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.

Initiation of Pilot Clinical Study

RNS


RNS Number : 8811B

Oxford Pharmascience Group PLC

10 March 2014






Oxford Pharmascience Group plc

("Oxford Pharmascience" or the "Company")

Oxford Pharmascience Announces Initiation of Pilot Clinical Study of OXP001 (Reduced Gastric Irritation Ibuprofen)



Oxford Pharmascience, the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, today announces that dosing of subjects in its pilot clinical study of OXP001 400mg Ibuprofen has begun. OXP001 delivers 400mg of ibuprofen via the company's OXPzero™ technology in a novel salt oral formulation and it aims to provide significantly reduced risks of gastrointestinal (GI) side effects for use in the treatment of conditions requiring the chronic use of Non Steroidal Anti-Inflammatory Drugs (NSAIDs).



The randomised, controlled pilot study - which is being conducted at a single site in the UK - is a two arm study between OXP001 and the reference Ibuprofen 400mg tablets. The purpose of the study is to assess the incidence of upper gastrointestinal irritation via endoscopy using a modified Lanza score. Further details about the study can be found at www.ClinicalTrials.gov.



NSAIDs are one of the most widely used classes of drugs, with more than 30 million users worldwide consuming NSAIDs each day. However, chronic use of NSAIDs causes well documented GI side effects including ulcers and bleeding and leads to significant morbidity and mortality in many patients.



Marcelo Bravo, Chief Executive Officer of Oxford Pharmascience commented:



"The development of GI safer NSAIDs is a key priority for Oxford Pharmascience and it is a great achievement for the Company to have reached this milestone. The study will provide the data that will allow Oxford Pharmascience to proceed with confidence to late Phase III pivotal trials for its reduced gastric irritation ibuprofen product as well as further potential NSAIDs in our pipeline."

Appointment of Director of Research & Development
RNS
RNS Number : 4032C
Oxford Pharmascience Group PLC
17 March 2014



Oxford Pharmascience Group Plc



("Oxford Pharmascience" or the "Company")



Appointment of Director of Research & Development





Oxford Pharmascience, the speciality pharmaceutical company that redevelops medicines to make them better, safer and easier to take, today announces it has appointed Dr. Liz King as Director of Research & Development to manage all of the Company's development activities. Liz will be responsible for leading and executing the company's development programme focused on the company's two main medicines reformulation programmes in NSAIDs and Statins with reduced side effects. Liz will be a non-board member of the Oxford Pharmascience management team reporting to Marcelo Bravo, Chief Executive Officer.

Dr. Liz King has a comprehensive background in the pharmaceutical industry and in-depth experience of pharmaceutical drug development within the EU and US from the discovery phase through to registration and life-cycle management. Liz has managed multi-functional, international teams, defined and implemented drug development strategies and plans, led due diligence activities, submitted orphan drug applications, managed strategic alliances, participated in FDA and EU regulatory agency meetings and overseen global licence conformance programmes. Liz also has experience of pharmaceutical sciences, technology transfer and business development. Liz has a PhD from the University of Cambridge on polymer science and has worked at Pfizer, Shire Pharmaceuticals, ProStrakan, Mitovie and Pharmalink Consulting.



"I am delighted Dr. Liz King is joining Oxford Pharmascience at this crucial point as we advance a broad pipeline of products into market. Liz is a perfect fit for Oxford PharmaScience with her background in both big Pharma and experience of small, lean organisations. The appointment of Dr. King represents a substantial strengthening of our management team as we continue to move Oxford Pharmascience to a new level of development and performance."

Director Deals - Oxford Pharmascience Group PLC (OXP)
BFN
Dave Norwood, Chairman, bought 1,000,000 shares in the company on the 25th March 2014 at a price of 4.30p. The Director now holds 105,938,633 shares.

Story provided by StockMarketWire.com
Director deals data provided by www.directorsholdings.com

Having a look at this one.

For a share that usually ticks along quietly this suddenly seems to have put a spurt on this week and it's surely not just from the Chairman's buy announced on the 25th. News in the pipeline, or has it been tipped somewhere?

Plenty of strength here could be news soon.

Perhaps news of the trials, as detailed in the 10th March RNS, are going well ? Potentially a huge market for this company - "30 million users worldwide consuming NSAIDs each day".

Tipped in yesterdays FT a 9p target price apparently.

90 million shares traded today.

One very large trade early this afternoon in that volume mitzy - 89,412,584 @ 5.55p.

Noticed that doodlebug.

That's mine. :-))

CEO Showcasing Ibuprofen Taste Masked Products

RNS


RNS Number : 2019E

Oxford Pharmascience Group PLC

08 April 2014










Oxford Pharmascience Group plc

("Oxford Pharmascience" or the "Company")



CEO Showcasing Ibuprofen Taste Masked Products





Oxford Pharmascience, the AIM-quoted specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, today announces that CEO Marcelo Bravo will be showcasing for the first time its taste masked Ibuprofen OTC products which use the Company's proprietary delivery platform OXPzeroTM. Mr. Bravo will also be giving an overview of the Company and its programmes at the Proactive Investors One2One Investor Forum in London on 10th April at 6pm at Chesterfield Mayfair Hotel, 35 Charles Street, Mayfair, W1J 5EB.

A copy of the presentation given will be made available on the Company's website after the event. Oxford Pharmascience has a diverse pipeline spanning pain relief (Non Steroidal Anti-Inflammatory Drugs or NSAIDs) and cardiovascular disease (Atorvastatin) indications with products aimed at both over-the-counter ("OTC") and prescription ("Rx") markets. The Company has two lead products that is beginning to commercialise this year, specifically a 200mg/5ml Ibuprofen suspension and 200mg soft 'gummie', both aimed at the OTC paediatrics market. These are the first products of their kind, completely taste and burn free. The Company is now establishing product supply both in Europe and North America with the aim of conducting preregistration bioequivalence trials of final versions of these products in early 2015. In parallel, the company is progressing its programmes in safer NSAIDs and safer statins as well as further NSAID OTC products.

NSAIDs and statins are some of the most widely used classes of drugs with known problems that affect patient adherence and ultimate therapeutic outcomes. The Company's portfolio addresses major unmet patient needs with significant commercial potential in global markets.

Marcelo Bravo, Chief Executive Officer of Oxford Pharmascience commented:

"I look forward to showcasing for the first time the lead products that Oxford Pharmascience is beginning to commercialise this year. We believe that our completely taste masked "burn free" high dose ibuprofen suspension and soft gummies are disruptive products in their category and signal Oxford Pharmascience's entrance in to the medicines market".

The marketing campaign about to start this week.

Up 10% today.

Nice chunky buy at 5.6p just gone through.

Is ibuprofen making us sick? Research suggests it may cause gut conditions such as coeliac disease

Taking non-steroidal anti-inflammatory drugs is linked to coeliac disease
They can cause intestinal inflammation and make intestines too permeable
This can allow gluten to leak out of the intestines and into the bloodstream

It can trigger an autoimmune response by the immune system

In people prone to coeliac disease, this can cause the condition to develop


ByEmma Innes

Published: 10:43, 22 April 2014 | Updated: 11:38, 22 April 2014

Taking ibuprofen is linked to the development of coeliac disease, research suggests

When people have a headache, their first reaction is often to pop a couple of painkillers.


These drugs have become such a big part of everyday life that few people even consider whether there are likely to be any ill effects from their regular use.

In fact, ibuprofen is well known for irritating the gut and can cause stomach ulcers.

And now, research suggests ibuprofen could be linked to the development of coeliac disease.


A review of the last 20 years of research into non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, suggests that the drugs are linked to ‘leaky gut syndrome’ meaning the walls of the intestines become more permeable, The Daily Beast reports.


And, a National Institutes of Health study supported this theory by revealing that NSAIDs can cause intestinal inflammation and increase the permeability of the intestines.


The intestinal inflammation and permeability caused by NSAIDs is problematic because it allows toxic substances to leak into the bloodstream.


When this happens, an autoimmune response can be triggered which prevents digestion and effective absorption of nutrients, the researchers say.


When the gut is more permeable than it should be, it also allows gluten to leak out.


In people who have a predisposition to coeliac disease, the researchers believe this can lead to adverse reactions to gluten.


Coeliac disease is a common digestive condition which occurs when a person has an adverse reaction to gluten.


In these people, eating foods containing gluten can trigger a range of symptoms.

Gluten is found in pasta, cakes, cereal, bread, some sauces and some ready meals.

The painkiller can cause the intestines to become inflamed and too permeable meaning gluten leaks out



These include diarrhoea, bloating and flatulence, abdominal pain, weight loss and tiredness.

Coeliac disease is an autoimmune condition - this is where the immune system mistakenly attacks healthy tissue.

Dr Alessio Fasano, director of the Center for Celiac Research at Massachusetts General Hospital, told The Daily Beast: ‘From what we understand, [with NSAIDs] one of the side effects is that they can affect the permeability of the gut.


‘Now, you have increased passage of gluten, and if you are genetically predisposed, you can develop coeliac or gluten-intolerance.’


The situation is thought to be worst for people who take the painkillers after exercising.

If gluten leaks out of the intestines it can trigger an autoimmune response associated with the development of coeliac disease. People with coeliac disease can't eat products containing gluten, such as pasta and bread



Another study, published in the journal Medicine and Science in Sport and Exercise, revealed NSAIDs can also cause intestinal damage when they are taken after exercise.

This causes damage to the surface of the intestines reducing their ability to absorb nutrients.


There is no cure for coeliac disease but switching to a gluten-free diet can help control symptoms and prevent long-term complications.


In the long-term, if it is not managed, the condition can cause anaemia, osteoporosis and even bowel cancer.



Read more: http://www.dailymail.co.uk/health/article-2610158/Is-ibuprofen-making-sick-Research-suggests-cause-coeliac-disease.html#ixzz2zd12YS73

Holding(s) in Company

Invesco Limited disposed of 294,266,667 29% to a 0 holding.


http://www.moneyam.com/action/news/showArticle?id=4807719

Positive Results from Pilot Clinical Study
RNS
RNS Number : 5563I
Oxford Pharmascience Group PLC
02 June 2014



Oxford Pharmascience Group plc
("Oxford Pharmascience" or the "Company")

Positive Results from Pilot Clinical Study of OXP001
(Reduced Gastric Irritation Ibuprofen)

Oxford Pharmascience, the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, today announces the positive results of its proof of concept clinical study to determine the extent of upper gastrointestinal irritation of the OXP001 400mg tablet compared with the Brufen 400mg (Ibuprofen) tablet by endoscopic evaluation. Further details are included below and more information can be found at www.ClinicalTrials.gov.

HIGHLIGHTS

· Significantly less gastrointestinal irritation after administration of OXP001 compared to Ibuprofen

· Primary and secondary trial endpoints met

· Minor optimisation work required to OXP001 tablet to achieve bioequivalence compared to reference

· Results allow the company to proceed with confidence to phase III clinical trial

· Results validate the OXPzeroTM platform technology, giving confidence to continue development programmes with other NSAIDs.



The primary endpoint of the study was a comparison of the overall Lanza score (a rating score of gastrointestinal irritation on endoscopic evaluation) in the stomach and duodenum. The reduction in mean Lanza scores for OXP001 versus Ibuprofen was 0.9 (p=0.007).

The secondary endpoints included a comparison of the number of erosions observed separately in the stomach and duodenum. The result of the trial showed that OXP001 was associated with significantly fewer erosions: the OXP001 arm displayed 73% (p=0.007) fewer erosions in the stomach and 89% (p=0.020) fewer in the duodenum.

The pharmacokinetic data obtained from the study indicated that while 65% of OXP001 subjects had comparable absorption to Brufen, OXP001 achieved a smaller average dose of Ibuprofen absorbed (approx. 76%). An average in the 80-125% range is required to achieve bioequivalence. Minor optimisation work on the tablet formulation is required before proceeding to final larger scale pivotal phase III trials. This work has already been initiated and is expected to be completed imminently.

Marcelo Bravo, Chief Executive Officer commented:

"Oxford Pharmascience is very encouraged by the positive results of this proof of concept study in humans showing significant reduction in gastrointestinal irritation of OXP001 compared to Ibuprofen.

Gastrointestinal side effects are a major risk affecting patients taking NSAIDs and reducing these effects is a major step in improving patient safety, quality of care and reducing the cost of care. Following tablet optimisation, the Company looks forward to proceeding with confidence to pivotal trials for our reduced gastric irritation Ibuprofen. In conjunction with this, Oxford Pharmascience continues to advance development to apply this exciting technology to other commonly used NSAIDs including Naproxen, Diclofenac and Aspirin, which represent further substantial opportunities."

Dr Stuart Mair, Medical Director at Quotient Clinical and Principal Investigator, commented:

"These results are potentially meaningful in a clinical context representing an improved safety profile."

Further information to the trial and the OXP001 pilot study results

NSAIDs are one of the most widely used classes of drugs, with more than 30 million users worldwide consuming NSAIDs each day (1). However, use of NSAIDs causes well documented gastrointestinal effects, including erosions, bleeding and ulcers, and leads to significant morbidity, mortality and economic healthcare burden (2)(3).

OXP001 delivers 400mg of Ibuprofen per tablet via the Company's OXPzero™ technology in a novel salt oral formulation. OXP001 aims to provide significantly reduced risks of gastrointestinal damage for use in the treatment of conditions requiring continued use of prescription dose Ibuprofen.

The two arm proof of concept trial included 43 healthy adult participants: one arm administered with OXP001 and the other Ibuprofen (day 1: Single dose 800mg, days 2-8: 800mg three times daily - total daily dose 2400mg). Participants underwent endoscopy evaluation in advance of day 1 and on day 9 to establish the resulting gastrointestinal effects.

In this pilot study OXP001 exhibited significantly lower incidence of gastrointestinal irritation compared to Brufen with study data showing statistically significant differences between OXP001 and Ibuprofen in primary and secondary endpoints, both in Lanza scores and in the number of gastrointestinal erosions. Specifically, following dosing for seven days and with patients being assessed via endoscopic evaluation, the difference in mean Lanza scores for OXP001 versus Ibuprofen was 0.9 (p=0.007) with the median number of erosions 73% (p=0.007) lower in the stomach and 89% (p=0.020) lower in the duodenum.

The pharmacokinetic data showed a different drug release profile for OXP001 compared to the Ibuprofen reference, including slower drug release and some OXP001 subjects showing lower bioavailability. However, analysis of the data from this study shows no relationship between the drug release profile and the amount of gastric irritation. Specifically there is no correlation between the standard pharmacokinetic parameters tested - peak plasma concentration, area under the concentration-time curve, time to peak plasma concentration and concentration half-life - and gastric irritation and analysis of the comparable subgroup confirm the positive effect of the OXP technology on gastric irritation compared to Ibuprofen. Based on in-vitro testing, the pharmacokinetic behaviour of OXP001 is believed to be due to slow tablet disintegration. Accordingly, Oxford Pharmascience is initiating tablet optimisation work to ensure bioequivalence to the reference Brufen 400mg tablet. The Company will be validating an optimised tablet via a further pharmacokinetic and gastric irritation study, expected to conclude in the coming months, before proceeding to larger scale pivotal trials in line with previous guidance.

References:
(1) Evaluate Pharma

(2) Guidelines for prevention of NSAID-related ulcer complications, Lanza et al., Am J Gastroenterol. 2009 Mar;104
(3):728-38. doi:10.1038/ajg.2009.115 .

(3) The economics of upper gastrointestinal bleeding in a US managed-care setting: a retrospective, claims-based analysis, Cryer et al., Journal of Medical Economics, 2010; 13(1): 70-77

Chew Product - Line Extension

RNS


RNS Number : 7534J

Oxford Pharmascience Group PLC

17 June 2014






Oxford Pharmascience Group plc
("Oxford Pharmascience" or "the Company")
Chew Product - Line Extension

Oxford Pharmascience, the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, today announces that it has agreed a line extension in Brazil with its partner Aché Pharmaceuticos (Aché) for a new version of its calcium and vitamin D chew marketed under the brand name Inellare.

Sales to Aché of this new format are expected to begin in Q3 2014 for launch in Brazil later this year.

Marcelo Bravo, Chief Executive Officer of Oxford Pharmascience commented,

"The Inellare calcium and vitamin D product continues to consolidate its presence in the Brazilian market and we are working closely with our partner Ache Laboratorios to provide them with further innovative extensions to their product range. We look forward to continue building the OXPChew business in Brazil and elsewhere as opportunities arise."