Zydis

Melt Pharmaceuticals Announces Exclusive Development and License Agreement with Catalent for Its Zydis® Fast-Dissolve Technology for Use in MELT-300 for Needle- and Opioid-Free Procedural Sedation

Retrieved on: 
Tuesday, September 26, 2023

Melt Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing novel approaches for procedural sedation, today announced it recently entered into an exclusive development and license agreement with Catalent, the global leader in enabling the development and supply of better treatments across multiple modalities.

Key Points: 
  • Melt Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing novel approaches for procedural sedation, today announced it recently entered into an exclusive development and license agreement with Catalent, the global leader in enabling the development and supply of better treatments across multiple modalities.
  • Catalent’s Zydis® ODT technology is currently used in over 35 FDA-approved and U.S.-marketed products.
  • “This exclusive license with Catalent is a key milestone for the continued development of MELT-300,” said Larry Dillaha, M.D., CEO of Melt Pharmaceuticals.
  • Melt Pharmaceuticals is currently in discussions with the FDA (U.S. Food and Drug Administration) on the Phase 3 program, which Melt expects to begin in early 2024.

MindMed Announces Exclusive License Agreement With Catalent for Its Patented Zydis® Fast-Dissolve Technology for Use with MM-120

Retrieved on: 
Thursday, August 3, 2023

Under the terms of the licensing agreement, Catalent has granted MindMed access to its Zydis technology for the development of MindMed’s lead product candidate MM-120 (lysergide D-tartrate), which is a proprietary, pharmaceutically optimized form of lysergide.

Key Points: 
  • Under the terms of the licensing agreement, Catalent has granted MindMed access to its Zydis technology for the development of MindMed’s lead product candidate MM-120 (lysergide D-tartrate), which is a proprietary, pharmaceutically optimized form of lysergide.
  • The agreement also provides MindMed with exclusive rights for the use of the Zydis technology to develop all salt and polymorphic forms of lysergide in the United States, United Kingdom, and European Union among other key territories.
  • Zydis ODT is a unique, freeze-dried, oral solid dosage form that disperses almost instantly in the mouth, without the need for water.
  • In addition, MindMed is in the process of initiating a Phase 1 pharmacokinetics bridging study to support advancement of the MM-120 ODT formulation into pivotal clinical trials.

Lusaris Therapeutics Launches with $60 Million Series A Financing to Redefine the Treatment of Severe Neuropsychiatric and Neurological Disorders

Retrieved on: 
Wednesday, November 2, 2022

Lusaris Therapeutics, a biotechnology company advancing next-generation serotonergic neuroplastogen therapeutics to treat severe neuropsychiatric and neurological conditions, launched today with a $60 million Series A financing.

Key Points: 
  • Lusaris Therapeutics, a biotechnology company advancing next-generation serotonergic neuroplastogen therapeutics to treat severe neuropsychiatric and neurological conditions, launched today with a $60 million Series A financing.
  • Psychoplastogens have emerged as a promising treatment approach supported by compelling scientific evidence in patients with TRD and other severe neuropsychiatric conditions.
  • Lusaris plans to develop LSR-1019 for the treatment of TRD and additional severe neuropsychiatric disorders.
  • Lusaris is a biotechnology company advancing next-generation serotonergic neuroplastogen therapeutics to treat severe neuropsychiatric and neurological disorders.

Catalent and MigVax Sign Agreement to Develop an Orally Disintegrating Freeze-Dried Tablet Vaccine Against COVID-19

Retrieved on: 
Tuesday, June 7, 2022

SOMERSET, N.J. and KIRYAT SHMONA, Israel, June 7, 2022 /PRNewswire-PRWeb/ -- Catalent, the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, and MigVax, an Israeli biopharmaceutical company developing an oral subunit vaccine against COVID-19, today announced that they have signed a development agreement to leverage Catalent's proprietary Zydis® Bio orally disintegrating tablet (ODT) technology for delivering the MigVax-101 vaccine.

Key Points: 
  • Catalent and MigVax today announced that they have signed a development agreement to leverage Catalent's proprietary Zydis Bio orally disintegrating tablet (ODT) technology for delivering the MigVax-101 vaccine against COVID-19.
  • MigVax's lead oral vaccine program, MigVax-101, has shown positive results in preclinical tests, and in November 2021.
  • In addition, MigVax's oral approach may allow for mucosal protection, a benefit that may prove important in preventing infection.
  • Using the methods learned from the existing vaccine, MigVax's new vaccine is an oral subunit human vaccine against COVID-19 administered as a tablet.

Cybin Signs Drug Development Agreement with Catalent for its Fast-Dissolve Formulation of Novel, Deuterated Tryptamine (CYB003)

Retrieved on: 
Monday, March 22, 2021

ft. site in Swindon, U.K. houses the companys Zydis development and manufacturing operation, which produces over one billion ODTs annually.

Key Points: 
  • ft. site in Swindon, U.K. houses the companys Zydis development and manufacturing operation, which produces over one billion ODTs annually.
  • The Zydis platform is an ideal technology to leverage for this type of drug formulation, as pre-gastric absorption is crucial for efficacy.
  • Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products.
  • If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybins performance and operations.

Catalent Partners with Biohaven on New Fast-Dissolve Migraine Treatment

Retrieved on: 
Tuesday, March 17, 2020

NURTEC ODT is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting ODT.

Key Points: 
  • NURTEC ODT is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting ODT.
  • Zydis technology is recognized as one of the world's best-performing ODTs and has well-established advantages over conventional oral dosage forms, including improved patient compliance, adherence, and convenience.
  • NURTEC ODT is the first FDA-approved product for Biohaven, a company dedicated to advancing innovative therapies for neurological diseases.
  • He added, "We are pleased to have partnered with Biohaven on the formulation, and now commercial manufacture, of this important treatment for such a debilitating condition."

Catalent to Partner with Ethicann on New Fast-Dissolve Cannabinoid-Based Treatment for Multiple Sclerosis Spasticity

Retrieved on: 
Tuesday, December 3, 2019

One of the more common symptoms of MS, muscular spasticity causes feelings of stiffness and a wide range of involuntary muscle spasms in patients.

Key Points: 
  • One of the more common symptoms of MS, muscular spasticity causes feelings of stiffness and a wide range of involuntary muscle spasms in patients.
  • Ethicann will investigate the new Zydis product for the treatment of patients who have shown inadequate response to other symptomatic treatments or who have difficulty tolerating the side effects of other treatments.
  • Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products.
  • Ethicann Pharmaceuticals develops cannabinoid-based ethical pharmaceuticals for treatment of a variety of disorders.

Cycle Pharmaceuticals and Catalent Partner to Develop Treatments for Rare Diseases Using Zydis ODT Technology

Retrieved on: 
Thursday, October 31, 2019

Cycle Pharmaceuticals Ltd (Cycle) is pleased to announce that it has signed an agreement with Catalent, Inc. (Catalent) (NYSE: CTLT), to develop innovative formulations targeting rare disease patients.

Key Points: 
  • Cycle Pharmaceuticals Ltd (Cycle) is pleased to announce that it has signed an agreement with Catalent, Inc. (Catalent) (NYSE: CTLT), to develop innovative formulations targeting rare disease patients.
  • This agreement covers four products in rare metabolic and neurological disorders and each product will utilise Catalents Zydis oral disintegrating tablet (ODT) and Zydis Ultra technologies.
  • The Zydis Ultra platform is the companys next generation ODT technology and allows for increased drug load and better taste masking to be incorporated into its proven Zydis ODT dosage form.
  • Working in partnership with Catalent to apply the Zydis technology to Cycles product pipeline will be life-changing for both patients and their caregivers.

As ALK Prepares to Further Extend Their SLIT-tablet Portfolio, Tablet Formulation is Seen as Key in Delivering Consistent Positive Clinical Trial Results

Retrieved on: 
Monday, June 3, 2019

Zydis freeze-dried tablet technology used in ALK's SLIT-tablet range makes them faster dissolving than conventional compressed sublingual tablets in in-vitro testing.

Key Points: 
  • Zydis freeze-dried tablet technology used in ALK's SLIT-tablet range makes them faster dissolving than conventional compressed sublingual tablets in in-vitro testing.
  • Resulting in rapid and predictable release of the active ingredient contained in the ALK SLIT-tablets.
  • We believe that the tablet formulation technology is an important factor in this success."
  • Headquartered in Hrsholm, Denmark, ALK employs around 2,400 people worldwide and is listed on Nasdaq Copenhagen.

Catalent Selected to Provide Oral Delivery Systems for GB Sciences' Proprietary Parkinson's Disease Therapies

Retrieved on: 
Wednesday, September 26, 2018

SWINDON, U.K., and LAS VEGAS, Sept. 26, 2018 /PRNewswire/ --GB Sciences, Inc. (OTCQB: GBLX) and Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that GB Sciences has selected Catalent to provide oral delivery systems, formulation development, and clinical-scale oral dose manufacturing of GB Sciences' proprietary active pharmaceutical ingredients ("APIs") for its Parkinson's disease therapies.

Key Points: 
  • SWINDON, U.K., and LAS VEGAS, Sept. 26, 2018 /PRNewswire/ --GB Sciences, Inc. (OTCQB: GBLX) and Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that GB Sciences has selected Catalent to provide oral delivery systems, formulation development, and clinical-scale oral dose manufacturing of GB Sciences' proprietary active pharmaceutical ingredients ("APIs") for its Parkinson's disease therapies.
  • GB Sciences' three patent-pending APIs for Parkinson's disease are complex mixtures containing up to nine individual components that function synergistically.
  • Catalent's proprietary delivery method also potentially offers consistent dosing for our complex cannabinoid- and terpenoid-containing APIs," explained Dr. Andrea Small-Howard, Chief Science Officer of GB Sciences.
  • In addition to its Zydis technology, Catalent has early development and oral drug delivery solutions available for the efficient delivery of GB Sciences' proprietary APIs.