Cellceutix Receives Rare Pediatric Disease Designation from FDA for Kevetrin for the Treatment of Retinoblastoma

BEVERLY, MA–(Marketwired – December 01, 2015) - Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that on November 30, 2015 the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation to Kevetrin for the treatment of retinoblastoma, a rare form of eye cancer that begins in the retina, the light sensitive nerve tissue that lines the back of the eye. Retinoblastoma is most generally found in children, usually before the age of three, and rarely found in adults. It is sight threatening and potentially fatal if not diagnosed early.

The rare pediatric disease designation supplements the Orphan Drug Designation granted by the FDA to Kevetrin for retinoblastoma, as announced on November 23, 2015.

The designation of Rare Pediatric Disease provides the opportunity to apply for participation in the FDA’s Rare Pediatric Disease Priority Review Voucher Program. The program is intended to incentivize development of drugs for neglected diseases where no adequate therapies exist. Due to a provision triggered earlier this year, the voucher program will be up for review and reauthorization by Congress, as it is scheduled to end early in 2016. While the voucher program has wide support, there are no assurances to reauthorization in whole or changes that could be made.

“Receiving the Rare Pediatric Disease designation strengthens our portfolio and adds to our belief that Kevetrin has the potential to provide a meaningful therapeutic benefit to children and families affected by retinoblastoma, where enucleation (removal) of the eye is often the only solution,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. “We are putting plans in place to move ahead with this exciting project. We view the voucher program as very valuable in meeting areas of unmet medical need and certainly keep in mind the monetary component considering United Therapeutics recently agreed to sell its Rare Pediatric Disease Priority Review Voucher to a subsidiary of AbbVie for $350 million.”

About Rare Pediatric Disease Designation

The FDA defines a “rare pediatric disease” as a disease that affects fewer than 200,000 individuals in the U.S. aged from birth to 18 years. Under the FDA’s current Rare Pediatric Disease Priority Review Voucher Program, a sponsor who receives an approval for a drug or biologic for a “rare pediatric disease” may qualify for a voucher which can be redeemed to receive a priority review of a subsequent marketing application for a different product. The Rare Pediatric Disease Priority Review Voucher may be sold or transferred by the recipient.