the process of gaining a license in all member states of the EU, thereby accelerating the availability of the candidate upon approval.

Meanwhile, SteadyMed plans to submit a New Drug Application to the FDA for Trevyent in the third quarter of 2016. The company plans to commercialize Trevyent in the U.S. on its own.

However, the PAH market is already crowded with players like United Therapeutics Corporation UTHR and Actelion Ltd. ALIOF among others. United Therapeutics' Remodulin is one of the leading therapies in PAH. Actelion too boasts a comprehensive PAH portfolio with drugs like Opsumit, Tracleer, Ventavis and Veletri. Actelion's portfolio recently received a boost when the FDA approved Uptravi for the treatment of patients with PAH.

Cardiome currently sports a Zacks Rank #2 (Buy).

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