Oxford Pharmascience, the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, today announces it has received pre-IND scientific advice from the FDA (US regulatory authority) regarding the development programme requirements likely to be needed to support a future new drug application ("NDA") in the US for an OTC product containing OXPzero™ Ibuprofen. Key points from the advice are:
The Company is pleased that OTC formulations of OXPzero™ Ibuprofen can, in principle, be registered in the US with relatively low cost and low risk pharmacokinetic data.
Subject to completion of the planned demerger (as announced on 10 November 2017 and described in detail in the Circular sent to shareholders on the same date), the OXPzero™ platform will be owned by the separate private entity, Oxford Pharmascience Limited ("OPL") (currently a subsidiary of the Company). OPL will continue with the ongoing commercialisation of the OXPzero™ platform assets in both OTC and prescription markets.
Marcelo Bravo, Chief Executive Officer of Oxford Pharmascience, commented:
"This FDA advice underpins our product development strategy for the US OTC market and it is encouraging that our novel, taste-masked OXPzero™ Ibuprofen formulations can be developed for approval in the US without the need for costly Phase III trials."
For further information:
|Oxford Pharmascience Group Plc|
|Marcelo Bravo, Chief Executive
Chris Hill, Chief Financial Officer
|+44 20 7554 5875|
|N+1 Singer (Nominated Adviser & Broker)|
|Aubrey Powell/Jen Boorer||+44 20 7496 3000|