Tonix Pharmaceuticals Expands Intellectual Property Portfolio for TNX-102 SL
March 21 2018 - 4:05PM
U.S. Patent Issued Covering the Use of Tonmya®
(Cyclobenzaprine HCl Sublingual Tablets) for treating Posttraumatic
Stress Disorder (PTSD)
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a
clinical-stage biopharmaceutical company focused on developing
pharmaceutical products to treat serious neuropsychiatric
conditions and biological products to improve biodefense, announced
today that U.S. Patent No. 9,918,948 was issued on March 20, 2018
by the U.S. Patent and Trademark Office. The U.S. patent, “Methods
and Compositions for Treating Symptoms Associated with
Posttraumatic Stress Disorder using Cyclobenzaprine,” covers the
use of Tonmya®*, or TNX-102 SL, for the treatment of PTSD. Upon FDA
approval, the patent will provide Tonix with U.S. market
exclusivity until at least 2030 for the allowed claims. The
term of this patent is eligible for extension depending on the
regulatory review period and the approval date.
“This U.S. method of use patent for TNX-102 SL strengthens and
expands our intellectual property portfolio, which already includes
patents protecting novel compositions of TNX-102 SL in the U.S.,
the novel pharmacokinetic profile of TNX-102 SL in Japan and the
use of TNX-102 SL in treating PTSD in Europe” commented Seth
Lederman, M.D., President and Chief Executive Officer of Tonix.
“Tonix has conducted or sponsored the development of the
technology for all of its programs, including the TNX-102 SL
program, and therefore does not expect to owe development-based
royalties or license fees upon commercialization.”
The Tonmya eutectic formulation of cyclobenzaprine, or TNX-102
SL, is designed for under-the-tongue administration, facilitating
transmucosal absorption of cyclobenzaprine, which bypasses first
pass liver metabolism that is necessary for orally ingested
cyclobenzaprine drug products. Marketed cyclobenzaprine drug
products are limited for oral ingestion and short-term use
(two-three weeks) for relief of muscle spasm associated with acute,
painful musculoskeletal conditions. Tonmya has a different
pharmacokinetic profile than marketed oral cyclobenzaprine drug
products and is intended as a long-term bedtime treatment for
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.
About Tonmya and the Phase 3 HONOR Study
Tonmya is a 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 U.S., 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 40 U.S. sites. An
unblinded interim analysis will be conducted once the study has
accumulated efficacy results from approximately 275 randomized
participants. In a 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 www.thehonorstudy.com or
https://clinicaltrials.gov/ct2/show/NCT03062540.
The newly issued U.S. method of use patent for Tonmya extends
upon the portfolio of previously granted patent claims, including
those related to the composition of matter of TNX-102 SL in the
U.S. (U.S. Patent No. 9,636,408), the pharmacokinetic profile of
TNX-102 SL in Japan (Japanese Patent No. 6,259,452), and the method
of use for the treatment of PTSD in Europe (European Patent No.
2,501,234). In addition, the Japanese Patent Office issued a Notice
of Allowance for Patent Application 2016-503239 related to the
composition of matter of TNX-102 SL in March 2018.
About Tonix Pharmaceuticals Holding Corp.
Tonix is a clinical-stage biopharmaceutical company focused on
discovering and developing pharmaceutical products to treat serious
neuropsychiatric conditions and biological products to improve
biodefense through potential medical counter-measures. Tonix’s lead
product candidate, Tonmya, or TNX-102 SL, is in Phase 3 development
as a bedtime treatment for PTSD. Tonix is also developing TNX-102
SL as a bedtime treatment for agitation in Alzheimer’s disease.
A Phase 2 IND (Investigational New Drug) application is
planned for March 2018 after completion of a successful pre-IND
meeting with the FDA. TNX-601 (tianeptine oxalate) is in the
pre-IND 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, risks related to
failure to obtain FDA clearances or approvals and noncompliance
with FDA regulations; 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
substantial competition. 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, 2017, as filed with the Securities and Exchange
Commission (the “SEC”) on March 9, 2018, 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
Tonix Pharmaceuticals (NASDAQ:TNXP)
Historical Stock Chart
From Mar 2024 to Apr 2024
Tonix Pharmaceuticals (NASDAQ:TNXP)
Historical Stock Chart
From Apr 2023 to Apr 2024