Tonix Pharmaceuticals Receives European Patent for the Active Ingredient in Tonmya® (Cyclobenzaprine HCl Sublingual Tablets)...
September 14 2017 - 4:05PM
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a
company developing innovative pharmaceutical and biological
products to address major public health challenges, today announced
that Tonix has received a European patent (Patent No. 2501234,
“Methods and Compositions for Treating Symptoms Associated with
Posttraumatic Stress Disorders Using Cyclobenzaprine”). This patent
protects the use of Tonmya*, or TNX-102 SL, for the treatment of
PTSD. The patent expires in November 2030 and may be extended based
on the timing of the European marketing authorization of Tonmya for
PTSD. Tonix is in Phase 3 development of Tonmya, a U.S. Food
and Drug Administration (FDA)-designated Breakthrough Therapy for
the treatment of PTSD.
“The grant of this European methods and
compositions use patent is a big step forward for the global Tonmya
development program,” commented Seth Lederman, M.D., president and
chief executive officer of Tonix. “Adding this European use patent
to the existing Tonmya U.S. composition of matter patent** can
provide us broad protection of using cyclobenzaprine to treat PTSD
in major pharmaceutical markets.”
This patent protects the use of Tonmya’s active
ingredient cyclobenzaprine for the treatment of PTSD. The Tonmya
eutectic formulation of cyclobenzaprine for under-the-tongue
administration allows transmucosal absorption of cyclobenzaprine,
which bypasses first pass liver metabolism. Other forms of
cyclobenzaprine are approved for short-term use (two-three weeks)
for relief of muscle spasm associated with acute, painful
musculoskeletal conditions. Tonmya has a different route of
administration and different pharmacokinetic profile than other
marketed formulations of cyclobenzaprine and is intended for a new
indication (PTSD).
* Tonmya has been conditionally accepted by the
U.S. Food and Drug Administration (FDA) as the proposed trade name
for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for PTSD.
TNX-102 SL is an investigational new drug and has not been approved
for any indication.
** U.S. Patent 9,636,408 was issued covering the
proprietary sublingual formulation of cyclobenzaprine. This
patent is expected to provide Tonix with U.S. market exclusivity
until 2034.
About Tonix Pharmaceuticals Holding
Corp.
Tonix is developing innovative pharmaceutical and
biological products to address major public health challenges. In
addition to Tonmya for PTSD, Tonix is developing TNX-601
(tianeptine oxalate), a clinical candidate at pre-IND
(Investigational New Drug) application stage, designed as a daytime
treatment for PTSD and TNX-801, a live synthetic version of
horsepox virus, at the pre-IND application stage, to be developed
as a potential smallpox-preventing vaccine.
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, 2016, as filed with the Securities and Exchange
Commission (the “SEC”) on April 13, 2017, 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 Morris (investors)Tonix Pharmaceuticals
investor.relations@tonixpharma.com(212) 980-9159
Rich Allan (media)Russo
Partnersrich.allan@russopartnersllc.com(646) 942-5588
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