Oxford Pharmascience Group PLC Update regarding OXPzeroTM Ibuprofen Programmes (5321E)
09 Maio 2017 - 03:00AM
UK Regulatory
TIDMOXP
RNS Number : 5321E
Oxford Pharmascience Group PLC
09 May 2017
Oxford Pharmascience Group plc
("Oxford Pharmascience" or the "Company")
Update regarding OXPzeroTM Ibuprofen Programmes
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(TM) Ibuprofen programmes, following its consideration
of further FDA feedback.
Summary
-- Feedback received from the US Food and Drug Agency (FDA)
over-the-counter (OTC) division on OXPzero(TM) Ibuprofen
-- Consistent responses from both OTC and prescription (Rx)
divisions requiring outcomes based endpoints in order to obtain
approval for an OXPzero(TM) Ibuprofen product making a GI safety
claim
-- Both FDA divisions have now confirmed that bioequivalent
products which do not make the gastro-intestinal (GI) safety claim
can be registered without requiring further efficacy data
-- Further positive data from second phase of the exploratory
pharmacokinetic (PK) study OAT-01 giving reassurance that
bioequivalent formulations can be achieved
-- The Company is carefully reviewing its next steps in terms of
regulatory, clinical and commercial development
-- Further announcements will be made in due course; the Company
remains well-funded to pursue the commercial opportunities
available to it
The Company announced on 31 March 2017 that it had received
feedback from the FDA in respect of the Rx application of its
OXPzero(TM) 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(TM)
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(TM) 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(TM) 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(TM) 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(TM) technology
modifications tested, these data provide reassurance that
bioequivalent products can be formulated using the OXPzero(TM)
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(TM) 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(TM) 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(TM) products. The
Company maintains a strong capital base which provides the
flexibility to achieve its strategic objectives, with cash balances
of GBP21.5 million as at 30 April 2017.
Further announcements will be made in due course.
Contacts:
Oxford Pharmascience Group
plc
Marcelo Bravo, Chief Executive
Officer +44 20 7554 5875
N+1 Singer
Aubrey Powell +44 20 7496 3000
Lauren Kettle
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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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