Key Takeaways:
- Orphelia Pharma secures a crucial US patent for KIZFIZO®, a novel drinkable cancer treatment.
- The medication targets high-risk neuroblastoma in children, promising a significant medical advance.
- Patent protection extends until 2038, ensuring exclusive rights and encouraging further innovation.
Introduction: A Milestone in Pediatric Cancer Care In a significant leap forward for pediatric oncology, Orphelia Pharma, a French pharmaceutical company specializing in pediatric and orphan drugs, announces a groundbreaking development. The US Patent and Trademark Office has granted a patent for KIZFIZO®, the first pediatric drinkable formulation of temozolomide, marking a major advancement in the treatment of high-risk neuroblastoma in children.
KIZFIZO®: A Tailored Solution for Young Patients KIZFIZO® (temozolomide oral suspension, 40 mg/ml) represents a pioneering effort in developing age-appropriate cancer treatments for children. Known as Ped-TMZ or KIMOZO during its clinical development, this taste-masked oral suspension has been specifically formulated for easy administration to young patients, either orally or via a nasogastric tube, in a precisely measured, small volume.
Collaboration at the Heart of Innovation The development of KIZFIZO® is the result of a six-year collaboration between Orphelia Pharma and Gustave Roussy, Europe’s leading cancer center. This partnership underscores the importance of collaborative efforts in advancing medical science, particularly in specialized fields like pediatric oncology.
The Significance of the US Patent Jeremy Bastid, Chief Development Officer at Orphelia Pharma, emphasizes the innovative formulation of KIZFIZO®, which improves the stability and rheological properties of the suspension. The US patent, alongside the previously issued European patent, provides dual exclusivity protection for KIZFIZO® in these significant markets. This exclusivity is crucial for safeguarding the intellectual property and encouraging ongoing innovation in pharmaceutical development.
Overcoming Previous Challenges Maxime Annereau, a pharmacist at Gustave Roussy and co-inventor of the patent, highlights the challenges previously faced in developing an oral formulation of temozolomide. The new formulation successfully addresses issues like low concentrations, large administration volumes, short shelf lives, and erratic recrystallization, which were common in earlier attempts.
Tackling High-Risk Neuroblastoma According to Jeremy Bastid, KIZFIZO® is essential in treating refractory or relapsed high-risk neuroblastoma, a disease affecting very young children and carrying a poor prognosis. The focus now shifts to making KIZFIZO® widely available, with an application already submitted for marketing authorization in Europe.
Patent Protection and Future Implications The granted US (US11/730,732) and European (EP3613436) patents co-owned by Orphelia Pharma and Gustave Roussy extend until 2038, providing a substantial period of protection. This safeguarding is vital for fostering ongoing research and development in the field.
About KIZFIZO® KIZFIZO® is a ready-to-use oral liquid pediatric formulation of temozolomide developed for treating relapsed or refractory high-risk neuroblastoma. Its age-adapted, taste-masked formulation ensures accurate dosage and minimizes drug handling risks for caregivers. The drug has already received Early Access Authorization in France and Orphan Drug Designations from the EMA and FDA.
Orphelia Pharma and Gustave Roussy: Pioneers in Pediatric Oncology Orphelia Pharma, based in Paris and Lyon, is committed to developing and marketing medicines for pediatric and orphan diseases. Gustave Roussy, a globally recognized cancer center, brings comprehensive expertise in patient care, research, and teaching, specializing in rare cancers and complex tumors.
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