Fennec Pharmaceuticals' Breakthrough Treatment Gains Approval

Fennec Pharmaceuticals Celebrates Positive NICE Recommendation

Fennec Pharmaceuticals Inc. has announced an exciting development for young cancer patients and their families. The National Institute for Health and Care Excellence (NICE) has issued a positive final draft guidance recommending PEDMARQSI® for the prevention of hearing loss caused by cisplatin chemotherapy. This recommendation is particularly crucial for patients aged between 1 month and 17 years suffering from localized, non-metastatic solid tumors.

Understanding Cisplatin-Induced Hearing Loss

Cisplatin is a vital chemotherapy agent used in treating various pediatric cancers. However, it is notorious for causing permanent hearing loss or ototoxicity as a side effect, which can severely impact the quality of life and development of young survivors. Children exposed to cisplatin often face challenges such as speech and language delays, social-emotional development issues, and educational struggles.

PEDMARQSI®: A Groundbreaking Solution

PEDMARQSI is the first approved treatment in the European Union and the U.K. specifically designed to prevent cisplatin-induced hearing loss in children and young adults. The treatment has been shown to significantly reduce the risk of ototoxicity by approximately 50%, based on data from Phase 3 clinical trials, including SIOPEL 6 and COG Protocol ACCL0431. These studies highlighted the urgent need for a preventative option, as prior to PEDMARQSI, there were no pharmacological interventions available.

Collaboration With Norgine Pharmaceuticals

Building on this success, Fennec Pharmaceuticals recently entered into an exclusive licensing agreement with Norgine Pharmaceuticals Ltd., a well-respected European pharmaceutical company. Norgine will be responsible for the commercialization of PEDMARQSI® across Europe, Australia, and New Zealand. This collaboration is pivotal, ensuring that this life-changing treatment reaches those in need.

Commitment to Pediatric Care

Jeff Hackman, CEO of Fennec Pharmaceuticals, expressed his enthusiasm about this crucial milestone for the cancer community. He emphasized that gaining access to PEDMARQSI is a significant step towards reducing the risk of permanent hearing loss linked to cisplatin treatment in young patients. The collaboration underlines the importance of interventions aimed at improving cancer treatment outcomes and patient quality of life.

Financial Aspects of the Licensing Agreement

As part of the licensing deal, Fennec Pharmaceuticals received an upfront payment of approximately $43 million. Additionally, the agreement includes the potential for up to $230 million in future commercial and regulatory milestone payments, alongside royalties from the sales of PEDMARQSI. These financial arrangements will support the ongoing efforts to enhance the treatment landscape for pediatric oncology patients.

About Fennec Pharmaceuticals

Fennec Pharmaceuticals Inc. is dedicated to developing and commercializing innovative therapies aimed at reducing platinum-induced ototoxicity, particularly in children. With the FDA approval of PEDMARK® in the U.S. and the subsequent permissions granted in Europe and the U.K., Fennec is at the forefront of addressing a significant unmet need in pediatric oncology care. Their diligent focus on research and development is aimed at improving patient outcomes for future generations.

Continuing Research and Impact

The importance of PEDMARQSI extends beyond just treatment; it aligns with Fennec Pharmaceuticals' commitment to ongoing research and development. By continuously examining various signal pathways and treatment responses, Fennec is dedicated to creating a comprehensive support system for pediatric patients undergoing chemotherapy.

Frequently Asked Questions

What is PEDMARQSI®?

PEDMARQSI® (anhydrous sodium thiosulfate) is a treatment approved to prevent cisplatin-induced hearing loss in children and young adults.

Which patients can benefit from this treatment?

This treatment is aimed at pediatric patients aged 1 month to 17 years with localized, non-metastatic solid tumors undergoing cisplatin therapy.

What does the NICE recommendation signify?

NICE’s positive guidance endorses PEDMARQSI as a key intervention in reducing the risk of hearing loss caused by cisplatin chemotherapy, allowing for better patient outcomes.

How does the licensing deal with Norgine impact availability?

The exclusive licensing agreement with Norgine Pharmaceuticals will facilitate the commercialization of PEDMARQSI in Europe, Australia, and New Zealand, enhancing access for patients.

Why is preventing hearing loss important for cancer patients?

Preventing hearing loss is vital as it can significantly impact speech and language development, social interactions, and educational achievements, essential for lifelong success.

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