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

Tonix Pharmaceuticals Holding Corp., a biopharmaceutical company, and its wholly-owned commercialization subsidiary Tonix Medicines, Inc. (Tonix Medicines), announced it has completed the acquisition of two currently-marketed products from Upsher-Smith Laboratories, LLC (Upsher-Smith): Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are both indicated for the treatment of acute migraine with or without aura in adults. As previously announced, these products collectively generated product sales of approximately $23 million for the full year 2022.

“The acquisition of these two products represents an important step in the evolution of Tonix into a fully integrated biopharmaceutical company and builds on our expertise in central nervous systems disorders,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “In addition to the potential growth that these two on-market products represent over time, the acquisition helps build Tonix’s commercial capabilities ahead of the potential launch of our TNX-102 SL product candidate for the treatment of fibromyalgia, and aligns strongly with our TNX-1900 (intranasal potentiated oxytocin) product candidate in clinical development for the prevention of headaches in chronic migraine.”

“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,” said James Hunter, Executive Vice President of Commercial Operations at Tonix Pharmaceuticals and President of Tonix Medicines.

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 (17% of patients vs. 5% for placebo). Zembrace SymTouch also demonstrated migraine pain freedom for 46% of patients (vs 27% for placebo) at 2 hours in a single-attack, double-blind study (N=230). Zembrace SymTouch currently has patent protection to 2036. 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 (13% vs. 5% for placebo). Tosymra currently has patent protection to 2031.