Pipeline
Lung Rx, Inc. has licensed the rights from Toray Industries, Inc., a Japanese company, to develop and market Beraprost Sodium Modified Release tablets (BPS-MR) for the treatment of Pulmonary Arterial Hypertension.
BPS-MR was synthesized at Toray's Basic Research Laboratories in 1979, as a PGI2 derivative to be administered orally. BPS-MR has been demonstrated in various pharmacological studies to exhibit potent antiplatelet effects (inhibition of platelet aggregation and adhesion) and vasodilatory effects. BPS-MR consists of four optical isomers, which are two pairs of diastereomers.
BPS-MR has been granted orphan medicinal product designation by the European Commission for the treatment of pulmonary arterial hypertension. This designation is based on a recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency (EMEA). According to the EMEA, orphan medicinal products are for treating life-threatening or very serious conditions that are rare and affect less than five of every 10,000 persons in the European Union (EU). An Orphan Drug designation provides 10 years of market exclusivity upon receipt of EU marketing approval. It also allows for regulatory assistance in preparing the marketing application, free protocol assistance to optimize clinical development, reduced regulatory fees associated with applying for marketing approval and direct access to the centralized procedure for Marketing Authorization Application through the EMEA.
A Phase I trial in healthy volunteers was completed in 2008 and a Phase II dose ranging trial is currently enrolling. Lung Rx is also in the planning stages for a double blind Phase III efficacy and safety registration trial.