Clinuvel files European dossier for new drug
Key points
- Clinuvel Pharmaceuticals submitted a regulatory dossier in Europe for its second pharmaceutical product, NEURACTHEL Instant.
- The filing initiates a 300-day review period across three key European Union member states.
- The company seeks to enter the global adrenocorticotropic hormone market, currently estimated at US$1.3 billion annually.
Clinuvel Pharmaceuticals (ASX:CUV) has submitted a marketing authorisation dossier in Europe for NEURACTHEL Instant, its branded generic formulation of tetracosactide.
The decentralised procedure filing allows national regulators in three initial European Union member states to evaluate the drug simultaneously based on local demand and supply shortages.
The company stated that the global adrenocorticotropic hormone market is currently estimated at US$1.3 billion annually.
Under European guidelines, the decentralised procedure requires 300 days of review, excluding potential clock stops, with a final position anticipated at day 270.
The company stated that further regulatory submissions are under evaluation for the United Kingdom and the United States.
Following the announcement, the Clinuvel Pharmaceuticals share price was unchanged at $7.19.
Clinuvel Pharmaceuticals distributes its lead product SCENESSE to treat adult patients with erythropoietic protoporphyria.
The speciality pharmaceutical company relies on its existing commercial infrastructure to roll out new treatment programmes across international markets.
