Tonix Pharmaceuticals Announces New Patent Coverage Protecting Tonmya®
November 07 2018 - 7:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company) today announced that the U.S. Patent and Trademark Office
("USPTO") issued U.S. Patent No. 10,117,936 to the Company on
November 6, 2018. This patent, “Eutectic Formulations of
Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride,”
includes 34 claims directed to pharmaceutical compositions of
eutectics of cyclobenzaprine hydrochloride and mannitol and methods
of making those compositions. This patent is expected to
provide Tonix with U.S. market exclusivity until 2034.
The patent is part of an expanding portfolio of patents and
patent applications and other intellectual property addressing the
formulation, manufacturing, and uses of Tonmya*, or TNX-102 SL, for
a variety of indications including posttraumatic stress disorder,
agitation in Alzheimer’s disease, and fibromyalgia.
Seth Lederman, M.D., Chief Executive Officer of Tonix commented,
“We are committed to building our intellectual property covering
the unique properties of Tonmya. These newly issued claims
strengthen and expand Tonmya’s overall patent portfolio and provide
Tonix with significant intellectual property protection for Tonmya
in the U.S."
*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 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 is
developing Tonmya, which has been granted Breakthrough Therapy
designation, as a bedtime treatment for PTSD. Tonix is also
developing TNX-102 SL as a bedtime treatment for agitation in
Alzheimer’s disease under a separate IND to support a Phase 2,
potential pivotal, efficacy study and has been granted Fast Track
designation by the FDA for this indication. TNX-601
(tianeptine oxalate) is in the pre-IND application stage, also for
the treatment of PTSD but by a unique mechanism and 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 (corporate)Tonix
Pharmaceuticalsinvestor.relations@tonixpharma.com(212) 980-9159
Scott Stachowiak (media)Russo
Partnersscott.stachowiak@russopartnersllc.com (646) 942-5630
Peter Vozzo (investors)Westwicke
Partnerspeter.vozzo@westwicke.com (443) 213-0505
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