for the record

Hi everyone

An enquiry was made to the company and I have received this.

For the record, and all of this information is already on the public record…

Ropren is a registered pharmaceutical in Russia. It was approved by the Russian Ministry of Health in July 2007, having previously gained full medical approval from the Pharmacological Committee of the RMOH in February 2006. The indication for which it was approved is as a hepatoprotector for use in the treatment of chronic liver diseases of various aetiologies.

Russia follows a pharmaceutical registration process essentially identical to that employed in the US and Western Europe. In fact, if people expressing such opinions about Russian research were to take the time to check their facts, they would discover that many if not most of the leading European pharmaceutical companies have extensive clinical trials programs underway with Russian Clinical Research Organisations (CROs) – including the St Petersburg Postgraduate Medical Academy who co-ordinated Solagran’s liver disease clinical trials with Ropren.

Medical approval was gained following successful completion of multi-centre Phase II clinical trials. These included infections diseases hospitals where the trial participants had Hep C, Hep B or Hep C&B, and the Centre for Infectious Diseases and AIDS where many of the patients also had HIV/AIDS.

Ropren was specifically exempted from Phase III trials because of its high level of efficacy, the fact that no negative side effects were detected (although positive ones were including cholesterol or lipid metabolism normalisation), and the very real need for a safe and effective treatment for chronic liver disease in Russia.

Russia does have a medical category known as a Biologically Active Nutritional Additive. This category allows much higher level claims than Australia’s complementary medicine category. But Ropren is not a BANA. It is a full pharmaceutical, and Bioeffective R, the active in Ropren, is also registered as a pharmaceutical substance. In fact, Ropren and Bioeffective R were the first pharmaceuticals of natural origin approved by the Russian Ministry of Health for nearly 20 years.

Bioeffective R is a long chain polyprenol or isoprenoid alcohol. Polyprenols are the subject of a great deal of research in the pharmaceutical industry. Most of that research is in Japan and Europe – a fact that can be established by searching the medical research databases. Solagran is the only company to have conducted clinical trials with polyprenols though because for many years we have been the only company that has pharmaceutical grade prenols in the volumes necessary to conduct trials. The Tomsk plant gives us commercial scale production.

It is possible to purchase relatively short chain polyprenols in analytical quantities from providers of specialty chemicals for the research community. To the best of my knowledge, these are only 90-92 purity, which is well below the level required for pharmaceutical use. Nevertheless these prenols are priced at levels that translate into USD 10,000 and USD 20,000 per gram. Ultimately that would translate into USD 50,000 to 100,000 per 3 month course of Ropren (containing 5 g of Bioeffective R which is comprised entirely of long chain polyprenols). I think most would agree that this would be somewhat outside the bounds of pricing achievable for a 3 month course for a nutritional supplement.

Our primary commercial objectives with Ropren were not to publish our clinical trials results, but rather to submit them to the RMOH and achieve registration. In chronological order, our first goal was to prove in Phased Clinical Trials what nearly 20 years research by our scientists (Victor Roschin first extracted plant polyprenols in 1986) and many smaller trials conducted under previous Russian and USSR trials protocols had already indicated. Our second goal was to get the product registered by the RMOH. Our third goal was to create a production facility capable of extracting prenols in pharmaceutical grade quality in commercial quantities. All three objectives have been met.