Business Strategy

Ark focuses on areas of clear unmet need where effective new products can gain rapid market acceptance. Its strategy is to work in specialist areas of medicine, where marketing and clinical trial costs are generally lower than in non-specialist areas. Our strategy is to select key lead candidates where it is possible to fund the clinical development through to regulatory approval and also to take a leadership role in marketing them using a small sales force approach. Ark pursues an international operating strategy. Its headquarters are in London, and it has research laboratories and manufacturing facilities in Finland. Ark carries out clinical development in Europe and the US, where marketing authorisation provides access to at least 70 per cent. of the world market for new biotechnology drugs.

Development strategy
Ark targets high value indications where Orphan Drug Status or Fast Track Designation is likely. Achievement of these gives a range of financial and regulatory benefits in bringing products to market and commercialising them thereafter. Orphan Drug Status affords Ark practical and financial assistance with the regulatory approval process and facilitates the appropriate clinical trial design where possible incorporating surrogate end points. Fast Track Designation gives a considerably shortened approval time and aids access to the rolling marketing authorisation review process. We have received Orphan Drug Status or Fast Track Designation for three of our clinical stage products.

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Commercialisation strategy
The company’s products are being developed to address clear unmet clinical need in areas of specialist medicine. The company intends to market certain of its key products itself while securing marketing/distribution partners for others. For specialist products, Ark's strategy is to use small, targeted sales forces to promote to physicians in the small number of key hospitals which have “specialist centres” throughout the US and Europe. These hospitals are readily identifiable and have wide patient catchment areas allowing significant sales to be generated form relatively few market entry points. We intend to enter into agreements with pharmaceutical companies or CSOs on a fee-for-service basis to achieve higher penetration in particular markets.

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Manufacturing strategy
Ark’s strategy is to manufacture its gene-based medicines (including Cerepro® and Trinam®) in-house and to outsource the production of its other products to third parties. There are a number of well-established contract manufacturing companies who are able to manufacture such products effectively for the Group. The manufacturing of Kerraboot® is currently being outsourced to Flexicare Medical Limited in the UK.

Ark has a GMP manufacturing facility in Kuopio, Finland with one suite (GMP1) operating at Biosafety level 3 and a second suite (GMP2) at Biosafety level 2. The facility enables the manufacturing of DNA plasmid, adenoviral, retroviral and lentiviral vectors for injection. In 1998 and 2000 the GMP1 suite was approved by the Finnish National Agency for Medicines for the manufacture of injectable gene-based medicines for Phase I and II trials.

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