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The_Muns

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Chaps & Chapesses,

 

Here's just an overview, more coming, but I thought you'd like a read, so far.

 

[B]Ernst & Young (2001) identified seven key areas where Australian biotechnology companies are

concentrating their efforts:[/b]

human health - 47 per cent

agriculture - 14 per cent

genomics/proteomics and bio-informatics - 13 per cent

equipment and services - 14 per cent

food production and processing - 5 per cent

environmental and resources - 4 per cent

biochemicals - 1 per cent

In the knowledge economy, small businesses are considered the key drivers of innovation, because

they are able to innovate more quickly and cheaply than larger companies. However, their success

on lucrative international markets often depends on strategic alliances with larger partners to deliver

access to:

research and development

finance

marketing expertise

distribution resources

In response to globalisation and increasing worldwide interest in biotechnology, Australia is finding

creative ways to commercialise research through scientific collaboration and through technology

transfer and licensing agreements with a variety of strategic partners.

 

In 1999-2000, total revenue for the Australian biotechnology industry was estimated at just over A$1

billion, with over A$801 million coming from product sales. Approximately 190 core biotechnology

companies operate across Australia, mainly in New South Wales, Victoria and Queensland. About 460

biotechnology-related companies are thought to be in operation. (Source: Australian Biotechnology

Report 2001, Ernst & Young/Freehills/ISR survey and research data 2001)

Trends

While Australia has more biotechnology companies per capita and per gross domestic product than the

USA, its biotechnology sector is still considered ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Â¹Ãƒƒâ€Â¦ÃƒÆ’¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã¢â‚¬Å“emergentÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢. However, involving mostly small and

medium sized companies, biotechnology is a dynamic sector within the Australian economy.

Reinforcing its robust nature was the latest Deloitte Biotech Index for Australia, which has risen at a

greater rate than the Nasdaq Biotech Index.

The diversity of AustraliaÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s biotechnology sector is influenced by:

a traditional presence in the human health sector

AustraliaÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s historical emphasis on primary industries

the positioning of biotechnology companies in industries where Australia has existing competitive

advantages (eg. agriculture, food processing and the environment)

Characteristics of Australian biotechnology industry

Australia has a globally competitive industry when measured relative to available national labour force

and resources. However, the industry is still small in size when compared with the USA and EU nations

 

The Australian biotechnology industry exhibits many other competitive strengths, including:

a clear business cost advantage in running R&D facilities compared with other nations

a quality and readily available supply of graduates with excellent training and skills

a strong international reputation for quality of science and intellectual capital

excellent and inexpensive international and domestic communications infrastructure

high expenditure relative to GDP, of public sector R&D in areas fundamental to biotechnology

(compared with competitor nations)

increasing Federal and State government support through funding

and infrastructure support and identification of biotechnology as a national priority for investment

attraction

Australia is internationally renowned for scientific excellence in a range of biotechnology

disciplines that include:

genetics

molecular biology

immunology

plant and agricultural biotechnology

Australia has an innovative and cost-effective research base, assisted by active government policies

designed to support biotechnology innovation. Compared to 15 countries in Europe, North America and

Asia, Australia was considered (as at December 2000) the most cost-effective location to conduct

biotechnology research. AustraliaÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s competitiveness in biotechnology research is supported by a strong

supply of highly-qualified scientists, with more graduates in the fields of science and technology

(per 1000) than in the USA.

 

SOLBEC PHARMACEUTICALS

 

Solbec is a Perth-based drug discovery and development company listed on the Australian Stock

Exchange (Code: SBP).

They are working to commercialise their flagship anti-cancer therapy SBP002, as well as their evolving

development pipeline of other products.

Solbec had its genesis in the pioneering work conducted at the University of Queensland where

extensive pre-clinical trials showing the efficacy of selected extracts of solanum plants in treating both

human and animal cancers were carried out. In March 2000, Solbec acquired the license to the

intellectual property.

Since then they have significantly advanced the research and development process, deriving the

patented SBP002 formulation and conducting extensive pre-clinical testing. They have made

considerable progress toward achieving Orphan Drug status for SBP002 with the objective of

reducing clinical development time. And in parallel with this process, they have begun the commercial

cultivation of Solanum linnaeanum plants in order to provide the active ingredients of SBP002 ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã‚¡ÃƒÆ’‚¬Ãƒâ€Â¦ÃƒÆ’¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã¢â‚¬Å“

solasonine and solamargine.

The value of SolbecÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s work has already been recognised by the Federal Government of Australia.

In 2003, the Biotechnology Innovation Fund awarded Solbec funding towards the costs of further

research.

Solbec understands the need to work to the rigorous standards of international regulatory bodies

and is also accredited to the international Quality Standard ISO9001:2000.

Studies already conducted on Special Access Scheme patients have provided extremely encouraging

evidence that SBP002 has the potential to become a highly effective, non-invasive, anti-cancer therapy,

using naturally-occurring agents to treat a wide range of cancers without significant side-effects.

 

To fulfil their corporate mission, they have developed a three-part strategy:

 

to continue to progress SBP002 through pre-clinical and clinical trials

to seek Orphan Drug status for SBP002, thereby significantly reducing the time required to take

the product to market

to develop cultivation and processing facilities to provide sufficient SBP002 for expected demand

going forward

Solbec is pursuing an aggressive Research & Development strategy designed to take the flagship,

anti-cancer therapy SBP002 to the market within 3-5 years. This will be achieved by targeting the

relatively low-incidence cancers Mesothelioma and Melanoma, achieving Orphan Drug status for

SBP002, fast-tracking the clinical trials process, and thereafter demonstrating the efficacy of SBP002

in treating an extensive range of cancer types.

 

SolbecÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s specific objectives are to:

 

develop an injectable formulation of SBP002

cultivate Solanum linneanum as an SBP002 source

 

In addition to SBP002, Solbec is also conducting trials on a number of other compounds shown to

have a strong activity against a number of cancers, viruses and some dermatological conditions.

 

DPXÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã‚¡ÃƒÆ’‚¬Ãƒâ€Â¦ÃƒÆ’¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã¢â‚¬Å“01 is in early stage development but the initial studies carried out by the Centre for Applied

Cancer Studies at the University of Western Australia, have shown very strong anti tumour activity

against nine cancer types; Epidermal Carcinomas, Melanoma (met), Renal Cell Carcinoma, Colorectal

Carcinoma, Uterine Cervical Carcinoma, Mesothelioma, Bladder Carcinoma and Prostate

Adenocarcinoma with very strong activity against stomach cancer.

 

BCTC-01 is a potential anti psoriasitic compound based on the core Glycoalkaloid technology of

SBP002.

 

Interleukin-6

A recent study carried out at the University of Western Australia, Department of Medicine investigated

the ability of SBP002 to affect the levels of the compound Interleukin 6 (IL-6) in cancer cell lines. IL-6

is a member of the class of chemicals in the body that affect such process as inflammation and

wellbeing. IL-6 has been shown in animals to be the causative agent in cachexia. Cachexia is the

medical term for the loss of condition, muscle wasting and general feeling of unwellness that occurs

in advanced disease such as AIDS and cancer. Animal studies have shown that if you can slow down

or stop the production of IL-6 in the body, whilst the disease may still progress, the patient has a much

improved quality of life without the wasting and unwell feeling that is often associated with late stage

terminal disease.

 

Significant matters within the past 12 months include:

 

A positive outcome for pre-clinical studies in Canada for SBP002 and the commercial cultivation of

Solaum linnaeanum being the plant from which SBP002 is derived.

 

Following the positive outcome from the pre-clinical studies in Canada, preparation for Phase 1

clinical trials of SBP002.

 

A grant from the Federal Government Biotechnology Innovation Fund to progress development

of immune response qualities of SBP002 with a study now being undertaken jointly with the University

of Western AustraliaÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s Department of Medicine and Solbec.

 

Changes on the Board of Directors with Michael Grant and Anthony Kiernan joining and Dr

Michael Ruane resigning.

 

In relation to the Phase 1 clinical trials of SBP002 the Board had hoped to have been able to announce

commencement of these during the year however this has not been the case as preparation has taken

longer than initially anticipated. The Board is confident that these trials will commence shortly.

 

The study being undertaken in conjunction with the Department of Medicine at UWA into the immune

response qualities of SBP002 is very exciting and underlines the potential of SBP002 for application in

other areas.

Subsequent to year end the Company agreed to sell its interests in Lawley Pharmaceuticals Ltd for

$850,000, $200,000 of which is dependent upon registration with the Therapeutic Goods

Administration of any of Lawley Pharmaceuticals current range of hormone replacement products.

Sale proceeds will enable Solbec to redirect funds to projects that carry greater intellectual protection

and the possibility of greater equity participation for Solbec Pharmaceuticals.

Efforts to sell the remaining mineral assets of the Company have continued and the Board is hopeful

of completing these prior to December 2003. Funds from these sales will provide further capabilities to

Solbec in pharmaceutical developments without the need to access capital markets.

Completion of the options issue in September 2003 together with the sale of SolbecÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s interest in Lawley

Pharmaceuticals increase cash and receivables to approximately $3,600,000, and once the mineral

assets sales are completed will bring further increases.

An improved capital base coupled with a more focused direction in development and research places

Solbec in a most interesting and exciting position.

At the end of the year, the company made a pro-rata entitlement offer to all existing share and option

holders for them to subscribe to receive one new option for every two shares or options held at the

record date. This entitlement offer was ratified at an Extraordinary General Meeting of Shareholders

held after the reporting period. The offer will, if fully subscribed, raise additional working capital of

$788,836 for the company. Completion of this issue and the sale of SolbecÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s interest in Lawley

Pharmaceuticals, increased cash and receivables to approximately $3.6 million which will further

increase once the final mineral assets are sold.

In addition Solbec received an Australian Government grant of $196,000 through the Ausindustry

Biotechnology Innovation Fund to carry out further research on its anti cancer drug.

 

I hold and hope there is good news coming shortly.

 

Very Spec Buy, but good rewards could be forth coming.

 

 

 

 

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Here's that annoucement I mentioned.

 

Page 1

ASX PRESS RELEASE 20th November 2003

Solbec to commence Human Clinical Trials of its lead compound, SBP002

Summary:

ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚¢ Solbec Pharmaceuticals Ltd receives all regulatory approvals to commence Human Clinical

trials on SBP002, its lead compound

ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚¢ Clinical Trials will be commenced immediately at Western AustraliaÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s Sir Charles Gardiner

Hospital an Oncology center of excellence.

ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚¢ The results of these trials will be used by Solbec to complete an Investigational New Drug

application (IND) for the United States Food & Drug Administration (FDA) to permit further

clinical trials in the Australia and the USA.

Australian Biotechnology Company Solbec Pharmaceuticals Ltd has received all regulatory

approvals to commence human clinical trials of its lead anti-cancer drug SBP002 at Sir Charles

Gardiner Hospital in Perth Western Australia.

The objective of the Phase I trial is to evaluate the safety, tolerability and pharmacokinetics of

SolbecÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s lead compound in patients with advanced solid tumours. Approximately 25 patients will

be treated in the Phase I trial. Based on results, further clinical trials may be done, focussing on

difficult to treat cancers like melanoma and mesothelioma.

In separate animal studies, SBP002 has shown reduced tumour growth rates and eradication of

melanoma and mesothelioma in mice. It is anticipated that the trial will confirm the favourable

results that we have seen in animal studies and in humans treated under the Federal Governments

Special Access Scheme.

Confirmation that SBP002 is safe and effective in treating of solid tumours, will increase the

commercial potential of the technology and will attract further international interest in Solbec and

its technology.

The trial will be carried out at Sir Charles Gairdner Hospital (SCGH) in Western Australia under

Professor Michael Millward. Professor Millward is an experienced Phase I Clinical Trial Researcher

who has recently returned to Western Australia. Solbec is fortunate to have secured the support of

both SCGH and the University of Western AustraliaÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s Department of Medical Research. These are

leading centers of excellence for oncology, especially mesothelioma, in the Southern Hemisphere.

The results of this trial will be used by Solbec to complete an Investigational New Drug application

(IND) for the United States Food & Drug Administration (FDA) to permit a clinical trial program in

the USA.

Patients wishing to determine whether they are suitable to be considered for this trial should

contact (08)9346 4226, or email the study research nurse (sasha.tyson@health.wa.gov.au)

Stephen Carter

Managing Director

Tel: (08) 9446 7555

Mob: 0412 154 029

Email: stephen.carter@solbec.com.au

Page 2

Background Information

Solbec Pharmaceuticals Ltd is a publicly listed company on the Australian Stock exchange (code

SBP).

SBP002 is a combination of two glycoalkaloids isolated from the fruit of Solanum linnaeanum, a

weed more commonly know as DevilÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s Apple.

Currently the drug has completed its pre-clinical phase of trials as an anti cancer treatment.

Human Phase 1 clinical trials are now underway.

Solbec is focussing SBP002 research on treatment of mesothelioma and malignant melanoma

which qualifies the drug for the fast track Orphan Drug Program.

However, under the Therapeutic Good AdministrationÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s Special Access Scheme (SAS), SBP002 has

been administered to a number of cancer patients with encouraging results. These have included:

Increased well-being, Tumour size reduction, Reduced tumour growth rates, extended expected

life span, Tumour eradication

In previous studies carried out by the University of Western Australia, it was observed that

SBP002-treated cells reduced the production of IL-6 when compared to the control and to cells

treated with the anti-cancer drugs Gemcitabine and Docetaxol. IL-6 is known to be one of the

chemicals produced by the body during disease that makes people feel unwell. IL-6 is also known

to be involved in cancer cell proliferation.

As well as a range of cancers, SBP002 may be useful for treating a wide range of IL-6 related

diseases. These include inflammatory diseases such as rheumatoid arthritis; microbial diseases

such as HIV, chronic fatigue syndrome and malaria; heart disease such as cardiac myopathy; and

other diseases such as AlzheimerÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s disease, arteriosclerosis, thyroiditis and CastlemanÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s disease.

Solbec has lodged patents to cover this exciting aspect of the drugÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s activity.

Solbec has received an Australian Government grant of $196,000 through the Ausindustry

Biotechnology Innovation Fund to carry out further research on SBP002. This research is to look at

the ability of SBP002 to boost the immune system. This new line of investigation at UWA by

Professor Robinson and his team represents a significant new direction for Solbec and the use of

SBP002.

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Announcement just release.

 

Page 1 of 2

ASX RELEASE 27th November 2003

Jervois Mining Project

Summary:

ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚¢ Solbec sells Jervois mining lease for $1,000,000

ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚¢ Terms of Sale are $500,000 cash $500,000 production royalties

ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚¢ The sale marks the divesting of the last of SolbecÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s mineral assets.

Solbec Pharmaceuticals Ltd advises that it has agreed to the sale of its interests in the Jervois Copper

Mining Project to Asia Multi-Foods and Oils (Australia) Ltd.

The terms of the sale, are $500,000 cash and the balance as a royalty from production calculated at $2

per tonne of ore mined capped at $500,000 providing the company with a total of $1,000,000 for the

asset.

The sale agreement is in line with the companyÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s policy of divesting its mineral assets and will

contribute significantly to the companyÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s cash reserves with an immediate cash injection of $500,000.

This sale marks the divesting of SolbecÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s last major mineral asset.

Stephen Carter

Managing Director

Tel: +61(08) 9446 7555

Fax: +61(08) 9446 8777

Email: stephen.carter@solbec.com.au

 

 

Page 2 of 2

Background Information

Solbec Pharmaceuticals Ltd is a publicly listed company on the Australian Stock exchange (code

SBP).

SBP002 is a combination of two glycoalkaloids isolated from the fruit of Solanum linnaeanum, a

weed more commonly know as DevilÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s Apple.

Currently the drug has completed its pre-clinical phase of trials as an anti cancer treatment. Human

Phase 1 clinical trials are now underway.

Solbec is focussing SBP002 research on treatment of mesothelioma and malignant melanoma which

qualifies the drug for the fast track Orphan Drug Program.

However, under the Therapeutic Good AdministrationÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s Special Access Scheme (SAS), SBP002 has

been administered to a number of cancer patients with encouraging results. These have included:

Increased well-being, Tumour size reduction, Reduced tumour growth rates, extended expected life

span, Tumour eradication

In previous studies carried out by the University of Western Australia, it was observed that SBP002-

treated cells reduced the production of IL-6 when compared to the control and to cells treated with the

anti-cancer drugs Gemcitabine and Docetaxol. IL-6 is known to be one of the chemicals produced by

the body during disease that makes people feel unwell. IL-6 is also known to be involved in cancer

cell proliferation.

As well as a range of cancers, SBP002 may be useful for treating a wide range of IL-6 related

diseases. These include inflammatory diseases such as rheumatoid arthritis; microbial diseases such as

HIV, chronic fatigue syndrome and malaria; heart disease such as cardiac myopathy; and other

diseases such as AlzheimerÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s disease, arteriosclerosis, thyroiditis and CastlemanÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s disease. Solbec has

lodged patents to cover this exciting aspect of the drugÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s activity.

Solbec has received an Australian Government grant of $196,000 through the Ausindustry

Biotechnology Innovation Fund to carry out further research on SBP002. This research is to look at

the ability of SBP002 to boost the immune system. This new line of investigation at UWA by

Professor Robinson and his team represents a significant new direction for Solbec and the use of

SBP002.

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AGM details.

 

I'm trying to get hold of the full presentation and will post as soon as I've required.

 

Enjoy..

 

CHAIRMANÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢S ADDRESS

to the Annual General Meeting of Shareholders

of Solbec Pharmaceuticals Ltd

held 27 November 2003

On behalf of the Board I am pleased to provide my address to this yearÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s Annual General

Meeting.

Shareholders will be aware that last week the Company announced it had received all

necessary approvals to commence human clinical trials of its lead anti-cancer drug SBP002.

The trials are to commence immediately and be carried out at Sir Charles Gairdner Hospital

in Western Australia under Professor Michael Millwood. The clinical trials are designed to

evaluate the safety, tolerability and pharmacokinetics of SBP002 in patients with advanced

solid tumours.

The commencement of these Phase 1 clinical trials is the singly most important event for

Solbec in its life as a pharmaceutical development company.

In the announcement to ASX, Solbec advised that the Phase 1 trials followed favourable

results seen in animal studies and in humans treated under the Federal Grants Special

Access Scheme. When Steve Carter makes his presentation at the end of the meeting, he

will expand upon the earlier favourable results, particularly on humans under the Special

Access Scheme.

This morning Solbec announced to the Stock Exchange the sale of the Jervois mining

project for $500,000 plus a royalty, payable from production, capped at $500,000. This was

its last remaining mining asset.

The commencement of the human clinical trials and the final acquisition of mineral assets

clearly focuses Solbec on its chosen path as a pharmaceutical development company.

Subsequent to the end of the financial year Solbec agreed to sell its interest in Lawley

Pharmaceuticals for $850,000 of which $200,000 is dependent upon registration with

Therapeutic Goods Administration of any of Lawley Pharmaceuticals current range of

hormone replacement products. The decision to exit the Lawley Pharmaceuticals joint

venture came after balancing the costs and likely timing of registration of one or more of the

hormone replacement products with the CompanyÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s current capital base. The Board also

had to consider that Solbec would most probably be sole risking all registration costs of more

than $500,000 given that its fellow joint venturer was not prepared to spend money whilst

Solbec remained in the joint venture. We also took into consideration that even upon

registration there was no intellectual property protection.

Solbec/AnnualReport2003/ChairmanÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢sAddress2003 Page 2

Funds flowing from the exit of Lawley Pharmaceuticals and now the final sale of the mineral

assets brings cash and receivables to around $3.8m and, as noted in relation to Lawley

Pharmaceuticals, saves further risk expenditure.

In September 2003 the Company completed an options issue which whilst bringing capital

into the Company allowed previous option holders who were ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Â¦ÃƒƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…âہ“out of the moneyÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚ to

participate in a new issue.

Since balance date Peter Alcock has resigned as a director of the Company. Peter has

been with the Company for a considerable period of time and I would like to record not only

did he make a valuable contribution whilst the Company was a mineral explorer he has

continued to do so through the change in activities.

Following a grant from the Federal Government Biotechnology Innovation Fund, Solbec

commenced a joint study during the year with the Department of Medicine at the University

of WA into the immune response qualities of SBP002. This study highlights the overall

potential of our lead compound. Other possible applications are being considered and

shareholders will be kept fully informed.

I would like to thank Steve Carter for his efforts and enthusiasm throughout the year and his

continued work in striving to have commenced the Phase 1 human clinical trials.

I would also like to thank my other fellow Director, Michael Grant, for his tireless work in

relation to Solbec. Also, and most importantly, on behalf of the Board I thank Shareholders

for their continuing support.

There is only one item of Business today and that is consideration of the Financial

Statements for the year ended 30 June 2003.

Following consideration of those Statements I will ask Steve Carter to give a more detailed

presentation on Solbec and its products.

Anthony Kiernan

Chairman

27 November 2003

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Directors on a roadshow to the brokers in the Eastern States over the next 2 weeks.

 

This will include 45 min PPoint presentation (Trying to get hold of a copy) as shown at the AGM.

 

Hopefully they will be explaining the significance of Phase 1 clinical trials and that the approval was directly from the FDA/TGA.

 

Shame to see this wasn't made obvious in the announcement and feel Solbec need to improve their PR, a point which they acknowledged at the AGM !!!!!

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I have held SBP for a couple of years and like most Bio techs is frustratingly slow to move forward. One of thoise times when a trader becomes an investor.

 

However, it is a very interesting investment from the perspective of the simplicity of the drug and ease of access to market.

 

My understanding is that the next expected move is a significant investment by an US based biotech investor.

 

Apart from that I expect some positive news in coming months as phase 1 results are selectively leaked.

 

From a trading perspective not worth a watch at the moment

 

regards

Peter

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An update from my broker who is in ongoing contact with SBP.

SBP GM on Eastern States trip at present to update/ generate broker interest.

 

News is that stage 1 trials expected to be completed in around 3 months total, reason is that this is repeating work already completed. Expected to move into stage 2 trials at that time.

 

regards

Peter

 

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