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.

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."