Full Press Release Details
TONIX PHARMACEUTICALS HOLDING CORP. 8-K
Tonix Pharmaceuticals Announces Issuance of U.S.
Patent by the United States
Patent and Trademark Office Covering the Intranasal Delivery of
FDA-Approved Tosymra
New patent expected to expire in 2030
Tosymra (sumatriptan nasal spray)
10mg is indicated and marketed for the acute treatment of migraine in adults
CHATHAM, N.J., September 19, 2024 (GLOBE NEWSWIRE)
- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with
marketed products and a pipeline of development candidates, today announced that the United States Patent and Trademark Office issued
U.S. Patent No. 12,090,139 to the Company on September, 17, 2024. The patent, entitled "Formulations Comprising Triptan Compounds",
claims a pharmaceutical composition, a method of treating migraine via intranasal administration, and an intranasal delivery system for
Tosymra . This patent, excluding possible patent term extensions, is expected to expire in 2030.
"We believe this patent further solidifies
Tosymra in the market as a differentiated drug with a differentiated administration method," said Seth Lederman,
M.D., Chief Executive Officer of Tonix Pharmaceuticals. "This new patent targets specific delivery and composition. We are thrilled
to have these additional issued patent claims, which add to the intellectual property protection existing for Tosymra ."
Nearly 40 million people in the United States suffer
from migraine1 and it has been recognized as the second leading cause of disability in the world2,3. Migraine is
characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe
pain intensity often associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia)4.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully integrated biopharmaceutical company
focused on transforming therapies for pain management and modernizing solutions for public health challenges. Tonix's development
portfolio is focused on central nervous system (CNS) disorders, and its priority is to submit a New Drug Application (NDA) to the FDA
in October 2024 for TNX-102 SL, a product candidate for which two statistically significant Phase 3 studies have been completed for the
management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is
also being developed to treat acute stress reaction. Tonix's CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in
Phase 2 development designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix's immunology development
portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized
monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment
of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease, including TNX-2900 for Prader-Willi
syndrome, and infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced the U.S. Department of Defense (DoD),
Defense Threat Reduction Agency (DTRA) awarded it a contract for up to $34 million over five years in an Other Transaction Agreement
(OTA) to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections
to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art
infectious disease research facility in Frederick, MD, instrumental in progressing this development. Tonix Medicines, our commercial
subsidiary, markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan
nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
Zembrace SymTouch and Tosymra are registered trademarks
of Tonix Medicines. All other marks are property of their respective owners.
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 the failure to obtain FDA clearances or approvals and noncompliance
with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress
of clinical development of our product candidates; 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, 2023, as filed with
the Securities and Exchange Commission (the "SEC") on April 1, 2024, 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.
Tonix Pharmaceuticals
Tosymra (sumatriptan nasal spray): IMPORTANT SAFETY INFORMATION
Tosymra can cause serious side effects, including
heart attack and other heart problems, which may lead to death. Stop Tosymra and get emergency medical help if you have any signs of heart
discomfort in the center of your chest that lasts
for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in
your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw,
shortness of breath with or without chest discomfort
breaking out in a cold sweat
Tosymra is not for people with risk factors for heart
disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam is done
and shows no problem.
Do not use Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach,
or kidney (peripheral vascular disease)
uncontrolled high blood pressure
severe liver problems
hemiplegic or basilar migraines. If you are not sure
if you have these, ask your healthcare provider.
had a stroke, transient ischemic attacks (TIAs),
or problems with blood circulation
taken any of the following medicines in the last
24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider if you
are not sure if your medicine is listed above.
are taking certain antidepressants, known as monoamine
oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of
these medicines if you are not sure.
an allergy to sumatriptan or any ingredient in Tosymra
Tell your provider about all of your medical conditions
and medicines you take, including vitamins and supplements.
Tosymra can cause dizziness, weakness, or drowsiness.
If so, do not drive a car, use machinery, or do anything where you need to be alert.
Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and