PVG.L Regulatory News (PVG)

ARK THERAPEUTICS GROUP PLC

Ark's newest manufacturing suite receives GMP approval

London, UK - 25 April 2012: Ark Therapeutics Group plc ("Ark" or the "Company") is pleased to announce that following inspection of the Company's manufacturing site, the Finnish Medicines Agency (FIMEA) has extended Ark's Good Manufacturing Practice (GMP) certification to include the Company's newest and largest production facility, GMP 3. The certification will greatly increase the Company's manufacturing capacity, including an automated "fill and finish" line capable of handling up to 2,000 product units/hour.

GMP 3 encompasses an area of 650m2 designed for larger scale production from suspension cell cultures utilizing state-of-the-art single use systems. Ark's other two suites GMP 1 and GMP 2 were originally approved by FIMEA in late 2005 and 2008 respectively. GMP1 is the first ever facility to receive regulatory approval to manufacture adenoviral gene-based medicines for commercial supply in Europe. The work to complete the validation of GMP 3 was supported by a grant from the Finnish governmental organization Centre for Economic Development, Transport and the Environment (ELY-centre).

In response to growing demand for the Company's bio-manufacturing expertise, earlier this month Ark appointed Dr David Venables to the Board as Executive Director - Manufacturing Services. David has extensive industry experience and is responsible for building Ark's manufacturing services business. David's appointment combined with Ark's unrivalled viral-based manufacturing expertise and facilities uniquely positions the Company to capture a greater share of this market and increase its client base.

David Venables, Ark's Director of Manufacturing Services commented: 

 "The availability of the GMP 3 suite will allow us to continue to attract high quality clients wishing to avail themselves of Ark's unrivalled viral-based manufacturing expertise and facilities. At a time when I have been brought in to build the revenue generating aspect of this business I am very excited by this newly validated capacity coming on-line."

Martyn Williams, Chief Executive Officer of Ark commented: 

"The extension of our GMP certification together with David's arrival are key steps forward in the next phase of Ark's development providing us with a facility which will directly benefit both Ark's own programmes and those of an increasing number of our third party clients."

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Ark Therapeutics Group plc

Ark Therapeutics Group plc is an innovative gene-based medicine company with operations in the UK and Finland that seeks to capitalise through partnerships on its pipeline of programmes in high value areas of unmet medical need within vascular disease and cancer, and to exploit its unrivalled viral manufacturing capability based in Kuopio, Finland. Ark Therapeutics' biological manufacturing operations provide process development and manufacturing for a growing number of third party clients for a variety of stages of therapeutic development, as well as for its own internal programmes.

Ark's research is focused on discovering new approaches to gene delivery using viral vectors with particular emphasis on genes that control tissue vascularisation, especially VEGF, and is based on the work of its two world-leading research centres in Kuopio and London. The Finnish group is led by Professor Seppo Ylä-Herttuala and is expert in the exploitation of viral technology to address serious medical problems, while Professor John Martin leads a team in London who have complementary skills in the understanding of biological structures and the development of small molecule agonists and antagonists. This combination of skills has resulted in Ark identifying and bringing forward a number of attractive programmes in gene therapeutics and small molecules.

Ark's shares were first listed on the London Stock Exchange in March 2004 (AKT.L).

This announcement includes "forward-looking statements" which include all statements other than statements of historical facts, including, without limitation, those regarding the Group's financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to the Group's products and services), and any statements preceded by, followed by or that include forward-looking terminology such as the words "targets", "believes", "estimates", "expects", "aims", "intends", "will", "can", "may", "anticipates", "would", "should", "could" or similar expressions or the negative thereof. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors beyond the Group's control that could cause the actual results, performance or achievements of the Group to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Such forward-looking statements are based on numerous assumptions regarding the Group's present and future business strategies and the environment in which the Group will operate in the future. Among the important factors that could cause the Group's actual results, performance or achievements to differ materially from those in forward-looking statements include those relating to Ark's funding requirements, regulatory approvals, clinical trials, reliance on third parties, intellectual property, key personnel and other factors. These forward-looking statements speak only as at the date of this announcement. The Group expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained in this announcement to reflect any change in the Group's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, readers are cautioned not to rely on any forward-looking statement.