SRX 0.00% $33.55 sirtex medical limited

Sirtex - i was right!, page-4

  1. 1,590 Posts.
    lightbulb Created with Sketch. 42
    It's great to see the fundamentals are exciting - I normally just trade using charts, and SRX has one of
    the best I've seen in a while.... Here's a copy
    of the announcement anyways:

    USA running ahead of schedule

    SIRTEX MEDICAL LIMITED 2002-08-21 ASX-SIGNAL-G

    HOMEX - Sydney

    +++++++++++++++++++++++++
    SIRTeX Medical Limited is pleased to announce that its USA entry
    strategy is progressing ahead of schedule. SIRTeX had a target to
    establish 10 treating centres in the USA in the first 12 months of
    operation. Since treating its first patient in the USA four months
    ago, the company has already trained five centres in the use of
    SIR-Spheres(R).

    The USA market for the treatment of liver cancer is significant with
    over 11,000 cases of primary liver cancer per year and over 57,000
    cases of secondary cancer. As SIRTeX Medical's treatment approach is
    novel, the ability of the company to develop and penetrate this
    market will depend largely on the support it receives from key
    opinion leaders. To this end the company is working with leading
    cancer centres and the company is extremely pleased with the level of
    support its therapy is receiving in the USA market.

    In the first month of entering the USA market (May 2002), USA sales
    were AUD$25,436 representing a single dose of SIR-Spheres (R). June
    sales increased to AUD$70,372 then USA increased further in July to
    AUD$303,413. The company expects to invoice over AUD$400,000 of
    SIR-Spheres (R) in the USA for the month of August. The revenue base
    will expand further in the USA as more centres are established in the
    near future.

    The USA has already become the company's major source of revenue. The
    AUD$303,413 in sales for July from the USA has overtaken the total
    revenue from Asia Pacific that was AUD$92,350 for the same period.
    This illustrates the importance of the USA market to SIRTeX Medical's
    future success and validates management's focus in targeting this
    market.

    SIRTeX Medical will continue to roll out its technology to high
    profile cancer treatment hospitals in the USA. It is expected that
    the original first year target of training 10 centres will be
    exceeded within the next few months.

    EXTENDED INDICATIONS FOR SIR-SPHERES(R)

    Currently, SIR-Spheres(R) is indicated for the treatment of secondary
    liver cancer derived from the bowel in the USA. The company has an
    ongoing program to increase the ways SIR-Spheres(R) can be delivered
    and is used to treat a variety of cancers. To this end, company
    executives met with the Food and Drug Administration (FDA) on 2
    August 2002 to outline its recent phase II trial results. The small
    phase II trial showed that median survival of 10 patients treated
    with systemic chemotherapy alone was 12.8 months and this was
    extended to 27.1 months for the 11 patients treated with systemic
    chemotherapy and SIR-Spheres(R). Following that successful meeting, it
    was agreed that the company would now submit the results of this
    randomised trial to the FDA as a supplemental Pre-Market Approval
    (PMA) application. The supplemental application will request
    extension of the labelled indications-for-use of its SIR-Spheres(R)
    product in the USA to include the use of SIR-Spheres(R) together with
    systemic chemotherapy.

    SIRTeX Medical has also agreed to work with the FDA to design several
    new USA based clinical studies. These new studies will evaluate the
    efficacy of SIR-Spheres(R) in primary liver cancer and secondary liver
    cancer from neuro-endocrine cancer and pancreas cancer. As all three
    groups of patients have been successfully treated in Australia and
    Hong Kong, SIRTeX Management is confident that these new studies in
    the USA will be successful and will lead to the FDA granting further
    extensions to the indications-for-use of the product.

    INVESTOR UPDATE

    An update on the company will be presented at the AusBiotech 2002
    Annual Conference today in Melbourne. A copy of the presentation can
    be found on the companys website at www.sirtex.com.

    CN Sutton (PhD)
    CHIEF EXECUTIVE OFFICER



 
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