Fennec Pharmaceuticals has signed an exclusive licence agreement with Norgine to commercialise the former’s hearing loss therapy Pedmarqsi (sodium thiosulphate injection) for paediatric cancer patients undergoing chemotherapy.
UK-based Norgine will oversee marketing duties in Europe, Australia, and New Zealand following the deal, according to an 18 March press release.
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As per the agreement, Norgine will pay $43.6m (€40m) upfront to Fennec. The US pharma company could also be in line for a further $229m in milestone and royalty-based payments.
Pedmarqsi is indicated for the treatment of ototoxicity induced by cisplatin chemotherapy in patients with non-metastatic solid tumours aged one month to 18 years. Ototoxicity is a type of hearing loss associated with taking certain medications.
Cisplatin, similar to other platinum-containing drugs, can damage the cochlea. The risk of hearing impairment following chemotherapy is thought to be approximately five-fold with more than half of patients treated with cisplatin developing auditory issues.
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Pedmarqsi gained marketing authorisation from the European Commission in June 2023, followed by approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in October 2023. The therapy, under the US brand name Pedmark, was approved by the Food and Drug Administration (FDA) in September 2022.
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By GlobalDataFennec has seven years of market exclusivity for the drug in the US, according to orphan drug designation benefits. Competitors to the drug will only be able to join the market in September 2029.
Together, Pedmark and Pedmarqsi are forecast to see global sales of $161m by 2029, according to GlobalData’s Pharma Intelligence Centre.
GlobalData is the parent company of Pharmaceutical Technology.
Fennec’s CEO Rosty Raykov said: “From a deal perspective, the terms provided us many important benefits, including an upfront payment further solidifying our balance sheet, attractive economic terms providing meaningful participation in the ex-US success of Pedmarqsi.”
Data from two Phase III trials demonstrated that children who took Pedmarqsi with cisplatin-based regimens had a significantly reduced occurrence of hearing loss compared to those who only had the chemotherapy. A total of 239 paediatric cancer patients were enrolled across the two studies.
Fennec states that Pedmarqsi is the only therapy approved to treat cisplatin-induced hearing loss. The drug was the subject of an FDA notice that clarified its labelled use last month, after reports that some providers were using other sodium thiosulphate products instead of Pedmark.
