ValiRx Regulatory News (VAL)

15 May 2012

ValiRx Plc

("ValiRx" or the "Company")

New US Patent Grant for ValiRx's

Cancer Screening Gene Biomarker

ValiRx Plc (AIM: VAL), a life science company with a focus on cancer diagnostics and therapeutics for personalised medicine, is pleased to announce that a method for cancer screening, using specific gene biomarkers in the field of genetics and oncology, has recently received patent approval by the United States' patent office.

The granting of this latest patent means that ValiRx now has biomarker patent protection in both the US and across Europe, alongside granted and pending patents for its therapeutic technologies across Europe, the US, Canada and Australia.

This latest patent concerns the method or process by which gene biomarkers can be used in the detection or identification of a patient's susceptibility to cutaneous T-cell lymphoma (a type of non-Hodgkin's lymphoma) and also for improving treatment methods.

The use of biomarkers in oncology therapeutics is one of the fastest growing areas in cancer diagnosis and monitoring. In combination with specific therapeutic approaches,it is the growth of personalised medicine, particularly in cancer research, alongside support from regulatory agencies that are the key factors behind the increase in demand for biomarkers.

Personalised therapeutics are gaining popularity due to their ability to provide customised treatment to patients based on their genetic and medical profile. Since biomarkers help in predicting patient response to a compound, personalised medicines are increasingly using biomarkers to identify the patient population set that is more likely to respond to a particular drug therapy. Personalised medicines are also increasingly being used along with targeted cancer therapies and as personalised medicines gain more importance and popularity, the demand for suitable companion biomarkers is also expected to increase.

Dr Satu Vainikka, CEO, commented: "I am delighted we have received the US patent office's approval for our gene biomarkers' activity. This grant significantly strengthens our patent portfolio and it is a particularly pleasing endorsement, coming as it does from under the rigorous scrutiny of the US patent authorities. I am very pleased by the continuing validation of our technologies and of our approach to therapeutics and biomarkers themselves and I believe this patent grant further underlines the importance of a genetic approach to the management and detection of oncological diseases."

- ENDS -

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Notes for Editors

Background on Biomarkers (Sources: BCC Research and researchandmarkets 2010/2011)

Biomarkers in Cancer Research 2010 stated that the use of Biomarkers in Oncology Therapeutics is one of the biggest application areas with main emphasis on predictive and personalized medicine.

The global cancer biomarkers market for 2007 was estimated to be $3.6 billion and is expected to grow at a CAGR (Compounded Annual Growth Rate) of 6.3% to reach $6.3 billion by 2016.

This growth is primarily attributed to the rise in the number of biomarker tests in a wide variety of Cancer types.

In the future, the growth of personalized medicines and the strong support from regulatory agencies such as the FDA will be the two major factors that will drive the demand for biomarkers, particularly in cancer research.

Personalized medicines are gaining popularity due to their ability to provide customized treatment to patients based on their genetic as well as medical profile. Since biomarkers help in predicting patient response to a compound, personalized medicine are increasingly using biomarkers to identify the patient population set that is more likely to respond to a particular drug therapy. Personalized medicines are also increasingly being used in targeted cancer therapies. Thus, going forward, as personalized medicines gain more importance and popularity, the demand for biomarkers is also expected to increase.

ValiRx Plc

ValiRx Plc is a biopharmaceutical company developing novel technologies and products in oncology therapeutics and diagnostics. The product focus is in the epigenomic analysis and treatment of cancer, but the technologies can be applied to other fields as well, such as neurology and inflammatory diseases.

The Company listed on AIM in October 2006 and is creating a portfolio of innovative products through investment in specific development projects. It actively manages projects within this portfolio as a trading company and is not an investment vehicle. The ValiRx business model spreads the risks of life science technology developments by minimising financial exposure and running a set of projects to defined commercial endpoints. This maximises returns to shareholders by adding value at the earlier stages where value increases per investment unit are the greatest.

The Company operates through the following divisional companies:

·;  ValiMedix is the sales and distribution division of ValiRx

·;  ValiPharma is the therapeutics division with two embedded technologies primarily directed at the treatment of cancers. Of particular note is GeneICE, ValiRx's technology for controlling rebellious genes, which was awarded a Eurostars grant to the value of €1.2 million to fund the development of the GeneICE products through preclinical stages in cancer treatments