Posted on Wednesday, 21 / Oct / 2020 Posted by michelle
Swiss partner EffRx Pharmaceuticals expects a market launch in 2022
Diurnal Group plc (AIM: DNL), a specialized pharmaceutical company targeting the needs of patients in chronic endocrine (hormonal) diseases, announced that the Company’s marketing and distribution partner in Switzerland, EffRx Pharmaceuticals (EffRx), has submitted a Market Authorization Application (MAA) to Swissmedic for Alkindi registration® (hydrocortisone granules in capsules for opening) in Switzerland.
MAA submission to Swissmedic for Alkindi® based on European regulatory files and published clinical trial data, with EffRx expecting a potential market launch in Switzerland by 2022.There are about 200 patients in Switzerland with pediatric AI, providing an estimate of the total market opportunity for Alkindi® about $ 1 million per year. As previously announced under the terms of the agreement, EffRx will receive the exclusive rights to market and sell Alkindi® in Switzerland once registered.
Alkindi® approved and marketed in Europe and is the first hydrocortisone preparation (synthetic version of cortisol) specifically designed for use in children with AI, including CAH-related conditions.
Diurnal will provide EffRx with products for sale from an established European supply chain and are part of the Company’s ongoing strategy for commercialization of its main products by optimizing market access outside of Europe’s main markets through marketing and distribution agreements with niche-focused and orphaned companies. condition.
Martin Whitaker, CEO of Diurnal, comments:
‘We are very pleased to see the MAA submission for Alkindi® in Switzerland by EffRx. Today’s announcement is a further validation of the quality of our products and extends Alkindi’s future availability® outside our core markets in line with our global strategy. We look forward to working with EffRx to create Alkindi® available to patients suffering from pediatric AI in Switzerland. ‘
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).
For more information, please visit www.diurnal.co.ukor contact:
Diurnal group plc +44 (0) 20 3727 1000
Martin Whitaker, Executive Director
Richard Bungay, Director of Finance
Panmure Gordon (UK) Limited (Nomination Advisor and Joint Brokerage) +44 (0) 20 7886 2500
Corporate Finance: Freddy Crossley, Emma Earl
Broking Company: Rupert Dearden
Consultation FTI +44 (0) 20 3727 1000
Victoria Foster Mitchell
Notes to Editors
About Alkindi® (hydrocortisone granules in capsules for opening)
Alkindi® is the first hydrocortisone preparation specifically designed for use in children with pediatric adrenal insufficiency (AI). Alkindi® is a patented, oral, immediately released hydrocortisone formulation for children in a capsule for the opening that allows age-appropriate dosing in children. This therapeutic approach has the potential to help young patients aged less than eighteen who suffer from cortisol deficiency diseases including AI in children and congenital adrenal hyperplasia (CAH). AI requires lifelong treatment and Diurnal’s new approach to product development has the potential to significantly improve the lives of young patients. The European Commission has granted a pediatric use marketing authorization (PUMA) for Alkindi® as replacement therapy for AI in infants, children and adolescents (from birth to
Alkindi® also approved in Israel and Australia.
Alkindi® known as Alkindi® Sprinkle in the US and approved by the US Food and Drug Administration (FDA) on September 29, 2020.
About Pediatric Adrenal Insufficiency
AI in children, including the genetic condition CAH is a condition characterized by a deficiency of cortisol, an essential hormone in the regulation of metabolism and response to stress. The main symptom of AI is chronic fatigue and patients are at risk for adrenal crisis and death if they are not given adequate cortisol replacement. AI is primary or secondary, with primary AI due to disease intrinsic to the adrenal glands and AI secondary to pituitary disease where there is failure of adrenal stimulation by the pituitary of the signaling hormone ACTH (adrenocorticotropic hormone).
About Diurnal Group plc
Founded in 2004, Diurnal is a European specialty pharmaceutical company headquartered in the UK that develops high quality products for the global market for the lifelong treatment of chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency, and hypogonadism. Her expertise and innovative research activities focus on circadian-based endocrinology to produce new product candidates in the arena of rare and chronic endocrine diseases.
For more information about Diurnal, please visit www.diurnal.co.uk
About EffRx Pharmaceuticals
EffRx Pharmaceuticals is a commercial-stage pharmaceutical company focused on the late-stage development and commercialization of prescription drugs for special indications and orphanages. The business model is centered on providing superior clinical and commercial value propositions for clinicians, payers and patients. EffRx is pro-actively exploring licensing opportunities for Europe in the specialty therapy field, with particular interest for rare diseases, for which EffRx has received the FDA’s orphaned drug (ODD) designation for pipeline assets.
For more information on EffRx Pharmaceuticals, please visit www.effrx.com
Preparation date: October 2020 Code: CORP-GB-0087
See the pdf document: The Market Authorization application for Alkindi® was submitted to Swissmedic
Diurnal group plc publish this content on 21 October 2020 and take full responsibility for the information contained therein. Distributed by the Public, unedited and unaltered, at October 21 2020 06:09:05 UTC