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.

On Monday, Oxford Pharmascience Group PLC (OXP:LSE) closed at 13.38, 317.97% above the 52 week low of 3.20 set on Dec 10, 2014.

Superb chart.

Initiation of Pilot Clinical Study for Ibuprofen
RNS
RNS Number : 1411T
Oxford Pharmascience Group PLC
16 July 2015

Oxford Pharmascience Group plc

("Oxford Pharmascience" or the "Company")



Initiation of Pilot Clinical Study
for Reduced Gastro-Intestinal Irritation Ibuprofen



Oxford Pharmascience Group plc (AIM: OXP), the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, today announces the initiation of dosing in its second pilot clinical study of 400mg OXPzeroTM Ibuprofen (OXP001) to assess a comparable PK profile.



OXP001 is an optimised, chewable, 400mg ibuprofen tablet that is expected to reduce the risk of gastro-intestinal ("GI") irritation from the ibuprofen and to taste-mask its bitter taste via OXP's patent protected OXPzero™ technology. Patient compliance to long-term therapy for chronic illnesses is a key issue and is reported to be around only 50% in developed countries.1 Providing patients with a gastro-intestinally safe treatment option, delivered in an easier to take dosage form, is believed to be a significant advantage in the non-steroidal anti-inflammatory drug (NSAID) treatment arena. The Company believes this would lead to improved patient compliance amongst long-term usage patients.



Last year the Company announced results from the first pilot study with a non-optimised OXP001 tablet. Results showed a significant reduction in gastro-intestinal irritation with OXP001 compared to Brufen®, however the pharmacokinetic profile of OXP001 showed a slower and incomplete release of ibuprofen. The OXPzeroTM Ibuprofen and the tablet formulation have since been optimised to provide immediate and complete drug release in vitro. This second proof-of-concept study is designed to compare the pharmacokinetic profile of OXP001 immediate release tablets with generic Brufen®, and with a second stage of this trial to confirm the reduction in gastro-intestinal irritation as measured by endoscopy.



The Company also reports that headline data from the recently conducted pilot clinical study with OXPzeroTM Naproxen (OXP005) will be available by the end of July 2015. Further details will be published in due course.



NSAIDs are one of the most widely used classes of drugs, with combined annual sales in excess of $12bn2 and more than 30 million users worldwide consuming NSAIDs each day3. Ibuprofen is currently the dominant NSAID molecule in the pain relief and anti-inflammatory sector. Worldwide sales of Ibuprofen are in excess of $4bn per annum at manufacturers selling prices2. Chronic use of NSAIDs causes well-documented GI side effects, including ulcers and bleeding, and leads to significant morbidity and mortality in a substantial number of patients, with significant associated healthcare costs. The OXPzero™ platform technology reduces these risks and is being selectively applied to the most commonly used NSAID molecules, namely ibuprofen, naproxen and diclofenac for pain and inflammation and aspirin for primary and secondary prevention of cardiovascular disease.



Marcelo Bravo, Chief Executive Officer, commented:

"We are pleased to have overcome the significant technical hurdles in the development of an immediate release, chewable, taste masked OXPzeroTM Ibuprofen tablet. Progressing this optimised OXP001 product to the clinic will provide the data to confirm further the benefits of the OXPzero™ technology including reduced GI irritation."





Sources

1. WHO Report "Adherence to long-term therapies. Evidence for action." 2003.

2. Evaluate Pharma

3. Black Swan Analysis Ltd - Market Evaluation for OXPzero™ technology to improve compliance with leading NSAID brands, November 2013 (commissioned by OXP)

One worth watching for a new entry point.


Results from Pilot Clinical Study of OXP500
RNS
RNS Number : 6490U
Oxford Pharmascience Group PLC
31 July 2015

Oxford Pharmascience Group plc

("Oxford Pharmascience" or the "Company")



Encouraging Results
from Pilot Clinical Study of OXPzeroTM Naproxen (OXP005)



Oxford Pharmascience, the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, today announces the results of its proof of concept clinical study to determine the extent of upper gastrointestinal (GI) tract irritation of its OXPzeroTM 250mg tablet ("OXP005") compared with the Naprosyn® 250mg (Naproxen) tablet by endoscopic evaluation. Further details are included below and more information can be found at www.ClinicalTrials.gov.



HIGHLIGHTS



• Achieved a statistically significant reduction in the number of upper gastrointestinal erosions observed by endoscopy after administration of OXP005 compared to Naprosyn® in healthy volunteers.



• Lanza score (a clinical rating score of gastrointestinal irritation in the stomach and duodenum on endoscopic evaluation) was comparable between OXP005 and Naprosyn®.



• PK data confirms bioequivalence of OXP005 and Naprosyn® at Day 1 and Day 7.



• The Company believes the technology can be further optimized specifically for naproxen and a programme to define the improved product is being initiated.



The primary endpoints of the study were 1. a comparison of the overall Lanza score and 2. a comparison of the total number of erosions observed in the stomach and duodenum.



In the study both OXP005 and Naprosyn® exhibited a similar Lanza score while OXP005 exhibits a moderate (c. 26%) reduction in total erosions, albeit at a non statistically significant level.



OXP005 meets the primary endpoint of reduced erosions exhibiting a major (c. 38%) reduction of total erosions which is statistically significant after accounting for ineligible subjects. While OXP005 is reducing the number of erosions, the Lanza score endpoint was not met.



The pharmacokinetic (PK) data obtained on Day 1 of the study confirm results observed in the first phase of the study and also confirm that on Day 7 OXP005 is fully bioequivalent to Naprosyn® based on mean values of core PK measures as detailed below.



Oxford Pharmascience is encouraged by these results and believes that further work will bring the OXPzeroTM Naproxen technology to its full potential. OXP005 was a direct re-application of the technology as developed for ibuprofen, which is known to cause less upper GI irritation than naproxen.



The Company believes it can further improve these results by adapting OXPzero™ specifically for the naproxen molecule. In the past few months a significant understanding of the technology and its ability to be modified has been gained in the lab and through its clinical trial observations and this will be applied to reiterate with a reformulated OXP005.


Headline pharmacokinetic data from a further pilot clinical study of OXPZeroTM Ibuprofen (OXP001) in an optimized, chewable form, will be reported in the coming weeks.



The Company plans to begin partnering discussions in the coming months with opportunities evaluated on the basis of both current and anticipated data, with the aim of achieving the optimal commercial outcome and value for shareholders. The Company's strong balance sheet provides greater commercial flexibility as it enters these discussions, including to conduct further work to adapt the platform for naproxen.



Marcelo Bravo, Chief Executive Officer, commented:



"We are encouraged by these results and take confidence from the fact that we now have two clinical data sets for OXPzeroTM variants of major NSAIDs demonstrating reduced GI irritation. Ibuprofen and naproxen account for $4.8 billion of the total $12 billion global market. We are confident in the future potential of the OXPzeroTM platform as we implement the further work to be done to exploit the full potential of naproxen and provide further data to support commercial discussions. With additional funds on board to allow us to generate further data, and additional endoscopy data from our further pilot clinical study for ibuprofen expected by the end of October, the plan remains to commence partnering discussions with the aim of maximising future value for the Company and its shareholders.



We look forward to providing further updates on our development pipeline, including the OXPzeroTM NSAIDs programme and other OXPzeroTM applications and the OXPtargetTM SafestatTM programme and other OXPtargetTM applications."



Summary PK Data



OXP005 achieved mean relative values for absorption (Area Under the Curve, AUC) and maximum concentration (Cmax) of 101.9% and 86.1% respectively on Day 1 and 105.6% and 91.7% respectively on Day 7. The mean values for AUC and Cmax are within the guidelines for bioequivalence (80.0 to 125.0%).

Preliminary PK Data & Initiation of Further Study
RNS
RNS Number : 7988V
Oxford Pharmascience Group PLC
12 August 2015



Oxford Pharmascience Group plc

("Oxford Pharmascience" or the "Company")



Preliminary Pharmacokinetic Data and
Initiation of Pilot Clinical Study

to Demonstrate Improved GI Profile for OXPzero™ Ibuprofen



Oxford Pharmascience Group Plc (AIM: OXP), the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, today announces that preliminary pharmacokinetic (PK) data confirms that OXP001(2) has successfully met its optimisation objectives for immediate release and complete drug absorption. The Company has commenced dosing in the second phase of the study, which seeks to prove the reduced gastro-intestinal (GI) irritation benefit of OXPzero™ Ibuprofen by endoscopic evaluation.



The randomized pilot PK study was a single-dose, two-arm UK study comparing the OXP001(2) 400mg chewable OXPzero™ Ibuprofen tablet and the reference Brufen® 400mg tablet (ibuprofen), in ten subjects. Preliminary PK data show comparable AUC (Area Under the Curve or total drug exposure over time) and tmax (time to reach maximum serum concentration) results, demonstrating that OXP001(2) is now a product with immediate and complete drug release characteristics. While the PK profile of the product appears to be similar to that of Brufen® on these measures, the maximum level of drug concentration in plasma (Cmax) appears to be lower compared to Brufen® but remains well within the range which the drug has therapeutic effect. The Company believes this preliminary PK data represents an acceptable clinical profile suitable for commercialisation. Additional PK data will be collected during the next phase of the study.



The taste masked benefit of OXPzero™ Ibuprofen was also assessed via subject interviews, during the first phase of this study, with consistent feedback confirming that the chewable tablets were tasteless, with none of the burn or after-taste issues associated with standard ibuprofen.



Following analysis of the preliminary PK data, the Company is proceeding to the second phase of the study, which aims to demonstrate a significantly reduced GI side effect profile compared to standard 400mg Brufen® tablets. The product to be tested, OXP001(2), is a 400mg chewable, taste masked, oral formulation of ibuprofen.



This phase of the study is a randomised, assessor-blinded, controlled pilot clinical study to assess the severity of upper GI damage via endoscopic assessment following 7 days' treatment of 2.4g/day of ibuprofen dosed as either OXP001(2) or Brufen®. A prior study in 2014 demonstrated significant GI side-effect benefits, compared to Brufen®, using an early version of OXP001 for which the PK profile has since been optimised for immediate release and complete drug absorption. Headline results on the second phase are expected to be released in Q4 2015, along with complete PK data and further taste masking assessments.



Marcelo Bravo, Chief Executive Officer, commented:

"We are pleased to confirm that OXP001(2) now achieves immediate release and complete drug absorption in vivo and that the taste masking benefit of the technology has been validated. We are confident the product is achieving release properties in line with the objective of delivering a reduction in GI irritation. Demonstrating that OXP001(2) achieves a significant reduction in GI erosions compared to Brufen® in this new formulation will validate OXPzero™ Ibuprofen as a disruptive compound in the major $4bn ibuprofen market."



Further details about the study can be found at www.ClinicalTrials.gov.

Listen: Preliminary PK Data & Initiation of Further Study

click here

Who Should Attend?Date:

Wednesday 25th May 2016

Venue:

Novotel Tower Bridge, London EC3N, 10 Pepys Street, London, EC3N 2NR

Event Timings:Sponsored by:

Making good progress in May.

For my own Info
Formerly Oxford NutraScience . . .they reformulate existing preparations to reduce risk . . . I guess the Old Name was likely to be associated with Nutrition, whereas they target Pain and other areas..... SP= 7.25p - almost doubled since early 2016 -late 2015.
Some Trials are underway - may explain the increased interest, etc.
EDIT (27Oct2016)- Spoke too soon...sp 3p-ish... Trial-delays...? -Or needing Trial-Cash?
EDIT(1Nov2016)- sp 2.13 - Is Ibrpru now in the Wild?... i.e. Others can use it? So it would not be an exclusive...
EDIT (11Jan2017)- sp 1.8p doesn't look like those Institutions ( at 10p, 2015) were betting their own money...
EDIT (10April2017)- fall-back to 1.9p - Oh dear.

Bought some earlier today

KEEP an EYE

OXP 2.225p ( 2.20/2.25p )

Large volume 40.4M at LSE and 3.3M at ISDX, share price bounce today after a fall from 7.75p this year and 13.50p last year. Cash rich £22M worth 1.82p, so 80% is in cash adn the rest of the company has almost no value.
video presentation from CEO

2.525p +0.25p

Going places now on a very narrow spread 2.50 v 2.55p
level 2 is 2 v 1
the last 2 days of large volume is working wonders for the share price now

2.525p +0.25p

level 2 of 2 v 1

Good post from Twitter group chat ........

Highlights

Substantive progress in commercialisation discussions regarding the Company's lead NSAID1 assets, OXPzeroTM Ibuprofen and OXPzeroTM Naproxen

Feedback has identified the key precursors to successful partnership outcomes, including:
additional platform development
clarity on regulatory pathway for over the counter (OTC) and Prescription (Rx) product approval

Significant progress advancing the OXPzeroTM technology platform:

Improvement of drug release in vitro
Scale-up and optimisation of the manufacturing process
Strengthening of the intellectual property (IP) portfolio

Planning to conduct small-scale exploratory pharmacokinetic (PK) trials to validate the in vivo performance of formulation improvements, with details to be announced separately in due course

Ongoing dialogue including the initiation of broader outreach to include the Rx market

Proceeding to seek pre-IND meetings with the US FDA to clarify US regulatory pathway

License per product would mean £20-30m upfront payment, Further sales milestone payments and mid teen royalty payments, Gastric safe NSAID's potential sales of over £500m

Marcelo Bravo, Chief Executive Officer, commented

We are very encouraged with the strong traction we are getting from some of the major potential partners in our discussions and we are also continuing to progress our other pipeline opportunities including Asprin and statins

Ibuprofen is currently the dominant NSAID molecule in the pain relief and anti-inflammatory sector with worldwide sales of Ibuprofen in excess of $5bn per annum. The Company has initiated contact with a number of large, global pharmaceutical companies with strategic interest in the ibuprofen market and is at an advanced stage of preparing information to proceed to the commercialisation phase with the OXPzeroTM Ibuprofen asset.

Large volume for the last few days

Below is the last holdings list of investor's over 3% and in the absence of a change of major holdings RNS assume is still current, they could now be adding and the free float looks tiny.

Woodford Investment Managers 401,597,920 33.31%
Mr R Griffiths 173,071,097 14.35%
David Norwood 105,938,633 8.79%
Marcelo Bravo 65,000,000 5.39%
Southern Fox Investments Ltd 51,000,000 4.23%
Henderson Global Investors 49,400,000 4.10%
Octopus Investments 42,140,345 3.50%
Aviva Investors 37,964,329 3.15%
Mr R Quested 37,247,753 3.09%

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."