MMN macmin silver ltd

silver spikes. avl, mmn firming up

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    The June quarter result should show a developing sales and financial position.

    Here's the announcement:

    ASX Announcement and Media Release
    8 July 2003
    SciGen Limited
    SCIGEN OBTAINS SCI-B-VAC GEAC APPROVAL IN INDIA
    SciGen Limited (“SciGen”) today announced that it has received approval from the Genetic Engineering Advisory Committee (GEAC) in India for its third generation Hepatitis B vaccine (“Sci-B-Vac”). This approval by GEAC is an important milestone in the registration process for Sci-B-Vac in India.

    SciGen is currently working with its partners in India and the Indian Ministry of Health to arrange a clinical trial for registration purposes. Following the short clinical trial the registration application will be submitted to the Drug Controller General of India for final approval. It is anticipated that the clinical trial for registration purposes will take less than 12 months to complete, and that sales of SciGen’s Sci-B-Vac will commence early in FY05 subject to that final approval.

    SciGen has previously announced the execution of a commercialisation agreement with Shreya Life Sciences (“Shreya”) in India to market, sell and distribute SciGen’s Sci-B-Vac in India. The previously executed commercialisation agreement comprehends the sale of other products in SciGen’s portfolio. The agreement requires Shreya to exclusively sell Sci-B-Vac during the 10 year term of the agreement.

    Human Insulin
    By way of an update on SciGen’s human insulin (“SciLin”) registration in India, following GEAC approval on 6 March 2003, the clinical trial for registration purposes is now well underway. There were some initial delays in the expected registration timelines, but the administrative issues which caused these have largely been dealt with and the process is now back on course. SciGen anticipates that registration approval for “SciLin” will be complete in fourth quarter of calendar year 2003 with sales anticipated to commence early in 2004.

    SciGen continues to consolidate its position in entering the large pharmaceutical market of India. In addition to this, the company will continue to grow in other territories in the Asia Pacific region.

    About SciGen
    SciGen Ltd is a progressive biotechnology/biopharmaceutical company involved in co-developing and marketing genetically engineered biopharmaceutical products for human healthcare. SciGen focuses in the areas of gastroenterology, endocrinology and immunology. Its product portfolio includes vaccines and therapeutics.

    SciGen has acquired the rights to manufacture, distribute and market biopharmaceutical products under exclusive licensing arrangements. SciGen’s portfolio currently includes proprietary biotechnology-derived products, and biogeneric products, which allows for faster entry into the market, as the biogeneric products have undergone much of the clinical development and trials required to bring new drugs to market. This minimises the risks associated with early stage product development. SciGen currently undertakes R&D activities in collaboration with strategic partners and institutions.

    SciGen’s major strength lies in its ability to recognise the potential of new products in their early stages of development. Through joint collaboration with its strategic partners, SciGen uses its extensive expertise in regulatory and clinical environments, in conjunction with marketing and promotional infrastructure, to bring to market products which will have significant long-term benefit.

    SciGen’s business was established in 1988. SciGen is a Singaporean biotechnology company, publicly listed on the Australian Stock Exchange (ASX code SIE). SciGen’s headquarters is in Singapore and it also has offices in Australia, USA, Korea, Vietnam, Hong Kong and Philippines and partners in India, Indonesia, Israel, Poland and the Netherlands.


    Media enquiries
    Mark Compton
    Managing Director & CEO
    Telephone: Kylie Clarke +61 2 9234 1706
    Web: www.scigen.com.au
 
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