Russia recommends approval of Solagran liver disease drug
Friday, 27 January, 2006
The Russian Ministry of Health has recommended the approval of Melbourne-based Solagran's (ASX:SLA) Ropren, the finished form of Bioeffective R, as a treatment for chronic liver disease.
The Specialist Committee for Pharmaceuticals used in Gastroenterology considered Solagran's application to register Ropren as a new medicine at their meeting on November 25 and December 29, 2005. The committee reviewed the full clinical trials report and resolved to recommend approval of Ropren for the treatment of hepatobiliary system diseases (chronic liver disease).
In reviewing the trials documentation and making its recommendation, the committee noted that "the efficacy of Ropren in treating patients with various pathologies of the liver was confirmed and no adverse reactions were registered."
The committee's recommendation will now go to the Executive Board Russian Ministry of Health Pharmacological Committee to formalise the medical approval. This board is scheduled to meet in Moscow during the last week of January.
In a letter to shareholders, Solagran director Peter Stedwell said: "Solagran's scientific team in St Petersburg together with our pharmaceutical production partner Galenopharm, are confident that all remaining technical documentation required to be provided in support of the Pharmacopeial entry can be submitted within the next two to three weeks. The directors anticipate that full registration of Ropren should be in place during the second quarter of 2006, with the first sales generated in the third quarter."
Noting the safety, efficacy and speed of action of Ropren, the four major hospitals involved in Solagran's clinical trials have all indicated their intention to use Ropren in treating chronic liver disease as soon as it is available.
Solagran's current production capacity can meet the project demand from these hospitals for the forthcoming year. Once Ropren is entered into the Russian Pharmacopeia, Solagran plans to upscale its Russian Bioeffective R production facility to meet the increased demand projected over the next several years.
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