Wait a bit longer RNS2 Oct 2017 11:23
2 October 2017
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Oxford Pharmascience Group plc
("Oxford Pharmascience" or the "Company")
MHRA Advice on OXPzeroTM Ibuprofen OTC Opportunity
Oxford Pharmascience, the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, today announces it has received written advice from the MHRA (UK regulatory authority) regarding a possible application for marketing authorisation for an OTC product under development containing OXPzeroTM Ibuprofen.� Key points from the advice are:
������ The application can be submitted as a hybrid application (under article 10(3) of Directive 2001/83/EC), bridging to the well-established safety and efficacy of the reference product.
������ The MHRA did not consider the OXPzeroTM Ibuprofen product to be bioequivalent to the reference due to faster Tmax (time to maximum concentration) compared to the reference product.
������ While the earlier Tmax of the OXPzeroTM Ibuprofen product is believed by the Company to be advantageous for onset of efficacy, due to the Tmax not sufficiently matching reference, the MHRA requires additional clinical data on safety and efficacy to support the marketing authorisation application.
Following receipt of the latest regulatory feedback from the MHRA, the Company is pleased to note that the hybrid application route can be used to register the product. However, the requirement for further clinical safety and efficacy data (in the absence of bioequivalence) may affect the economic viability of the programme. �
A decision is required regarding whether to invest in the above additional clinical work or to embark on other further development to match the reference within the required range for bioequivalence. Before deciding how best to take the programme forward, the Company will seek further regulatory agency advice in different jurisdictions and is now in the process of preparing for scientific advice meetings with the MPA (Swedish regulatory agency) and the US FDA. �Additionally, the Company may also seek advice from other EU agencies if considered necessary.
At present the Company has suspended development activities while the Board concludes a strategic review to assess how to best realise the value of the Company's assets at the present time and/or how to best obtain better value from these assets over time.� The Company will confirm the Board's findings as soon as conclusions have been reached.
Marcelo Bravo, Chief Executive Officer of Oxford Pharmascience, commented:
"We have received very positive consumer research results on our lead OTC programme, but need to better understand the regulatory pathway to product approval in key markets before proceeding with further development. The MHRA advice has been very informative to us as we map out ou
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