SOURCE: CTD Holdings, Inc.

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June 24, 2015 07:00 ET

CTD Holdings Obtains US Orphan Drug Designation for Trappsol® Cyclo™

UCSF Benioff Children's Hospital Oakland Agrees to Transfer of Orphan Drug Designation Sponsorship to CTD Holdings

ALACHUA, FL--(Marketwired - June 24, 2015) - CTD Holdings, Inc. (OTCQB: CTDH), a family of biotechnology growth companies that develop cyclodextrin-based treatments, today announced that the company has signed an agreement with UCSF Benioff Children's Hospital Oakland to transfer sponsorship of their US FDA Orphan Drug Designation for Trappsol® Cyclo™ to CTD Holdings. CTD's orphan drug designated Trappsol® Cyclo™ is being developed for the treatment of Niemann-Pick Type C (NPC), a rare and fatal disease found primarily in children.

The FDA issued this first Orphan Drug Designation for Trappsol® Cyclo™ to Children's Hospital in 2010 after a submission by Dr. Caroline Hastings, pediatric hematologist/oncologist at UCSF Benioff Children's Hospital Oakland, to support her treatment of NPC patients. The designation specifically cites the Trappsol® brand of hydroxypropyl beta cyclodextrin as the active pharmaceutical ingredient in granting the designation. Trappsol® Cyclo™ is the only commercial product to hold an FDA Orphan Drug Designation as a treatment for NPC.

"Orphan Drug Designation provides significant advantages that enable the development of effective treatments for rare diseases," said CTD Holdings President and CEO Dr. Jeffrey Tate. "The US Orphan Drug Designation complements our European ODD and strengthens our International Clinical Program for rapid progress."

"Transfer of sponsorship for the Orphan Drug Designation to CTD paves the way to important drug discovery and establishing clinical efficacy for treatment of patients with NPC," said Dr. Caroline Hastings.

About CTD Holdings, Inc.:
CTD Holdings, Inc. is a family of biotechnology growth companies based on cyclodextrin chemistry. Its individual divisions distribute and manufacture the trademarked Trappsol® and Aquaplex® cyclodextrins, cyclodextrin derivatives, and cyclodextrin complexes for biotechnology and life science companies involved in research, pharmaceutical, medical device, cosmetics and nutrition markets. Sphingo Biotechnology, Inc. is developing Trappsol® Cyclo™, an orphan drug designated product, for the treatment of Niemann-Pick Type C, a rare and fatal genetic disease in young children. NanoSonic Products, Inc. operates the world's only cGMP pulse drying facility for the production of UltraPure™ cyclodextrin derivatives and pharmaceutical grade Aquaplex® cyclodextrin complexes. CTD, Inc. supplies cyclodextrins to biotechnology and life science researchers around the globe from the world's largest catalog of cyclodextrins. The companies offer a wide variety of cyclodextrin related manufacturing services to worldwide customers, including custom formulation, manufacturing, and commercial-scale supply of pharmaceutical grade cyclodextrin complexes. For additional information, visit the Company's websites: www.ctd-holdings.com and www.cyclodex.com.

About UCSF Benioff Children's Hospital Oakland
UCSF Benioff Children's Hospital Oakland (formerly Children's Hospital & Research Center Oakland) is a premier, not-for-profit medical center and is the only hospital in the East Bay 100% devoted to pediatrics. UCSF Benioff Children's Hospital Oakland is a national leader in many pediatric specialties including hematology/oncology, cardiology, neonatology, neurosurgery, orthopedics, pulmonology, and sports medicine. The hospital is one of only five ACS Pediatric Level I Trauma Centers in the state, and has one of largest pediatric intensive care units in Northern California.

UCSF Benioff Children's Hospital Oakland's research arm, Children's Hospital Oakland Research Institute (CHORI), is internationally known for its basic and clinical research. CHORI is at the forefront of translating research into interventions for treating and preventing human diseases. As one of the nation's top 10 National Institute of Health (NIH) funded pediatric research centers, CHORI researchers are making significant progress in areas such as diagnosing and treating pediatric cancers, sickle cell disease, AIDS and HIV, hemophilia, cystic fibrosis; developing prenatal techniques for diagnosing mental retardation and birth defects; and improving infant nutrition.
For more information, go to www.childrenshospitaloakland.org and www.chori.org.

Safe Harbor Statement:
This press release contains "forward-looking statements" about the Company's current expectations about future results, performance, prospects and opportunities. Statements that are not historical facts, such as "anticipates," "believes" and "expects" or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual results in future periods to differ materially from what is expressed in, or implied by, these statements. The factors which may influence the Company's future performance include the Company's ability to obtain additional capital to expand operations as planned, success in attracting additional customers and profitable contracts, and regulatory risks associated with producing food and pharmaceutical grade products. These and other risk factors are described from time to time in the Company's filings with the Securities and Exchange Commission, including, but not limited to, the Company's reports on Forms 10-K and 10-Q. Unless required by law, the Company assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

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