Injectable Glycoside ProjectBEC is a mixture of glycosides...

Injectable Glycoside Project
BEC is a mixture of glycosides isolated from the plant Solanum sodomeum (Apple of Sodom) which grows naturally in the wild.
The mixture has shown considerable promise as a cream for the treatment of certain forms of
skin cancer1. Significantly, the extract has also shown invitro (test tube) activity against a wide range of cancers (unpublished).

The cream form of BEC (Curaderm) is currently being marketed as a treatment for early stage
skin cancers, however, its application has produced varied results2,3.
The company has acquired the rights to theBEC for use in a non-cream formulation.
The company aims to develop the product as an injectable for use bydermatologists.
It is thought that this formulation (two subcutaneous injections) would increase the efficiency of
action of BEC while reducing the need for strict patient compliance.
Studies have also demonstrated that BEC can show invitro anti-cancer activity against a broad range of tumour targets, demonstrating the potential for BEC development as an anti-cancer agent.
Comparative studies demonstrated that BEC was more efficient in its anticancer activity when compared with other anti-cancer agents.
The mode of action of BEC has been studied and identified that certain sugars attached to the glycosides specifically bind to cell receptors, which are more prevalent on certain tumour cells than normal cells.
This knowledge allows BNA to exploit the binding characteristics of the sugars to link to anti-cancer agents.
This may result in increased specificity of activity while also reducing the harmful side effects commonly associated with these agents (much as the same way as
Meditech Research Ltd’s anti-cancer agent carrier).



Topical Steroid Cream
The company has agreed to “farm-in” to a joint venture partnership with Lawley Pharmaceuticals to market their range of topical steroid creams.
BNA will earn their 49.9% involvement in the joint venture by advancing the products through a regulatory review and marketing the products.
It is likely that this review will take between 6 to 9 months to process.
These creams have a broad range of uses including the treatment of menopausal symptoms, osteoporosis, oestrogen and testosterone deficiency and loss of libido.
The joint venture would seek regulatory approval for thecream formulations and its applications where indicated.
The products currently produced by Lawley Pharmaceuticals have the added benefit over other
hormone replacement therapies in that they can be topically applied rather than being taken orally in a tablet form, injected or implanted.
Preliminary studies have shown that stable serum levels of the steroids can be
readily maintained when topically applied in contrast to the other routes of administration.
Once these products obtain regulatory approval they canbe marketed to general practitioners to provide a continuous revenue stream.

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revenue today ??the date was 2001

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Management
Dr Michael Ruane: Managing Director BNA,experience in the cultivation and extraction of glycosides.
Mr Stephen Carter: Operations Director/General
Manager of Delta West P/L. Has extensive drug
development and regulatory issues experience.
Mr Terry Sweet: founder of Western BiotechnologyLtd, director of Heartlink Ltd.
Risks
The following are potential risks in the development of asuite of biotechnology applications from recent
agreements:
BNA fails to convert the memorandum of understanding into a formal binding agreement.
BEC fails to demonstrate anti-cancer activity or the applications produce toxic side effects when injected
subcutaneously.
Failure to achieve government funding in the form of aSTART grant or other form of funding.
Delays in getting proper regulatory approval for use ofBEC as an injectable or steroid creams for topical use.
Key personnel being unable to advance projects to acommercial stage of development.
References
1. Cham BE; Daunter B; Evans RA Cancer Lett 1991
Sep;59(3):183-92.
2. Evans R; Cham BE; Daunter B Med J Aust 1989 Mar
20;150(6):350-1.
3. Cham B; Daunter B; Evans R Med J Aust 1990 Mar
19;152(6):329-30
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Company Announcement

Licence and Supply Agmt Signed for New Zealand SOLBEC PHARMACEUTICALS LIMITED 2001-07-04 ASX-SIGNAL-G HOMEX - Perth +++++++++++++++++++++++++ Solbec Pharmaceuticals are pleased to announce that in conjunction with joint venture partner Lawley Pharmaceuticals Ltd has completed negotiations with New Zealand based AFT Pharmaceuticals for the distribution of their hormone replacement products within New Zealand, Fiji and the Cook Islands.
An agreement was signed on June 26th in Auckland. AFT are a pharmaceutical sales group that distribute products for Schien International, Bioglan UK, Taro International and Lifehealth UK.
They have an extensive direct marketing operation to doctors and pharmacists and cover in excess of 90% of all pharmacies and hospitals in NZ.
AFT will also assist Lawley in the registration of their products in NZ and the territory.
Lawley's Chief Pharmacist Mr Michael Buckley is excited by the opportunity to further distribute Lawley's products and believes that AFT are able to play an important part in our marketing and distribution strategy.
It is envisaged that the first Regulatory filings for the Lawley range of products will be lodged with the TGA in Australia in July and Ministry of Health in NZ in August 2001 with further filings following.
For further information contact Mr Stephen Carter at Solbec Pharmaceuticals Ltd or Mr Michael Buckley at Lawley Pharmaceuticals. S Carter MANAGING DIRECTOR