Melbourne, Feb 20, 2008 AEST (ABN Newswire) - The Directors of Solagran Limited (ASX: SLA) are pleased to announce the achievement of the last significant milestone in the process of obtaining Manufacturing Licences for both the prescription pharmaceutical Ropren(r) and its active ingredient Bioeffective R.
The Scientific Centre for the Examination of Substances for Medicinal Use in Moscow has confirmed that both substances conform to their respective Pharmacopeial Monographs and they have now been released from "preliminary control".
The Directors have been advised that receipt of this notification means that the award of the Manufacturing Licences is now imminent.
The Directors also believe that, as was indicated when Ropren was entered into the Russian Pharmacopeia in July 2007 (announced to the market on 18 July 2007), once the licence has been granted, the principal operational challenge for the company will be to ensure sufficient supply to meet expected demand. Consistent with this, Solagran's Operations Director, Mr Charles Pellegrino, will travel to Russia at the beginning of March to be present when commercial production comes on stream at the SibEX Tomsk plant.
Manufacture of Bioeffective R is a particularly complex process relying on sophisticated organic chemistry. Process complexity has been a critical factor in the time taken to achieve this outcome.
The SibEX Tomsk plant will be the world's first truly commercial production facility for the isolation and extraction of plant polyprenols.
Solagran is already working towards the establishment of a more extensive manufacturing footprint to meet the expected demand for Ropren as well as other Bioeffectives. As part of that effort, the final application to locate a larger plant within the Tomsk Special Economic Zone (SEZ) is being submitted to the SEZ authority this week.
Solagran's production challenge, and the associated commercial opportunity, is significant. A representative of a potential pharmaceutical industry distribution partner has already offered the view that Ropren has the potential to become a blockbuster drug - based solely on its potential sales in the liver disease segment in Europe.
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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