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Media Release: SCENESSE® to be prescribed in China

Australian-based company CLINUVEL is launching SCENESSE® (afamelanotide 16mg) in the People’s Republic of China for the treatment of the rare genetic metabolic disorder erythropoietic protoporphyria (EPP).1

It is estimated that 5,000 Chinese residents live with EPP – based on a prevalence of 1:75,000 to 1:211,000 – with no therapy approved prior to SCENESSE®.

Under a Named Patient Program, CLINUVEL is collaborating with local partner Winhealth Pharma to facilitate treatment in prominent Chinese hospitals, with patients treated exclusively in selected large medical centres and hospitals. Local subsidies are available to enable eligible EPP patients to receive treatment.

EPP is an inherited disorder which causes incapacitating burns and internal damage to vessels whenever patients expose to visible light, particularly sunlight. Patients are forced to live indoors, deprived from birth onwards of social contacts and a normal life.

The innovation SCENESSE® was approved by the US Food and Drug Administration (FDA) in October 2019 and the European Medicines Agency (EMA) in October 2014 as the world’s first systemic photoprotective drug. Afamelanotide, a potent hormone and the active ingredient in SCENESSE®, acts as an anti-oxidative, strengthens blood vessels (vaso-active) and reduces swelling (anti-phlogistic) protecting patients against any light source and ultraviolet (UV) radiation.

 

CLINUVEL AND WINHEALTH PHARMA
Under an exclusive Collaboration Agreement, CLINUVEL and Winhealth Pharma will distribute SCENESSE® and train and accredit local hospitals to provide long-term care to Chinese EPP patients.

Clinical data generated in the United States and European Union, as well as under the Named Patient Program in China, will be filed to the National Medical Product Administration (NMPA) to obtain full registration of SCENESSE®. CLINUVEL will remain responsible for the pharmacovigilance and safety monitoring of the product while Winhealth will be responsible for the selection and management of Chinese hospitals and health care professionals. The commercial terms of the collaboration have not been disclosed. 

 

COMMENTARY
“It has taken some time in selecting a reputable Chinese partner with a firm standing locally, more so to find one who shows the same expansion thrift as we do,” CLINUVEL’s Director of Global Operations, Mr Lachlan Hay said. “In Winhealth Pharma we believe we have identified a trustworthy counterpart who will work towards the same goals as CLINUVEL’s team. The long-term thinking of Winhealth’s management fits well within our horizon. 

“CLINUVEL has gradually become known in our sector for blazing the trail on clinical, regulatory, and reimbursement matters. With the expansion of our R&D facilities in Singapore, we progressively became focussed on China as part of our long-term entry to Asia. Our staff identified the time after regulatory approvals – following the approvals from the FDA in October 2019 and EMA in 2014 – as the optimum moment to enter China and start facilitating the first ever treatment for Chinese EPP patients. CLINUVEL is now establishing an office in Shanghai to coordinate its activities,” Mr Hay said.

“EPP is a severe rare disorder in China representing an unmet medical need,” Winhealth’s Chair and CEO, Mr Jack Wang said. “We are very excited about the partnership with CLINUVEL and looking forward to bringing the breakthrough therapeutic into China in the very near future. As an organisation dedicated to the local development and commercialisation of branded therapeutics in the China region, Winhealth focuses on bringing external innovation from world-reputable firms into the hands of the Chinese patients. We will be working closely with our colleagues at CLINUVEL in order to accelerate the availability of SCENESSE® to the Chinese patients.” 

CLINUVEL is a specialty pharmaceutical group focussed on rare and critical diseases with expertise in financial, clinical and regulatory affairs. Winhealth Pharma is a leading and fast-growing local development and commercialisation organisation with vast experience in serving international life science firms and knowledge of product registration in the People’s Republic of China. 

Note to editors: A release to the Australian Securities Exchange is available from www.clinuvel.com

 

1 SCENESSE® (afamelanotide 16mg) is approved in the European Union as an orphan medicinal product for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). SCENESSE® is approved in the USA to increase pain free light exposure in adult EPP patients with a history of phototoxicity. Information on the product, including the approved prescribing information, can be found on CLINUVEL’s website at www.clinuvel.com.