dreamcatcher
- 13 Sep 2012 19:53
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.

doodlebug4
- 28 Mar 2014 16:06
- 130 of 182
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".
mitzy
- 29 Mar 2014 09:32
- 131 of 182
Tipped in yesterdays FT a 9p target price apparently.
mitzy
- 31 Mar 2014 14:56
- 132 of 182
90 million shares traded today.
doodlebug4
- 31 Mar 2014 15:33
- 133 of 182
One very large trade early this afternoon in that volume mitzy - 89,412,584 @ 5.55p.
mitzy
- 31 Mar 2014 18:20
- 134 of 182
Noticed that doodlebug.
dreamcatcher
- 31 Mar 2014 18:21
- 135 of 182
That's mine. :-))
dreamcatcher
- 08 Apr 2014 07:28
- 136 of 182
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".
doodlebug4
- 08 Apr 2014 12:36
- 137 of 182
The marketing campaign about to start this week.
mitzy
- 09 Apr 2014 13:23
- 138 of 182
Up 10% today.
doodlebug4
- 09 Apr 2014 16:27
- 139 of 182
Nice chunky buy at 5.6p just gone through.
doodlebug4
- 22 Apr 2014 16:18
- 140 of 182
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
dreamcatcher
- 09 May 2014 21:17
- 141 of 182
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
doodlebug4
- 02 Jun 2014 09:58
- 142 of 182
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
dreamcatcher
- 17 Jun 2014 07:06
- 143 of 182
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."
dreamcatcher
- 15 Sep 2014 19:09
- 144 of 182
Progression of Reduced Gastric Irritation Naproxen
RNS
RNS Number : 6058R
Oxford Pharmascience Group PLC
15 September 2014
Oxford Pharmascience Group plc
("Oxford Pharmascience" or the "Company")
Oxford Pharmascience Announces Progression
of Reduced Gastric Irritation Taste Masked Naproxen
Oxford Pharmascience, the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, today announces that it has successfully synthesised reduced gastric irritation taste masked naproxen at lab scale and is progressing to manufacturing scale-up and clinical proof of concept.
In June this year, the Company announced the positive results of its pilot clinical study of reduced gastric irritation ibuprofen and that it would advance development to apply this exciting technology to other commonly used Non Steroidal Anti-Inflammatory Drugs (NSAIDs). Following these encouraging results, the Company has accelerated the application of the technology to the four most commonly used NSAIDs, aiming to take naproxen, diclofenac and aspirin forward alongside ibuprofen.
The Company's novel salt of naproxen aims to provide significantly reduced risks of gastrointestinal (GI) side effects for use in the treatment of conditions requiring the chronic use of NSAIDs and is also completely taste masked allowing the formulation of "burn-free" non-tablet forms. This reflects the Company's ability to improve the properties of commonly used medicines. The synthesis of reduced gastric irritation naproxen also represents encouraging, early stage confirmation that these improvements can be applied to other drugs in the same class. 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. Ibuprofen, naproxen and diclofenac are the most commonly used drugs for pain and inflammation and aspirin is widely used as an antiplatelet agent.
Marcelo Bravo, Chief Executive Officer, commented:
"Oxford Pharmascience has made great progress applying its technology to other NSAIDs and we are excited by the progression of naproxen into scale-up and readiness for further Proof of Concept evaluation. Diclofenac and aspirin are expected to follow closely behind. We believe that moving forward with the four main NSAIDs in parallel represents a more compelling proposition for adding further shareholder value, as it increases the potential licensing scope and value of applying our technology across multiple products in the anti-inflammatory pain relief category.
"We are now prioritising our work to demonstrate that reduced gastric irritation is a class effect for NSAIDS formulated using our technology and also to establish comparable absorption vs. standard (generic) ibuprofen and naproxen. Our aim is build a robust clinical data package to enable the commercialisation of a number of NSAID assets in 2015 and beyond."
dreamcatcher
- 29 Sep 2014 18:15
- 145 of 182
Interim results for the six months to 30 June 2014
HIGHLIGHTS
• Positive results of pilot clinical study to determine the extent of upper gastrointestinal irritation of the Company's OXP001 400mg ibuprofen tablet compared with standard ibuprofen by endoscopic evaluation, with optimisation work required to achieve bioequivalence.
• As well as ibuprofen, we now expect the platform will deliver across the vast non-steroidal anti-inflammatory drugs (NSAIDs) category gastric safer naproxen, diclofenac and potentially aspirin.
• Refocusing of activities to fine tune the release properties of the NSAID technology and validate its application across the four most commonly used NSAIDs.
• Recent work on NSAIDs has created further opportunities to strengthen the Company's intellectual property across the NSAIDs platform.
• Cash and cash equivalents at 30 June 2014of £8.2m (2013: £6.6m, 31 December 2013: £9.9m.).
• Loss before tax for the period of £1.7m (2013 loss before tax: £0.6m), reflecting scale-up of the NSAIDs programme
http://www.moneyam.com/action/news/showArticle?id=4893442
dreamcatcher
- 08 Jan 2015 11:08
- 146 of 182
Optimisation of OXP001 & progression to study
RNS
RNS Number : 5780B
Oxford Pharmascience Group PLC
08 January 2015
Oxford Pharmascience Group plc
("Oxford Pharmascience" or the "Company")
Successful optimisation of OXPZeroTM Ibuprofen (OXP001) and progression to pilot clinical study
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 successful optimisation of OXPzeroTM Ibuprofen (OXP001) to deliver a product offering immediate release of the drug and the appointment of a clinical research organisation (CRO) to conduct a further clinical proof-of-concept study for this product.
Highlights
· OXPzeroTM Ibuprofen successfully optimised to deliver an immediate release product that demonstrated in vitro equivalence to standard Brufen (Ibuprofen)
· Appointment of UK based Quotient Clinical to perform clinical proof-of-concept study to confirm significantly less gastrointestinal (GI) irritation observed in earlier study
· Preliminary study results expected mid 2015
In June 2014, the Company announced the positive results of its proof-of-concept clinical study to determine the extent of upper GI tract irritation of the 400mg OXPzeroTM Ibuprofen tablet (OXP001) compared to the standard 400mg Brufen (Ibuprofen) tablet. The results showed significantly less GI irritation after administration of OXP001 compared to standard Ibuprofen, but that minor optimisation work was required to ensure bioequivalence of OXP001 vs. Brufen.
The Company has now successfully optimised both the active pharmaceutical ingredient (API) and the formulation, developing an immediate release product that achieves comparable in vitro drug release to the Ibuprofen reference. The Company is now proceeding to conduct a proof-of-concept clinical study with the optimised product.
The Company has appointed Quotient Clinical to conduct the upcoming study with OXPzeroTM Ibuprofen in the United Kingdom. This is the same CRO that conducted the proof-of-concept clinical study in 2014. The study for OXPzeroTM Ibuprofen has already received ethics committee approval and is expected to begin in Q2 2015 with headline PK data expected by mid-2015 and headline endoscopy data expected in Q3 2015. Further details will be provided in the coming weeks.
The optimisation work and progression to clinical study is a key milestone in the Company's programme to develop a range of prescription and over-the-counter strength non-steroidal anti-inflammatory drugs (NSAIDs), as well gastric safe taste-masked paediatric formulations and will provide the Company with the data required to provide a robust data package to initiate the commercialisation of these clinical stage assets.
Development work on the Company's other OXPzeroTM NSAID molecules (naproxen, diclofenac and aspirin) is continuing and Oxford Pharmascience expects to update the market regarding these molecules in the coming weeks.
NSAIDs are one of the most widely used classes of drugs, with more than 30 million users worldwide consuming NSAIDs each day with combined annual sales in excess of $12 billion (source: Evaluate Pharma). 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. The OXPzeroTM platform technology reduces these risks and is being selectively applied to the most commonly used molecules in the NSAID category, namely ibuprofen, naproxen, diclofenac and aspirin, to maximise both the significant health benefits to users and the capture of commercial value for the Company over the medium term. Ibuprofen, naproxen and diclofenac are the most commonly used drugs for pain and inflammation (accounting for 76% of chronic pain prescriptions in the US and Europe in 2013) and aspirin is widely used as an antiplatelet agent. Ibuprofen accounts for approximately 35 per cent or $4 billion of the $12 billion annual sales value of NSAIDs (source: Evaluate Pharma).
Marcelo Bravo, Chief Executive Officer, commented:
"Clinical evidence to demonstrate bioequivalence and confirm the significant reduction in gastrointestinal irritation observed in the earlier study for our optimised OXPzeroTM Ibuprofen, compared to standard Ibuprofen, will represent a further major milestone for the Company. Gastric safe NSAIDs are a major commercial opportunity and we believe we are well placed to start seeking partnerships with major pharmaceutical companies during 2015. The Company is now poised to begin realising significant value from the OXPzero TM platform as further data emerges during 2015 and beyond."
doodlebug4
- 08 Jan 2015 17:22
- 147 of 182
You've shown great patience with this one dc and I'm sure it will be worth it in the end - certainly heading in the right direction.:-)
dreamcatcher
- 08 Jan 2015 17:30
- 148 of 182
I hope so :-)) Cheers doodlebug
dreamcatcher
- 20 Jan 2015 07:33
- 149 of 182
Naproxen Progresses into Proof of Concept Trials
RNS
RNS Number : 5689C
Oxford Pharmascience Group PLC
20 January 2015
Oxford Pharmascience Group plc
("Oxford Pharmascience" or the "Company")
Naproxen Progresses into Proof of Concept Trials
2nd OXPzeroTM NSAID molecule to enter PoC studies in man
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 successful development of an immediate release clinical formulation of OXPzero™ Naproxen, which has been accelerated to clinical proof-of-concept with subject dosing planned to start during Q1 2015.
Highlights
• Successful development of immediate release clinical formulation of OXPzero™ Naproxen that demonstrated in vitro equivalence to standard naproxen tablets
• Appointment of Quotient Clinical to conduct two clinical proof-of-concept studies, which aim to demonstrate (1) a comparable pharmacokinetic (PK) profile and 2) reduced gastrointestinal (GI) side effects of OXPzero™ Naproxen versus standard naproxen tablets (the "PoC Studies")
• Headline PK results expected by the end of Q1 2015, and headline endoscopy data expected in Q2 2015
Following the September 2014 announcement that the Company had successfully synthesised OXPzero™Naproxen at lab scale, the Company is pleased to announce that an immediate release clinical formulation has been successfully developed. Final preparations are being made to progress this programme through the two PoC Studies, with the ethics committee application and the MHRA clinical trial application already submitted.
The Company has appointed UK-based Quotient Clinical as its clinical partner to run these PoC Studies (as well as the recently announced OXPzero™ ibuprofen study), using its in-house formulation development, GMP manufacturing and clinical facilities. The PoC Studies aim to demonstrate (1) a comparable PK profile of 250 mg OXPzero™ Naproxen tablets to 250 mg Naprosyn (standard naproxen) tablets and (2) proof-of-concept of reduced GI side effects compared to Naprosyn tablets.
Headline PK results are expected by the end of Q1 2015 with headline endoscopy data expected in Q2 2015. Further details on these trials will be provided in the coming weeks.
NSAIDs are one of the most widely used classes of drugs, with more than 30 million users worldwide consuming NSAIDs each day and combined annual sales in excess of $12 billion (source: Evaluate Pharma). 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. The OXPzero™ platform technology reduces these risks and is being selectively applied to the most commonly used molecules in the NSAID category, namely ibuprofen, naproxen, diclofenac and aspirin, to maximise both the significant health benefits to users and the capture of commercial value for the company over the medium term. Ibuprofen, naproxen and diclofenac are the most commonly used drugs for pain and inflammation (accounting for 76 % of chronic pain prescriptions in the US and Europe in 2013) and aspirin is widely used as an antiplatelet agent. Naproxen accounts for approximately 7% or c. $815 million of the $12 billion annual sales value of NSAIDs (source: Evaluate Pharma).
Marcelo Bravo, Chief Executive Officer of Oxford Pharmascience, commented:
"The progression to proof of concept studies for naproxen brings the Company significantly closer to proving that the OXPzero™ proprietary platform technology can be applied across a range of molecules in the vast NSAIDs market, and to providing a robust data package to support the commercialisation of our NSAID clinical stage assets. Naproxen alongside ibuprofen are two of the most widely used NSAIDs in both over-the-counter and prescription markets, and advancing these two lead programmes in parallel significantly strengthens our commercial profile and offering. Gastric-safe NSAIDs are a major opportunity and the Company is poised to begin realising significant value from this during 2015 and beyond."
Mark Egerton, CEO of Quotient Clinical, added: "Using our Translational Pharmaceutics platform, we enable companies like Oxford Pharmascience to conduct clinical proof-of-concept studies faster and more effectively, by providing access to formulation development, real-time manufacturing and clinical testing capabilities at a single site,. We look forward to applying our unique approach to Oxford Pharmascience's OXP ZeroTM Naproxen and Ibuprofen studies."