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Tonix Pharmaceuticals Holding Corp and its wholly-owned commercialization subsidiary, Tonix Medicines, Inc. have completed the acquisition of two FDA-approved products from Upsher-Smith Laboratories, LLC. The acquisition of Zembrace SymTouch and Tosymra is a strategic move to build Tonix's commercial capabilities and infrastructure ahead of the potential launch of TNX-102 SL for the management of fibromyalgia.
Introduction
Tonix Pharmaceuticals Holding Corp, a biopharmaceutical company, has acquired two currently marketed FDA-approved products, Zembrace SymTouch and Tosymra, from Upsher-Smith Laboratories, LLC. The products are indicated for the treatment of acute migraine with or without aura in adults. The acquisition is a significant step in the evolution of Tonix into a fully integrated biopharmaceutical company and builds on its expertise in central nervous systems disorders.
Purpose of the Acquisition
The acquisition of the two products complements Tonix's current intranasal clinical development program of TNX-1900 for migraine prevention. The acquisition of the products helps to build Tonix's commercial capabilities and infrastructure ahead of the potential launch of its TNX-102 SL product candidate for the treatment of fibromyalgia. The acquisition aligns strongly with Tonix's TNX-1900 product candidate in clinical development for the prevention of headaches in chronic migraine.
About Zembrace SymTouch
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. Zembrace SymTouch also demonstrated migraine pain freedom for 46% of patients at 2 hours in a single-attack, double-blind study.
About Tosymra
Tosymra employs Intravail® permeation enhancer technology and is pharmacokinetically equivalent to 4 mg subcutaneous sumatriptan. Tosymra delivers migraine pain relief in as little as 10 minutes with just one spray for some patients.
Unmet Needs of Patients
Migraine headaches and breakthrough migraine headaches remain a significant burden, and both Zembrace SymTouch and Tosymra are well-suited to address the unmet needs of patients currently using traditional or emerging oral acute migraine medications, particularly for rapid-onset treatment. Nearly 40 million people in the United States suffer from migraine, and it has been recognized as the second leading cause of disability in the world. 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).
Product Sales
As previously announced, Zembrace SymTouch and Tosymra collectively generated product sales of approximately $23 million for the full year 2022. Zembrace SymTouch currently has patent protection to 2036, while Tosymra currently has patent protection to 2031.
Expert Commentary
According to James Hunter, Executive Vice President of Commercial Operations at Tonix Pharmaceuticals and President of Tonix Medicines, "Migraine headaches and breakthrough migraine headaches remain a significant burden, and we believe both Zembrace SymTouch and Tosymra are well-suited to address the unmet needs of patients currently using traditional or emerging oral acute migraine medications, particularly for rapid-onset treatment".
Conclusion
The acquisition of Zembrace SymTouch and Tosymra is an important step in the evolution of Tonix into a fully integrated biopharmaceutical company and builds on its expertise in central nervous systems disorders. The acquisition helps to build Tonix's commercial capabilities and infrastructure ahead of the potential launch of its TNX-102 SL product candidate for the treatment of fibromyalgia, and aligns strongly with its TNX-1900 product candidate in clinical development for the prevention of headaches in chronic migraine. The products are well-suited to address the unmet needs of patients currently using traditional or emerging oral acute migraine medications, particularly for rapid-onset treatment.
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