Tonix Pharmaceuticals Announces Issuance of U.S. Patent for the Composition and Formulation of TNX-102 SL
July 25 2019 - 7:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced that the U.S. Patent and Trademark Office ("USPTO")
issued U.S. Patent No. 10,357,465 to the Company on July 23, 2019.
This patent, “Eutectic Formulations of Cyclobenzaprine
Hydrochloride,” includes 14 claims directed to eutectics of
cyclobenzaprine hydrochloride and mannitol and methods of making
those eutectics. This patent is expected to provide Tonix
with U.S. market exclusivity until 2035.
Tonix’s proprietary eutectic formulation of cyclobenzaprine, or
TNX-102 SL, is designed for chronic sublingual (under-the-tongue)
administration daily at bedtime, which facilitates transmucosal
absorption of cyclobenzaprine and bypasses first pass liver
metabolism. Marketed cyclobenzaprine drug products are limited to
short-term use (two to three weeks) and formulated for oral
ingestion, which results in significant liver metabolism.
Sublingual TNX-102 SL has a different pharmacokinetic profile than
marketed oral cyclobenzaprine drug products. TNX-102 SL is
being developed as a treatment for three indications: posttraumatic
stress disorder (PTSD), fibromyalgia and agitation in Alzheimer’s
disease. Marketed oral cyclobenzaprine products are indicated
for the relief of muscle spasm.
Seth Lederman, M.D., President and Chief Executive Officer of
Tonix commented, “We are committed to building our intellectual
property covering the unique properties of TNX-102 SL in multiple
markets around the world. These newly issued claims strengthen and
expand TNX-102 SL’s overall patent portfolio and provide Tonix with
significant intellectual property protection for TNX-102 SL in the
U.S."
About Tonix Pharmaceuticals Holding Corp.
Tonix is a clinical-stage biopharmaceutical company focused on
discovering and developing small molecules and biologics to treat
psychiatric, pain and addiction conditions, and biological products
to improve biodefense through potential medical counter-measures.
Tonix’s lead program is for the development of Tonmya* (TNX-102
SL), which is in Phase 3 development as a bedtime treatment for
PTSD. Tonix is also developing TNX-102 SL as a bedtime treatment
for fibromyalgia and agitation in Alzheimer’s disease under
separate Investigational New Drug applications (INDs) to support
potential pivotal efficacy studies. The fibromyalgia program is in
Phase 3 development and the agitation in Alzheimer’s program is
Phase 2 ready. TNX-1300** (double-mutant cocaine esterase) is being
developed under an IND and is in Phase 2 development for the
treatment of cocaine intoxication. TNX-601 (tianeptine oxalate) is
in the pre-IND application stage, also for the treatment of PTSD
but by a different mechanism from TNX-102 SL and designed for
daytime dosing. TNX-601 is also in development for a potential
indication - neurocognitive dysfunction associated with
corticosteroid use. Data is expected in the second half of 2019 for
a Phase 1 clinical formulation selection pharmacokinetic study of
TNX-601 that is being conducted outside of the U.S. TNX-801 (live
virus vaccine for percutaneous (scarification) administration) is a
potential smallpox-preventing vaccine based on a live synthetic
version of horsepox virus, currently in the pre-IND application
stage.
*Tonmya has been conditionally accepted by the U.S. Food and
Drug Administration (FDA) as the proposed trade name for TNX-102 SL
for the treatment of PTSD. TNX-102 SL (cyclobenzaprine HCl
sublingual tablets) is an investigational new drug and has not been
approved for any indication.
**TNX-1300 (T172R/G173Q double-mutant cocaine esterase 200 mg,
i.v. solution) is an investigational new biological product and has
not been approved for any indication.
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, 2018, as filed with the Securities and Exchange
Commission (the “SEC”) on March 18, 2019, and quarterly and
periodic reports filed with the SEC on or after the date thereof.
Tonix does not undertake any obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise, except as required by law.
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)Westwickepeter.vozzo@westwicke.com (443)
213-0505
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