http://oxfordpharmascience.com/


Oxford Pharmascience is a drug development company that re-develops approved drugs to make them better, safer and easier to take.

Oxford Pharmascience is using its proprietary oral drug delivery technologies to develop improved formulations of non-steroidal anti-inflammatory drugs (NSAIDs) and statins for global markets.

The Company's risk-diversified pipeline of prescription and OTC medicines is focused on cardiovascular disease and pain relief indications. Since the products incorporate previously approved drugs, this reduces risk and results in a simplified drug development regulatory pathway allowing less expensive development programs and faster access to market.

The Company has also commercialized calcium/vitamin D chews that taste better and dissolve faster than currently available regular formats. These products are now marketed in the UK, Middle East and Brazil.

Oxford Pharmascience is located in the UK and is led by a highly experienced management team that directs and manages the outsourcing of its development; pre-clinical and clinical programs; and manufacturing to a trusted network of partners and suppliers.

The Company commercializes its portfolio of product opportunities through out-licensing to leading pharmaceutical companies worldwide. Currently the Company has partnerships with Aché Laboratories and Bayer.

Oxford Pharmascience (LON:OXP) was established by a team of entrepreneurs in 2008 and is a publicly listed company on London's Alternative Investment Market (AIM), with a strong blue chip investor base.

R&D Update
RNS
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.
OXPzeroTM
As reported within the interim results, the Company continues commercialisation discussions for its lead assets, OXPzeroTM Ibuprofen and OXPzeroTM Naproxen. In parallel, the Company has focused its technical activities on advancing the OXPzeroTM 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 OXPzeroTM 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 OXPzeroTM 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 OXPzeroTM Ibuprofen.  The OXPzeroTM 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 OXPzeroTM 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 OXPzeroTM 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 OXPzeroTM 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 OXPzeroTM NSAIDs, the company also carried out development work to further its cardiovascular pipeline.
Following extensive process development work, OXPzeroTM 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 OXPzeroTM products, as well as the development work on atorvastatin, with cash balances as at 31 October 2016 of circa £22.6 million.
 
Commenting on the progress, CEO Marcelo Bravo said:
 
"In parallel to the ongoing commercial partnering activities, we are pleased to see OXPzeroTM Ibuprofen going back into the clinic and our OXPzeroTM NSAIDs IP protection being strengthened.  We look forward to receiving advice from the FDA on our over-the-counter and prescription OXPzeroTM Ibuprofen product development strategies."
This announcement contains inside information.

Company Update
RNS
RNS Number : 6402X
Oxford Pharmascience Group PLC
23 February 2017
 
Oxford Pharmascience Group plc
("Oxford Pharmascience" or the "Company")
OXPzeroTM Ibuprofen - Positive Exploratory PK Study Data
Oxford Pharmascience (AIM: OXP), the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, provides the following update on its lead OXPzeroTM Ibuprofen clinical programme.
On 17 January 2017 the Company confirmed that it had started dosing of healthy subjects in its Phase I exploratory pharmacokinetic (PK) study "OAT-01", as previously outlined in an earlier announcement dated 9 November 2016.  OAT-01 is a three-part, open label, active controlled, crossover study designed to assess the PK profile of the lead OXPzeroTM Ibuprofen technology modifications against licensed ibuprofen products to verify that the improvements in speed of ibuprofen release seen in laboratory studies translate into improvements in healthy human subjects.  Interim PK data from the first part of the study in 10 subjects indicate that the technology modifications can successfully change the PK profile of ibuprofen released into the body from OXPzeroTM Ibuprofen and that it is possible to achieve a PK profile comparable to NurofenTM (a licensed over-the-counter ibuprofen product) displaying:
•             equivalent maximum plasma levels (Cmax);
•             equivalent total absorption of ibuprofen (AUC); and
•             a faster rate of absorption (Tmax) (i.e. onset of efficacy). 
In addition, alternative technology modifications are able to achieve a PK profile for OXPzeroTM Ibuprofen with a slower rate of release and extended duration of effect as compared to NurofenTM.
The OAT-01 study will continue as planned to further elucidate the range of impact on PK by the technology modifications.  Further data from this study will help select the optimal technology modifications to guide subsequent formulation development of over-the-counter and prescription strength products. The Company do not intend to announce further OAT-01 study results since details of the technology modifications are the subject of a recently filed UK patent application with international filings to be expanded over the next two years as the UK application progresses. Further details on the OAT-01 study can be found at ClinicalTrials.gov using the identifier NCT02974361. 
 
Commenting on the results, CEO Marcelo Bravo said:
"Oxford Pharmascience is very pleased with these exploratory, interim PK study results, which demonstrate that the technolology modifications can not only make OXPzero™ Ibuprofen bioequivalent to ibuprofen free acid  (NurofenTM), but also potentially faster acting.  Achieving a product that is bioequivalent to reference is highly important to OXP as the regulatory pathway to gaining product approval generally becomes faster, simpler and therefore less costly for bioequivalent products.  The potential to accelerate speed of action or to extend the duration of effect is expected to further differentiate prospective OXPzeroTM products. 
"These results indicate a strong position with an OXPzeroTM Ibuprofen asset that can be made bioequivalent, completely taste masked and either faster acting or having an extended duration of effect compared to the reference product."

FDA Advice on OXPzero Ibuprofen OTC Opportunity
RNS
RNS Number : 7843X
Oxford Pharmascience Group PLC
29 November 2017
 
Oxford Pharmascience Group plc
("Oxford Pharmascience" or the "Company")
 
FDA Pre-IND Advice on OXPzero™ Ibuprofen OTC Opportunity
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 OXPzero™ Ibuprofen drug substance is considered a new ibuprofen salt form and hence will need to be submitted as a 505(b)(2) application (which is typically a faster route to approval than a traditional development path), as it bridges to the well-established safety and efficacy of the reference ibuprofen product.
 
·      Based on the FDA responses, the understanding is that the US NDA can be submitted with only Phase I PK data and that no further safety or efficacy studies are required to licence the product for use in adults, however this will be further assessed once PK data are available with the final to-be-marketed OTC formulation.
 
·      Further data will be required for US paediatric development.
The Company is pleased that OTC formulations of OXPzeroTM 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 OXPzeroTM 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 OXPzeroTM 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 OXPzeroTM Ibuprofen formulations can be developed for approval in the US without the need for costly Phase III trials."