Pharmsynthez Announces Product Pipeline Progress

31 July 2013

Recruitment surpasses half-way point for MyeloXEN® Phase IIa and Rayaldy™ Phase III Studies.

Pharmsynthez (MICEX: LIFE) the leading Russian biopharmaceutical company that specializes in the development, manufacture and distribution of pharmaceuticals announces today that key pipeline products MyeloXEN® and Rayaldy™ have surpassed the half-way point for enrollment in their respective ongoing clinical trials.

MyeloXEN®

MyeloXEN® is a therapeutic targeted liposomal vaccine developed by Pharmsynthez using liposomal entrapment technology. The active ingredient of MyeloXEN® is the three peptides homologous to immunogenic sites of the myelin basic protein (MBP). MBP is thought to have a central role in demyelineating diseases, such as multiple sclerosis. A Phase I trial in healthy volunteers has already been completed and demonstrated MyeloXEN®’s excellent safety profile.

MyeloXEN® is currently being evaluated in a multicentre Phase IIa clinical trial for the treatment of relapsing remitting and secondary progressive multiple sclerosis. The primary endpoint of the trial is safety and tolerability of MyeloXEN® when administered subcutaneously. Secondary surrogate efficacy endpoints are also being evaluated. Over half of the 20 patients in the study have been successfully recruited and results are expected to be announced in the fourth quarter of 2013.

Rayaldy™

Rayaldy™ (CTAP101 Capsules) is a first-in-class vitamin D prohormone treatment with modified release being developed by OPKO Health, Inc. for secondary hyperthyroidism (SHPT) in stage 3 and 4 chronic kidney disease (CKD) patients with vitamin D insufficiency. The first of two identical Phase III randomized, double-blind, placebo controlled, multi-site studies carried out by OPKO Health has enrolled over half of the 210 patients set to enter the study. The endpoints of both studies, which will be conducted in parallel, include vitamin D status and changes in serum calcium, serum phosphorus and plasma intact parathyroid hormone (PTH).

Pharmsynthez has exclusive manufacturing and distribution rights to Rayaldy™ in Russia and the CIS. Results from the Phase III trials are expected in in the third quarter of 2014.

Dmitry Genkin, Chairman of Pharmsynthez, commented, “We are excited to report on the successful recruitment progress of MyeloXEN® and Rayaldy™. Both products have significant commercial potential if approved and we very much look forward to reporting the results from these studies by the end of the year for MyeloXEN® and in the third quarter of 2014 for Rayaldy™.”

Reference

Pharmsynthez is a leading Russian pharmaceutical company focused on research, manufacture and distribution of active pharmaceutical ingredients (APIs), including those intended for import substitution. Pharmsynthez also produces medicines (Neovir, Segidrin, Fenasid and Penkrofton) used in oncology, gynecology, treatment of immunodeficiencies and tuberculosis.