Oxford Pharmascience Group plc (AIM: OXP), the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, provides the following update on its OXPzero™ Ibuprofen programmes, following its consideration of further FDA feedback.
The Company announced on 31 March 2017 that it had received feedback from the FDA in respect of the Rx application of its OXPzero™ Ibuprofen platform. At that time, shareholders were advised that, following receipt of further feedback from the FDA division reviewing the OTC application and the Company's subsequent considered review in respect of both the OTC and Rx responses from the FDA, that the Company would be in a position to confirm its clinical development and commercial plans for its OXPzero™ Ibuprofen assets.
The Company confirms that it has now received the FDA's response to its pre-IND submission in relation to the OTC application of OXPzero™ Ibuprofen. The response with regard to the OTC application is similar to that received for the Rx application, namely that, in order for OXP to be able to market an approved OXPzero™ product making a gastro-intestinal (GI) safety claim, an outcomes based Phase III study would be required. Such a study would be longer and require a very large sample size relative to those originally envisaged by the Company using endoscopic data.
The OTC division has echoed advice given by the Rx division and suggested that the Company could pursue a claim of reduced GI symptoms only, without requiring such a clinical outcomes study. This suggestion will need to be considered carefully by the Company and its specialist advisers before a decision is made on the OXPzero™ development programme. Importantly, both FDA divisions agreed that products without a GI safety claim would not require further efficacy data for approval and further that they can be approved on the basis of demonstration of bioequivalence (in both fasted and fed states).
The Company now has clear guidance on the regulatory pathway to registration for products that do not make the stronger GI safety claim. The Company has responded to the FDA for several points of clarification with regard to both sets of feedback.
Separately, the Company has received further positive PK data from the second part of its exploratory PK study (OAT-01) to provide in vivo validation of the technology improvements to drug release properties. From the multiple OXPzero™ technology modifications tested, these data provide reassurance that bioequivalent products can be formulated using the OXPzero™ technology, with matching total absorption (as measured by AUC) and peak serum concentration (Cmax) compared to the Nurofen reference product. Also, speed of absorption can be increased with median Tmax results (time to peak serum concentration) of 0.5 hours and 0.6 hours observed with some OXPzero™ Ibuprofen modifications, compared to 1.5 - 1.8 hours for the Nurofen reference. The OAT-01 study has now proceeded to its final stage assessing the higher Rx dose.
The Company is encouraged by the results of these exploratory studies, as bioequivalent products provide for simplified regulatory pathways to product approval. Also, the improved speed of onset observed is an important benefit for analgesics and the Company believes that this strengthens the commercial proposition for OXPzero™ Ibuprofen.
The Directors believe that further careful consideration needs to be given to the implications of these developments with regard to the Company's strategy, particularly for the US Rx market. Given the current FDA guidance regarding the GI safety study requirements, the economic feasibility of performing the phase III trial appears compromised, as an outcomes based study would be lengthy and require a very large sample size. However, the elucidation of the regulatory path to approval for products without a GI safety claim provides a potentially attractive, low-risk route to market for the Company's pipeline of OXPzero™ products. The Company maintains a strong capital base which provides the flexibility to achieve its strategic objectives, with cash balances of £21.5 million as at 30 April 2017.
Further announcements will be made in due course.
|Oxford Pharmascience Group Plc|
|Marcelo Bravo, Chief Executive Officer||+44 207 554 5875|
|+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.