The risk of hearing impairment following chemotherapy is thought to be about five-fold with more than half of patients treated with cisplatin developing auditory issues. Image credit: Shutterstock/Marija Stepanovic.

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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Fennec 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.