RNS Number : 5992V
Oxford Pharmascience Group PLC
19 April 2016
Oxford Pharmascience Group plc
("Oxford Pharmascience" or "the Company")
Oxford Pharmascience Announces Positive Regulatory Advice from MHRA on OXPzeroTM NSAIDs programme
Oxford Pharmascience, the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, announces that it has received clear and positive feedback from the Medicines & Healthcare products Regulatory Agency (MHRA) on the UK regulatory pathway to obtain marketing authorisation for OXPzeroTM Ibuprofen.
The Company currently has OXPzeroTM variants of two non-steroidal anti-inflammatory drug (NSAID) molecules in clinical development, OXPzeroTM Ibuprofen and OXPzeroTM Naproxen. These leverage the company's proprietary technology platform which aims to mask the bitter taste and irritation of NSAIDs and to provide reduced risk of gastrointestinal (GI) side effects. Ibuprofen and naproxen are the two dominant NSAID molecules in the pain relief and anti-inflammatory sector, with combined worldwide sales in excess of $5bn per annum.(1) The Company is in ongoing partnering discussions relating to its OXPzeroTM assets.
The recently received feedback follows a scientific advice meeting with the MHRA in early March on the development programme for OXPzeroTM Ibuprofen. Specific key elements of the MHRA feedback received are:
· OXPzeroTM Ibuprofen can be classified as a new salt form of Ibuprofen, not a new active substance or combination product, which greatly simplifies the regulatory pathway
· The phase III study protocol for the product registration application with improved GI safety claim has been clarified
Marcelo Bravo, Chief Executive Officer of Oxford Pharmascience, commented:
"We are very pleased with the outcome of this meeting. The MHRA's feedback has provided clear direction for the pivotal studies required to gain approval of marketing authorisation for OXPzeroTM Ibuprofen. This gives us a clear understanding of the timelines and associated investment required. We believe this puts us in a strong position as we continue with our partnering discussion process for both OXPzeroTM Ibuprofen and Naproxen."
The Company has obtained confirmation from the MHRA that OXPzeroTM Ibuprofen can be classified as a new salt form of ibuprofen and not a new active substance or combination product which greatly simplifies the regulatory pathway. During this meeting only OXPzeroTM Ibuprofen was discussed, however, it is the Company's opinion that the MHRA feedback received is equally applicable to OXPzeroTM Naproxen and to OXPzeroTM NSAIDs in general. Following this scientific advice meeting, the Company can confirm that the MHRA has provided guidance on its requirements for the pivotal development programme of OXPzeroTM Ibuprofen. The most appropriate legal basis of application for the over-the-counter and prescription strength product marketing authorisation applications was also confirmed - bioequivalent products will follow the 10(3) route, while non-bioequivalent products will follow the 8(3) route and require an additional single dose, dental pain study to prove the efficacy of OXPzeroTM Ibuprofen.
OXPzeroTM Ibuprofen and OXPzeroTM Naproxen compounds have been shown to deliver a range of key benefits that can be leveraged across multiple differentiated product applications. Specifically, by comparison with generic NSAIDs, OXPzeroTM Ibuprofen and OXPzeroTM Naproxen:
· are milder in the GI tract, delivering major reduction in severe GI mucosal damage;
· significantly mask the bitter taste/burn associated with NSAIDs; and
· deliver an attractive PK profile with adaptable drug release properties.
NSAIDs are one of the most widely used classes of drugs, with more than 30 million users worldwide consuming NSAIDs each day.(1)
For further information:
Oxford Pharmascience Group Plc
Marcelo Bravo, Chief Executive +44 20 7554 5875
N+1 Singer (Nominated Adviser and Broker)
Aubrey Powell / Jen Boorer +44 20 7496 3000
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.
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