Tonix Pharmaceuticals Receives Notice of Allowance for New U.S. Patent Covering Composition and Manufacture of TNX-102 SL
March 14 2017 - 7:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a
company that is developing innovative pharmaceutical products to
address public health challenges, announced today that the U.S.
Patent and Trademark Office has issued a Notice of Allowance for
U.S. Patent Application 14/214,433, “Eutectic Formulations of
Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride,”
covering the proprietary sublingual formulation of TNX-102 SL*. A
Notice of Allowance signifies that Tonix will be entitled to
receive patent protection until 2034 in the U.S. for the allowed
claims when the patent is issued. Tonix expects the patent to
be issued within two months.
The allowed claims protect the pharmaceutical composition and
the method of manufacturing of TNX-102 SL. The TNX-102 SL
sublingual formulation is based on a eutectic between
cyclobenzaprine HCl and mannitol, which protects the acidic
hydrochloride salt of cyclobenzaprine from molecular interactions
with the basic excipient, potassium phosphate dibasic, which is
added to enhance transmucosal absorption. Transmucosal absorption
of cyclobenzaprine increases the rate of absorption into the blood
stream and bypasses first pass liver metabolism. TNX-102 SL
is distinct from orally ingested forms of cyclobenzaprine, which
are available as generic immediate-release tablets and branded
extended-release capsules (AMRIX®), and are approved for short-term
use (2-3 weeks) for relief of muscle spasm associated with acute,
painful musculoskeletal conditions. Since TNX-102 SL has a
different route of administration and different pharmacokinetic
profile from orally ingested cyclobenzaprine and is intended for a
new indication (PTSD), pharmacists will not be able to substitute
orally ingested forms of cyclobenzaprine for TNX-102 SL.
Tonix has filed trademarks to describe the protective eutectic,
Protectic™, and the formulation that utilizes interactions at the
angstrom scale, Angstro-Technology™. The Protectic™ protective
eutectic and Angstro-Technology™ formulation enable TNX-102 SL to
be a sublingual tablet of cyclobenzaprine HCl, while ensuring that
the tablets have robust manufacturability and pharmaceutical
stability.
Seth Lederman, M.D., president and chief executive officer of
Tonix, stated, “This notice of allowance strengthens the value of
our pipeline with near-term intellectual property protection and
highlights Tonix’s innovation in proprietary pharmaceutical
development. Most importantly, the Protectic™ protective eutectic
and Angstro-Technology™ formulation are essential elements of the
proprietary TNX-102 SL composition.”
*TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an
investigational new drug and has not been approved for any
indication.
About Tonix Pharmaceuticals Holding Corp.
Tonix is developing innovative pharmaceutical products to
address public health challenges. TNX-102 SL is in Phase 3
development and has been granted Breakthrough Therapy designation
by the U.S. Food and Drug Administration (FDA) for the treatment of
PTSD. PTSD is a serious condition characterized by chronic
disability, inadequate treatment options especially for
military-related PTSD, and an overall high utilization of
healthcare services that contributes to significant economic
burdens. Other development efforts include TNX-601 (tianeptine
oxalate), a clinical candidate at Pre-IND (Investigational New
Drug) application stage, designed for daytime use for the treatment
of PTSD, and TNX-801, a potential smallpox-preventing vaccine based
on a live synthetic version of horsepox virus (HPXV). HPXV has
protective vaccine activity in mice, using a model of lethal
vaccinia infection. Vaccine manufacturing activities have been
initiated to support further nonclinical testing of
TNX-801.
This press release and further information about Tonix can be
found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking
within the meaning of the Private Securities Litigation Reform Act
of 1995. These statements may be identified by the use of
forward-looking words such as “anticipate,” “believe,” “forecast,”
“estimate,” “expect,” and “intend,” among others. These
forward-looking statements are based on Tonix's current
expectations and actual results could differ materially. There are
a number of factors that could cause actual events to differ
materially from those indicated by such forward-looking statements.
These factors include, but are not limited to, substantial
competition; our need for additional financing; uncertainties of
patent protection and litigation; uncertainties of government or
third party payor reimbursement; limited research and development
efforts and dependence upon third parties; and risks related to
failure to obtain FDA clearances or approvals and noncompliance
with FDA regulations. As with any pharmaceutical under development,
there are significant risks in the development, regulatory approval
and commercialization of new products. Tonix does not undertake an
obligation to update or revise any forward-looking statement.
Investors should read the risk factors set forth in the Annual
Report on Form 10-K for the year ended December 31, 2015, as filed
with the Securities and Exchange Commission (the “SEC”) on March 3,
2016, and future periodic reports filed with the SEC on or after
the date hereof. All of Tonix's forward-looking statements are
expressly qualified by all such risk factors and other cautionary
statements. The information set forth herein speaks only as of the
date hereof.
Contacts
Jessica Smiley
Investor Relations
investor.relations@tonixpharma.com
(212) 980-9155 x185
Edison Advisors (investors)
Tirth Patel
tpatel@edisongroup.com
(646) 653-7035
Russo Partners (media)
Rich Allan
rich.allan@russopartnersllc.com
(646) 942-5588
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