can someone please post the ann., page-2

18 July, 2007
Company Announcement
Pharmaceutical Registration of Bioeffective® R and Ropren
The Directors of Solagran Limited are pleased to announce that the Company has received
formal documentation from the Russian Ministry of Heath advising that pharmaceutical
registration of both the substance Bioeffective® R and the medicine Ropren has been
finalised.
The Directors regard this as a tremendous achievement after an intense four year effort.
Solagran is now free to promote Ropren in Russia as a highly effective treatment for chronic
liver disease.
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 as a precursor to taking it to North
America and Asia.
Strategy in Russia
Ropren is a unique natural medicine. Its active ingredient Bioeffective® R is one of a family of
17 Bioeffectives® that Solagran’s research team has developed over 30 years. Each has
multifaceted activity and few if any side effects.
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 lipid
metabolism, strengthen the immune system, 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 in Russia
and the CIS countries, with up to 1 million new cases and 100,000 deaths each year.
Figure 1 illustrates Solagran’s expectations in relation to the demand for Ropren in Russia.
The Board expects demand for use in treating liver disease alone to 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.
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Figure 1. Projected Demand for Ropren to Treat Liver Disease in Russia
Moscow and
St Petersburg
0
2007 2008 2009 2010 2011
100
200
300
Number of 400
Courses
(000) Remainder
of Russia
Production Capacity
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 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® A, Bioeffective® V and Bioeffective® R.
Beyond that, Solagran is looking to establish sites in Finland and in North America
(potentially in either British Columbia or the Pacific Northwest).
An Executive Director has been appointed with primary responsibility for overseeing
Solagran’s global manufacturing capability.
Strategy Beyond Russia
Solagran’s current strategy involves firstly building a strong market position in Russia with
Ropren and Bioeffective® A, and then using Russia as a base to take Ropren and other
Bioeffectives® to the world.
Chronic liver disease is a significant global problem. In the US, it is estimated to affect
around 4 million people with 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 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.
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At the same time, trials in St Petersburg are progressing well with both the injectable and
liposomal forms of Bioeffective® R, as well as with Bioeffectives® A, B and N.
In Summary
The Directors consider the registration of Bioeffective® 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®.
Peter Stedwell
Company Secretary
On behalf of the Board of Directors
Solagran Limited