Full Press Release Details
TONIX PHARMACEUTICALS HOLDING CORP. 8-K
Tonix Pharmaceuticals
Announces Issuance of U.S. Patent Covering the Subcutaneous Delivery of FDA-Approved Zembrace SymTouch
New patent expected to provide market exclusivity
Zembrace SymTouch (sumatriptan
succinate injection) 10mg is indicated for the acute treatment of migraine in adults
CHATHAM, N.J., September 27, 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. 12,097,183 to the Company on September 24, 2024. The patent, entitled "Pharmaceutical Composition for Treating Migraine",
claims use of a pre-filled autoinjector comprising a composition of Zembrace SymTouch
for treating migraines via subcutaneous administration. This patent, excluding possible patent term extensions, is expected to provide
protection into 2036.
"We are excited to announce the issuance
of this additional patent, providing additional protection for our exclusive marketing and sale of FDA-approved Zembrace
for the treatment of migraines," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. "We believe Zembrace
is a compelling non-oral option for people who suffer with migraines."
Tonix recently launched a new educational campaign,
"Does Your Migraine Pill Work Every Time?" The goal of the campaign is to educate patients and their healthcare providers
on the benefits of non-oral migraine medications including nasal and injectable treatment options. Non-oral migraine medications, such
as injectables and nasal sprays, do not rely on the digestive system to be absorbed and can offer the potential for faster relief from
migraine symptoms in as little as 10 minutes.
Migraine often requires patients to advocate
for themselves to develop an effective migraine treatment plan. Empowering patients to understand why they are experiencing delayed or
inconsistent relief from oral medications and educating them on other migraine treatment options could ultimately improve their management
of migraine symptoms and ultimately enhance their quality of life.
For example, gastroparesis is common before,
during, and sometimes in between migraine attacks. Gastroparesis can slow or even block the absorption of oral medications causing delayed,
incomplete, or no migraine symptom relief. Tonix will launch a new disease education website, www.gpmigraine.com, for patients who
want to learn more about gastroparesis and migraine and why their oral medications do not work.
Dr. Lederman continued, "Tonix is dedicated
to educating patients and their healthcare providers on gastroparesis and how non-oral medicines including nasal and injectable medications
can help patients manage their migraines. We hope to inspire patients to optimize their migraine treatment plan with non-oral medications."
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.
1Law, H. Z., Chung, M. H., Nissan,
G., Janis, J. E., & Amirlak, B. (2020). Hospital Burden of Migraine in United States Adults: A 15-year National Inpatient Sample Analysis.
Plastic and reconstructive surgery. Global open, 8(4), e2790. https://doi.org/10.1097/GOX.0000000000002790
2GBD 2016 Headache Collaborators.
Global, regional, and national burden of migraine and tension-type headache, 1990-2016: a systematic analysis for the Global Burden of
Disease Study 2016. Lancet Neurol 2018;17(11):954-976.
3Steiner, T.J., Stovner, L.J.,
Jensen, R. et al. Lifting the Burden: the Global Campaign against Headache. Migraine remains second among the world's causes of disability,
and first among young women: findings from GBD2019. J Headache Pain 21, 137 (2020).
4Headache Classification Committee
of the International Headache Society (IHS). The international classification of headache disorders, 3rd edition. Cephalalgia. 2018;38(1):1-211.
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.
*Tonix's product development candidates are
investigational new drugs or biologics and have not been approved for any indication.
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
Indication/Limitations of Use
ZEMBRACE SymTouch (sumatriptan
succinate) and TOSYMRA (sumatriptan spray) are indicated for the acute treatment of migraine with or without aura in adults. ZEMBRACE
SymTouch and TOSYMRA should only be used where a clear diagnosis of migraine has been established. ZEMBRACE SymTouch and TOSYMRA are not
indicated for the prevention of migraine attacks or for the treatment of cluster headache.
Important Safety Information CONTRAINDICATED
WARNINGS AND PRECAUTIONS
The most common adverse reactions ( 5%