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Tonix Pharmaceuticals Completes Acquisition of Two FDA-Approved, Marketed Migraine Products

Tonix Pharmaceuticals Holding Corp. has announced the completion of the acquisition of two currently-marketed products, Zembrace SymTouch and Tosymra, from Upsher-Smith Laboratories. The acquisition of these two FDA-approved products, indicated for the treatment of acute migraine with or without aura in adults, represents an important step in the evolution of Tonix into a fully integrated biopharmaceutical company.


The Importance of the Acquisition

The acquisition of Zembrace SymTouch and Tosymra is expected to help build Tonix’s commercial capabilities and infrastructure ahead of the potential launch of TNX-102 SL product candidate for the treatment of fibromyalgia. It also aligns strongly with TNX-1900, Tonix’s intranasal potentiated oxytocin product candidate in clinical development for the prevention of headaches in chronic migraine. The acquisition is a strategic move for Tonix as it builds on the company's expertise in central nervous systems disorders.

Zembrace SymTouch

Zembrace SymTouch is the only actively promoted brand of sumatriptan autoinjector in the United States. 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. Zembrace SymTouch currently has patent protection to 2036.

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. Tosymra currently has patent protection to 2031.

Migraine as a Debilitating Condition

Migraine is a debilitating condition characterized by pulsating headaches of moderate to severe pain intensity often associated with nausea or vomiting, and/or sensitivity to sound and sensitivity to light. 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.

The Potential of Zembrace SymTouch and Tosymra

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. These products can provide patients with an effective treatment option that can quickly relieve migraine pain or prevent it from occurring in the first place.

The Market Potential of the Products

Zembrace SymTouch and Tosymra collectively generated product sales of approximately $23 million for the full year 2022. These products have significant market potential, as they offer a differentiated option for the treatment of acute migraine with or without aura in adults. The acquisition of Zembrace SymTouch and Tosymra is expected to help build Tonix’s commercial capabilities and infrastructure, which will be crucial in realizing the full market potential of the products.

The Impact on Tonix's Commercial Capabilities

The acquisition of Zembrace SymTouch and Tosymra will help Tonix to build its commercial capabilities and infrastructure ahead of the potential launch of TNX-102 SL for the treatment of fibromyalgia. Tonix will be able to leverage its expertise in central nervous systems disorders to effectively market these products to healthcare professionals and patients.

Tonix's Potential as a Fully Integrated Biopharmaceutical Company

The acquisition of Zembrace SymTouch and Tosymra is an important step in the evolution of Tonix into a fully integrated biopharmaceutical company. The company's expertise in central nervous systems disorders will be instrumental in unlocking the full market potential of these products. Tonix will be able to leverage its commercial capabilities and infrastructure to effectively bring these products to market and provide patients with an effective treatment option for acute migraine with or without aura in adults.

Conclusion

The acquisition of Zembrace SymTouch and Tosymra is a strategic move for Tonix Pharmaceuticals as it builds on the company's expertise in central nervous systems disorders, and helps to build Tonix’s commercial capabilities and infrastructure ahead of the potential launch of TNX-102 SL for the treatment of fibromyalgia. Zembrace SymTouch and Tosymra offer a differentiated treatment option for the millions of people suffering from acute migraine with or without aura in adults, and have significant market potential. Tonix's acquisition of these products is expected to help build the company's commercial capabilities and infrastructure, and position it as a fully integrated biopharmaceutical company.


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