Oxford Pharmascience, the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, today announces it has received scientific advice from the MPA (Swedish regulatory authority) regarding the development programme requirements likely to be needed to support a future marketing authorisation application ("MAA") in Sweden for an OTC product containing OXPzero™ Ibuprofen. Key points from the advice are:
The Company is pleased that OTC formulations of OXPzeroTM Ibuprofen can in principle be registered with relatively low cost and low risk pharmacokinetic data in Sweden and potentially in other EU countries (subject to further scientific advice discussions and MAAs to be filed with regulators in the those countries). Advice on the US development requirements is expected from FDA in the coming weeks.
Should the proposed demerger (as announced on 10 November 2017 and described in detail in the Circular sent to shareholders on the same date) complete, the OXPzeroTM platform will be owned by the separate private entity, Oxford Pharmascience Limited (currently a subsidiary of the Company).
Marcelo Bravo, Chief Executive Officer of Oxford Pharmascience, commented:
"The MPA advice has been very informative to us as we map out our portfolio product development strategies and it's pleasing to know that novel, taste-masked OXPzeroTM Ibuprofen formulations can be developed for approval in Sweden without the need for costly Phase III trials. This gives us encouragement that, subject to further scientific advice discussions with relevant country regulators and the acceptance of marketing authorisation applications by the same bodies when filed, a similar approach may be acceptable in other EU countries."
For further information:
|Oxford Pharmascience Group Plc|
|Marcelo Bravo, Chief Executive||+44 207 554 5875|
|Chris Hill, Chief Financial Officer|
|N+1 Singer (Nominated Adviser & Broker)|
|Aubrey Powell/Jen Boorer||+44 20 7496 3000|