Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a biopharmaceutical company with marketed products and a
pipeline of development candidates, today announced that it will
achieve its goal of transitioning to a fully integrated
pharmaceutical company on April 1, 2024. Since the acquisition of
Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra®
(sumatriptan nasal spray) 10 mg on June 30, 2023, Tonix
Pharmaceuticals has been putting in place the personnel, systems
and contracts required to support a commercial organization. Both
products are indicated for the treatment of acute migraine with or
without aura in adults.
“Tonix will become a fully integrated
biopharmaceutical company with a mission of developing and
marketing innovative, high-value therapeutics,” said Seth Lederman,
M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Tonix will
assume responsibility for the distribution, selling and marketing
of Zembrace SymTouch and Tosymra, as well as supply chain,
regulatory and quality control of the two products.”
Dr. Lederman added, “The assumption of
commercial activities by Tonix represents an important milestone in
the evolution of Tonix as we continue to build and strengthen our
commercial organization for the potential launch of Tonmya™
(cyclobenzaprine HCl sublingual tablets) for fibromyalgia in 2025,
assuming approval by the U.S. Food and Drug Administration
(FDA).”
About Zembrace® SymTouch® and
Tosymra®
Zembrace SymTouch is the only actively promoted
brand of sumatriptan autoinjector in the United States (other
sumatriptan autoinjector products on the market are Imitrex® and
generics to Imitrex®). It has a unique low dose and has
demonstrated onset of migraine pain relief in as few as 10 minutes
(17% of patients vs. 5% for placebo).1 Zembrace SymTouch also
demonstrated migraine pain freedom for 46% of patients (vs 27% for
placebo) at 2 hours in a single-attack, double-blind study
(N=230).1 Zembrace SymTouch currently has patent protection to
2036. Tosymra employs Intravail® permeation enhancer technology and
is pharmacokinetically equivalent to 4 mg subcutaneous
sumatriptan.2 Tosymra delivers migraine pain relief in as
little as 10 minutes with just one spray for some
patients (13% vs. 5% for placebo).2 Tosymra currently has patent
protection to 2031.
About Migraine
Nearly 40 million people in the United States
suffer from migraine3 and it has been recognized as the second
leading cause of disability in the world.4 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).3
References:
- Zembrace SymTouch [package insert].
Maple Grove, MN: Upsher-Smith Laboratories, LLC: February
2021.
- Tosymra [package insert]. Maple
Grove, MN: Upsher-Smith Laboratories, LLC: Feb 2021.
- Headache Classification Committee of the International Headache
Society (IHS). The international classification of headache
disorders, 3rd edition. Cephalalgia. 2018;38(1):1–211.
- GBD 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.
About Tonmya* (also known as TNX-102
SL)
Tonmya is a centrally acting, non-opioid,
non-addictive, bedtime medication. The tablet is a patented
sublingual formulation of cyclobenzaprine hydrochloride developed
for the management of fibromyalgia. In December 2023, the company
announced highly statistically significant and clinically
meaningful topline results in RESILIENT, a second positive Phase 3
clinical trial of Tonmya for the management of fibromyalgia. In the
study, Tonmya met its pre-specified primary endpoint, significantly
reducing daily pain compared to placebo (p=0.00005) in participants
with fibromyalgia. Statistically significant and clinically
meaningful results were also seen in all key secondary endpoints
related to improving sleep quality, reducing fatigue and improving
overall fibromyalgia symptoms and function. RELIEF, the first
positive Phase 3 trial of Tonmya in fibromyalgia, was completed in
December 2020. It met its pre-specified primary endpoint of daily
pain reduction compared to placebo (p=0.010) and showed activity in
key secondary endpoints.
*Tonmya™ is conditionally accepted by the U.S.
Food and Drug Administration as the tradename for TNX-102 SL for
the management of fibromyalgia. Tonmya has not been approved for
any indication.
Tonix Pharmaceuticals Holding
Corp.*
Tonix is a biopharmaceutical company focused on
developing, licensing and commercializing therapeutics to treat and
prevent human disease and alleviate suffering. Tonix’s development
portfolio is focused on central nervous system (CNS) disorders.
Tonix’s priority is to submit a New Drug Application (NDA) to the
FDA in the second half of 2024 for Tonmya, a product candidate for
which two positive Phase 3 studies have been completed for the
management of fibromyalgia. TNX-102 SL is also being developed to
treat acute stress reaction as well as fibromyalgia-type Long
COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase) a
biologic designed to treat cocaine intoxication with 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 and infectious disease.
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, 2022, as filed
with the Securities and Exchange Commission (the “SEC”) on March
13, 2023, 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.
Investor Contact
Jessica MorrisTonix
Pharmaceuticalsinvestor.relations@tonixpharma.com (862)
904-8182
Peter VozzoICR Westwickepeter.vozzo@westwicke.com (443)
213-0505
Media Contact
Ben ShannonICR Westwickeben.shannon@westwicke.com(919)
360-3039
Zembrace® SymTouch® (sumatriptan
Injection): IMPORTANT SAFETY
INFORMATION
Zembrace SymTouch (Zembrace) can cause serious side
effects, including heart attack and other heart problems, which may
lead to death. Stop use and get emergency help if you have any
signs of a heart attack:
- 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 or stomach
- shortness of breath
with or without chest discomfort
- breaking out in a
cold sweat
- nausea or
vomiting
- feeling
lightheaded
Zembrace 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 shows no
problem.
Do not use Zembrace 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
- hemiplegic or basilar migraines. If you are not sure if you
have these, ask your provider.
- had a stroke, transient ischemic attacks (TIAs), or problems
with blood circulation
- severe liver problems
- taken any of the following medicines in the last 24 hours:
almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan,
ergotamines, dihydroergotamine.
- 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 of the components of
Zembrace
Tell your provider about all of your medical conditions and
medicines you take, including vitamins and supplements.
Zembrace can cause dizziness, weakness, or drowsiness. If so, do
not drive a car, use machinery, or do anything where you need to be
alert.
Zembrace may cause serious side effects including:
- changes in color or sensation in your fingers and toes
- sudden or severe stomach pain, stomach pain after meals, weight
loss, nausea or vomiting, constipation or diarrhea, bloody
diarrhea, fever
- cramping and pain in your legs or hips; feeling of heaviness or
tightness in your leg muscles; burning or aching pain in your feet
or toes while resting; numbness, tingling, or weakness in your
legs; cold feeling or color changes in one or both legs or
feet
- increased blood pressure including a sudden severe increase
even if you have no history of high blood pressure
- medication overuse headaches from using migraine medicine for
10 or more days each month. If your headaches get worse, call your
provider.
- serotonin syndrome, a rare but serious problem that can happen
in people using Zembrace, especially when used with anti-depressant
medicines called SSRIs or SNRIs. Call your provider right away if
you have: mental changes such as seeing things that are not there
(hallucinations), agitation, or coma; fast heartbeat; changes in
blood pressure; high body temperature; tight muscles; or trouble
walking.
- hives (itchy bumps); swelling of your tongue, mouth, or
throat
- seizures even in people who have never had seizures before
The most common side effects of Zembrace
include: pain and redness at injection site; tingling or
numbness in your fingers or toes; dizziness; warm, hot, burning
feeling to your face (flushing); discomfort or stiffness in your
neck; feeling weak, drowsy, or tired.
Tell your provider if you have any side effect that bothers you
or does not go away. These are not all the possible side effects of
Zembrace. For more information, ask your provider.
This is the most important information to know about Zembrace
but is not comprehensive. For more information, talk to your
provider and read the Patient Information and Instructions for Use.
You can also visit www.tonixpharma.com or
call 1-888-869-7633.
You are encouraged to report adverse effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.
INDICATION AND USAGE
Zembrace is a prescription medicine used to treat acute migraine
headaches with or without aura in adults who have been diagnosed
with migraine.
Zembrace is not used to prevent migraines. It is not known if it
is safe and effective in children under 18 years of age.
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 attack:
- 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, or
stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
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 toes
- sudden or severe stomach pain, stomach pain after meals, weight
loss, nausea or vomiting, constipation or diarrhea, bloody
diarrhea, fever
- cramping and pain in your legs or hips, feeling of heaviness or
tightness in your leg muscles, burning or aching pain in your feet
or toes while resting, numbness, tingling, or weakness in your
legs, cold feeling or color changes in one or both legs or
feet
- increased blood pressure including a sudden severe increase
even if you have no history of high blood pressure
- medication overuse headaches from using migraine medicine for
10 or more days each month. If your headaches get worse,
call your provider.
- serotonin syndrome, a rare but serious problem that can happen
in people using Tosymra, especially when used with anti-depressant
medicines called SSRIs or SNRIs. Call your provider right
away if you have: mental changes such as seeing things
that are not there (hallucinations), agitation, or coma; fast
heartbeat; changes in blood pressure; high body temperature; tight
muscles; or trouble walking.
- hives (itchy bumps); swelling of your tongue, mouth, or
throat
- seizures even in people who have never had seizures before
The most common side effects of Tosymra
include: tingling, dizziness, feeling warm or hot, burning
feeling, feeling of heaviness, feeling of pressure, flushing,
feeling of tightness, numbness, application site (nasal) reactions,
abnormal taste, and throat irritation.
Tell your provider if you have any side effect that bothers you
or does not go away. These are not all the possible side effects of
Tosymra. For more information, ask your provider.
This is the most important information to know about Tosymra but
is not comprehensive. For more information, talk to your provider
and read the Patient Information and Instructions for Use. You can
also visit www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.
INDICATION AND USAGETosymra is a prescription
medicine used to treat acute migraine headaches with or without
aura in adults.
Tosymra is not used to treat other types of headaches such as
hemiplegic or basilar migraines or cluster headaches.
Tosymra is not used to prevent migraines. It is not known if
Tosymra is safe and effective in children under 18 years of
age.
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