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Launch of Glycopyrronium Bromide Oral Solution

Launch of Glycopyrronium Bromide Oral Solution

Quantum Pharma Plc (AIM:QP.), the growing, service-led niche pharmaceutical developer, manufacturer and supplier to the health and care sectors, is pleased to announce that Colonis Pharma Limited (“Colonis”), part of the Group’s Niche Pharmaceuticals division, has successfully launched its licensed Glycopyrronium Bromide 1mg/5ml Oral Solution. The solution is licensed in adults as an add-on therapy in the treatment of peptic ulcers, which occur in the lining of the stomach or duodenum. 

Colonis’ Glycopyrronium Bromide Oral Solution 1mg/5ml is the first unlicensed to licensed liquid formulation of this product in the UK and will be launched by way of 'cease and desist' notices1, which will mean that the equivalent unlicensed medicinal products (“specials"2), which are used for a number of chronic conditions,  cannot now be supplied.  Between March 2015 and February 2016 the NHS in England spent £1.13 million in the community on liquid formulation specials of Glycopyrronium Bromide 1mg/5ml3.

Chris Rigg, Acting Chief Executive Officer and Chief Financial Officer of Quantum Pharma Plc, commented: “We are pleased to announce the launch of our Glycopyrronium Bromide solution.  This is the first licensed presentation of this product in the UK and marks further progress in our strategy to deliver unlicensed to licensed and other niche products to the market.

We are excited by the market opportunity for this core product in our Niche Pharmaceuticals portfolio.  The product provides the NHS with a fully regulated product to replace the current liquid formulation special and also provides the NHS with choice, value and an alternative to current prescribing for peptic ulcers.

Glycopyrronium Bromide solution is one of the most important launches of the current financial year for our Niche Pharmaceuticals division.  As such it is pleasing that we have been able to achieve the regulatory hurdles and launch in line with our expected timetable and now move into sales delivery phase.”


1 Cease and desist - MHRA guidance note 14 (May 2014) states, 'An unlicensed medicinal product should not be supplied where an equivalent licensed medicinal product can meet the special needs of the patient.'  Unlicensed medicines may only be supplied by importers or specials manufacturers against valid special clinical needs of a patient.  This requires that there is no authorised equivalent licensed medicinal product available on the national market.  Once a medicine has been granted a licence and stock is available to satisfy orders, all importers and suppliers of unlicensed medicines or specials must stop supplying that medicine as an import or a special and all prescribers should prescribe the licensed version and pharmacies should source the licensed product from a licence holder.

2 Special - a special is an unlicensed medicine which is prescribed to a patient when the licensed form of a drug does not meet their specific clinical need, or when there is no licensed form of drug available on the market suitable to treat their condition.  Specials are requested and prescribed for treatment by appropriately qualified doctors under their own authority.

3 Source PCA data to February 2016

Posted by: Quantum Webmaster on 10th August 2016