Tonix Pharmaceuticals Announces Issuance of Patent in China for the Composition and Formulation of TNX-102 SL
June 13 2019 - 7:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company focused on
developing small molecules and biologics to treat psychiatric, pain
and addiction conditions as well as to improve biodefense, today
announced that the China National Intellectual Property
Administration issued Chinese Patent No. ZL 201480024011.1 to the
Company on April 16, 2019. This patent, “Eutectic Formulations of
Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride,” is
directed to a unique eutectic that characterizes TNX-102 SL*, and
claims pharmaceutical compositions containing that eutectic and
methods of making those compositions.
Tonix’s proprietary eutectic formulation of cyclobenzaprine, or
TNX-102 SL, is designed for long-term daily use at bedtime and
sublingual (under-the-tongue) administration, 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 indicated 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.
About Tonix Pharmaceuticals Holding Corp.
Tonix is a clinical-stage biopharmaceutical company focused on
discovering and developing pharmaceutical products 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. TNX-102 SL for the treatment of PTSD has U.S. Food and Drug
Administration (FDA) Breakthrough Therapy designation. 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. The agitation in
Alzheimer’s disease IND has been designated a Fast Track
development program by the FDA. 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-1300 is
a recombinant protein enzyme produced through rDNA technology in E.
coli bacteria. TNX-1300 for cocaine intoxication has FDA
Breakthrough Therapy designation. 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.
*TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an
investigational new drug and has not been approved for any
indication.
**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-1300 (T172R/G173Q double-mutant cocaine esterase 200 mg,
i.v. solution) is an investigational new biologic 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 periodic reports on
Form 10-Q 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)Westwicke
Partnerspeter.vozzo@westwicke.com (443) 213-0505
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