Initiation of Pilot Clinical Study

Oxford Pharmascience Group plc

("Oxford Pharmascience" or the "Company")

Initiation of Pilot Clinical Studyfor Reduced Gastro-Intestinal Irritation Ibuprofen

Oxford Pharmascience Group plc (AIM: OXP), the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, today announces the initiation of dosing in its second pilot clinical study of 400mg OXPzeroTM Ibuprofen (OXP001). 

OXP001 is an optimised, chewable, 400mg ibuprofen tablet that is expected to reduce the risk of gastro-intestinal ("GI") irritation from the ibuprofen and to taste-mask its bitter taste via OXP's patent protected OXPzero™ technology. Patient compliance to long-term therapy for chronic illnesses is a key issue and is reported to be around only 50% in developed countries.1 Providing patients with a gastro-intestinally safe treatment option, delivered in an easier to take dosage form, is believed to be a significant advantage in the non-steroidal anti-inflammatory drug (NSAID) treatment arena. The Company believes this would lead to improved patient compliance amongst long-term usage patients.

Last year the Company announced results from the first pilot study with a non-optimised OXP001 tablet. Results showed a significant reduction in gastro-intestinal irritation with OXP001 compared to Brufen®, however the pharmacokinetic profile of OXP001 showed a slower and incomplete release of ibuprofen. The OXPzeroTM Ibuprofen and the tablet formulation have since been optimised to provide immediate and complete drug release in vitro. This second proof-of-concept study is designed to compare the pharmacokinetic profile of OXP001 immediate release tablets with generic Brufen®, and to confirm the reduction in gastro-intestinal irritation as measured by endoscopy.

The Company also reports that headline data from the recently conducted pilot clinical study with OXPzeroTM Naproxen (OXP005) will be available by the end of July 2015. Further details will be published in due course.

NSAIDs are one of the most widely used classes of drugs, with combined annual sales in excess of $12bn2 and more than 30 million users worldwide consuming NSAIDs each day3. Ibuprofen is currently the dominant NSAID molecule in the pain relief and anti-inflammatory sector. Worldwide sales of Ibuprofen are in excess of $4bn per annum at manufacturers selling prices2. Chronic use of NSAIDs causes well-documented GI side effects, including ulcers and bleeding, and leads to significant morbidity and mortality in a substantial number of patients, with significant associated healthcare costs. The OXPzero™ platform technology reduces these risks and is being selectively applied to the most commonly used NSAID molecules, namely ibuprofen, naproxen and diclofenac for pain and inflammation and aspirin for primary and secondary prevention of cardiovascular disease.

Marcelo Bravo, Chief Executive Officer, commented:

 "We are pleased to have overcome the significant technical hurdles in the development of an immediate release, chewable, taste masked OXPzeroTM Ibuprofen tablet. Progressing this optimised OXP001 product to the clinic will provide the data to confirm further the benefits of the OXPzero™ technology including reduced GI irritation."

Sources

1. WHO Report "Adherence to long-term therapies. Evidence for action." 2003.

2. Evaluate Pharma

3. Black Swan Analysis Ltd - Market Evaluation for OXPzero™ technology to improve compliance with leading NSAID brands, November 2013 (commissioned by OXP)

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About Oxford Pharmascience Group Plc

Oxford Pharmascience Group Plc uses a range of proprietary technology platforms to re-develop existing medicines to make them better, safer or easier to take. The Company does not manufacture or sell its own pharmaceutical products direct to consumers but instead seeks to license its technologies and dossiers to a network of partners, mainly leading pharmaceutical companies with Rx (prescription) and OTC (Over the Counter) branded portfolios.

Oxford Pharmascience Group Plc focuses on existing medicines that are proven to be safe and effective but nevertheless still have associated issues and side effects often affecting compliance. By working with such medicines the Company is able to develop new innovative products for a fraction of the cost, in much quicker timescales and without the high risk of failure associated with developing new drugs.