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    Corporate Responsibility Careers Newsroom News Archive Subscribe to News Alert Search News by Date Contact CSL Home Newsroom News Archive CSL Limited today announced its first half result for period ended 31 December 2005 CSL Limited today announced its first half result for period ended 31 December 2005 Melbourne Australia 22 02 2006 CSL Limited today announced its first half result for period ended 31 December 2005 and forecast a

    Original URL path: http://www.csl.com.au/s1/cs/auhq/1196562649899/news/1196562740245/prdetail.htm (2014-01-05)
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    announced plans to introduce its influenza vaccine into the U S market Speaking at Merrill Lynch s Global Pharmaceutical and Biotechnology Conference in New York CSL Chief Executive Officer and Managing Director Dr Brian McNamee said CSL is the leading producer of influenza vaccine in the Southern Hemisphere and has a long heritage in biological research and manufacture With the planned expansion of our influenza vaccine production capabilities we look forward to working with the Food and Drug Administration FDA on the licensing of our vaccine in the U S Dr McNamee announced a 80 million investment in plant and equipment to double capacity at its Melbourne facility to approximately 40 million doses per season making it one of the largest vaccine manufacturing plants in the world This will increase the diversity of supply in the U S helping to meet the public health need for vaccinations identified by the Centres for Disease Control and Prevention and other policy makers Dr McNamee added CSL plans to initiate a human clinical study of the vaccine in the US later this year and submit a Biologics License Application BLA to the FDA within 12 months for both multi dose vial and thiomersal

    Original URL path: http://www.csl.com.au/s1/cs/auhq/1196562649899/news/1196562740185/prdetail.htm (2014-01-05)
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    of GARDASIL has also been submitted to the TGA Once GARDASIL has been granted registration the world s first vaccine specifically developed to prevent a cancer will be made available to the Australian public Part of the submission to TGA included clinical trial data from Australian women Phase III data showed that GARDASIL prevented 100 per cent of high grade cervical pre cancers and non invasive cervical cancers CIN 2 3 and AIS associated with human papillomavirus HPV types 16 and 18 The Human papillomavirus types 6 11 16 and 18 in the vaccine are the most common types affecting women s health and cause 70 of cervical cancer and account for a significant proportion of abnormal pap tests Dr Andrew Cuthbertson Chief Scientific Officer at CSL Limited said today that he was keen to see the vaccine made available to Australian women as soon as possible A preventative vaccine complimented by regular pap tests will be a major leap forward in eradicating this disease Dr Cuthbertson said In Australia there are approximately 15 000 women each year who are detected with high grade cervical abnormalities on histology These abnormalities require surgical treatment to remove part of the cervix causing

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    Subscribe to News Alert Search News by Date Contact CSL Home Newsroom News Archive CSL Announces Application for Licensure of Gardasil by Merck Co Inc CSL Announces Application for Licensure of Gardasil by Merck Co Inc Melbourne Australia 06 12 2005 CSL Limited announced today that its licensee Merck Co Inc has submitted a Biologics License Application BLA for GARDASIL quadrivalent human papillomavirus types 6 11 16 18 recombinant vaccine to the U S Food and Drug Administration FDA on December 1 2005 CSL noted that within 60 days following submission the FDA will determine whether it will accept the BLA for review Merck has advised that it is seeking priority review designation for GARDASIL which means that it is possible that the FDA could register GARDASIL within six months of receipt CSL also confirmed plans to file for the registration of GARDASIL with the Australian Therapeutic Goods Administration in December 2005 with applications for registration being filed in Europe and other countries by Merck in December 2005 and early 2006 CSL announced in October 2005 that in Phase III clinical trials GARDASIL had prevented 100 of high grade cervical pre cancers and non invasive cervical cancers associated with human

    Original URL path: http://www.csl.com.au/s1/cs/auhq/1196562649899/news/1196562810117/prdetail.htm (2014-01-05)
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    GARDASIL to placebo in women who were not infected with HPV 16 and 18 at enrolment and who remained free of infection through the completion of the vaccination regimen A secondary analysis of the trial data demonstrated that even trial women who may have become infected with HPV16 or 18 during the vaccination period or who violated the protocol in significant ways were at a reduced risk of developing high grade pre cancer and non invasive cervical cancer The Company noted that Merck remained on track to submit a Biologics Licence Application for GARDASIL to the Food and Drug Administration FDA in the fourth quarter of 2005 with the Australian regulatory file being submitted to the Therapeutic Goods Administration TGA soon thereafter These results could not be better Dr Brian McNamee Managing Director of CSL Limited said today They show that prophylactic vaccination with GARDASIL comprehensively eliminates HPV 16 and 18 related cervical pre cancer and non invasive cervical cancer CSL is proud of the development of this investigational vaccine from discovery of the fundamental technology by Professor Ian Frazer of the University of Queensland in 1991 to its potential filing for approval for international marketing by Merck Co Inc The success of this phase III trial validates CSL s commitment to realizing the potential of Australia s first class scientific base and represents a further step in recognising the value of our R D portfolio Dr McNamee said The Company advised that more than 12 000 women from 13 countries worldwide participated in the trial Women received three doses of either the investigational vaccine or placebo over a six month period and were subsequently tested for signs of cervical cancer or pre cancerous lesions over a two year period The Company commented that the technology licensed by CSL to

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    Plasma Germany About CSL Our Businesses Our Products Research and Development Business Development Investors Corporate Responsibility Careers Newsroom News Archive Subscribe to News Alert Search News by Date Contact CSL Home Newsroom News Archive CSL Announces 2005 Full Year Results CSL Announces 2005 Full Year Results Melbourne Australia 24 08 2005 CSL today announced its operational results for the full year ended 30 June 2005 Download this release CSL Announces

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    options to Merck in a number of fields for the use of CSL s ISCOMATRIX adjuvant in Merck s pipeline of investigational vaccine products This agreement builds upon the considerable investment and commitment that CSL has made in this technology in the last 10 years said Dr Andrew Cuthbertson Chief Scientific Officer at CSL He added CSL has developed proprietary industrial scale processes for the manufacture of ISCOMATRIX adjuvant including a fractionation process for the critical saponin components Merck s continued and serious commitment as a leader in the area of vaccines is driven by the magnitude of the unmet medical need in both infectious and non infectious diseases This latest collaboration with CSL underscores our significant research and development commitment to this area by pursuing the use of the ISCOMATRIX adjuvant across a range of investigational vaccine programs at Merck said Dr Mervyn Turner Senior Vice President of Worldwide Licensing and External Research for Merck Further this agreement highlights our continued belief in the importance of accessing the most promising new technologies from outside Merck that complement our existing pipeline Dr Turner added We look forward to a fruitful collaboration with CSL Under the terms of the agreement CSL

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    buyback and we are committed to managing the company s capital structure to the best advantage of our shareholders which includes retaining a prudent level of gearing The buyback will improve investment return rations such as earnings per share and return on equity and all shareholders will benefit Dr McNamee went on to say Combined with the buyback completed in May of this year it is very likely that we will have returned to shareholders in excess of the 550m we raised to acquire the global plasma therapeutics business of Aventis Behring in December 2004 At the same time the market value of CSL has more than doubled since making the announcement to acquire the business The Company pointed out that shares would be purchased during a twelve month period commencing 12 July 2005 OUTLOOK The company reaffirmed its outlook statement made of the 15 th of April 2005 that net profit after tax for 2004 05 would be between 270 and 295 million 2 with a result towards the upper end of this range largely dependent upon selling a higher amount of inventory acquired at a discount from Aventis Behring Download this release Further Share Buyback Announced For further

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