Post by highskier on Jun 26, 2023 19:46:19 GMT
The stk is down over 10% on the news.
Tonix Pharmaceuticals Enters into Agreement to Acquire Two FDA-Approved, Marketed Migraine Products from Upsher-Smith Laboratories, LLC
Tonix Pharmaceuticals Holding Corp.
Mon, June 26, 2023 at 7:00 AM EDT
Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray) are Indicated for the Treatment of Acute Migraine in Adults
Strategic Acquisition Helps Build Tonix’s Commercial Capabilities and Infrastructure Ahead of Potential Launch of TNX-102 SL for the Treatment of Fibromyalgia
Acute Migraine Products Complement Tonix’s Current Intranasal Clinical Development Program of TNX-1900 for Migraine Prevention
Injection and Nasal Spray Products that Bypass the Gastrointestinal Tract Have the Potential to Provide Treatment Options for Migraine Associated with Nausea
CHATHAM, N.J., June 26, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix Pharmaceuticals or Tonix) and its wholly-owned subsidiary Tonix Medicines, Inc. (Tonix Medicines), a clinical-stage biopharmaceutical company, today announced that they have entered into an agreement to acquire 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. Zembrace SymTouch is the only branded sumatriptan autoinjector professionally promoted in the United States and is designed for ease of use and favorable tolerability with a low 3 mg dose.1,3 Tosymra is a novel intranasal sumatriptan product formulated with a permeation enhancer that provides rapid and efficient absorption of sumatriptan.4,5 Collectively, these products generated product sales of approximately $23 million for the full year 2022.6 Zembrace SymTouch and Tosymra each may provide onset of migraine pain relief in as few as 10 minutes for some patients and currently have patent protection to 2036 and 2031, respectively.1,4
Under the terms of the agreement with Upsher-Smith:
Tonix Medicines will make an upfront payment of $12 million in cash to Upsher-Smith at closing and an additional $3 million in March 2024, or upon earlier conclusion of the transition services period.
In addition, Tonix Medicines will pay approximately $10 million in cash to Upsher-Smith at closing to acquire certain product-related inventories.
To support the transition of the products, Upsher-Smith has agreed to provide certain commercial operations, regulatory and other transition services to Tonix Medicines for up to nine months after closing, in exchange for agreed upon service fees.
The assets to be acquired include New Drug Applications issued by the U.S. Food & Drug Administration for the products, as well as patents and trademarks related to the products in the United States and in certain countries outside the United States.
The closing is expected to take place on June 30, 2023.
“Approximately 16% of Americans suffer from migraines, which represents about 40 million patients in the U.S.7,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Sumatriptan remains the acute migraine ‘gold standard’ treatment for many patients and continues to represent the largest segment of the market in terms of unit sales.8 With migraine pain relief possible in as few as ten minutes for some patients and convenient administration, we believe both Zembrace SymTouch and Tosymra are well-suited to address the unmet needs of patients using traditional or emerging oral acute migraine medications, particularly for rapid-onset treatment.”
“Despite increasing options for prevention and treatment of migraine, migraine headaches and breakthrough migraine headaches remain significant unmet needs, and can lead to emergency room visits," said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “For adults needing acute treatment of migraine, Zembrace SymTouch and Tosymra have the potential to be first-line treatments or ‘rescue’ medications for breakthrough migraines, due to their fast onset of action and high pain-relief rates. For certain patients who present to ERs, Zembrace SymTouch and Tosymra also provide ER staff a straightforward acute treatment option. Additionally, because both of these products bypass the gastrointestinal tract, they have the potential to provide a treatment option for migraines complicated by severe nausea and vomiting.”
“These two products are a strategic fit for our company, and we look forward to working with Upsher-Smith to ensure a smooth product transition. To that end, this transaction includes established manufacturing and supplier relationships that allow for a seamless transition of manufacturing and supply chain responsibilities. The franchise today is supported by managed care contracts covering approximately 200 million lives. During the transition, we expect to secure our own contracts,” said James Hunter, Executive Vice President of Commercial Operations at Tonix Pharmaceuticals and President of Tonix Medicines.
Dr. Lederman concluded, “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. In addition, these products align strongly with our TNX-1900 (intranasal potentiated oxytocin) product candidate, in clinical development for the prevention of chronic migraine. This is an important step in the evolution of Tonix into a fully integrated pharmaceutical company.”
Zembrace SymTouch (sumatriptan injection) 3 mg 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).9 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).2 Zembrace SymTouch currently has patent protection to 2036. Tosymra (sumatriptan nasal spray) 10 mg employs Intravail® permeation enhancer technology and is pharmacokinetically equivalent to 4 mg subcutaneous sumatriptan.3,4 Tosymra delivers migraine pain relief in as little as 10 minutes with just one spray for some patients (13% vs. 5% for placebo).4,9,10 Tosymra currently has patent protection to 2031.
About Migraine
Nearly 40 million people in the United States suffer from migraine6 and it has been recognized as the second leading cause of disability in the world.11 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).12
References:
Zembrace SymTouch [package insert]. Maple Grove, MN: Upsher-Smith Laboratories, LLC: February 2021.
Landy, S. et al. Efficacy and safety of DFN-11 (sumatriptan injection, 3 mg) in adults with episodic migraine: a multicenter, randomized, double-blind, placebo-controlled study. J Headache Pain. 19, 69 (2018).
Brand-Schieber E, Munjal S, Kumar R, et al. Human factors validation study of 3 mg sumatriptan autoinjector, for migraine patients. Med Devices (Auckl). 2016;9:131-137.
Tosymra [package insert]. Maple Grove, MN: Upsher-Smith Laboratories, LLC: Feb 2021.
Maggio ET. Intravail®: highly effective intranasal delivery of peptide and protein drugs. Expert Opinion Drug Delivery. 2006;3(4):529-539.
IQVIA 2022 retail sales from the National Sales Perspectives (NSP) audit within the SMART database estimates Zembrace sales of ~$19.6 M and Tosymra sales of ~$3.5 M
Buse et al. Burden of Illness Among People with Migraine and ≥ 4 Monthly Headache Days While Using Acute and/or Preventive Prescription Medications for Migraine. Journal of Managed Care & Specialty Pharmacy. 2020;26(10):1334-1343.
Upsher-Smith Laboratories; Data on File; 2023
Mathew NT, et al. Dose ranging efficacy and safety of subcutaneous sumatriptan in the acute treatment of migraine. US Sumatriptan Research Group. Arch Neurol. 1992;49(12):1271-1276.
Wendt J, et al. A randomized, double-blind, placebo-controlled trial of the efficacy and tolerability of a 4-mg dose of subcutaneous sumatriptan for the treatment of acute migraine attacks in adults. Clinical Therapeutics. 2006;28(4):517-526.
GBD 2016 Headache Collaborators. Global, regional, and national burden of migraine and tension-type headache, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol 2018;17(11):954-976.
Headache Classification Committee of the International Headache Society (IHS). The international classification of headache disorders, 3rd edition. Cephalalgia. 2018;38(1):1–211.
Strategic Acquisition Helps Build Tonix’s Commercial Capabilities and Infrastructure Ahead of Potential Launch of TNX-102 SL for the Treatment of Fibromyalgia
Acute Migraine Products Complement Tonix’s Current Intranasal Clinical Development Program of TNX-1900 for Migraine Prevention
Injection and Nasal Spray Products that Bypass the Gastrointestinal Tract Have the Potential to Provide Treatment Options for Migraine Associated with Nausea
CHATHAM, N.J., June 26, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix Pharmaceuticals or Tonix) and its wholly-owned subsidiary Tonix Medicines, Inc. (Tonix Medicines), a clinical-stage biopharmaceutical company, today announced that they have entered into an agreement to acquire 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. Zembrace SymTouch is the only branded sumatriptan autoinjector professionally promoted in the United States and is designed for ease of use and favorable tolerability with a low 3 mg dose.1,3 Tosymra is a novel intranasal sumatriptan product formulated with a permeation enhancer that provides rapid and efficient absorption of sumatriptan.4,5 Collectively, these products generated product sales of approximately $23 million for the full year 2022.6 Zembrace SymTouch and Tosymra each may provide onset of migraine pain relief in as few as 10 minutes for some patients and currently have patent protection to 2036 and 2031, respectively.1,4
Under the terms of the agreement with Upsher-Smith:
Tonix Medicines will make an upfront payment of $12 million in cash to Upsher-Smith at closing and an additional $3 million in March 2024, or upon earlier conclusion of the transition services period.
In addition, Tonix Medicines will pay approximately $10 million in cash to Upsher-Smith at closing to acquire certain product-related inventories.
To support the transition of the products, Upsher-Smith has agreed to provide certain commercial operations, regulatory and other transition services to Tonix Medicines for up to nine months after closing, in exchange for agreed upon service fees.
The assets to be acquired include New Drug Applications issued by the U.S. Food & Drug Administration for the products, as well as patents and trademarks related to the products in the United States and in certain countries outside the United States.
The closing is expected to take place on June 30, 2023.
“Approximately 16% of Americans suffer from migraines, which represents about 40 million patients in the U.S.7,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Sumatriptan remains the acute migraine ‘gold standard’ treatment for many patients and continues to represent the largest segment of the market in terms of unit sales.8 With migraine pain relief possible in as few as ten minutes for some patients and convenient administration, we believe both Zembrace SymTouch and Tosymra are well-suited to address the unmet needs of patients using traditional or emerging oral acute migraine medications, particularly for rapid-onset treatment.”
“Despite increasing options for prevention and treatment of migraine, migraine headaches and breakthrough migraine headaches remain significant unmet needs, and can lead to emergency room visits," said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “For adults needing acute treatment of migraine, Zembrace SymTouch and Tosymra have the potential to be first-line treatments or ‘rescue’ medications for breakthrough migraines, due to their fast onset of action and high pain-relief rates. For certain patients who present to ERs, Zembrace SymTouch and Tosymra also provide ER staff a straightforward acute treatment option. Additionally, because both of these products bypass the gastrointestinal tract, they have the potential to provide a treatment option for migraines complicated by severe nausea and vomiting.”
“These two products are a strategic fit for our company, and we look forward to working with Upsher-Smith to ensure a smooth product transition. To that end, this transaction includes established manufacturing and supplier relationships that allow for a seamless transition of manufacturing and supply chain responsibilities. The franchise today is supported by managed care contracts covering approximately 200 million lives. During the transition, we expect to secure our own contracts,” said James Hunter, Executive Vice President of Commercial Operations at Tonix Pharmaceuticals and President of Tonix Medicines.
Dr. Lederman concluded, “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. In addition, these products align strongly with our TNX-1900 (intranasal potentiated oxytocin) product candidate, in clinical development for the prevention of chronic migraine. This is an important step in the evolution of Tonix into a fully integrated pharmaceutical company.”
Zembrace SymTouch (sumatriptan injection) 3 mg 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).9 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).2 Zembrace SymTouch currently has patent protection to 2036. Tosymra (sumatriptan nasal spray) 10 mg employs Intravail® permeation enhancer technology and is pharmacokinetically equivalent to 4 mg subcutaneous sumatriptan.3,4 Tosymra delivers migraine pain relief in as little as 10 minutes with just one spray for some patients (13% vs. 5% for placebo).4,9,10 Tosymra currently has patent protection to 2031.
About Migraine
Nearly 40 million people in the United States suffer from migraine6 and it has been recognized as the second leading cause of disability in the world.11 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).12
References:
Zembrace SymTouch [package insert]. Maple Grove, MN: Upsher-Smith Laboratories, LLC: February 2021.
Landy, S. et al. Efficacy and safety of DFN-11 (sumatriptan injection, 3 mg) in adults with episodic migraine: a multicenter, randomized, double-blind, placebo-controlled study. J Headache Pain. 19, 69 (2018).
Brand-Schieber E, Munjal S, Kumar R, et al. Human factors validation study of 3 mg sumatriptan autoinjector, for migraine patients. Med Devices (Auckl). 2016;9:131-137.
Tosymra [package insert]. Maple Grove, MN: Upsher-Smith Laboratories, LLC: Feb 2021.
Maggio ET. Intravail®: highly effective intranasal delivery of peptide and protein drugs. Expert Opinion Drug Delivery. 2006;3(4):529-539.
IQVIA 2022 retail sales from the National Sales Perspectives (NSP) audit within the SMART database estimates Zembrace sales of ~$19.6 M and Tosymra sales of ~$3.5 M
Buse et al. Burden of Illness Among People with Migraine and ≥ 4 Monthly Headache Days While Using Acute and/or Preventive Prescription Medications for Migraine. Journal of Managed Care & Specialty Pharmacy. 2020;26(10):1334-1343.
Upsher-Smith Laboratories; Data on File; 2023
Mathew NT, et al. Dose ranging efficacy and safety of subcutaneous sumatriptan in the acute treatment of migraine. US Sumatriptan Research Group. Arch Neurol. 1992;49(12):1271-1276.
Wendt J, et al. A randomized, double-blind, placebo-controlled trial of the efficacy and tolerability of a 4-mg dose of subcutaneous sumatriptan for the treatment of acute migraine attacks in adults. Clinical Therapeutics. 2006;28(4):517-526.
GBD 2016 Headache Collaborators. Global, regional, and national burden of migraine and tension-type headache, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol 2018;17(11):954-976.
Headache Classification Committee of the International Headache Society (IHS). The international classification of headache disorders, 3rd edition. Cephalalgia. 2018;38(1):1–211.
