Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a biopharmaceutical company with marketed products and a
pipeline of development candidates, today announced it has selected
two contract manufacturing organizations (CMOs), one of which is
Almac Pharma Services, a member of the privately owned Almac Group,
as dual supply sources for the potential launch and
commercialization of Tonmya™ (also known as TNX-102 SL,
cyclobenzaprine HCl sublingual tablets) in the U.S.
“Dual sourcing is a critical element for the
successful commercial launch and supply chain management of a
product,” said Seth Lederman, M.D., Chief Executive Officer of
Tonix Pharmaceuticals. “We are excited to advance our first
internally developed program toward NDA submission and to work with
two well-established CMOs for commercial supply and potential
launch of Tonmya.”
“Having supported the development and clinical
trial supply of this drug, we’re thrilled to be continuing our
partnership with Tonix to support the commercial launch and ongoing
supply of this important new non-opioid analgesic to patients with
fibromyalgia, a chronic debilitating disease,” said Mark English,
VP Operations, Almac Pharma Services.
Tonmya is a centrally acting, non-opioid
medication. As previously announced, Tonix’s second positive Phase
3 study, RESILIENT, 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 (p=0.001 or better) were also seen in
all key secondary endpoints related to improving sleep quality,
reducing fatigue, and improving overall fibromyalgia symptoms and
function. TNX-102 SL was well tolerated with an adverse event
profile comparable to prior studies, and no new safety signals were
observed.
Tonix plans to submit a New Drug Application
(NDA) to the U.S. Food and Drug Administration in the second half
of 2024 for Tonmya for the management of fibromyalgia.
About Tonmya* (also known as TNX-102
SL)
TNX-102 SL is a tablet containing 2.8 mg
cyclobenzaprine HCl that will be administered sublingually once
daily at bedtime for the first 2 weeks, titrating subsequently to 2
tablets (5.6 mg total per day) at bedtime, as tolerated, for
chronic, long-term use. The sublingual tablet is formulated using a
patented Protectic™ eutectic formulation including a basifying
agent for transmucosal absorption with rapid systemic exposure
pharmacokinetic properties suitable for bedtime administration. The
eutectic properties enhance the stability with a predicted shelf
life of greater than 48 months, at room temperature conditions. The
planned commercial distribution will be a 14, 60 and 90 count
tablet bottles allowing for titration, flexible and three-month
chronic supply. Tonmya is a centrally acting, non-opioid,
non-addictive, bedtime medication. 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.
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 (FDA) as the tradename for TNX-102 SL
for the management of fibromyalgia. Tonmya has not been approved
for any indication.
About Almac Pharma Services
Tailormade pharmaceutical development and
commercial solutions
With over 50 years’ experience, Almac Pharma
Services is a world leading outsourcing partner to the global
pharmaceutical and biotechnology industry.
Employing over 1,600 highly skilled individuals
across 4 locations in Europe and the US, the company provides
tailored, quality-led and timely solutions from early and late
phase pharmaceutical development, clinical and commercial drug
product manufacture, product launch through to commercial packaging
and global distribution.
On March 6, 2024, the company announced the
completion of a custom-built, high-volume facility that
significantly increases commercial manufacturing and packaging of
sachet drug product presentations forming part of the Group’s
ongoing global expansion investment now totaling over £400
million.
To keep up to date with latest news, follow us
on LinkedIn or visit our website.
About Almac Group
The Almac Group is an established contract
development and manufacturing organisation providing an extensive
range of integrated services across the drug development lifecycle
to the pharmaceutical and biotech sectors globally. Its innovative
services range from R&D, biomarker discovery development and
commercialisation, API manufacture, analytical services,
formulation development, clinical trial supply, IRT (IVRS/IWRS)
through to commercial-scale manufacture.
The international company is a privately owned
organisation which has grown organically, now employing 7,200
highly skilled personnel across 18 facilities including Europe, the
USA and Asia.
To keep up to date with latest news, follow us
on X and LinkedIn or visit almacgroup.com.
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.com443-213-0495
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