International Niemann–Pick Disease Alliance
ALACHUA, FL – (BusinessWire) – July 08, 2019 – CTD Holdings, Inc. (OTCQB: CTDH), a clinical stage biotechnology company that develops cyclodextrin-based products for the treatment of disease with unmet medical need, today announced the appointment of Mr. Michael Lisjak as Global Head of Regulatory Affairs and Senior Vice President for Business Development.
CTD’s Chairman and CEO N. Scott Fine said, “As our company expands, we are pleased to add Michael to our executive team. His wealth of experience in global regulatory affairs will be invaluable as the company moves toward market registration of our proprietary drug, Trappsol® Cyclo™, for the orphan disease indication, Niemann-Pick Disease Type C. As we consider additional indications, his broad knowledge base and networks will be critical assets to help the company move forward with speed and precision. A hearty welcome to Michael!” Mr. Lisjak brings over 20 years of experience in global regulatory strategy and operations within the pharmaceutical industry. He served most recently at Sanofi where over the past 4 years he held the positions of Head of Global Regulatory Affairs for Established Products and Global Health, and previously as the Director, Global Regulatory Affairs for the Endocrinology and Lysosomal Storage Disorders Rare Disease areas. Prior to Sanofi, Mr. Lisjak served as the Global Regulatory Services Lead at Accenture, and at Pfizer where he held a number of positions with increasing responsibility, including Director of Worldwide Regulatory Strategy, a position he held for 5 years. Mr. Lisjak is a Pittsburgh, PA native and currently resides with his family in Greenwich, CT. He holds a Bachelor of Science degree from Rochester Institute of Technology in biology and environmental studies.
CTD’s Chief Scientific Advisor and Senior Vice President for Medical Affairs, Sharon Hrynkow, Ph.D., added, “It is clear from Michael’s past accomplishments that he will bring enormous value and leadership to CTD’s regulatory and business operations. We are all looking forward to working with him in his new and vital capacity.” About CTD Holdings: CTD Holdings, Inc. is a clinical-stage biotechnology company that develops cyclodextrin-based products for the treatment of disease. The company’s Trappsol® Cyclo™, an orphan drug designated product in the United States and Europe, is used to treat Niemann-Pick Disease Type C, a rare and fatal genetic disease, on a compassionate use basis as well as in three ongoing formal clinical trials (Clinical Trials.gov NCT02939547, NCT02912793 and NCT03893071). Additional indications for the active ingredient in Trappsol® Cyclo™ are in development. For additional information, visit the company’s website: www.ctd-holdings.com 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 achieving regulatory approval for clinical protocols, enrollment of adequate numbers of patients in clinical trials, unforeseen difficulties in showing efficacy of the company’s biopharmaceutical products, success in attracting additional customers and profitable contracts, and regulatory risks associated with producing pharmaceutical grade and food 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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