SOURCE: CTD Holdings, Inc.

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April 07, 2015 07:00 ET

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

EMA and European Commission Approved Transfer of Orphan Drug Sponsorship to CTD Partner Medical Need Europe

ALACHUA, FL--(Marketwired - April 07, 2015) - CTD Holdings, Inc. (OTCQB: CTDH), a family of biotechnology growth companies that develop cyclodextrin-based treatments, today announced that the European Medicines Agency and European Commission approved transfer of the Orphan Drug Designation for Trappsol® Cyclo™ to CTD's European partner, Medical Need Europe (MNE), from Sue and David French and their Niemann Pick Research Foundation. MNE, which is the exclusive distributor of Trappsol® Cyclo™ in Europe, will be the official sponsor of the European orphan drug designation on behalf of CTD.

CTD's orphan drug designated Trappsol® Cyclo™ is being developed for the treatment of Niemann-Pick Type C, a rare and fatal disease found primarily in children.

"The Orphan Drug Designation provides significant advantages to the beneficiary that enable the development of effective treatments for rare diseases," said CTD President and CEO Dr. Jeffrey Tate. "It is an honor for us to be entrusted with this important development advantage by the French family and their Foundation."

"We are delighted to be collaborating with CTD and MNE in their pursuit of a viable treatment for NPC using Trappsol® Cyclo™," said Sue French. "CTD played an important part in obtaining the Orphan Drug Designation from the EMA back in 2011 and has supported clinicians and patients in many countries in their use of the drug for this disease for many years. We fully support the CTD team in their pursuit of organizing a formal trial of this drug as quickly as possible, to increase the number of patients that can benefit from it in Europe and worldwide."

About the 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 Medical Need Europe AB:
Medical Need Europe is a privately held pharmaceutical company headquartered in Stockholm, Sweden, focusing on the provision of physical access to unlicensed medicines under international named patient regulations and the registration, distribution, marketing and sale of licensed orphan drugs and niche specialty pharmaceuticals across Europe, for the treatment of rare diseases where there is a high unmet medical need.

The company is currently active within several rare and niche disorders, such as; Urea Cycle Disorders, Niemann-Pick Type C, Congenital-Sucrase-Isomaltase Deficiency, progressive multiple sclerosis (MS), multi-resistant tuberculosis, hematological stem cell transplantation, brain tumors and Ménières disease.

About Niemann Pick Research Foundation:
The Niemann Pick Research Foundation (NRFP) is a charitable trust established in 2011 with the sole aim of funding research and trials of promising therapies for the treatment of NPC. Its primary objective is to accelerate the development of therapies that may be of benefit to today's generation of NPC patients.

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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