Launch of Glycopyrronium Bromide Oral Solution

Quantum Pharma Plc

('Quantum' or the 'Group')

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."

Footnotes:

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

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Notes to Editors

Quantum Pharma Plc is a service-led, niche pharmaceutical developer, manufacturer and supplier to the retail pharmacy, pharmaceutical wholesaler, hospital, homecare and care home markets. Quantum Pharma operates through three divisions, offering a portfolio of innovative and complementary products and services.

Specials comprises four business units (Quantum Pharmaceutical, UL Medicines, NuPharm and Quantum Aseptics Services), which manufacture, procure and supply unlicensed medicines (specials) and special obtains. In response to a request from a prescriber for a bespoke medicine or special product to optimise patient treatment, the division manufactures, procures and supplies bespoke specials; batch made specials; aseptically prepared sterile intravenous medicines; imported medicines and special obtain products. With an expansive portfolio of products, Quantum is a trusted partner to the majority of large retail pharmacy chains in the UK, as well as pharmaceutical wholesalers, hospitals, independent pharmacies and dispensing doctors.  The division offers an unrivalled and constantly expanding range of products. It has a customer-focused, service-driven business model, which provides shorter lead times than any of its competitors.

Niche Pharmaceuticals comprises three business units (Colonis, Lamda and PERN Consumer Products) which develop and commercialise niche pharmaceuticals. This division is a product development and commercialisation business focusing on taking niche drugs through the regulatory pathway to achieve regulated status (licensed product or medical device). The division uses the excellent visibility of trends in the UK pharmacy and hospital markets gained through our Specials and Medication Adherence divisions, to allow early identification of the market opportunity to take products from unlicensed (special) status to licensed status. The division has a growing portfolio and pipeline of products that fit this unlicensed to licensed pathway, as well as complementary generic, generic plus or medical devices intended to meet unmet patient needs across a number of therapeutic areas.

Medication Adherence comprises two business units (Biodose® and Biodose Services®) which provide products and services to enhance the likelihood of a patient adhering to a medication regime, patient-focused homecare services and services to pharmaceutical companies. It owns Biodose®, the only medication delivery system on the market that accommodates both liquid and solid doses. Biodose Connect™ takes patient safety and adherence to the next level by enabling remote monitoring of adherence to medication regimes. The division also operates a range of specialist patient-focused homecare services to the NHS, private clinics and pharmaceutical companies across the UK and provides the Group with exposure to the homecare and supported living sectors of the care pathway complementing the focus of the remainder of the Group.

For further information, please visit www.quantumpharmaplc.com.