Scenesse (afamelanotide) will be made available in China for people with erythropoietic protoporphyria (EPP), following the partnership between the treatment’s developer, Clinuvel, and the Chinese company Winhealth Pharma.
The companies will collaborate to provide Scenesse — the first approved treatment for EPP — to large medical centers and hospitals in China, where an estimated 5,000 people have the disease. They also will train healthcare providers and accredit Chinese hospitals to care for EPP patients in the long-term.
Winhealth was chosen as a local partner to facilitate distribution of the therapy.
“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,” Lachlan Hay, Clinuvel’s director of global operations, said in a press release. “In Winhealth Pharma we believe we have identified a trustworthy counterpart who will work towards the same goals as CLINUVEL’s team.”
Added Jack Wang, Winhealth’s CEO: “EPP is a severe rare disorder in China representing an unmet medical need.”
“We are very excited about the partnership with CLINUVEL and looking forward to bringing the breakthrough therapeutic into China in the very near future,” Wang said.
Clinuvel will be responsible for monitoring the safety of Scenesse in China, while Winhealth will focus on the selection of healthcare providers for treatment distribution.
“Winhealth focuses on bringing external innovation from world-reputable firms into the hands of the Chinese patients,” said Wang. “We will be working closely with our colleagues at CLINUVEL in order to accelerate the availability of SCENESSE to the Chinese patients.”
EPP is characterized by hypersensitivity to sunlight and even some types of artificial light (such as fluorescent light), causing pain, skin burns, and blood vessel damage in patients. The disorder is caused by impaired activity of ferrochelatase, an enzyme involved in heme production — a key molecule for red blood cells to transport oxygen. This defect leads to the buildup of a compound called protoporphyrin IX in the blood and tissues.
Scenesse is a skin implant that works as a potent antioxidant and protector against the effects of sunlight.
The medication was first approved by the European Medicines Agency (EMA) and by the U.S. Food and Drug Administration (FDA). As it was in the European Union and the U.S., Scenesse will be available in China in a 16 mg dose.
“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,” Hay said.
The expansion was made possible by a Named Patient Program, a legal means to provide patients and physicians with access to treatments that have been approved in other countries. Clinical data from patients taking Scenesse in the U.S., EU, and now in China will contribute toward the full registration of Scenesse with China’s National Medical Products Association.
Scenesse’s effectiveness was shown in two Phase 3 clinical trials with EPP patients. Results from a Phase 3 study (NCT01605136) showed that EPP patients in the U.S. given three Scenesse implants spent a median of 70 hours over six months in direct sunlight with no pain, while the placebo group spent only 41 hours.
A Phase 3 trial conducted in Europe (NCT00979745) revealed that the duration of pain-free time after nine months also was longer with Scenesse than a placebo group (six hours for the treated group vs. 0.8 hours for the placebo group).
Quality of life improved with Scenesse in both studies.
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