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Rare Diseases: PKU GOLIKE® Debuts in Germany

PKU GOLIKE®, the brand new generation of Phenylalanine (PHe)-free medical food for Phenylketonuria (PKU) dietary management, is now available in Germany and Austria, promoted and distributed directly by APR Applied Pharma Research s.a. (APR) through its local subsidiary, APR Deutschland .

The company has taken advantage of the 33th Annual Meeting of the APS (German Association for Pediatric Metabolic Medicine) in Fulda to showcase to healthcare professionals dealing with PKU the distinctive features of the patented amino acids (AAs) mixtures and the pharma technology enabling it – the Physiomimic™ Technology .

This conference, summoning every year more than 300 pediatricians from Germany, Austria and Switzerland, gives the participants the opportunity to be updated on the most significant advancements in metabolic diseases as well as new therapeutic approaches.

Germany is the biggest country in Europe in terms of prevalence of PKU and population of patients under treatment. According to IMS data, the outlook of the German market for PKU medical food is very positive, showing a growth rate of 9% on a yearly basis, driven mostly by products addressed to patients from 3 years of age onwards.

As confirmed by both German HCPs and patients interviewed during an international market research, palatability (taste and odor) of AA formulations is still one of the key criteria when deciding on a specific AA supplement, as it impacts significantly on the long-term compliance to the dietary treatment and consequently on the overall clinical outcomes.

PKU GOLIKE® , developed by APR and powered by the proprietary Physiomimic™ Technology, could offer a new dietary treatment option to the benefit of patients and HCPs.

During the event, physicians who visited the company booth learned about the key benefit of the innovative AAs mix – the prolonged absorption of AAs , how it makes PKU GOLIKE® a major step in PKU dietary management towards a more efficient AA utilization as well as the scientific data supporting its profile.

Physicians had also the chance to literally taste the unique formulation in special coating micro granules, experiencing how the Physiomimic™ Technology is able to mask the unpleasant taste and odor of free AAs . The audience agreed on the extent of this significant advantage for PKU patients’ compliance to life-long dietary regimen, while appreciating how PKU GOLIKE® could be easily integrated into the daily food routine.

“With PKU GOLIKE® our ambition is to set a new pace in PKU management by providing healthcare professionals, patients and caregivers with a treatment option which can make a real change in their lives.” said Paolo Galfetti, CEO of APR. “In Italy where we launched the product last October with our own sales & marketing organization, we are indeed receiving extremely positive feedbacks from physicians who have already recommended PKU GOLIKE® to a promising number of patients. We are confident this will soon happen also in Germany, a strategic market for us, where again we will be in direct control of the distribution and promotion of the product”.

To further support PKU GOLIKE® awareness among the healthcare professionals dealing with PKU, APR Deutschland is going to participate to the forthcoming congress of the VDD (German Dieticians Association) in Wolfsburg beginning of May, where scientific data will be divulged, while other initiatives are being prepared both on a local and international basis.

About Phenylketonuria or PKU

Phenylketonuria or PKU is a rare, genetic, recessive metabolic disorder affecting about 50.000 people worldwide. PKU is characterized by the deficiency or the malfunctioning of a liver enzyme needed to process phenylalanine (“Phe”). PKU has to be treated through a strict, life-long, low-protein (low-Phe) dietetic treatment combined with a daily assumption of low-protein modified foods and medical food or irreversible mental and physical disabilities will develop.

About PKU GOLIKE®

PKU GOLIKE is an innovative food for special medical purposes (FSMP) consisting of a Phe-free amino acid mixture. For the first time a pharmaceutical technology has been applied to a FSMP and the innovative PKU GOLIKE, engineered with Physiomimic technology™, provides a prolonged-released of amino acids and grants a remarkable taste and odor masking while preventing aftertaste. This prolonged release leads to a physiological absorption of amino acids, similar to dietary proteins, to favor a more efficient amino acid utilization and health benefits. The improvement of free-amino acids' organoleptic features aims to support compliance to the nutritional management of the diet for a better quality of life.

The product line is formed by: PKU GOLIKE PLUS 3-16 & PKU GOLIKE PLUS 16+ with amino acids, vitamins & minerals, and PKU GOLIKE PURE 3+ with only amino acids.

For more information about PKU GOLIKE® and the Physiomimic™ Technology, please visit: www.apr.ch/apr-pharma-products/medical-prescription/genetic-metabolic-disease/

About APR Applied Pharma Research s.a.

APR is a Swiss independent pharma company focused on development and global commercialization of innovative, research-driven products designed to address unmet needs in specialized therapeutic areas and rare diseases. APR combine pharmaceutical development expertise with proprietary drug delivery technologies to realize solutions that meaningfully improve the lives of people with rare diseases and empower families through novel approaches to disease management. A diverse and balanced portfolio of revenue-generating products in all major markets is complemented by a robust pipeline of innovative products at different stages of development for the treatment of recessive metabolic disorders, as well as rare dermatological and ocular diseases. Products are directly commercialized by APR through inhouse sales and marketing teams in strategically important countries across Europe and a growing worldwide network of commercial partners.

Contact:

APR Applied Pharma Research s.a.: Elisabetta Bianchi, Corporate Communication Manager elisabetta.bianchi@apr.ch +41 91 6957020

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