Class I medical device status for Biodose Connect

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Quantum Pharma Plc

("Quantum" or the "Group")

Class I medical device status for Biodose Connect®

Quantum Pharma Plc (AIM: QP.), the growing, service-led niche pharmaceutical manufacturer, developer and supplier to the health and care sectors, is pleased to announce that the Group's innovative telemedicine technology, Biodose Connect® ("the device") has successfully completed formal validation testing and now has Class I medical device status. Quantum can now implement its commercialisation strategy for the device.

The Class I medical device status of Biodose Connect® means that it now has CE mark authorisation. The process is governed by the Medicines and Healthcare products Regulatory Agency (MHRA), the UK healthcare regulatory authority.

Biodose Connect® is now ready for use in live patient settings, allowing the patient, carer, doctor or pharmacist to be alerted by remote monitoring if medicines are not taken as prescribed, with the aim of reducing the costs of poor medication adherence to both the NHS and social care fund holders.

The Quantum Board believes this is an exciting development that presents healthcare professionals with an opportunity to remotely monitor patients and to gather empirical data on adherence to the relevant prescription regime for their medication. It is estimated that between a third and half of all medicines prescribed for long-term conditions are not taken as recommended with an estimated cost of waste medication alone of around £100m per year, excluding any associated social or healthcare costs of not achieving the intended health outcomes from treatment1. A report published by the Department of Health said that medication errors contributed to 5 to 8% of hospital admissions in the UK 2.

Quantum is now able to move forward with its commercialisation strategy for this device, which will be branded as "Biodose Connect® by Vaica". Quantum has been working with Vaica Medical Ltd, a leader in the medical adherence industry, to develop the device since November 2014. Vaica has expertise in developing devices and associated IT to support patients with their adherence and Biodose Connect® works in conjunction with Vaica's software and further IT applications developed within the Quantum Group.

There will be an initial soft launch of Biodose Connect® by Vaica to the private pay market through selected pharmacies that are part of a national pharmacy chain. Quantum is also planning services to independent pharmacies on a regional basis. The product's use will then be extended to trials with Clinical Commissioning Groups (CCGs) which it is hoped will lead to funded services and in time to services funded by large pharmaceutical companies.

Biodose Connect® is an extension of Biodose® that supports the delivery of medicines with real-time information delivered electronically to carers and clinicians about their patients' adherence to their medication regime. Biodose® consists of a tray, 28 medicine pods and a seal, used to arrange medication in a patient specific format. It is currently used by around 50,000 patients across the UK and Ireland in either a care home or domiciliary care and transforms medication management in these settings.  It is the only medication delivery system on the market that accommodates both liquid and solid doses.

Andrew Scaife, Chief Executive of Quantum Pharma Plc, commented: "We are delighted that our Biodose Connect® device now has Class I medical device status and we can start to commercialise it. It is an exciting product that we believe will provide a huge benefit to the NHS, social care providers and pharmaceutical companies, not only by reducing the burden created by medication non-adherence, but also in allowing patients to be treated at home. We look forward to bringing Biodose Connect® to the market and showcasing its strong benefits."

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Footnotes

1) Medicines Adherence: Involving patients in decisions about prescribed medicines and supporting adherence (CG76) Jan 2009 NICE http://publications.nice.org.uk/medicines-adherence-cg76 

2) Exploring the costs of unsafe care in the NHS. A Report prepared for the Department of Health. Frontier Economics Oct 2014 http://www.frontier-economics.com/documents/2014/10/exploring-the-costs-of-unsafe-care-in-the-nhs-frontier-report-2-2-2-2.pdf 

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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 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.