MedPath

Clinuvel Pharmaceuticals Ltd

🇦🇺Australia
Ownership
-
Employees
16
Market Cap
$473M
Website
Introduction

Clinuvel distributes a single product, Scenesse, the only approved treatment for phototoxic reactions specifically associated with a rare genetic disease called erythropoietic protoporphyria. EPP causes extreme pain or burns from brief exposure to light, affecting a patient’s quality of life. Scenesse is a patented dissolvable implant, comparable in size with a rice grain, injected underneath the skin roughly every three months for ongoing protection. The implant controls the release of a synthetic drug which promotes the production of more melanin, thereby reducing pain and increasing tolerance for light exposure. The majority of Clinuvel’s earnings stem from Europe and the US.

sharecafe.com.au
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Injecting hope: Clinuvel eyes higher SCENESSE usage in Europe

Clinuvel Pharmaceuticals discusses with EMA to raise SCENESSE dosage for EPP patients from four to six doses, aligning with US guidelines. This aims to provide year-round treatment, supported by global safety data from 16,000 doses administered.
finance.yahoo.com
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Putting the DACH region on the map for clinical trials

The OCT DACH 2024 conference in Zurich discussed EU regulations, digitalisation, AI, and ethics in clinical trials, with concerns over MDR hindering innovation and the need for inclusive trial designs. Experts emphasized the importance of partnerships and patient-centric approaches, while WHO guidance aimed at reducing research waste through better trial design and inclusivity.

Disc teases potential NDA for rare skin disorder drug

Disc Medicine secures FDA agreement for bitopertin, an investigational drug for erythropoietic protoporphyria (EPP), with potential accelerated approval based on Phase II data. The Phase III APOLLO trial, set to begin mid-2025, will serve as a confirmatory study, focusing on pain-free sunlight exposure. Bitopertin showed good tolerability in Phase II, with no serious adverse events reported.

How a patient helped shape a treatment for rare skin disorder

Dr Jasmin Barman-Aksӧzen, diagnosed with erythropoietic protoporphyria (EPP), joined a University of Zurich research group working on Scenesse, a treatment increasing skin pigmentation to protect against light-induced skin damage. Scenesse, approved in Europe in 2014 and the US in 2019, allows EPP patients to spend more time in sunlight without pain. Barman-Aksӧzen co-founded the International Porphyria Patient Network (IPPN) and advocates for head-to-head studies comparing new treatments to existing therapies.
globenewswire.com
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CLINUVEL files Canadian New Drug Submission for SCENESSE® in EPP

CLINUVEL filed a New Drug Submission to Health Canada for SCENESSE® (afamelanotide) to prevent phototoxicity in EPP patients. If approved, it would be the first treatment for Canadian EPP patients. The drug, already approved in Europe, the US, Israel, and Australia, stimulates melanin production to protect skin cells from light exposure.
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