SOURCE: CTD Holdings, Inc.

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March 13, 2015 07:00 ET

CTD Holdings Selects Accenture to Lead Orphan Drug Clinical Program in Europe

Clinical Program Is the First Step Toward Marketing Trappsol® Cyclo™ in the European Union to Treat Niemann-Pick Type C Disease

NEW YORK, NY and ALACHUA, FL--(Marketwired - March 13, 2015) - Accenture (NYSE: ACN) announced today it will provide to CTD Holdings, Inc. (OTCQB: CTDH) data-driven clinical trial strategy and design through its Accelerated R&D Services, a business service that allows pharmaceutical companies to bring drugs to market faster, at less cost and with reduced execution risks. CTD Holdings is a family of biotechnology growth companies that distribute and manufacture cyclodextrin-based products.

Accenture will lead CTD's clinical program in Europe with the goal of gaining regulatory approvals to market orphan drug Trappsol® Cyclo™ for treatment of Niemann-Pick Type C (NPC) disease. NPC is a rare and fatal disease found primarily in children. As part of the contract work, Accenture will design, execute, analyze and submit the necessary clinical studies in accordance with European regulatory requirements. The program expands CTD's current distribution in the European Union that is done under named patient protocols approved individually.

"Accenture is working with CTD Holdings at a time when we are devising our clinical development program that will establish the safety and efficacy of Trappsol® Cyclo™ for the treatment of Niemann-Pick Type C disease," said Dr. Jeffrey Tate, President and CEO of CTD. "Accenture's global capabilities will give us access to the resources needed for our clinical program to be nimble and ultimately successful."

Kevin Julian, managing director of Accenture Accelerated R&D Services notes, "CTD understands the advantage in having a fully-integrated, technology-enabled business service that improves R&D cross functional processes, insights and outcomes. By utilizing Accenture Accelerated R&D Services, we will work with CTD to help them expedite the journey to European market-approval and bring this much-needed therapy to patients of a truly devastating childhood disease."

CTD has been developing its Trappsol® Cyclo™ orphan drug for the treatment of Niemann-Pick Type C since 2008. The second-generation Trappsol® Cyclo™ is a proprietary, ready-to-use sterile liquid solution that enables safe and precise dosing. CTD's Sphingo Biotechnology division will provide the drug to physicians and researchers who become participants in the clinical program in Europe and South America. The product is available in the U.S. for use by physicians with investigational new drug protocols that have received FDA approval.

About Accenture
Accenture is a global management consulting, technology services and outsourcing company, with approximately 319,000 people serving clients in more than 120 countries. Combining unparalleled experience, comprehensive capabilities across all industries and business functions, and extensive research on the world's most successful companies, Accenture collaborates with clients to help them become high-performance businesses and governments. The company generated net revenues of US$30.0 billion for the fiscal year ended Aug. 31, 2014. Its home page is www.accenture.com.

About CTD Holdings
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 Ultra-Pure™ 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.

Safe Harbor Statement:
This press release contains "forward-looking statements" about the Company's current expectations about future results, performance, prospects and opportunities, including statements about the potential future benefits of market authorization of the Company's Trappsol® Cyclo™ orphan drug, or the potential future use of Trappsol® Cyclo™ for the treatment of Niemann-Pick Type C disease. 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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