Clarity Pharmaceuticals Announces US FDA Grants 67Cu-SARTATE™ Orphan Drug Designation for Neuroblastoma

SYDNEY,April 21,2020 --Clarity Pharmaceuticals,a radiopharmaceutical company focused on the treatment of serious disease,is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for 67Cu-SARTATE™,a therapy for the clinical management of neuroblastoma.

Neuroblastoma most often occurs in children younger than 5 years of age and presents when the tumour grows and causes symptoms.It is the most common type of cancer to be diagnosed in the first year of life and accounts for around 15% of paediatric cancer mortality. High-risk neuroblastoma accounts for approximately 45% of all neuroblastoma cases. Patients with high-risk neuroblastoma have the lowest 5-year survival rates at 40%-50%.[1]

FDA grants ODDs to facilitate the development of investigational therapies intended to treat,diagnose or prevent rare diseases affecting fewer than 200,000 people in the United States. The designation allows Clarity Pharmaceuticals to qualify for a number of incentives,including: seven years of market exclusivity upon regulatory approval,if received;potential tax credits on US clinical costs; exemptions from certain administrative FDA fees; and eligibility for grants to fund future clinical work.

Dr Alan Taylor,Clarity's Executive Chairman,commented,"At Clarity,we are especially passionate about the development of SARTATE™ in neuroblastoma. At present,prognosis of high-risk neuroblastoma patients remains unfavourable,despite intensive,multimodal therapy. Also,the effectiveness of current neuroblastoma treatment strategies,such as chemotherapy,radiation,and surgery,is limited in late-stage disease due to patients' numerous metastases. It is clear that improvements in current treatment approaches are needed to overcome poor outcomes for the patients."

"ODD status will potentially provide a number of advantages for the development of SARTATE™ for the treatment of neuroblastoma and allow us to progress more swiftly to our ultimate goal of better treatment of children and adults with cancer."

References

Valeria Smith and Jennifer Foster 2018,High Risk Neuroblastoma Treatment Review,<https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6162495/>

About Clarity

Clarity is a personalised medicine company focused on the treatment of serious diseases. The Company is a leader in innovative radiopharmaceuticals,developing targeted therapies for the treatment of cancer and other serious diseases in adults and children.

www.claritypharmaceuticals.com

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