regulators release ropren for sale in russia., page-3

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Company Announcement
Regulators Release Ropren® for Sale in Russia
On 28 February 2008, Solagran 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®.
The Board wishes to express its appreciation for the efforts of all personnel involved.