Oxford Pharmascience Group Plc | Medicines made better

 

News

08 June 2017

Further Update Regarding OXPzero™ Ibuprofen Programmes

Oxford Pharmascience Group plc (AIM: OXP), the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, is providing a further update regarding its clinical and commercial plans, centred on its OXPzero™ NSAID (non-steroidal anti-inflammatory drug) portfolio.

Summary

OTC (Over the counter products):

  • Proceeding to develop selected OTC products with the intention to register for approval those which have a compelling business case, lower clinical risk and simple regulatory pathway
    • Lead OTC programme already initiated
    • Further market research being initiated to validate and prioritise other compelling OTC opportunities

Rx (Prescription based products):

  • Commercialisation efforts underway for Rx candidates in selected regions with favourable regulatory frameworks
  • Further clarification to be sought from regulatory agencies for 'GI (gastrointestinal) symptoms' endpoint and regulatory pathway

Funding

  • Strong capital base to support strategic objectives

Further detail in relation to the Company's plans is provided below under the same key headings.

OTC

As announced on 9 May 2017, the Company considers that the regulatory path to approval for products without a GI safety claim in the USA and UK/EU provides an attractive, low-risk route to market for a number of its pipeline OXPzero™ products. Having established that it can develop OXPzero™ Ibuprofen products that are bioequivalent to reference products, the Company sees opportunity to progress selected ibuprofen-based, taste masked products to the OTC market.

The Company is initiating market research in Europe and the USA to validate the most attractive opportunities and has already identified and started work on a lead programme. The Company's objective is to get the chosen product or products fully developed and approved for sale in at least one major geography and then to seek to commercialise via out-license, product launch or both.

Rx

For Rx markets, the Company's technology provides several, clinical-stage, high-value candidates available for licensing which solve key unmet needs across multiple pain markets. Our OXPzero™ products are clinically proven to have fewer GI side effects compared to standard form NSAIDs, enhancing safety and simplifying therapy. OXPzero™ Ibuprofen is demonstrably faster (and at the same time with fewer /reduced GI side effects') than standard ibuprofen tablets, providing faster onset and potentially faster pain relief. 

For territories where the regulatory pathway to a 'GI-safer' label claim involves endoscopic trial endpoints, the Company will continue to look to form commercial partnerships to maximize value. Following the regulatory guidance received from the US FDA in April, the Company has conducted market research both in the UK and in the USA to assess prescriber reaction to various Rx product concepts and label claims to help define its Rx strategy. This research has concluded:

  • As suggested by the FDA, claims of 'reduced GI symptoms" rather than 'GI safe' are considered to be sufficient to drive a prescription switch from other NSAIDs to OXPzero™ Ibuprofen, provided that reimbursement is at an acceptable level. The Company will now re-engage with the regulatory agencies to clarify the regulatory pathway for a 'reduced GI symptoms' label claim.
  • The speed of onset advantage associated with OXPzero™ Ibuprofen could also drive a switch of prescriptions, especially from diclofenac.  Diclofenac is a fast-acting NSAID prescribed for acute pain but its usage is associated with higher cardiovascular risk than other NSAIDs.
  • Ketorolac is acknowledged as an excellent pain reliever and the potential to develop a GI-safer version would be well received in the post-operative and acute pain markets where opioids are traditionally used, but should be avoided or used for limited periods only, due to the risk of opioid overdose and the high levels of addiction associated with use. 

The Company now will begin investigations to understand the regulatory pathway and the associated reimbursement scenarios for these various opportunities across several geographies, so as to inform the business case to prospective partners. The Company will seek partnerships to complete development and commercialisation of these assets. 

Sole focus on OXPzero™ NSAIDs

In order to ensure focus on its lead NSAID programmes, the Company has decided not to progress its cardiovascular programmes further at this time.

Strong cash balance

The Company maintains a strong capital base which supports the attainment of the Group's strategic objectives, with cash balances of £21.5 million as at 30 April 2017.

Further announcements including financial implications will be announced in due course.

 

Contacts:

Oxford Pharmascience Group Plc  
Marcelo Bravo, Chief Executive Officer +44 207 554 5875
   
N+1 Singer  
Aubrey Powell
Lauren Kettle
+44 20 7496 3000

 

About Oxford Pharmascience Group Plc

Oxford Pharmascience Group Plc uses a range of proprietary technology platforms to re-develop existing medicines to make them better, safer or easier to take. The Company does not manufacture or sell its own pharmaceutical products direct to consumers, but instead seeks to license its technologies and dossiers to a network of partners, mainly leading pharmaceutical companies with Rx (prescription) and OTC (over the counter) branded portfolios.

Oxford Pharmascience Group Plc focuses on existing medicines that are proven to be safe and effective but nevertheless still have associated issues and side effects often affecting compliance. By working with such medicines, the Company is able to develop new innovative products for a fraction of the cost, in much quicker timescales and without the high risk of failure associated with developing new drugs.

 

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