Australia's Solagran Registers New Pharmaceutical in Russia.Sydney, Australia, July 18, 2007 - (JCN JCN Japan Corporate News
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JCN joint communications network (US DoD) Newswire) - Australian Biotech Solagran Limited (ASX ASX
See: Australian Stock Exchange : SLA (1) (StereoLithography Apparatus) See 3D printing.
(2) (Service Level Agreement) A contract between the provider and the user that specifies the level of service expected during its term. ) today announced that it had received formal documentation from the Russian Ministry of Heath advising that pharmaceutical registration of both its substance Bioeffective(R) R and the associated medicine Ropren has been finalised. Ropren is a safe and effective natural hepatoprotector which will be used to treat chronic liver disease Chronic liver disease is a liver disease of slow process and persisting over a long period of time, resulting in a progressive destruction of the liver.
It includes amongst others:
Solagran will now focus on scaling up production facilities sufficient to meet the expected demand in Russia. It can also now initiate the next stage of its Ropren strategy which is to obtain pharmaceutical registration in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the
European Community as a precursor to taking it to North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. and Asia.
Ropren is a unique natural medicine. Its active ingredient An active ingredient, also active pharmaceutical ingredient (or API), is the substance in a drug that is pharmaceutically active. Some medications may contain more than one active ingredient. Bioeffective(R) R is one of a family of 17 Bioeffectives(R) that Solagran's research team has developed over 30 years. Each has multifaceted activity and few if any side effects Side effects
Effects of a proposed project on other parts of the firm. .
Ropren has been approved in Russia as a strong and effective natural hepatoprotector. Clinical trials have also demonstrated that Ropren has the potential to normalise Verb 1. normalise - become normal or return to its normal state; "Let us hope that relations with this country will normalize soon"
change - undergo a change; become different in essence; losing one's or its original nature; "She changed completely lipid metabolism Lipid metabolism
The assimilation of dietary lipids and the synthesis and degradation of lipids; this article is restricted to mammals.
The principal dietary fat is triglyceride. , strengthen the immune system immune system
Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. , prevent and treat neurodegenerative disorders, and deal with conditions associated with drug and alcohol addiction.
The ability of Ropren to deal so effectively with chronic liver disease will have a very positive social impact in Russia. There are more than 10 million people with liver disease Liver Disease Definition
Liver disease is a general term for any damage that reduces the functioning of the liver.
The liver is a large, solid organ located in the upper right-hand side of the abdomen. in Russia and the CIS countries There are two lists concerning CIS countries:
Solagran expects demand for Ropren to treat liver disease alone will reach 320,000 courses in 2010 and exceed 1 million courses per year by 2012.
Initially, the market is expected to be supply constrained, with Solagran only having capacity to meet the demand expected from hospitals and pharmacies in the cities of Moscow and St Petersburg.
The next step for Solagran is to obtain a manufacturing licence which will apply throughout Russia. This process involves obtaining approval firstly at local level, followed by state and finally federal level approval. It is a procedure that usually takes 2-3 months.
Solagran is already well advanced with the expansion of the SibEX plant in Tomsk into a facility capable of producing 20kg of Bioeffective(R) R per month by November 2007. This will translate into 60,000 courses of Ropren per year. Planning is also progressing in relation to the development of a new plant on SibEX land adjacent to the existing facility that will be capable of producing 100-200kg per month or 300-600,000 courses per year.
At least three additional production facilities are now planned for Russia to produce Bioeffective(R) A, Bioeffective(R) V and Bioeffective(R) R.
Beyond that, Solagran is looking to establish sites in Finland and in North America (potentially in either British Columbia British Columbia, province (2001 pop. 3,907,738), 366,255 sq mi (948,600 sq km), including 6,976 sq mi (18,068 sq km) of water surface, W Canada. Geography
or the Pacific Northwest).
An Executive Director has been appointed with primary responsibility for overseeing Solagran's global manufacturing capability.
Solagran's current strategy involves firstly building a strong market position in Russia with Ropren and Bioeffective(R) A, and then using Russia as a base to take Ropren and other Bioeffectives(R) to the world.
Chronic liver disease is a significant global problem. In the US, there are some 200,000 new cases, 300,000 hospitalisations and 30,000 deaths each year. Nevertheless, Solagran expects Ropren's very real potential to prevent and treat neurodegenerative disorders (including Alzheimer's and Parkinson's diseases), together with its ability to normalise cholesterol levels, will have a particularly significant impact in that country over time.
While the intention is to obtain registration for Ropren in the European Union prior to pursuing FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. registration in the US, there is a possibility that both could be done in parallel. Enquiries have already been received from a considerable number of individual patients and their families in Europe and the US in relation to the availability of Ropren to treat both liver disease and neurodegenerative disorders.
At the same time, trials in St Petersburg are progressing well with both the injectable in·ject·a·ble
Capable of being injected. Used of a drug.
A drug or medicine that can be injected. and liposomal forms of Bioeffective(R) R, as well as with Bioeffectives(R) A, B and N.
Solagran's Directors consider the registration of Bioeffective(R) R and Ropren to be by far the most significant milestone achieved by Solagran since it listed in 2003. Achieving full registration for a new and multi-faceted pharmaceutical substance of natural origin in less than four years is truly outstanding - particularly given the amount of change that was occurring within the Russian Ministry of Health during the time that Solagran's application was being processed. Normally, the approval process would take at least twice as long.
Shortcutting this process was only possible due to the outstanding efficacy and safety of Ropren, the stature and reputation of Solagran's Executive Chairman Dr Vagif Soultanov within the Russian medical research community, the professionalism and dedication shown by Solagran's project team in Russia led by Professor Victor Roshchin.
Registration opens the door for Solagran to begin to activate its global development strategy. When executed successfully, that strategy has the potential to create a whole new direction in medicine involving the use of highly effective but low side-effect natural Bioeffectives(R).
Images: Projected Demand for Ropren to Treat Liver Disease in Russia
About Solagran Limited
Solagran is a biotechnology company with a portfolio of higly effective, low side effect, natural pharmaceuticals that it obtains from gree tree foliage. Its patented technology enables the extraction of the live elements of trees in a way that both preserves and amplifies their biological activity.
Source: Solagran Limited
Peter Stedwell Company Secretary Denis Kilroy Executive Director Solagran Limited TEL: +61 3 9820 2699 EMAIL: email@example.com www.solagran.com
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