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Details:

The funding is intended to support the clinical advancement of MELT-300, a non-intravenous, non-opioid tablet that blends fixed doses of midazolam and ketamine. This medication is designed for procedural sedation during cataract surgery.


Lead Product(s): Midazolam,Ketamine Hydrochloride

Therapeutic Area: Neurology Product Name: MELT-300

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Newbridge Securities Corporation

Deal Size: $24.0 million Upfront Cash: Undisclosed

Deal Type: Series B Financing April 02, 2024

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The financing aims to support the clinical development of Zepizure (midazolam), a short-acting hypnotic-sedative medication currently undergoing evaluation in patients for the treatment of epileptic seizures.


Lead Product(s): Midazolam

Therapeutic Area: Neurology Product Name: Zepizure

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Heights Capital Management

Deal Size: $12.0 million Upfront Cash: Undisclosed

Deal Type: Financing February 27, 2024

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Under the agreement, Syneos Health will provide support in all pre-launch and launch activities for Zepizure (midazolam), an epileptic rescue therapy for epileptic seizures.


Lead Product(s): Midazolam

Therapeutic Area: Neurology Product Name: Zepizure

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Crossject

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement January 04, 2024

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The agreement aims for the commercialization of Crossject's innovative rescue therapy for epileptic seizures Zepizure (midazolam), previously known as ZENEO® Midazolam, in northern Europe covering Germany, the UK, Denmark, Sweden, Finland and Norway.


Lead Product(s): Midazolam

Therapeutic Area: Neurology Product Name: Zepizure

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Undisclosed

Deal Size: $1.0 million Upfront Cash: Undisclosed

Deal Type: Agreement December 22, 2023

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Under the agreement, Melt Pharmaceuticals will utilize Catalent’s proprietary Zydis® orally disintegrating tablet fast-dissolve technology with MELT-300 (midazolam), a sublingual, needle- and opioid-free patented formulation for procedural sedation during cataract surgery.


Lead Product(s): Midazolam,Ketamine Hydrochloride

Therapeutic Area: Neurology Product Name: Melt-300

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Melt Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement September 26, 2023

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Under the agreement, AFT will commercialise ZENEO® Midazolam, a combination of the single use needle-free auto injector ZENEO® and the drug product midazolam, in epileptic seizures in Australia and New Zealand.


Lead Product(s): Midazolam

Therapeutic Area: Neurology Product Name: Zeneo

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: AFT Pharmaceuticals

Deal Size: $0.7 million Upfront Cash: Undisclosed

Deal Type: Licensing Agreement July 20, 2023

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MELT-300 combines fixed doses of midazolam (3mg) and ketamine (50mg) in one rapidly dissolving tablet (RDT) that is administered sublingually for procedural sedation during cataract surgery.


Lead Product(s): Midazolam,Ketamine Hydrochloride

Therapeutic Area: Neurology Product Name: MELT-300

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 21, 2022

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The MKO melt (midazolam) is being marketed as an anesthetic medication for cataract surgery that has the advantage that it eliminates the need for an IV in 85% of patients although that number was established anecdotally.


Lead Product(s): Midazolam,Ketamine Hydrochloride,Ondansetron

Therapeutic Area: Ophthalmology Product Name: MKO Melt

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: iOR Partners

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement November 30, 2022

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ZENEO and the syringe with intramucular needle showed a similar and low inter-subject variability of midazolam pharmacokinetics. This is an additional demonstration that an injection with ZENEO reached muscle in the same way as an injection with a syringe and a 30 mm needle.


Lead Product(s): Midazolam

Therapeutic Area: Neurology Product Name: Zeneo

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 02, 2022

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Details:

MELT-300 combines fixed doses of midazolam (3mg) and ketamine (50mg) in one dissolvable tablet that is administered sublingually for procedural sedation and analgesia during cataract surgery.


Lead Product(s): Midazolam,Ketamine Hydrochloride

Therapeutic Area: Ophthalmology Product Name: MELT-300

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 27, 2022

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EDP-235 achieved excellent penetration into monocytes and macrophages, including lung AM. EDP-235 has the potential to eliminate viral replication of SARS-CoV-2 in these critical immune cells, thus mitigating macrophage-mediated cytokine storm in high-risk COVID-19 patients.


Lead Product(s): EDP-235,Midazolam,Rosuvastatin

Therapeutic Area: Infections and Infectious Diseases Product Name: EDP-235

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 19, 2022

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Midazolam 10 mg autoinjector is indicated for the treatment of status epilepticus, or prolonged seizures, in adults. According to U.S. JPEO-CBRND, the autoinjector improves upon and will replace the currently fielded convulsant antidote for nerve agent diazepam autoinjector.


Lead Product(s): Midazolam

Therapeutic Area: Neurology Product Name: Undisclosed

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 30, 2022

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ZENEO's Midazolam is developed as a combination of the single use needle-free auto injector ZENEO and the drug product midazolam, which is an improved anti-convulsant benzodiazepine recommended for treatment of strong seizures resulting from epilepsia.


Lead Product(s): Midazolam

Therapeutic Area: Neurology Product Name: Zeneo

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: BARDA

Deal Size: $60.0 million Upfront Cash: Undisclosed

Deal Type: Agreement June 18, 2022

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MELT-210 is a fixed dose of 3 mg of midazolam formulated in a proprietary rapidly dissolving sublingual tablet using its proprietary Zydis® orally disintegrating tablet (ODT) technology to create a tablet that dissolves quickly when placed under the tongue.


Lead Product(s): Ketamine Hydrochloride,Midazolam

Therapeutic Area: Neurology Product Name: MELT-210

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Catalent Pharma Solutions

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 04, 2022

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Having acquired Brain Therapeutics, Neuraxpharm is now able to bring new products to the Greek market including the market-leading product for emergency treatment of children and adolescents with epilepsy, Buccolam®, will be among the products to be offered.


Lead Product(s): Midazolam

Therapeutic Area: Neurology Product Name: Buccolam

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Neuraxpharm

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition March 08, 2022

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Melt Pharmaceuticals will use the proceeds to conduct Phase 2 efficacy study for the lead drug candidate, MELT-300, a combination of midazolam and ketamine in a rapidly dissolving, sublingual tablet to provide sedation and analgesia for patients undergoing cataract surgery.


Lead Product(s): Midazolam,Ketamine Hydrochloride

Therapeutic Area: Neurology Product Name: MELT-300

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Harrow Health

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Financing September 02, 2021

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Details:

MELT is a patented combination of midazolam and ketamine in a rapidly dissolving, sublingual tablet to provide sedation and analgesia for patients undergoing cataract surgery.


Lead Product(s): Midazolam,Ketamine Hydrochloride

Therapeutic Area: Neurology Product Name: Undisclosed

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 09, 2021

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Buccolam (oromucosal midazolam), value-added buccal midazolam indicated for emergency treatment of children and adolescents from 3 months to 18 years with epilepsy suffering from prolonged acute convulsive seizures.


Lead Product(s): Midazolam

Therapeutic Area: Neurology Product Name: Buccolam

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Takeda Pharmaceutical

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 12, 2021

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Details:

Each sublingually administered MKO Melt troche contains 3 mg of midazolam, 25 mg of ketamine, and 2 mg of ondansetron, and is available for institutional purchase through Harrow’s wholly-owned subsidiary, ImprimisRx®.


Lead Product(s): Midazolam,Ketamine Hydrochloride,Ondansetron

Therapeutic Area: Neurology Product Name: MKO Melt

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 03, 2020

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Details:

Buccolam® (Midazolam), fits perfectly within Neuraxpharm’s portfolio, strengthening its position as the European CNS specialist in several European countries, and offers the opportunity to expand the commercial footprint, including into the Nordics and Ireland.


Lead Product(s): Midazolam

Therapeutic Area: Neurology Product Name: Buccolam

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Neuraxpharm

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition September 14, 2020

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MELT-100 is a patented combination of midazolam and ketamine in a rapidly dissolving, sublingual tablet to provide sedation and analgesia for patients undergoing cataract surgery.


Lead Product(s): Midazolam,Ketamine Hydrochloride

Therapeutic Area: Neurology Product Name: MELT-100

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 29, 2020

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