Sharesmagazine
 Home   Log In   Register   Our Services   My Account   Contact   Help 
 Stockwatch   Level 2   Portfolio   Charts   Share Price   Awards   Market Scan   Videos   Broker Notes   Director Deals   Traders' Room 
 Funds   Trades   Terminal   Alerts   Heatmaps   News   Indices   Forward Diary   Forex Prices   Shares Magazine   Investors' Room 
 CFDs   Shares   SIPPs   ISAs   Forex   ETFs   Comparison Tables   Spread Betting 
You are NOT currently logged in
 
Register now or login to post to this thread.

OXFORD PHARMASCIENCE GROUP (OXP)     

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.





Chart.aspx?Provider=EODIntra&Code=OXP&SiChart.aspx?Provider=EODIntra&Code=OXP&Si

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."

dreamcatcher - 30 Jan 2015 14:53 - 150 of 182

UPDATE - Oxford Pharma funded for NSAIDs development programme

By Philip Whiterow

January 30 2015, 2:11pm
Cash at end December was £6.7mln, which is enough to fund confirmatory proof-of-poncept (POC) studies on Ibuprofen and Naproxen formulations.
Cash at end December was £6.7mln, which is enough to fund confirmatory proof-of-poncept (POC) studies on Ibuprofen and Naproxen formulations.


--adds broker comment, updates share price--

Oxford Pharmasciences (LON:OXP) will start to look for a partner for its NSAIDs (non-steroidal anti-inflammatory drugs) platform in the second half of this year.

The company specialises in the reformulation of popular drugs such as Ibuprofen to make them easier to take with fewer side effects.

It said cash at end-December was £6.7mln, which is enough to fund confirmatory proof-of-concept (POC) studies on Ibuprofen and Naproxen formulations currently underway.

Data on tolerance and safety (PK) is expected by mid-2015 for the ibuprofen drug with headline endoscopy data due in the third quarter.

First results for the Naproxen reformulation are expected slightly earlier, with PK results expected this quarter and endoscopy results the quarter following.

Assuming successful outcomes, partnering discussions will begin during the second half 2015.

Its own internal models suggest every 1% of current market sales captured for its versions of Ibuprofen and Naproxen could equate to US$26m in retail sales and US$23m in research markets respectively.

Oxford added it is also in the early formulation stage of developing an Aspirin product that also uses its OXPZero platform.

The emphasis on research and development of NSAIDs products will mean losses in 2014 will be £3.5mln on revenues of £0.7mln.

Broker N+1 singer took bullish view on the group’s NSAID offering.

"NSAIDs represent one of the most widely used drug classes in the world, but their use is associated with gastrointestinel side effects.

"The group’s technology could potentially offer patients NSAIDs with an improved safety profile and there is enormous potential for OXP to exploit its reformulation expertise in what promises to be year of significant news flow."

Shares climbed 4% to 4.2p

mitzy - 11 Feb 2015 09:56 - 151 of 182

Amazing chart.

dreamcatcher - 12 Feb 2015 17:10 - 152 of 182

Chart.aspx?Provider=EODIntra&Code=OXP&Si

dreamcatcher - 05 Mar 2015 07:06 - 153 of 182

Final Results & Notice of AGM
RNS
RNS Number : 5882G
Oxford Pharmascience Group PLC
05 March 2015

Oxford Pharmascience Group Plc

("Oxford Pharmascience" or the "Company")

Results for the Year Ended 31 December 2014 and Notice of AGM



Oxford Pharmascience (AIM: OXP), the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, today announces its results for the year ended 31 December 2014 and gives notice of its AGM to be held on 24 June 2015 at 2.00pm at the offices of Fasken Martineau LLP, Third Floor, 17 Hanover Square, London, W1S 1HU. The Report and Accounts and Notice of AGM will today be posted to shareholders.



OPERATIONAL HIGHLIGHTS

· Lead gastric safe NSAIDs programme broadened to include OXPzeroTM Naproxen, Diclofenac and Aspirin, as well as Ibuprofen

· Successful optimisation of the OXPzeroTM Ibuprofen to enable immediate release formulations and to solve drug release issues

· Clear commercialisation strategy with Proof-of-Concept clinical trials for OXPzeroTM Ibuprofen and Naproxen planned for 2015

· Strengthening of the Board with the recruitment of John Goddard and Karl Van Horn. Both individuals bring significant experience and expertise to the Board.



FINANCIAL HIGHLIGHTS

· Cash and cash equivalents balances of £6.7m as at 31 December 2014, providing sufficient working capital to take the Company to commercial inflection points in 2015 and beyond

· Operating loss of £3.50m (2013: £1.56m) reflecting a planned increase in R&D spend, primarily on the NSAIDs programme



Marcelo Bravo, Chief Executive, Oxford Pharmascience Group Plc, commented:

"We finish 2014 with sharp focus on our lead 'gastric safe' non-steroidal anti-inflammatory drugs (NSAIDs) programme which is redeveloping the most widely used NSAIDs, ibuprofen, naproxen, diclofenac and aspirin to make them significantly milder in the gastrointestinal (GI) tract. We believe that the Group is firmly on track to achieve the clinical milestones it has set out for 2015 and the Board believes that the Group is well placed to deliver significant shareholder value should the results of trials be as expected."

dreamcatcher - 05 Mar 2015 18:16 - 154 of 182

UPDATE - Oxford Pharmascience shares rise as drug study gets underway

By Jamie Ashcroft

March 05 2015, 3:40pm
City broker N+1 said it was upbeat about Oxford Pharmascience and the company’s ability to exploit its re-formulation expertise.




Oxford Pharmascience (LON:OXP) shares shot up 18% as a study began, and the company revealed full year results in-line with expectations.

The novel drug delivery specialist, which aims to make medicines safer and easier to take, told investors human dosing is now underway in the comparative pharmacokinetic study.

Its candidate OXPzero Naproxen is being compared to Naprosyn, and the study aims to demonstrate bioequivalence.

Patent protected OXPzero Naproxen is an immediate release oral formulation which aims to provide significantly reduced risks of gastrointestinal (GI) side effects compared to standard naproxen tablets.

“The naproxen study builds on the successful GI irritation reduction results seen last year with our OXPzero Ibuprofen product and aims to demonstrate that the OXPzeroTM technology can also be tuned to enable immediate release,” said chief executive Marcelo Bravo.

“Completion of the PK study will allow Oxford Pharmascience to proceed with an endoscopy trial to demonstrate the gastric irritation reduction benefit is also obtained with naproxen."

Separately, for the twelve months to December 31, the company reported a £3.50mln operating loss, compared from £1.56mln last year. The increased loss was the result of higher research and development spending.

OXP had £6.7mln of cash and equivalents at the end of 2014, which the company says is sufficient working capital to commercial inflection points in 2015.

City broker N+1 said it was upbeat about Oxford Pharmascience and the company’s ability to exploit its re-formulation expertise.

The broker also predicted 2015 promises to be a year of significant news flow.

In London, OXP shares gained 1.12p or 17.79% to trade at 7.45p.

dreamcatcher - 17 Mar 2015 15:36 - 155 of 182

As of last trade Oxford Pharmascience Group PLC (OXP:LSE) traded at 7.90, 0.00% below its 52-week high of 7.90, set on Mar 05, 2015

dreamcatcher - 18 Mar 2015 16:01 - 156 of 182

Oxford Pharmascience Group PLC (OXP:LSE) set a new 52-week high during today's trading session when it reached 8.48. Over this period, the share price is up 93.83%.

dreamcatcher - 27 Mar 2015 07:08 - 157 of 182

Successful Pilot Clinical Study
RNS
RNS Number : 6350I
Oxford Pharmascience Group PLC
27 March 2015

Successful Pilot Clinical Study of
Immediate Release OXPzero™ Naproxen



Oxford Pharmascience, the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, today announces that the pilot comparative pharmacokinetics ("PK") study of OXPzero™ Naproxen ("OXP 005"), which commenced on 5 March, has been successful and the headline data from the trial demonstrates bioequivalence of OXP005 to Naprosyn® (generic naproxen).



OXPzero™ Naproxen aims to deliver 250mg of reduced gastric irritation naproxen via the Company's patent protected OXPzero™ technology in an immediate release oral formulation in order to provide a significantly reduced gastrointestinal (GI) side effect profile compared to standard naproxen tablets.



The headline PK data showed results which demonstrate bioequivalence and that the OXPzero™technology has been successfully optimised to enable immediate and complete drug release.



Full results of the study will be published in the following weeks. Based on this data, the company will now progress to a proof of concept endoscopy study to demonstrate the reduced GI irritation benefit of OXPzero™ Naproxen, as was previously demonstrated for OXPzero™ Ibuprofen in an earlier formulation.



Non-steroidal anti-inflammatory drugs (NSAIDs) are one of the most widely used classes of drugs, with combined annual sales in excess of $12 billion and more than 30 million users worldwide consuming NSAIDs each day (source: Evaluate Pharma). 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, diclofenac and aspirin.



Marcelo Bravo, Chief Executive Officer of Oxford Pharmascience commented:



"Demonstrating the bioequivalence of immediate release OXPzero™ Naproxen is a great result and a significant milestone for Oxford Pharmascience. This allows us to proceed with confidence to the endoscopy trial to demonstrate the reduced gastric irritation benefit of OXPzero™ Naproxen, and also confirms that the technology has been successfully optimised to achieve immediate and complete drug release. Oxford Pharmascience will now continue to progress confidently with our clinical programmes for both OXPzero™ Naproxen and OXPzero™ Ibuprofen."



Further information about the study:



The randomised pilot PK study, which was conducted by Quotient Clinical in the UK, was a single-dose, two arm study between OXPzero™ Naproxen and the reference Naprosyn® 250mg tablets with ten subjects in each arm. Headline PK data show mean AUC (Area Under the Curve or total drug exposure over time) and mean Cmax (maximum serum concentration) results meet the bioequivalence criteria, demonstrating that the OXPzero™ technology has been successfully optimised to enable immediate and complete drug release. Further details about the study can be found at www.ClinicalTrials.gov, ref: NCT02351024.

dreamcatcher - 27 Mar 2015 16:16 - 158 of 182

Oxford Pharmascience Group PLC (OXP.GB:ISD) set a new 52-week high during today's trading session when it reached 10.19. Over this period, the share price is up 70.73%.

dreamcatcher - 15 Apr 2015 16:06 - 159 of 182

Been in since 1.27p , going well.

dreamcatcher - 20 Apr 2015 16:24 - 160 of 182

As of last trade, Oxford Pharmascience Group PLC (OXP:LSE) traded at 11.45, 257.81% above the 52 week low of 3.20 set on Dec 10, 2014.

dreamcatcher - 13 May 2015 18:18 - 161 of 182

PK Results for OXPzero Naproxen vs. Naprosyn
RNS
RNS Number : 9880M
Oxford Pharmascience Group PLC
13 May 2015

Oxford Pharmascience Group plc

("Oxford Pharmascience" or "the Company")



Pharmacokinetic (PK) Study Results
for OXPzero™ Naproxen vs. Naprosyn®



Oxford Pharmascience, the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, is pleased to announce the positive full results of the pilot comparative pharmacokinetic (PK) study for OXPzeroTM Naproxen (OXP005), which - based on mean values - demonstrates an immediate release profile and bioequivalence to standard US and EU naproxen treatment.



OXP005 delivers 250mg of reduced gastric irritation naproxen via the Company's patent protected OXPzero™ technology. The full results of the study follow on from the headline data previously announced on 27 March.



The two-arm, pilot PK study was conducted in 10 healthy adult participants with each subject receiving both the OXP005 and the Naprosyn® treatments in a crossover design. The PK data show that all subjects had equivalent absorption of naproxen from OXP005 and of Naprosyn®, as indicated by area under the curve (AUC), with OXP005 being 100.5% of that observed for Naprosyn®. Mean maximum concentrations (Cmax) were 82.8% of that observed with Naprosyn®. In addition, both the mean half-life, time to maximum concentration and time to first measurable naproxen levels for OXP005 were comparable to Naprosyn®.



The amount of naproxen contained within the OXP005 tablets used for the PK trial was slightly low at 95.5% of the target naproxen dose, due to low tablet weight. Adjusting the PK results to account for the actual naproxen dose in both products tested provides mean relative values for absorption (from the AUC measurements) and maximum concentration (Cmax) of 102.8% and 84.3% respectively. The mean values for AUC and Cmax are within the guidelines for bioequivalence (80.0 to 125.0%). The fully powered bioequivalence study in later development will be designed to show that the 90% confidence intervals also fall within these limits, as per the FDA and EU guidelines.



These pilot PK study results demonstrate that, based on mean values, OXP005 is bioequivalent to Naprosyn® and therefore the Company is progressing to a proof of concept endoscopy study comparing the extent of gastroduodenal irritation between the OXP005 and Naprosyn. Dosing for this study is on track to start imminently with approvals required for the study in place and potential study subjects identified.



Non-steroidal anti-inflammatory drugs (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 gastrointestinal side effects, including ulcers and bleeding, and leads to significant morbidity and mortality in a substantial number of patients, with significant healthcare costs arising as a result of these side effects. 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.



Naproxen is an important NSAID with total sales of c $1bn at MSP (manufacturers' selling prices), mostly in North America.1 Naproxen was first approved for prescription use in the US in 1976 and was made available for OTC use as Aleve® (naproxen sodium 220 mg) in the US in 1994. Outside North America, naproxen is mostly used by prescription only. While naproxen has a somewhat higher risk of causing adverse GI effects as compared with ibuprofen2 it has some distinct advantages: Naproxen offers longer lasting relief and therefore requires less frequent dosing. Importantly, based on published analysis, naproxen is thought to have a reduced risk of cardiovascular events than all other NSAIDs3. It is therefore the preferred NSAID for long-term use in people with a high risk of cardiovascular complications4 and increasingly the preferred prescription option for patients with chronic conditions commonly treated with NSAIDs.





Marcelo Bravo, Chief Executive Officer of Oxford Pharmascience commented:



"These pilot study results with OXP005 support further development of our gastric safe naproxen and support our vision to revolutionise the NSAID treatment market. We are advancing development of a new pain relief treatment option for patients that offers improved gastrointestinal safety over the well-known NSAIDs, leading with the NSAID offering the safest cardiovascular profile, naproxen."



dreamcatcher - 15 May 2015 18:45 - 162 of 182

Ibuprofen progressing to proof of concept trial
RNS
RNS Number : 2857N
Oxford Pharmascience Group PLC
15 May 2015



Chewable Form of OXPzero™ Ibuprofen progressing to Proof-of-Concept Clinical Trial



Oxford Pharmascience Group Plc (AIM: OXP), the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, today announces completion of the development of an immediate release, taste masked, chewable 400mg ibuprofen product that is now ready for clinical evaluation. OXPzeroTM Ibuprofen (OXP001) delivers 400mg of reduced gastric irritation ibuprofen via the Company's patent protected OXPzero™ technology.



In January 2015, the Company announced that OXPzero™ Ibuprofen had been successfully optimised to deliver an immediate release tablet that demonstrated in vitro equivalence to standard Brufen® (400mg Ibuprofen tablet) and that a proof-of-concept clinical study with the optimised tablet was expected to begin in Q2 2015.



The Company has now developed a chewable 400mg ibuprofen tablet that is not only expected to reduce the risk of GI irritation but also to taste mask the bitter taste of the ibuprofen 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 GI safe treatment option, delivered in an easier to take dosing mechanism 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.



The Company has now decided to proceed to a proof-of-concept clinical trial with the chewable tablet and is planning to begin dosing in July 2015 with headline pharmacokinetic data also expected in July 2015. Endoscopy data to prove the reduction in GI irritation is due to follow in late Q3/early Q4 2015.



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. 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.



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. The Company hopes to provide the market with a much differentiated product, offering both a GI safer alternative to current NSAIDs and varied finished product forms to improve compliance rates.



Marcelo Bravo, Chief Executive Officer, commented:

"The development and progression of a chewable taste masked ibuprofen tablet to the clinic will not only provide the data to further confirm the GI irritation reduction benefit of the OXPzero™ technology but will also provide evidence in a clinical setting of its taste masking ability. Successful data from this study alongside data from OXPzero™ Naproxen will provide a robust data package moving forward into commercialisation of these assets."



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)

dreamcatcher - 18 May 2015 13:55 - 163 of 182

Initiation of Pilot Clinical Study for Naproxen
RNS
RNS Number : 4078N
Oxford Pharmascience Group PLC
18 May 2015

Oxford Pharmascience Group plc

("Oxford Pharmascience" or the "Company")

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


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 pilot clinical study of 250mg OXPzeroTM Naproxen (OXP005). OXP005 uses Oxford Pharmascience's patented OXPzero™ technology in an immediate release oral formulation and aims to provide a significantly reduced gastrointestinal (GI) side effect profile compared to standard naproxen tablets.



Following on from the recent announcement of the successful proof-of-concept pharmacokinetic (PK) study, the Company is pleased to announce that it has progressed to an endoscopic evaluation study to prove the reduced GI irritation of OXP005. The purpose of this Phase I, randomised, controlled pilot study is to assess the severity of upper GI damage via endoscopic assessment following 7 days treatment of 1 g/day naproxen dosed as either OXP005 or Naprosyn®. Headline results are expected to be released in late Q2/early Q3 2015. Further details about the study can be found at www.ClinicalTrials.gov.



Naproxen currently has worldwide sales of c.$1bn1 and is one of the most important molecules in the NSAID category due to a number of factors:

· its pain relief and anti-inflammatory effect are longer lasting than other NSAID molecules allowing for less frequent dosing regimes, which aids patient compliance; and

· its use is also associated with a lower incidence of cardiovascular complications compared to all other NSAIDs3. It is therefore the preferred NSAID for long-term use in people with a high risk of cardiovascular complications4.

However, the widespread use of Naproxen is hampered by the higher risk of GI irritation relative to Ibuprofen3. Accordingly, if GI irritation is reduced, OXP005 could provide a highly appealing combination of long lasting pain relief, lower cardiovascular risk profile and reduced GI irritation.



Marcelo Bravo, Chief Executive Officer, commented:

"The development of GI safer NSAIDs is a key priority for Oxford Pharmascience and we are very pleased to have commenced endoscopic evaluation of OXPzero™ Naproxen. Successful study data will confirm the results observed last year with OXPzero™ Ibuprofen demonstrating the class effect of the technology and putting the company in a strong position going into partnering discussions later this year."

NSAIDs are one of the most widely used classes of drugs, with combined annual sales in excess of $12bn1 and more than 30 million users worldwide consuming NSAIDs each day2. 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.



Sources

1. Evaluate Pharma

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

3. Lancet. 2013 Aug 31; 382(9894): 769-779. doi: 10.1016/S0140-6736(13)60900-9

4. American College of Gastroenterology - Ulcers and Gastrointestinal Bleeding: Protecting Your Health

dreamcatcher - 02 Jun 2015 18:00 - 164 of 182

Proactive investor -Oxford Pharmascience (LON:OXP), down 8.4%. The shares slipped a penny to 10.875p after the company said it had raised £20mln by placing shares at 10p a pop.

dreamcatcher - 02 Jun 2015 18:09 - 165 of 182

Shares - Why Oxford Pharmascience wants £20m


Upgrades are on the way for drug re-developer Oxford Pharmascience (OXP:AIM) as it raises £20 million to hone its pipeline.

The £115.6 million cap sold 200 million shares at 10p each to institutions. The stock only falls 3.1% to 11.5p following the deal, despite the shares selling for a near 16% discount to Monday’s closing price.

Oxford initially targeted £5 million, but demand was high with investors backing the company’s story of taking approved drugs and removing their side effects or making them easier to take.

Shares can reveal that around half the shares were bought by star fund manager Neil Woodford, who topped up his existing stake in the business to more than 30%. While going over the 30%-mark this would normally spark a mandatory bid for the entire business, although the investment expert has applied for a waiver from this obligation.

Web - Oxford Pharmascience - 2 June 2015

The proceeds will be used to develop Oxford’s pipeline and investigate new therapeutic uses for its technology. The cash will also strengthen its hand during commercial negotiations.

The deal is conditional on a shareholder vote on 24 June, when analysts at broker N+1 Singer say they will update their forecasts.

The main beneficially of the placing will be Oxford’s OXPzero Aspirin painkiller for cardiovascular disease sufferers, which is being designed to reduce gastric irritation while removing its taste. Alongside development, money will be spent on manufacturing and clinical trials.

Developing its statin product is also on the agenda, while a version of an ibuprofen tablet is expected to generate clinical proof of reducing gastric irritation this year.

dreamcatcher - 22 Jun 2015 19:58 - 166 of 182

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.
Register now or login to post to this thread.