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news.Norgine Pharmaceuticals has launched Pedmarqsi (sodium thiosulfate injection) commercially in Germany.
In the randomised Phase III trials, the data showed nearly a 50% decrease in the cisplatin-induced ototoxicity occurrence in subjects who received the treatment with cisplatin and sodium thiosulfate. Credit: National Cancer Institute in Unsplash.
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In March last year, Fennec Pharmaceuticals entered an exclusive licensing agreement, granting Norgine commercialisation rights for the injection in Australia, New Zealand, and Europe.
Under this agreement, Fennec obtained an upfront payment of $43m and is also eligible for up to $230m in additional commercial and regulatory milestone payments.
The agreement terms also included tiered royalties on net sales of the injection to Fennec, starting in the mid-teens and increasing to the mid-20s.
Fennec Pharmaceuticals CEO Jeff Hackman said: “Until now, there have been no pharmacological interventions available to cancer patients in Germany to prevent ototoxicity, or permanent hearing loss, caused by treatment with cisplatin.
“We congratulate Norgine on making Pedmarqsi available to patients and healthcare providers in Germany and look forward to future launches in other major European markets.”
The injection is claimed to be the first and only approved in the UK and European Union (EU) for preventing cisplatin chemotherapy-induced ototoxicity (hearing loss) in individuals aged one month to under 18 years with non-metastatic, localised solid tumours.
Cisplatin, alongside other platinum-based compounds, is used to treat a variety of paediatric cancers. But platinum-based therapies can lead to permanent, and irreversible hearing loss.
In the randomised Phase III trials, the Clinical Oncology Group (COG) Protocol ACCL0431, and SIOPEL 6, the data showed nearly a 50% decrease in the cisplatin-induced ototoxicity occurrence in subjects who received the treatment with cisplatin and sodium thiosulfate against those treated with only cisplatin.
In June 2023, a marketing authorisation was granted by the European Commission (EC) under the paediatric-use marketing authorisation (PUMA), providing eight and two additional years of data and market protection.
Also, in September 2022, the injection received the Food and Drug Administration (FDA) approval.
In October 2023, the product was approved in the UK under the brand name Pedmarqsi.
