Current Report Filing (8-k)
January 27 2015 - 8:43AM
Edgar (US Regulatory)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
January
27, 2015
(Date
of earliest event reported)
CTD
HOLDINGS, INC.
(Exact
Name of Registrant as Specified in Charter)
Florida |
|
000-25466 |
|
59-3029743 |
(State
or Other Jurisdiction of
Incorporation) |
|
(Commission
File No.) |
|
(IRS
Employer
Identification No.) |
14120
N.W. 126th Terrace
Alachua,
Florida |
|
32615 |
(Address
of Principal Executive Offices) |
|
(Zip
Code) |
|
(386)
418-8060 |
|
|
(Registrant’s
telephone number, including area code) |
|
|
|
|
|
Not
Applicable |
|
|
(Former
Name or Former Address, if Changed Since Last Report) |
|
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instructions A.2. below):
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item
7.01. Regulation FD Disclosure.
On January
27, 2015, the Registrant announced that the U.S. Food and Drug Administration (FDA) has accepted its Drug Master File (DMF) submission
relating to its second generation Trappsol® Cyclo™ orphan drug product.
A copy of
the press release issued by the Registrant relating to the FDA’s acceptance of the Drug Master File submission is attached
to this Current Report on Form 8-K as Exhibit 99.1.
Item
9.01. Financial Statements and Exhibits.
(d) |
Exhibits |
|
|
99.1 |
Press
Release of CTD Holdings, Inc. dated January 27, 2015 |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
|
CTD
HOLDINGS, INC. |
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|
|
|
By:
|
/s/
Jeffrey L. Tate |
|
Name: |
Jeffrey
L. Tate |
|
Title: |
Chief
Executive Officer |
Date: January
27, 2015
EXHIBIT
INDEX
Exhibit No. |
|
Description |
|
|
|
99.1 |
|
Press
Release of CTD Holdings, Inc. dated January 27, 2015 |
- 4 -
Exhibit 99.1
FDA Accepts CTD Holdings’ Drug Master File
for Second-Generation Orphan Drug
File
allows doctors and researchers to request FDA approval to use second-generation Trappsol(R) Cyclo(TM) to treat Niemann-Pick Type
C disease
ALACHUA,
FL -- (Marketwired) – January 27, 2015 -- CTD Holdings, Inc. (OTCQB: CTDH), a family of biotechnology growth
companies that distribute and manufacture cyclodextrin-based products, today announced that the U.S. Food and Drug Administration
accepted CTD’s Type II Drug Master File No. 28889 covering its second-generation Trappsol(R) Cyclo(TM) orphan drug product.
The
file allows clinicians and researchers to cite the drug in Investigational New Drug applications (INDs) and request FDA approval
for compassionate use treatment of Niemann-Pick Type C, a genetic disease that is often fatal in young children.
"This
Drug Master File is the result of work that began in 2012, and it lays the foundation for building our clinical program and expanding
availability of this important treatment for Niemann-Pick Type C,” said Dr. Jeffrey Tate, President and CEO of CTD.
First-generation
Trappsol(R) Cyclo(TM) is in powder form. Second-generation Trappsol(R) Cyclo(TM) is a proprietary, ready-to-use sterile liquid
solution that improves safety, enables precise dosing, and allows treatment without the services of a compounding pharmacist.
CTD’s Sphingo Biotechnology division will provide the drug to physicians and researchers whose INDs have received FDA approval.
The product is being used under similar regulatory regimens in Europe and South America to treat Niemann-Pick Type C.
About
the Company:
CTD Holdings, Inc. is a family of biotechnology growth companies based on cyclodextrin chemistry. Its individual divisions distribute
and manufacture the trademarked Trappsol(R) and Aquaplex(R) 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(R) Cyclo(TM), 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(R) 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 the Drug Master File submission, the use of the Drug Master File in future Investigational New Drug applications,
or the potential future use of Trappsol(R) Cyclo(TM) 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.
Contact:
Sitrick And Company
Wendy Tanaka
(415) 369-8447
wtanaka@sitrick.com
Thomas Mulligan
(212) 573-6100, Ext. 395
tmulligan@sitrick.com
Source:
CTD Holdings, Inc.