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Friday, May 16, 2008 8:38:57 AM
re Ark therapeutics -- Update
http://finance.yahoo.com/q?s=akt.l
Ark Therapeutics Group plc
Interim Management Statement
16 May 2008 Ark Therapeutics Group plc ('Ark' or the 'Company') today publishes its first interim management statement for the period 1 January 2008 to date. The Company intends to report its results for the six months to 30 June 2008 on 27 August 2008.
The overall performance of the business during the period has been in line with the Board's expectations.
Highlights
* Timing of Phase III Cerepro® preliminary results confirmed for Q3 2008
* Good progress made towards start of Phase III trials for Trinam® and VitorTM
* Acquisition of Lymphatix Oy strengthens gene technology research and secures access to VEGF C and VEGF D genes
* Positive opinion letter received from EMEA for Cerepro® Paediatric Investigation Plan
* Finnish manufacturing facility completes validation review to USA standards
* Ark products win inclusion on new NHS Advanced Woundcare Therapies Contract
* Neuropad® in-licensed and launched in the UK
Clinical Programmes
In Cerepro®, the major breakthroughs we achieved in 2007 with the key technical sections of the submission - CMC, pre-clinical and environmental - enable us to contemplate the filing of an application for a full licence once the results of the Phase III corroborative study are available in Q3 2008. In the meantime, work on the Finnish expanded manufacturing facilities, commercial-scale production process and sales and marketing infrastructure have proceeded.
Discussions with the regulators during the period concerning the Phase III trials for Trinam® and VitorTM have remained positive and we anticipate being cleared to start both trials by mid-year.
Pre-clinical Programmes
The acquisition of Lymphatix Oy in January has enabled us to accelerate our plans for a number of VEGF D-based pre-clinical programmes for which clone selection and planning for toxicity studies are well-advanced.
Woundcare
The good growth seen in our woundcare sales in 2007 has been maintained in the opening months of 2008. The inclusion of Ark's products on the new NHS Advanced Woundcare Therapies Contract and the recent launch of Neuropad® give us further confidence for the future success of this business.
Intellectual Property Portfolio
We have made continued progress in taking our key patents through the international prosecution process. Further progress has been made towards the commercialisation of the 'ACE Stroke' patent and the Company continues to receive enquiries concerning licensing of other intellectual property in Ark's portfolio.
Cash
As we reported in our 2007 annual results announcement, the Company had £65.1m in cash and money market investments at 31 December 2007. Cash usage in the business in the opening months of 2008 has been in line with the Board's expectations and Ark remains well-funded to build on its leading position in the gene therapy area. There have been no other significant changes in the position of the Company over the period since publication of the report and accounts for the year ended 31 December 2007.
Nigel Parker, CEO of Ark, commented:
"The progress achieved in our business in 2007 has continued in the opening months of this year. In our three late-stage clinical programmes, Cerepro® Phase III trial results have been confirmed for the third quarter and progress has been made towards starting the Phase III trials for Trinam® and VitorTM. We have commenced work to bring a number of our pre-clinical programmes through the late stage pre-clinical work prior to taking three of them into Phase I trials. I am delighted that the sales growth in our woundcare business reported in our 2007 annual results has been maintained in the period. With our broad range of products and strong cash position, we are well placed to continue meeting the objectives we have set."
http://finance.yahoo.com/q?s=akt.l
Ark Therapeutics Group plc
Interim Management Statement
16 May 2008 Ark Therapeutics Group plc ('Ark' or the 'Company') today publishes its first interim management statement for the period 1 January 2008 to date. The Company intends to report its results for the six months to 30 June 2008 on 27 August 2008.
The overall performance of the business during the period has been in line with the Board's expectations.
Highlights
* Timing of Phase III Cerepro® preliminary results confirmed for Q3 2008
* Good progress made towards start of Phase III trials for Trinam® and VitorTM
* Acquisition of Lymphatix Oy strengthens gene technology research and secures access to VEGF C and VEGF D genes
* Positive opinion letter received from EMEA for Cerepro® Paediatric Investigation Plan
* Finnish manufacturing facility completes validation review to USA standards
* Ark products win inclusion on new NHS Advanced Woundcare Therapies Contract
* Neuropad® in-licensed and launched in the UK
Clinical Programmes
In Cerepro®, the major breakthroughs we achieved in 2007 with the key technical sections of the submission - CMC, pre-clinical and environmental - enable us to contemplate the filing of an application for a full licence once the results of the Phase III corroborative study are available in Q3 2008. In the meantime, work on the Finnish expanded manufacturing facilities, commercial-scale production process and sales and marketing infrastructure have proceeded.
Discussions with the regulators during the period concerning the Phase III trials for Trinam® and VitorTM have remained positive and we anticipate being cleared to start both trials by mid-year.
Pre-clinical Programmes
The acquisition of Lymphatix Oy in January has enabled us to accelerate our plans for a number of VEGF D-based pre-clinical programmes for which clone selection and planning for toxicity studies are well-advanced.
Woundcare
The good growth seen in our woundcare sales in 2007 has been maintained in the opening months of 2008. The inclusion of Ark's products on the new NHS Advanced Woundcare Therapies Contract and the recent launch of Neuropad® give us further confidence for the future success of this business.
Intellectual Property Portfolio
We have made continued progress in taking our key patents through the international prosecution process. Further progress has been made towards the commercialisation of the 'ACE Stroke' patent and the Company continues to receive enquiries concerning licensing of other intellectual property in Ark's portfolio.
Cash
As we reported in our 2007 annual results announcement, the Company had £65.1m in cash and money market investments at 31 December 2007. Cash usage in the business in the opening months of 2008 has been in line with the Board's expectations and Ark remains well-funded to build on its leading position in the gene therapy area. There have been no other significant changes in the position of the Company over the period since publication of the report and accounts for the year ended 31 December 2007.
Nigel Parker, CEO of Ark, commented:
"The progress achieved in our business in 2007 has continued in the opening months of this year. In our three late-stage clinical programmes, Cerepro® Phase III trial results have been confirmed for the third quarter and progress has been made towards starting the Phase III trials for Trinam® and VitorTM. We have commenced work to bring a number of our pre-clinical programmes through the late stage pre-clinical work prior to taking three of them into Phase I trials. I am delighted that the sales growth in our woundcare business reported in our 2007 annual results has been maintained in the period. With our broad range of products and strong cash position, we are well placed to continue meeting the objectives we have set."
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