Launch of innovative medical food provides a palatable new option for people diagnosed with rare metabolic disorder in the UK

Craigavon, N.I., 13 Feb 2020 – An innovative medical food (food for special medical purpose) for people living with the rare, inherited metabolic disorder, phenylketonuria – or PKU as it is known for short – has been launched today in the UK. PKU EASY Microtabs provides a palatable alternative to other protein substitutes on the market, to help patients aged 8 and above manage the incurable condition and consume the protein they need each day.¹

Approximately 70 babies each year are born with PKU in the UK,² an inherited disorder which prevents the body from breaking down the proteins in foods to amino acids and if unmanaged, can lead to brain damage.³ Most patients in the UK are diagnosed at birth via newborn blood spot screening, also known as the heel-prick test, and are immediately started on treatment to reduce the risk of serious complications.³ Central to this is a lifelong, restrictive diet to limit the intake of one of the amino acids, phenylalanine, found in natural high-protein foods such as meat, fish, eggs and nuts. This is replaced with specially-designed medical foods to support the body’s everyday functions.^2,3

However, results from a 2018 survey of patients and caregivers in the UK found that the unpleasantness of available protein substitutes was one of the top three issues affecting both children and adults’ ability to follow their prescribed diet.⁴ PKU Easy Microtabs are small, innovative tablets with two distinct coatings that have been designed to overcome this challenge. The first delivers a palatable taste experience and prevents the tablet from dissolving before it hits the stomach, minimising acid reflux and bad breath; the second enables a slow release of amino acids into the body.⁵

“There’s no getting away from the fact that people living with PKU rely heavily on medical foods to supplement their diet in order to get the level of protein needed for good health. Yet we know from the community that many of the available options have an off-putting smell, taste bad and leave the patient with bad breath because of how they are digested. Today’s launch gives UK patients a more pleasant choice that other countries have already enjoyed the benefit of for years.” explained Simon Lawrence, Commercial Director of Galen Nordics (formerly known as POA Pharma).

PKU Easy Microtabs was first launched by POA Pharma across Scandinavia in 2011, but until now, was not available to UK patients via the NHS. Last month, Galen announced the completion of its acquisition and takeover of POA Pharma. Alongside its wider product portfolio, the move was intended to expand access to the company’s innovative nutritional therapies for people with PKU.

Dr Dennise Broderick, President & Managing Director Galen said: "Within one month of the completion of our acquisition of POA Pharma we are delighted to be able to bring this important new dietary management option to the 6,000 plus patients living with PKU across the UK. This is a condition that patients have to think about every single day of their lives to ensure they have the right levels of protein to function correctly. Portability, taste and digestion of medical foods are all important considerations that we are proud to have addressed for the community with our novel microtabs."

Notes to editors

 About PKU Easy Microtabs¹

PKU Easy Microtabs are small coated microtabs containing non-Phe amino acids, for the dietary management of PKU for patients aged 8 and above. They are swallowed with liquid or eaten with cold foods, such as jam or fruit purée.

The dose is established in cooperation with a dietician and it should only be used under medical supervision. It is not meant to be the only source of nutrition.

About Galen

Established in 1968, Galen is a privately owned pharmaceutical sales and marketing company, headquartered in Craigavon (Northern Ireland), with products in therapy areas including gastroenterology, pain management and dermatology.

As a subsidiary of Galen Limited, Galen US also has a growing presence in select conditions such as those requiring topical anaesthesia. The company plans to continue expanding its portfolio with selected specialty products on an international basis. By combining innovation in product development with competitive pricing, Galen aims to work in partnership with healthcare professionals and patients to create real, long-term value. Visit: www.galen-pharma.com

About Almac Group

Galen is a member of the Almac Group. The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across, and beyond, the drug development lifecycle to the pharmaceutical and biotech sectors globally.

Almac’s innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture, product development and marketing.

The international company is a privately owned organisation that has grown organically over the past five decades and now employs over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

Almac has a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

For further information please visit www.almacgroup.com.

References

1. PKU Easy Microtabs datasheet.
2. MacDonald A, Smith A, de Silva S, et al. The personal burden for caregivers of children with phenylketonuria: A cross-sectional study investigating time burden and costs in the UK. Molecular Genetics and Metabolism Reports 2016;9:1-5.
3. Phenylketonuria. Available at: https://www.nhs.uk/conditions/phenylketonuria/.
4. Ford S, O’Driscoll M, MacDonald A. Living with Phenylketonuria: Lessons from the PKU community. Molecular Genetics and Metabolism Reports 2018;17:57–63.
5. Giovannini M et al. (2014) Randomized Controlled Trial of a Protein Substitute with Prolonged Release on the Protein Status of Children with Phenylketonuria, Journal of the American College of Nutrition, 33:2, 103-110, DOI:1080/07315724.2013.857281