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If you have any questions about cyclodextrins or our company, feel free to email us, or contact Dr. Jeffrey Tate at 386-418-8060.
The mission of CTD Holdings Inc. is to develop, manufacture, and distribute cyclodextrin-based high value products. Our products treat disease, improve quality of life, and provide solutions in a broad range of applications including pharmaceutical formulation, medical diagnostics, cosmetics, nutraceuticals, and nutrition.
CTD Holdings Inc. provides the world’s widest range of cyclodextrin-based fine chemicals available from a single source. Through its Sphingo Biotechnology division it develops biopharmaceuticals using cyclodextrins as the active ingredient. The NanoSonic Products division provides industrial quantities of cyclodextrins for high value biotechnology manufacturing applications. The CTD division provides research quantities of cyclodextrins to biotechnology laboratories world-wide.
Substantially all of our revenues are derived from the sales of cyclodextrins, bio-pharmaceuticals containing cyclodextrins, cyclodextrin complexes, resale of cyclodextrins manufactured by others for our clients to their specifications, and our own licensed cyclodextrin products. We currently sell our products directly to customers in the diagnostics, pharmaceutical, and industrial chemical industries, and to chemical supply distributors. In 2012, we began offering pulse drying services.
Our core business has transitioned to a biotech drug development company from a business which had been primarily reselling basic cyclodextrin products, which have the least value-added attributes. Our strategy going forward is to pursue opportunities in healthcare where cyclodextrin applications have maximum value.
We market and sell bio-pharmaceuticals containing cyclodextrins, and cyclodextrins and related products to the pharmaceutical and other industries. Our revenues are principally from the sales of chemically modified cyclodextrins. For the year ended December 31, 2014, our revenues consisted of 58% biopharmaceuticals, 40% basic natural and chemically modified cyclodextrins, and 2% cyclodextrin complexes represented. Our business strategy is to increase sales by transitioning to the more value-added biopharmaceuticals and complexes and maintaining profitability for these products.
Our cyclodextrin sales historically involve small quantities (i.e., less than 1.0 Kg). We sell directly to our customers, package the orders at our facility and ship using common carriers.
The majority of our revenues are from five to ten customers who have historically been repeat purchasers. In 2014, one customer (UNO Healthcare, Inc.) accounted for more than 57% of our total revenue. In 2013, two customers (UNO Healthcare, Inc. and Sigma-Aldrich Fine Chemical, Inc.) accounted for more than 10% each of our total revenue, and collectively for 60% of our total revenue. Sigma-Aldrich Fine Chemical, Inc. accounts for almost 100% of our annual sales of Aquaplex®. In a year we typically sell to fewer than 200 individual customers.
We anticipate our customer trend to be moving to long-term or sole source contracts with our customers. In 2012, we signed a four-year supplier agreement for Trappsol® HPB with Siemens Corporation. Our customers buy products from us as needed primarily for product research and development purposes. Therefore, it is difficult to predict future sales, as it is dependent on the current cyclodextrin related research and development activities of others, which we have monitored in the past by following the issuance and applications of patents in the US and elsewhere.
We have identified pulse drying as a technology that promises benefits for turning commercial quantities of aqueous (liquid) solutions of Trappsol® cyclodextrins and Active Pharmaceutical Ingredients and other ingredients into a powdered solid. Pulse drying does this more economically and with less degradation to the materials than the traditional drying processes. The cyclodextrin and active ingredient come out in a complexed powder form that can be readily used by our customers to mix into their specific product formulations. In 2012 we completed construction of a c-GMP (current Good Manufacturing Practice) facility and installed a pulse drying system to manufacture commercial quantities of cyclodextrin complexes. These products will meet current food and Active Pharmaceutical Ingredient (“API”) production standards and will be sold using our Trappsol® and Aquaplex® product marks. API production quality standards are higher than those for foods but somewhat less stringent than those for finished pharmaceutical dosage manufacturers. We expect to expand and diversify our product offerings. We expect over time this will result in less volatility in our sales due to lower dependence on our cyclical research and development customers.
Share Structure:
Outstanding: 57,476,820
(as of August 11, 2015)
Sitrick and Company
Wendy Tanaka
11999 San Vicente Blvd
Los Angeles, CA 90049
415-369-8447
DD Links:
CTD Holdings Fact Sheet
March 31, 2012 - http://content.stockpr.com/ctdholdings/media/747eeebeb6c96b81d74eee2eecff9687.pdf
WSR Equity Research Report
February 21, 2012 - http://www.wallstreetresources.net/pdf/fc/CTDH.pdf
CTD Holdings - Nanosonic Uses USDA Grant to Install Solar Energy System
October 19, 2011 - http://www.gainesville.com/article/20111019/ARTICLES/111019423?tc=ar
FDA Orphan Drug Status Designation - Trappsol
May 17, 2010 - http://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm?Index_Number=303910
Dateline Story on Addi & Cassi Hempel - Using Trappsol to Treat Niemann Pick Type C
January 5, 2010 - http://www.youtube.com/watch?feature=player_embedded&v=se1Pzqjh26o
Cyclodextrin As A Therapeutic "Drug" For HIV AIDS, Niemann Pick Type C and other Viruses
April 16th, 2009 - http://webofhope.com/2009/04/cyclodextrin-as-a-theraputic-drug-for-hiv-aids-niemann-pick-type-c-and-other-viruses/
Mentioned in a Wall Street Journal Article:
http://online.wsj.com/article/SB123871183055784317.html
Cyclodextrin - Wikipedia:
http://en.wikipedia.org/wiki/Cyclodextrin
CEO Rick Strattan - Personally thanked following FDA Approval:
http://fightnpc.wordpress.com/2009/03/18/fda-approves-novel-cyclodextrin-treatment-for-addi-cassi/
Cyclodextrins are donut shaped circles of glucose (sugar) molecules that bring together oil and water and have potential applications anywhere oil and water must be used together. Successful applications have been made in the areas of agriculture, analytical chemistry, biotechnology, cosmetics, diagnostics, electronics, foodstuffs, pharmaceuticals and toxic waste treatment. Stabilization of food flavors and fragrances is the largest current worldwide market for Cyclodextrin applications. We and others have developed Cyclodextrin-based applications in stabilization of flavors for food products; elimination of undesirable tastes and odors; preparation of antifungal complexes for foods and toiletries; stabilization of fragrances and dyes; reduction of foaming in foods; cosmetics and toiletries; and the improvement of quality, stability and storability of foods.
Cyclodextrins can improve the solubility and stability of a wide range of drugs. Many promising drug compounds are unusable or have serious side effects because they are either too unstable or too insoluble in water. Strategies for administering currently approved compounds involve injection of formulations requiring pH adjustment and/or the use of organic solvents. The result is frequently painful, irritating, or damaging to the patient. These side effects can be ameliorated by Cyclodextrins. Cyclodextrins also have many potential uses in drug delivery for topical applications to the eyes and skin.
Cyclodextrins are formed naturally by the action of bacterial enzymes on starch. They were first noticed and isolated in 1891 by a French scientist, Villiers, as he studied rotting potatoes. The bacterial enzyme naturally creates a mixture of at least three different Cyclodextrins depending on how many glucose units are included in the molecular circle; six glucose units yield Alpha Cyclodextrin (“ACD”); seven units, Beta Cyclodextrin (“BCD”); eight units, Gamma Cyclodextrin (“GCD”). The more glucose units in the molecular circle, the greater the volume of the toroid. The inside of this “donut” provides an excellent resting place for “oily” molecules while the outside of the donut is significantly compatible with water enabling clear stable solutions of Cyclodextrins to exist in aqueous environments even when an “oily” molecule is carried within the donut hole. The net result is a molecular carrier that comes in small, medium, and large sizes with the ability to transport and deliver “oily” materials using water as the primary vehicle.
Cyclodextrins are manufactured in large quantities by mixing appropriate enzymes with starch solutions, thereby reproducing the natural process. ACD, BCD and GCD can be manufactured by an entirely natural process and therefore are considered to be natural products. Additional processing is required to isolate and separate the Cyclodextrins. The purified ACD, BCD, and GCD are referred to collectively as “natural” Cyclodextrins (NCDs).
The chemical groups on each glucose unit in a Cyclodextrin molecule provide chemists with ways to modify the properties of the Cyclodextrins, i.e. to make them more water soluble or less water soluble, thereby making them better carriers for a specific chemical. The Cyclodextrins that result from chemical modifications are no longer considered “natural” and are referred to as chemically modified Cyclodextrins. Since the property modifications achieved are often so advantageous to a specific application, the Company does not believe the loss of the “natural” product categorization will prevent its ultimate commercial use. It does, however, create a greater regulatory burden.
One of the premises that CTD based its future success on was the endless (literally) applications available to Cyclodextrin's. Wherever water and water insoluble or immiscible materials need to be brought together, one of the Cyclodextrin's is likely to make it possible and/or more efficiently accomplished.
The following table will give you an idea of the variety of the applications possible.
TABLE 4: Approved & Marketed Drugs Formulated with Cyclodextrins
| COMPONENT | TRADE NAME | FORMULATION | INDICATION | COMPANY/ COUNTRY |
|---|---|---|---|---|
| PGE-1/alpha Cyclodextrin | Prostandin | Intra-arterial infusion | Chronic arterial occlusive disease, etc. | Ono/Japan |
| PGE-1/alpha Cyclodextrin | Prostandin 500 | Intra-arterial infusion | Controls hypotension during surgery | Ono/Japan |
| PGE-2/beta Cyclodextrin | Prostarmon E | Sublingual tablet | Induction of labor | Ono/Japan |
| OP-1206/alpha Cyclodextrin | Opalmon | Tablet | Buerger's disease | Ono/Japan |
| Benexate/beta Cyclodextrin | Ulgut | Capsules | Antiulcerant | Teikoku/Japan |
| Benexate/beta Cyclodextrin | Lonmiel | Capsules | Antiulcerant | Shionogi/Japan |
| Iodine/beta Cyclodextrin | Mena-Gargle | Gargling | Throat disinfectant | Kyushin/Japan |
| Dexamethasone Glyteer/beta Cyclodextrin | Glymesason ointment | Ointment | Analgesic, anti-inflammatory | Fujinaga/Japan |
| Nitroglycerin/beta Cyclodextrin | Nitropen | Sublingual tablet | Coronary dilator | Nippon Kayaku/Japan |
| Cefotiam hexatil hydrochloride/alpha Cyclodextrin | Pansporin T | Tablet | Antibiotic | Takeda/Japan |
| Oral Cephalosporin/beta Cyclodextrin | Meiact | Tablet | Antibiotic | Meiji Seika/Japan |
| PGE-1/alpha Cyclodextrin | Prostavasin | Intra-arterial | Vasodilator | Schwarz/Germany |
| Piroxicam/beta Cyclodextrin | Brexin | Tablet | Analgesic & antiphlogistic | Chiesi/Italy |
| Itraconazole/hyroxypropyl beta Cyclodextrin | Sporanox Liquid | Oral liquid | Antifungal | Janssen/Belgium |
The global market demand for cyclodextrins continues to grow. A recent study (by QY Research Cyclodextrin Research Center) cites global demand as having almost doubled between 2009 and 2013 from 191,900 metric tons to 353,160 metric tons. Within the last 10 years, many more European countries have approved the use of cyclodextrins in food products. In the United States, major starch companies are renewing their earlier interest in cyclodextrins as food and nutraceutical additives. We believe the food additive industry world-wide will continue to increase its use of cyclodextrins.
Natural cyclodextrins have been confirmed to be generally recognized as safe (GRAS) in most of the world, now including the U.S. Moreover, approvals of products containing cyclodextrins by the U.S. Food and Drug Administration (FDA) since 2001 suggest that regulatory approval for new products may be easier in the future. In 2001, Janssen Pharmaceutica, now a subsidiary of Johnson & Johnson, received FDA approval to market Sporanox®, an antifungal which contained hydroxypropyl beta cyclodextrin as an excipient. In 2008, one of our clients used our product, Trappsol® hydroxypropyl beta cyclodextrin, in an FDA approved compassionate use investigational new drug protocol for the treatment of Niemann-Pick Type C disease. We now sell this product under our trademark Trappsol® Cyclo™. Our customer successfully applied to the FDA to designate Trappsol® Cyclo™ as an orphan drug in the treatment of Niemann Pick Type C disease in support of an Investigational New Drug protocol. Under the Orphan Drug Act, companies that develop a drug for a disorder affecting fewer than 200,000 people in the United States may seek designation as an orphan drug and, if such application is approved, they have the ability to sell it exclusively for seven years, and may get clinical trial tax incentives. On May 17, 2010, the FDA designated Trappsol® Cyclo™ as an orphan drug for the treatment of Niemann-Pick Type C disease.
Applications of cyclodextrins in personal products and for industrial uses have appeared in many patents and patent applications. Cyclodextrins are used in numerous brand-name household goods, including fabric softeners and air fresheners. With increased manufacturing capacity and supply the prices of the natural cyclodextrins have decreased to the point that use of these materials is considered in even the most price sensitive goods. We believe this will result in increasing demand for commercial uses of cyclodextrins.
In Japan, at least twelve pharmaceutical preparations are now marketed which contain cyclodextrins; there are also multiple products in Europe and the United States. The cyclodextrins permit the use of all routes of administration. Ease of delivery and improved bioavailability of such well-known drugs as nitroglycerin, dexamethasone, PGE(1&2), and cephalosporin permit these “old” drugs to command new market share and sometimes new patent lives. Because of the value added, it is management’s opinion that the dollar value of the worldwide market for products containing cyclodextrins and for complexes of cyclodextrins can be a hundred times that of the market sales of the cyclodextrin itself. This value increment portends opportunities for company growth in the pharmaceutical grade cyclodextrins and in custom cyclodextrin complexes.
Trappsol® Cyclo™ is a parenteral grade of hydroxypropyl beta cyclodextrin available in either a powdered or sterile liquid presentation. It has been designated an orphan drug by both the U.S. FDA and the European EMA. Trappsol® Cyclo™ is being developed in the Sphingo Biotechnology division for the treatment of Niemann Pick Type C disease, a rare and fatal illness tied to an autosomal recessive genetic defect.
Trappsol® is the trade name given to the Cyclodextrins CTD, Inc. provides to its customers. The Trappsol® name assures you the cyclodextrin you purchase is of the finest possible quality. The letter designations after the Trappsol® (T) name indicate the actual Cyclodextrin (Cyclodextrin); e.g. "B" is for Beta (β). THPG stands for Trappsol® Hydroxypropyl Gamma. Whenever possible, the catalog number will correspond to the cyclodextrin's name. Trappsol® products are organized by commercial category of Cyclodextrin: Alpha (α), Beta (β), and Gamma (γ).
While all of CTD's products are of Fine Chemical quality, CTD is also pleased to provide materials suitable for exacting Chromatographic procedures that are listed as Capillary Electrophoresis grade material. Therefore, the same catalog number may have two pricing levels referred to as FC-Grade and CE-Grade. The chemical entity is the same, but the isomeric purity and/or the level of impurities will be different for the CE-Grade, which is reflected in the higher pricing.
Within the Fine Chemical category, CTD is also pleased to be able to provide different grades of material, such as Pharmaceutical, Technical, Food, etc. These grade designations are primarily intended for Cyclodextrin's that are produced in bulk. The grade classification for these materials results from the manufacturing standards met by the manufacturer in terms of testing the bulk product before it is released. The different industries (Pharmaceutical, Food, Packaging, Adhesives, etc.) often require different kinds of testing; hence the grade designation is more an indication of the testing that has been done rather than differences in physical or chemical properties.
CAUTION
The Trappsol® and Aquaplex® products described on this site are intended for research and investigational uses only. They are not for human, veterinary or household use. (Since the pharmacological properties of the compounds described in this brochure are incompletely characterized, due care should be exercised in their use.) Material Safety Data Sheets and Certificates of Analysis are available upon request.
CTD offers a line of chemicals already complexed with Trappsol® cyclodextrins. They are categorized as Drugs, Flavors, and Miscellaneous chemicals. Their catalog numbers begin with AP to designate that they are Aquaplex complexes. The AP is followed by a four or five letter abbreviation of the active ingredient, ending with a number designating the type of Trappsol® cyclodextrin used in their manufacture as listed below.
| 1 | THPB | Trappsol® Hydroxypropyl Beta | ||
| 2 | TRMB | Trappsol® (Randomly) Methyl Beta | ||
| 3 | TBCD | Trappsol® Beta | ||
| 4 | TDMB | Trappsol® (2,6-di-O) Methyl Beta | ||
| 5 | TACD | Trappsol® Alpha | ||
| 6 | TGCD | Trappsol® Gamma | ||
| 7 | TG2BM | Trappsol® Maltosyl Mixture |
Management:
N. Scott Fine
Chairman of the Board and Chief Executive Officer
Mr. Fine has been involved in Investment Banking for more than 35 years working on a multitude of debt and equity financings, buy and sell side M & A, strategic advisory work and corporate restructurings. The majority of his time has been focused on transactions in the healthcare and consumer products area, including time with the Tempo Group of Jakarta, Indonesia when Mr. Fine and his family resided in Jakarta for two years.
Mr. Fine was the lead investment banker on the Initial Public Offering for Med-Design Corporation, a specialty medical device company, Keurig Green Mountain Coffee Roasters, and Central European Distribution Corporation, a multi-billion dollar alcohol company. He continued his involvement with CEDC serving as a director from 1996 until 2014, during which time he led the CEDC Board's successful efforts in 2013 to restructure the company through a pre-packaged Chapter 11 process whereby CEDC was acquired by the Russian Standard alcohol group.
Presently, Mr. Fine serves as Chairman and CEO of CTD Holdings Inc., a Biotechnology/Healthcare Company. He also serves on a number of Boards of Directors including: Better Place, Inc., where he is sole Director; Kenon Holdings Ltd, a spin-off from the Israel Corporation Ltd.; Global Virus Network where he is Chairman; and Forward Industries, where he serves as Chairman of the Audit Committee.
In addition to his business activities, Mr. Fine is an active participant with the Medal of Honor Foundation, the Intrepid Museum Foundation and is involved with the New York City Army Birthday Gala. He is also a director of Operation Respect, an anti-bullying education non-profit organization.
Mr. Fine has been a guest lecturer at Ohio State University's Moritz School of Law.
Dr. Jeffrey L. Tate
Director, Chief Operating Officer and Chief Scientific Officer
Dr. Tate is a seasoned executive with more than 30 years of experience in the biotechnology, pharmaceutical and nutritional supplements industries including: branded generic drugs, intellectual property strategy, product development, and cGMP manufacturing. He is intimately familiar with food and drug marketing approval procedures, documentation and strategy in U.S. and foreign markets, experienced in implementation of all aspects of regulatory compliance and in successfully communicating with regulatory agency representatives.
Dr. Tate has successfully established integrated regulatory compliance programs resulting in timely, cost effective corporate-wide compliance, meeting regulatory agency requirements and customer expectations. He closely monitors developments in U.S. and international regulations to maintain compliance and identify regulatory and intellectual property strategies for new products and markets. He holds patents and trademarks in material processing and food formulation.
C.E. "Rick" Strattan
Director and Founder
Mr. Strattan was with Pharmatec, Inc. where he became Director of Marketing and Business Development for CDs. He was responsible for CD sales and related business development efforts. From November, 1985 through May, 1987 he served as Chief Technical Officer for Boots-Celltech Diagnostics, Inc. He also served as Product Sales Manager for American Bio-Science Laboratories, a Division of American Hospital Supply Corporation.
Mr. Strattan is a graduate of the University of Florida with a BS degree in chemistry and mathematics and has also received an MS degree in Pharmacology and an MBA degree in Marketing/Computer Information Sciences from the same institution. Mr. Strattan has written and published numerous journal and white paper articles and a book chapter on the subject of cyclodextrins.
George L. Fails
Director, Vice President
Mr. Fails has served as Director of Operations for CTD Holdings Inc. since 2000 and was appointed president of CTD Inc. (a wholly owned subsidiary of CTDH) in 2008. From 1965 until his retirement in 1986, Mr. Fails served with the US Army Special Forces reaching the rank of Sergeant Major. Mr. Fails received his BA from the University of the Philippines, and also received degrees from 43 Military schools and the Federal Police Academy in Little Rock, Arkansas. Prior to joining the Company, Mr. Fails served as a Detective Sergeant with the Veterans Administration Hospital in Gainesville, Florida; and had special duties as an Officer with the US Marshall's Service.
Markus W. Sieger
Lead Director
Mr. Sieger advises companies in the pharmaceutical and media industries in Central and Eastern Europe. He is a Member of the Supervisory Board of Z.F. Polpharma S.A., the largest manufacturer of pharmaceuticals in Poland, and supervises the company’s operations. He also holds supervisory and board of director seats on other European and U.S. companies. For nearly two decades, Mr. Sieger was Managing Partner of fincoord, a company that advises entrepreneurs on business and financial strategies in emerging markets. At fincoord, Mr. Sieger focused on the media, pharmaceutical, engineering and food industries.
F. Patrick Ostronic
Director
Mr. Ostronic is an officer of US Pharmacia International, Inc., a subsidiary of USP, and also serves as the Chief Financial Officer of The USP Group. Mr. Ostronic is also a director of Novit US, Inc., the general partner of Novit
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