Oxford Pharmascience Group PLC R&D Update (6768O)
November 09 2016 - 1:00AM
UK Regulatory
TIDMOXP
RNS Number : 6768O
Oxford Pharmascience Group PLC
09 November 2016
Oxford Pharmascience Group plc
("Oxford Pharmascience" or the "Company")
R&D Update
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
the development of its R&D pipeline.
OXPzero(TM)
As reported within the interim results, the Company continues
commercialisation discussions for its lead assets, OXPzero(TM)
Ibuprofen and OXPzero(TM) Naproxen. In parallel, the Company has
focused its technical activities on advancing the OXPzero(TM)
technology to affect and control release properties, scaling-up and
optimising the manufacturing process and strengthening its
intellectual property (IP) portfolio.
The Company has now completed preliminary laboratory work
leading to the identification of OXPzero(TM) platform technical
modifications that alter the release properties and enable faster
release of the NSAID. As a result of this work, the company has
just filed a national application for a new patent in the UK with
international filings to be expanded over the next two years as the
application progresses, significantly strengthening the IP
portfolio for its OXPzero(TM) technology platform.
The Company will be now progressing to conduct UK based Phase I
exploratory pharmacokinetic (PK) clinical studies to validate the
in vivo performance of these technology improvements, focusing
first on its lead compound OXPzero(TM) Ibuprofen. The OXPzero(TM)
Ibuprofen study will be split into three parts and will assess the
PK profiles both at over-the-counter (OTC) and prescription (Rx)
strength doses of standard ibuprofen against OXPzero(TM) Ibuprofen
and the lead technology modifications identified. Regulatory and
Ethics submissions have been made for this study and dosing is
expected to start early in 2017. In addition, pre-clinical
evaluation of these technology modifications is ongoing using an
innovative gastric mucosal cell model at the University of
Newcastle to assess the effect of these technology modifications on
gastric mucosal damage.
In parallel to this technical and clinical work, the Company is
seeking clarity on the regulatory pathway for OTC and Rx
OXPzero(TM) NSAID products. The Company is now seeking advice from
the US Food and Drug Administration (FDA) on the development
pathway for the OTC and Rx OXPzero(TM) Ibuprofen programmes.
Pre-IND meeting requests have been submitted to the FDA for both
the OTC and Rx variants; the Company has assembled a team of
highly-experienced US and EU consultants to assist with these
meetings which are expected to take place early in 2017. Obtaining
clarity from the FDA on the regulatory pathway will be a major
milestone to further facilitate partnering discussions for the key
US market.
Other programmes
While the focus has been OXPzero(TM) NSAIDs, the company also
carried out development work to further its cardiovascular
pipeline.
Following extensive process development work, OXPzero(TM)
Aspirin has been successfully manufactured at laboratory scale. As
the material produced by this process has not attained the required
stability profile, a decision has been taken not to progress this
programme further at this time
In our statins portfolio, development of a new colon-targeted
formulation of atorvastatin is ongoing. The aim of this programme
is to reduce the degree of cytochrome P450 metabolism in the upper
GI tract, thereby reducing the formation of degradation products
known to cause statin related side effects such as myalgia (muscle
pain). A new formulation development and manufacturing contract
facility has been appointed and development of a new salt form of
atorvastatin with anticipated improved acid stability is
ongoing.
Funding
Oxford Pharmascience remains well-funded to complete this next
stage of work on clinical development and the regulatory pathway
for its OXPzero(TM) products, as well as the development work on
atorvastatin, with cash balances as at 31 October 2016 of circa
GBP22.6 million.
Commenting on the progress, CEO Marcelo Bravo said:
"In parallel to the ongoing commercial partnering activities, we
are pleased to see OXPzero(TM) Ibuprofen going back into the clinic
and our OXPzero(TM) NSAIDs IP protection being strengthened. We
look forward to receiving advice from the FDA on our
over-the-counter and prescription OXPzero(TM) Ibuprofen product
development strategies."
This announcement contains inside information.
For further information please contact:
Oxford Pharmascience Group Plc
Marcelo Bravo, Chief Executive +44 20 7554 5875
N+1 Singer (Nominated Adviser & 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.
About OXPzero(TM) NSAIDs
Specifically, by comparison with generic NSAIDs, OXPzero(TM)
Ibuprofen and OXPzero(TM) 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 pharmacokinetic profile with adaptable
drug release properties.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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