PVG.L Regulatory News (PVG)

Laurantis Pharma and Ark Therapeutics Sign Manufacturing Agreement for Production of LymfactinTM Investigational Treatment for Breast Cancer-Associated Lymphedema

15 October 2012, London, UK Ark Therapeutics has been selected to manufacture and supply LymfactinTM to Laurantis Pharma under a conditional agreement announced today by the Finland-based companies. The agreement is subject to Laurantis receiving regulatory approval to commence its phase I clinical trial. Specific terms of the agreement are not disclosed. LymfactinTM uses an adenoviral vector to deliver vascular endothelial growth factor (VEGF-C) during transplantation of lymph nodes in order to avoid lymphedema.

The phase I clinical trial using LymfactinTM to treat breast cancer-associated lymphedema is targeted to begin in 2013, and will recruit patients in the USA and Finland. Breast cancer-associated lymphedema is the most common form of secondary lymphedema, occurring in approximately 20% of breast cancer patients who undergo axillary lymph node dissection. The incidence is even higher in those who also receive radiotherapy, and this complication may even occur in those who undergo a lymph node biopsy as part of treatment. No therapeutic treatment currently exists to treat this disease.

In the US, approximately 110,000 patients are living with breast cancer-associated lymphedema, and nearly 15,000 new patients develop the complication each year. The number of lymphedema patients in Europe is estimated to be roughly the same as in the US.

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About Laurantis Pharma Oy

Based in Turku, Finland, Laurantis is a privately held clinical-stage biotechnology company with a broad portfolio of first-in-class products based on two proprietary technologies. The Company's pipeline includes proprietary and patent-protected formulations and applications of cis-urocanic acid, a locally acting anti-inflammatory and anti-proliferative agent for the treatment of Atopic Dermatitis, Dry Eye, Interstitial Cystitis, and Bladder Cancer. Laurantis is also developing Lymfactin™, a vascular endothelial growth factor C (VEGF-C) in an adenoviral vector, as a gene therapy product for the treatment of secondary lymphedema.

About Ark Therapeutics Group plc

Ark Therapeutics Group plc is a leading viral product focused contract development and manufacturing services company with world-class viral research, development and GMP manufacturing operations in Finland and the UK. Ark's business model is to offer product development and GMP manufacturing contract services for viral products, including the areas of viral mediated gene therapy, oncolytic viral vaccines, live and attenuated viral vaccines, viral vectored vaccines and virus like particles. Ark's capabilities span from translational research through preclinical and clinical product development, in addition to process and analytical development, GMP manufacture and sterile filling from pre-clinical through to commercial product supply. These capabilities have been established through the development of Ark's own products through to Marketing Authorisation Application registered with the European Medicines Agency. Following a change in business strategy in 2011, Ark is now building its business through contract development and manufacturing services and is seeking external partners to advance those products it previously had under development.

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.