Clarity Pharmaceuticals Announces that the US FDA Grants Rare Pediatric Disease Designation to 67Cu-SARTATE™ for the Treatment of Neuroblastoma

SYDNEY,June 3,2020 -- 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 Rare Pediatric Disease Designation (RPDD) to 67Cu-SARTATE™,a therapy for the clinical management of neuroblastoma.

The FDA defines a "rare pediatric disease" (RPD) as a serious or life-threatening disease primarily affecting individuals aged 18 years or younger that impacts fewer than 200,000 people in the United States. The program is intended to facilitate development of new drugs and biologics for the prevention and treatment of RPDs.

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.[1] 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%.[2]

Upon FDA marketing approval of 67Cu-SARTATE™ for neuroblastoma with RPD designation,Clarity may be eligible to receive a Priority Review Voucher (PRV),which can be used to obtain FDA review of a New Drug Application for another product in an expedited period of six months.The Voucher may also be sold or transferred and to date PRVs have been sold for between US$67.5 million to US$350 million.

Dr Alan Taylor,Clarity's Executive Chairman,commented,"The FDA decision to grant RPDD to 67Cu-SARTATE™ for the treatment of neuroblastoma,following an earlier decision to grant it an Orphan Drug Designation,emphasises the critical need for better treatments for this devastating disease,and is testament to the significant level of work we have completed to date on this therapy.

"The current neuroblastoma treatment strategies are limited,especially in late-stage disease,and the prognosis of high-risk neuroblastoma patients remains unfavourable. Our team at Clarity and our collaborators around the world are committed to improving these outcomes.

"We are very excited about the development of SARTATE™ in neuroblastoma and are looking forward to the results from our US-based Phase 1/2 trial[3]. We are hoping that the grant of RPDD will get us one step closer to our ultimate goal of developing better treatments for children and adults with cancer."

References

1. Nadja C. Colon and Dai H. Chung 2011,"Neuroblastoma",Advances in Pediatrics,https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3668791/

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

3. ClinicalTrials.gov Identifier: NCT04023331

https://clinicaltrials.gov/ct2/show/NCT04023331

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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