Tonix Pharmaceuticals Receives Notice of Allowance for New U.S. Patent for the Active Ingredient in Tonmya® (Cyclobenzaprine...
January 23 2018 - 7:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix) announced
today that the U.S. Patent and Trademark Office (USPTO) has issued
a Notice of Allowance for U.S. Patent Application 12/948,828,
“Methods and compositions for treating symptoms associated with
posttraumatic stress disorder using cyclobenzaprine,” covering the
use of Tonmya*, or TNX-102 SL, for the treatment of posttraumatic
stress disorder (PTSD). A Notice of Allowance signifies that Tonix
will be entitled to receive patent protection until 2030 in the
U.S. for the allowed claims when the patent is issued. Tonix
expects the patent to be issued within two months. Tonix is in
Phase 3 development of Tonmya, a U.S. Food and Drug Administration
(FDA)-designated Breakthrough Therapy for the treatment of PTSD.
This patent protects the method of using
Tonmya’s active ingredient cyclobenzaprine to treat PTSD. The
Tonmya eutectic formulation of cyclobenzaprine was designed for
sublingual (under-the-tongue) administration to enable transmucosal
absorption of cyclobenzaprine, which bypasses first pass liver
metabolism. Other oral formulations of cyclobenzaprine are approved
for short-term use (two-three weeks) for relief of muscle spasm
associated with acute, painful musculoskeletal conditions.
Sublingual administration of Tonmya provides a different
pharmacokinetic profile than the oral marketed formulations of
cyclobenzaprine and is suitable as a bedtime treatment for two new
indications, PTSD and agitation in Alzheimer’s disease, which are
under development by Tonix.
This method of use patent for Tonmya extends
upon previously granted patents related to the composition of
matter (U.S. Patent No. 9,636,408) and the active ingredient in
Tonmya (European Patent No. 2,501,234).
*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.
About Tonmya and the Phase 3 HONOR
Study
Tonmya is a patented sublingual transmucosal
formulation of cyclobenzaprine that is in Phase 3 development. 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. In a Phase 2 study,
Tonmya 5.6 mg (2 x 2.8 mg tablets), was found to be effective in
treating military-related PTSD, which formed the basis of the
Breakthrough Therapy designation granted by the FDA. Tonix is
currently conducting a Phase 3 trial of Tonmya in military-related
PTSD in the United States, the HONOR study, which is a 12-week
randomized, double-blind, placebo-controlled trial evaluating the
efficacy of Tonmya 5.6 mg in participants with military-related
PTSD. This two-arm, adaptive-design trial is targeting enrollment
of up to approximately 550 participants in approximately 45 U.S.
sites. An unblinded interim analysis will be conducted once the
study has accumulated efficacy results from approximately 275
randomized participants. In a recent Cross-Disciplinary
Breakthrough Therapy meeting, the FDA confirmed that (i) a
single-study NDA approval could be possible if the topline data
from the HONOR study are statistically very persuasive, and (ii) an
additional abuse assessment study is not required for the NDA
filing. Additional details of the HONOR study are available
at http://www.thehonorstudy.com or https://clinicaltrials.gov/ct2/show/NCT03062540.
The U.S. Patent and Trademark Office issued a
patent (U.S. Patent No. 9,636,408) protecting the composition and
manufacture of the unique Tonmya formulation. The Protectic™
protective eutectic and Angstro-Technology™ formulation are
important elements of Tonix’s proprietary Tonmya composition. This
patent is expected to provide Tonmya, upon NDA approval, with U.S.
market exclusivity until 2034. Tonix was also awarded
European patent (Patent No. 2,501,234, “Methods and Compositions
for Treating Symptoms Associated with Posttraumatic Stress
Disorders Using Cyclobenzaprine”). This patent is expected to
provide Tonmya, upon European marketing authorization, with
European market exclusivity until November 2030 and the exclusivity
may be extended based on the timing of the European marketing
authorization of Tonmya for PTSD.
About Tonix Pharmaceuticals Holding
Corp.
Tonix is developing innovative pharmaceutical
and biological products to address major public health challenges
and diseases with significant unmet needs. Tonix’s lead product
candidate, Tonmya, or TNX-102 SL, is in Phase 3 development as a
bedtime treatment for PTSD. Due to the unique mechanism of action
of the active ingredient (TNX-102 or cyclobenzaprine hydrochloride)
in Tonmya to improve sleep quality, TNX-102 SL is being developed
as a bedtime treatment for agitation in Alzheimer’s disease. Tonix
is planning to submit an IND for this additional indication in
1Q2018 after completing a successful pre-IND meeting with the FDA
in 4Q2017. TNX-601 (tianeptine oxalate) is in the pre-IND
(Investigational New Drug) application stage, also for the
treatment of PTSD but designed for daytime dosing. Tonix’s lead
biologic candidate, TNX-801, is a potential smallpox-preventing
vaccine based on a live synthetic version of horsepox virus,
currently in the pre-IND application stage.
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 periodic reports
filed with the SEC on or after the date thereof. 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 thereof.
Contacts
Jessica Morris (investors)Tonix
Pharmaceuticalsinvestor.relations@tonixpharma.com(212) 980-9159
Rich Allan (media)Russo
Partnersrich.allan@russopartnersllc.com(646) 942-5588
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