Full Press Release Details
PHARMACEUTICALS HOLDING CORP. 8-K
Pharmaceuticals Further Strengthens Commercial Leadership Team with Appointment of Gary Ainsworth as Vice President of Market Access
Ainsworth brings over two decades of industry and market access experience to Tonix
Food and Drug Administration (FDA) recently assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for U.S.
marketing authorization of TNX-102 SL for the management of fibromyalgia
N.J., January 8, 2025 (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 the appointment of Gary Ainsworth
as Vice President, Market Access, effective immediately. Mr. Ainsworth is an accomplished executive with leadership in market access
strategies from both large pharmaceutical companies and healthcare consultancies.
has a significant track record of success building market access functions, developing launch-ready access and reimbursement strategies
and payer-focused resources, including those for fibromyalgia and migraine treatment options," said Thomas Englese, EVP Commercial
of Tonix Pharmaceuticals. "His extensive experience will be especially valuable as we work towards the potential approval and commercial
launch of TNX-102 SL for the management of fibromyalgia this year."
recently, Mr. Ainsworth was Managing Director, Head of Market Access at Eversana Intouch, where he led the agency function and the efforts
to optimize the Company's vast market access capabilities and services. Prior to that, he was the founder and Managing Director
at Havas Gemini, the Market Access Business Unit of Havas Health & You that developed innovative market access strategies and solutions
for their clients. Mr. Ainsworth also had a distinguished career leading pharmaceutical organizations' market access functions.
Mr. Ainsworth was the Vice President of Corporate Accounts and Customer Operations for Baxter International within the Anesthesia, Critical
Care and Oncology Division where he led a team of national account managers and a patient services telemarketing center. Mr. Ainsworth
also led the National Accounts and Managed Care Marketing function at Roche Laboratories and held a variety of market access leadership
positions with the predecessor companies to Sanofi. Mr. Ainsworth holds a Master of Business Administration from Rockhurst University
and a Bachelor of Arts in Business Administration and a Bachelor of Arts in Public Relations from William Jewell College.
the Tonix team presents an exciting and fulfilling opportunity to help advance a treatment for the millions of individuals with fibromyalgia,"
said Mr. Ainsworth. "I look forward to providing additional expertise to a seasoned leadership team with the goal of bringing meaningful
therapeutics to patients in need."
the end of December 2024, Tonix announced that the U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act
(PDUFA) goal date of August 15, 2025, for a decision on marketing authorization for TNX-102 SL (cyclobenzaprine HCl sublingual tablets)
for fibromyalgia. TNX-102 SL is a non-opioid, centrally-acting analgesic. Fibromyalgia is a common chronic pain condition that affects
Pharmaceuticals Holding Corp.*
is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health
challenges. Tonix's development portfolio is focused on central nervous system (CNS) disorders. Tonix's priority is to advance
TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant
Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025
has been assigned for a decision on marketing authorization. The FDA has previously 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 and acute stress disorder under a Physician-Initiated
IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix's CNS portfolio
includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough
Therapy designation, and its development is supported by a grant from the U.S. National Institute of Drug Abuse and Addiction. Tonix's
immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500,
which is an Fc-modified 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. In July 2024, Tonix announced
a contract with the U.S. DoD's Defense Threat Reduction Agency (DTRA) for up to $34 million over five years 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. 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; their efficacy and safety have not been established
and have not been approved for any indication.
SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
press release and further information about Tonix can be found at www.tonixpharma.com.
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
Zembrace SymTouch (sumatriptan succinate) injection (Zembrace) and Tosymra (sumatriptan) nasal spray are prescription
medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under
and Tosymra 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:
and Tosymra are 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.
use Zembrace or Tosymra if you have:
provider about all of your medical conditions and medicines you take, including vitamins and supplements.
and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to
and Tosymra may cause serious side effects including:
most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrance only); 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; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
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 and
Tosymra. For more information, ask your provider.
the most important information to know about Zembrace and 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 https://www.tonixpharma.com or
call 1-888-869-7633.
encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.