Oxford Pharmascience progressing ibuprofen plans

Specialty pharmaceutical redevelopment company Oxford Pharmascience Group updated the market on Thursday regarding its clinical and commercial plans, centred on its OXPzero non-steroidal anti-inflammatory drug (NSAID) portfolio.

The AIM-traded firm said that, with regards to over-the-counter products, it was proceeding to develop selected products with the intention to register for approval those which had a compelling business case, lower clinical risk and a simple regulatory pathway.

It said a lead OTC programme had already been initiated, with further market research also being initiated to validate and prioritise other compelling OTC opportunities.

“As announced on 9 May, the company considers that the regulatory path to approval for products without a GI safety claim in the US and UK/EU provides an attractive, low-risk route to market for a number of its pipeline OXPzero products,” the board explained.

“Having established that it can develop OXPzero ibuprofen products that are bioequivalent to reference products, the company sees opportunity to progress selected ibuprofen-based, taste masked products to the OTC market.

“The company is initiating market research in Europe and the US to validate the most attractive opportunities and has already identified and started work on a lead programme.”

In prescription-based products, Oxford said commercialisation efforts were underway for candidates in selected regions with “favourable regulatory frameworks”.

Further clarification was to be sought from regulatory agencies for gastrointestinal symptoms endpoint and the regulatory pathway.

“For Rx markets, the company's technology provides several, clinical-stage, high-value candidates available for licensing which solve key unmet needs across multiple pain markets.

“Our OXPzero products are clinically proven to have fewer GI side effects compared to standard form NSAIDs, enhancing safety and simplifying therapy,” the board explained.

“OXPzero Ibuprofen is demonstrably faster - and at the same time with fewer / reduced GI side effects - than standard ibuprofen tablets, providing faster onset and potentially faster pain relief.”

On the funding front, the company said it had a “strong” capital base to support its strategic objectives.

“The company maintains a strong capital base which supports the attainment of the group's strategic objectives, with cash balances of £21.5m as at 30 April.”