CLINUVEL expands its pharmaceutical portfolio

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MELBOURNE, Australia, November 08, 2021 (GLOBE NEWSWIRE) – CLINUVEL has expanded its pharmaceutical development portfolio with NEURACTHEL®, new formulations of the adrenocorticotropic hormone melanocortin (ACTH). The Company has secured the supply of ACTH with one of its strategic partners to meet existing global demand, and will assess the potential of NEURACTHEL® for patients with neurological, endocrinological and degenerative disorders, who do not have alternative therapy.

ACTH belongs to the same family of bioactive hormones – melanocortins – as afamelanotide, the first pharmaceutical product that CLINUVEL has successfully marketed under the name SCENESSE.®.1 Various formulations of ACTH are approved worldwide for patients, with sales of the drug estimated at US $ 1.29 billion in 2020 and expected to reach approximately US $ 1.91 billion by 2031.2

ACTH is an approved and recognized treatment for a number of neurological and endocrinological diseases, but the global supply and availability of the product has recently been disrupted and its full clinical potential remains untapped.Said CLINUVEL Vice President of Scientific Affairs Dr Tim Zhao.

“Our research and commercial expertise in melanocortin-based drugs and peptide drug delivery platforms means that we are well positioned to ensure the successful, safe and effective development and commercialization of ACTH formulations under the name of NEURACTHEL.®. We also know that there are many other groups of underserved patients who would benefit from NEURACTHEL.® treatment, and we will address those unmet medical needs. The Company now has several products in development for patients and other populations ”, Dr Zhao said.

Melanocortins are hormones that act on cells throughout the body and may play a role in central nervous system regulation, energy balance, appetite, DNA photoprotection and repair, as well as function. sexual. The natural human hormone ACTH is essential for the production of cortisol, allowing the fight against stress and the regulation of immune responses, the maintenance of blood pressure, the moderation of blood sugar and the regulation of metabolism.

“Over the past two decades, CLINUVEL has established itself as the global expert in the development and commercialization of melanocortin-based drugs,” said CLINUVEL’s Director of Global Operations, Mr. Lachlan Hay. “Our understanding of the technology and the potential of these products allows us to unlock value for patients who lack alternatives. “

The CLINUVEL teams have proven expertise in the development of melanocortin with an initial focus on SCENESSE®, the world’s first systemic photoprotective drug, formulated as a controlled-release injectable implant for diseases caused by light and UV. The Company is currently evaluating the potential of afamelanotide and other melanocortin-based drugs as therapeutic agents for patients with acute and life-threatening genetic, metabolic, neurological, vascular, endocrine and degenerative disorders.

“We can now methodically pursue our NEURACTHEL® programs, having ensured the provision of ACTH to a current standard of good manufacturing practice, or cGMP, the standard required by global regulatory authorities. The CLINUVEL formulation teams at the VALLAURIX Research, Development and Innovation Center in Singapore have developed a number of innovative instant and controlled release formulations that are used as platforms for melanocortin therapies, including ACTH “, Dr Zhao said.

1 SCENE® is approved in Europe, the United States and Australia for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).
2 Adrenocorticotropic Hormone (ACTH) Market – Global industry analysis, size, share, trends and forecast, 2017-2031 by Transparency Market Research (TMR), 2021.

Media inquiries
Monsoon communications
Mr. Rudi Michelson, 61 411 402 737, rudim@monsoon.com.au

About CLINUVEL PHARMACEUTICALS LIMITED
CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY; XETRA-DAX: UR9) is a global and diverse biopharmaceutical company focused on the development and commercialization of therapies for patients with acute genetic, metabolic, systemic and potentially fatal. , as well as health solutions for the general population. A pioneer in photomedicine and understanding the interplay of light and human biology, CLINUVEL’s research and development has led to innovative treatments for patient populations with a clinical need for systemic photoprotection, DNA repair and acute or life-threatening conditions. These patient groups vary in size from 5,000 to 45 million worldwide. The flagship compound of CLINUVEL, SCENESE® (afamelanotide 16mg), was approved by the European Commission in 2014, the United States Food and Drug Administration in 2019, and the Australian Therapeutic Goods Administration in 2020 as the world’s first systemic photoprotective drug for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (PPE). You can find more information about EPP at http://www.epp.care. Based in Melbourne, Australia, CLINUVEL is present in Europe, Singapore and the United States. For more information, visit http://www.clinuvel.com.

SCENE® , PRENUMERO® , and NEURACTHEL® are registered trademarks of CLINUVEL PHARMACEUTICALS LTD.

Head of Investor Relations
Mr. Malcolm Bull, CLINUVEL PHARMACEUTICALS LTD

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Forward-looking statements
This press release contains forward-looking statements. Please see www.clinuvel.com for details

www.clinuvel.com

Level 11, 535 Bourke Street, Melbourne – Victoria, Australia, 3000 T +61 3 9660 4900 F +61 3 9660 4909


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