9 December 2008 - Ark Therapeutics Group plc (“Ark” or the “Company”) announces today that the Finnish National Agency for Medicines (NAM) has renewed Ark’s licence to produce gene-based medicine for commercial supply in Europe. The renewed Good Manufacturing Practice (GMP) certification has been extended to include the Company’s second Finnish production unit (GMP 2) which doubles Ark’s production capacity and greatly increases its manufacturing flexibility.
Ark’s first Finnish facility (GMP 1) was approved by NAM in late 2005 as the first ever facility to be allowed to manufacture adenoviral gene-based medicines for commercial supply in Europe. Ark has a third facility, GMP 3, which was opened in July 2008. This facility currently produces research grade gene material and will be validated and certified according to evolving needs.
Ark’s manufacturing facilities are based in Kuopio, Finland and are operated and maintained by Ark Therapeutics Oy, a wholly owned subsidiary within the Ark Therapeutics group of companies.
Robert Shaw, Technical Director at Ark, commented: “This renewal and extension to cover GMP 2 demonstrates not only the Company’s ability to consistently sustain the high operating standards necessary to maintain a Biosafety level 2 facility but also that Ark is able to fit out and achieve the equivalent engineering validations and documentation standards in a separate theatre.”
Dr Nigel Parker, CEO of Ark commented: “We are very pleased to receive this renewal and certificate extension which significantly increases Ark’s manufacturing and filling flexibility. GMP 1 will now be dedicated to manufacturing Cerepro® for commercial supply. Subject to positive pre-approval inspections of an individual product’s dedicated production line, we can now manufacture and fill a number of gene-based products for commercial supply as well as supplies for all phases of clinical trials.”
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.
