Melbourne, Mar 19, 2008 AEST (ABN Newswire) - On 28 February 2008, Solagran Limited (ASX: SLA)(PNK: SOGRF) announced to the ASX that Russian regulatory authorities were expected to release its new prescription pharmaceutical Ropren for sale in the Russian market within 1 to 1.5 months. The Directors of Solagran are pleased to announce that this final administrative formality was completed sooner than expected and the official release to market has now been received.
Solagran's manufacturing partner Galenopharm is now free to commence production of Ropren for sale throughout Russia. Solagran is hopeful that initial production volumes will be sufficient to meet the needs of the main population centres of Moscow and St Petersburg.
Solagran will now turn its attention to ensuring that it is in a position to respond effectively to the significant world wide interest in this product. A plant containing the world's first commercial polyprenols production facility is due to be opened by the Governor of the Tomsk Region, Mr Victor Kress, at 3.00pm tomorrow local time. When operating at full capacity, this facility will generate sufficient polyprenols (Bioeffective R) to produce 50-60,000 courses of Ropren per annum.
Coming together in the same week, these two events constitute a really major milestone for the company. They mark the beginning of Solagran's transition from a research-focussed biotechnology company into an important player in the international natural pharmaceuticals market.
The Russian pharmaceutical registration process is structured in such a way that approval of a new prescription medicine should take 6-7 years after the successful completion of phased clinical trials. Ropren has passed the entire regulatory approval process in just 4 years and 1 month from the receipt of Ministry of Health approval to conduct clinical trials in February 2004. This is an outstanding achievement, and a testament to both the efficacy and the safety of Ropren.
Contact
Denis Kilroy
Executive Director
Solagran Limited
Email: Denis.Kilroy@solagran.com
Phone: +61 3 9820 2699
Fax: +61 3 9820 3155
Mobile: +61 411 222 844
Web: www.solagran.com
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