European Approval for extended release product SCENESSE

SCENESSE, a new drug developed by the Australian company Clinuvel, used for treating erythropoietic protoporphyria (EPP) - a rare photosensitivity disorder, has now been granted regulatory approval from the European Medicines Agency (EMA). The medication, which is effective for up to two months, uses a drug release system that was developed by Evonik in Birmingham, Alabama, US. Evonik will also manufacture SCENESSE on behalf of Clinuvel from its state-of-the–art facilities.    

EPP is a debilitating genetic disorder associated with an absolute intolerance to light. EPP patients must avoid light in order to prevent second-degree burns. The active agent in SCENESSE is afamelanotide, which acts as an antioxidant and photoprotectant. This substance protects the skin from bright visible light and from UV radiation, allowing EPP patients to lead relatively normal lives.    

Evonik supported Clinuvel from the original concept to SCENESSE approval, developing the controlled release system for afamelanotide and preparing the product for clinical trials. The formulation of this extended release medication uses a biodegradable, rod-shaped implant based on poly(lactide-co-glycolide) (PLG), a biocompatible, biodegradable polymer from the RESOMER product line of Evonik. RESOMER can be used in drug-delivery formulations and medical devices.    

“SCENESSE, a small implant roughly the size of a grain of rice relieves patients' symptoms for up to two months,” says Dr. Jean-Luc Herbeaux, the head of Evonik’s Health Care business line. “This is an excellent example of what can be achieved by combining competencies via partnering.” Clinuvel CEO Dr. Philippe Wolgen expands on this thought, saying, “Evonik is a leader in the industry when it comes to technology and has shown itself to be exceptionally committed to taking the technology from the prototype stage to clinical studies, and now to market launch.”   

Clinuvel is now working on giving European patients access to SCENESSE. Evonik is preparing to manufacture the drug product for market launch in the coming months and will continue to produce implants for further clinical trials in other regions for Clinuvel.   

Evonik’s Health Care Business Line provides a large array of products and services for the pharmaceutical industry, including API and API intermediates manufacturing, excipient products and drug product development and production services. Evonik has exceptional expertise in the field of formulating and developing complex, injectable drug products like SCENESSE. The Evonik site in Birmingham is EMA-certified and serves as a competence centre for parenteral drug delivery systems and for commercial production of finished pharmaceutical products. The focus includes extended release parenterals, including microparticles, implants, liposomes and nanomedicines.