Press release post MHRA

Oxford PharmaScience progresses towards clinical pilot study having taken advantage of the MHRA Scientific Advice Scheme and appoints Quotient Clinical to undertake its early clinical development program

Oxford Pharmascience, the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, today announces that it has reviewed its proposed initial clinical development of its GI Safe Ibuprofen Tablet with the MHRA using the Scientific Advice Scheme* and has appointed Quotient Clinical, a well-established business with expertise in supporting clients to optimise oral drug products, as it proceeds through the regulatory process for a clinical pilot study.

The Company recently announced it had completed formulation of "Gastric Safe" 400mg Ibuprofen tablets applying its proprietary OXPzero™ technology and it was proceeding towards clinical pilot testing. A critical milestone for the Company was to seek feedback on the proposed clinical programme via a "Scientific Advice" meeting with the MHRA. Following successful completion of this milestone, the Company has appointed Quotient Clinical as its clinical partner to run the initial pilot study which aims to demonstrate proof of concept of reduced gastrointestinal side effects.

NSAIDs are one of the most widely used classes of drugs, with more than 30 million users worldwide consuming NSAIDs each day and annual sales of $12 billion. NSAIDs however cause well documented GI side effects which include ulcers and bleeding and lead to significant morbidity and mortality in many patients. The company is applying its OXPzero™ technology to develop safer formulations of broadly used NSAIDs such as ibuprofen, naproxen, diclofenac and aspirin.

Marcelo Bravo, Chief Technology Officer of Oxford Pharmascience commented, "Participating in the Scientific Advice programme of the MHRA and appointing Quotient Clinical are key milestones that enables us to proceed with confidence to the next stage. We plan to submit the application for the pilot clinical trial early in the New Year with subject screening to start in Q1".

Mark Egerton, Chief Executive Officer, Quotient Clinical commented "Quotient is delighted to be working with Oxford Pharmascience to investigate the potential for the OXPzero™ technology to deliver products with better safety profiles, which will represent a significant step forward for patients."

*Companies seeking scientific advice should note that any scientific advice given is not legally binding with regard to any future application of the product concerned, neither on the part of MHRA/CHM nor on the company. Furthermore, advice cannot be taken as indicative of any future agreed position