Tonix Pharmaceuticals Announces that the European Patent Office Opposition Division Has Upheld Its Patent for the Use of the ...
07 October 2019 - 10:00PM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced that the European Patent Office’s (EPO) Opposition
Division has upheld the Company's European Patent 2501234B1 with
claims covering compositions containing the active ingredient in
TNX-102 SL, cyclobenzaprine, for use in treating the development,
initiation, consolidation, and perpetuation of posttraumatic stress
disorder (PTSD) symptoms following a traumatic event. This patent
was originally granted by the EPO in September 2017 and an
opposition was filed against the patent in June 2018.
The U.S. counterpart to the European patent is U.S. Patent No.
9,918,948, the validity of which is not being challenged. In
addition to these patents, Tonix owns patents covering TNX-102 SL
and its use to treat PTSD in the U.S., Europe, and other countries.
Together, these patents protect the use of TNX-102 SL in Europe and
elsewhere.
Tonix’s President and Chief Executive Officer, Seth Lederman,
M.D. said, “We believe that the outcome of the European opposition
proceedings adds strength to the overall patent estate for TNX-102
SL. Tonix will continue to diligently defend the validity of its
intellectual property portfolio.”
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, to
improve biodefense through potential medical counter-measures, to
treat transplant rejection and to treat gastric and pancreatic
cancers. 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, agitation in Alzheimer’s
disease and alcohol use disorder, under separate Investigational
New Drug applications (INDs) to support potential pivotal efficacy
studies. The fibromyalgia program is in Phase 3 development, the
agitation in Alzheimer’s program is Phase 2 ready and the alcohol
use disorder program is in the pre-IND application stage.
TNX-1300** (double-mutant cocaine esterase) is being developed
under an IND and is in Phase 2 development for the treatment of
life-threatening cocaine intoxication. Tonix has two other programs
in the pre-IND application stage of development for PTSD, but with
different mechanisms than TNX-102 SL and designed for daytime
dosing: TNX-601 (tianeptine oxalate) and TNX-1600***, a triple
reuptake inhibitor. TNX-601 is also in development for a potential
indication - neurocognitive dysfunction associated with
corticosteroid use. Data on TNX-601 from a Phase 1 clinical
formulation selection pharmacokinetic study that is being conducted
outside of the U.S. is expected in the second half of 2019. 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-1500 is being developed to prevent
and treat organ transplant rejection, as well as to treat
autoimmune conditions, and is in the pre-IND application stage.
Finally, TNX-1700 is being developed to treat gastric and
pancreatic cancers and is 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 biologic
and has not been approved for any indication.
***TNX-1600
((2S,4R,5R)-5-(((2-aminobenzo[d]thiazol-6-yl)methyl)amino)-2-(bis(4-fluorophenyl)methyl)tetrahydro-2H-pyran-4-ol)
is an inhibitor of reuptake of three monoamine neurotransmitters
(serotonin, norepinephrine and dopamine), or a “triple
reuptake” inhibitor.
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)Westwickepeter.vozzo@westwicke.com (443)
213-0505
Tonix Pharmaceuticals (NASDAQ:TNXP)
Historical Stock Chart
From Apr 2024 to May 2024
Tonix Pharmaceuticals (NASDAQ:TNXP)
Historical Stock Chart
From May 2023 to May 2024