Solagran conifer extract granted TGA approval

Botanical biotech Solagran (ASX: SLA) has been granted approval from the Australian Therapeutic Goods Administration (TGA) for Bioeffective A as a new complementary medicinal substance for topical and internal use.

Solagran will now market a variety of end user therapeutic products based on Bioeffective A -- which will be known in Australia as Conifer Green Needle Extract or CGNC -- including oral care, gastrointestinal health, antioxidant, cold & flu and topical creams for burns and wounds.

"We can now go and speak to manufactures and product sponsors with an approval in hand," said Solagran executive director Denis Kilroy. "We will work in partnership with these groups to grow the consumer market."

Bioeffective A, is the first member of the Bioeffectives product family which was originally developed in the late 1930s in Russia and used in the second world war as a topical treatment by soldiers for burns, wounds, frost bite as well as a source of vitamins. It is a natural, compositionally complex extract of the 'live elements' of conifer needles. It has a wide spectrum of therapeutic activity and according to the company has virtually no side effects which has been confirmed in 49 separate clinical trials involving nearly 6000 patients aged from 7 to 84 years.

"We are expecting to make an appointment in the next week of one of two people who will be tasked for the commercialisation -- the focus will be to quickly turn this approval into revenues. We are fairly frugal in our use of resources and will now use the same sales people to commercialise Bioeffective B which has been used by the St Kilda football club to aid in post-game recovery used in conjunction with a sauna. It will be sold as consumer product and won't be making a therapeutic claim," said Kilroy.

CGNC is the source material for the isolation of some 15 other Bioeffectives including Bioeffective R, which in its finished from of Ropren is awaiting final administrative Russian approval to register as a new medicine for the treatment for chronic liver disease.

As the next step in gaining wider regulatory approval, Solagran plans to lodge a New Dietary Ingredient application for Bioeffective A with the US FDA.