Tonix Pharmaceuticals Selects EVERSANA® to Support Launch Strategy and Commercialization Planning of Tonmya™ for the Management of Fibromyalgia
March 06 2024 - 8:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a biopharmaceutical company with marketed products and a
pipeline of development candidates, announced today that EVERSANA®,
a leading provider of commercialization services to the global life
sciences industry, has been selected to support the launch strategy
and commercial planning of Tonmya (also known as TNX-102 SL,
cyclobenzaprine HCl sublingual tablets) in the U.S. Specifically,
EVERSANA will work with Tonix to assess the fibromyalgia landscape
and help plan an efficient go-to-market strategy.
“EVERSANA shares our commitment to delivering
novel therapeutics to patients in need,” said Seth Lederman, M.D.,
Chief Executive Officer of Tonix Pharmaceuticals. “We are excited
to further refine our business strategy for the anticipated launch
of Tonmya in 2025. It has been over a decade since patients
suffering with fibromyalgia have been provided a new therapeutic
option.”
“Today’s dynamic market requires experts that
can help customers navigate the complexities of launch and
commercial planning,” said Jim Lang, CEO, EVERSANA. “Together, we
look forward to bringing a new treatment option to market for the
millions of Americans suffering from this chronic disorder.”
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.
Tonix plans to submit a New Drug Application to
the U.S. Food and Drug Administration in the second half of 2024
for Tonmya for the management of fibromyalgia and has scheduled a
Type B pre-NDA meeting with FDA for the second quarter of 2024.
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.
About EVERSANA®
EVERSANA is a leading independent provider of
global services to the life sciences industry. The company’s
integrated solutions are rooted in the patient experience and span
all stages of the product life cycle to deliver long-term,
sustainable value for patients, prescribers, channel partners and
payers. The company serves more than 650 organizations, including
innovative start-ups and established pharmaceutical companies, to
advance life sciences solutions for a healthier world. To learn
more about EVERSANA, visit eversana.com or connect through
LinkedIn and X.
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
Matt BraunEVERSANAMatt.braun@eversana.com
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