Business Insights, PHARMACY MARKET
Businesswire | August 07, 2023
Mind Medicine Inc a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, announced today that it has entered into a license agreement with Catalent, a leader in enabling the development and supply of better treatments for patients worldwide, to access Catalent’s proprietary Zydis® orally disintegrating tablet (ODT) technology.
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. Zydis is also 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.
“We aim to develop best-in-class brain health treatments that have the potential to reach patients in need and are pleased to be working with Catalent, a global CDMO leader with broad, deep-scale expertise in delivery technologies, and multi-modality manufacturing capabilities to reach this objective”, said Robert Barrow, Chief Executive Officer and Director of MindMed. “ODT formulations have the potential to result in enhanced bioavailability and more rapid absorption, which could ultimately culminate in a shorter treatment session for MM-120. We believe that the Zydis ODT delivery technology, when incorporated into our MM-120 product candidate, represents an optimized pharmaceutical product that has the potential to enhance our competitive advantage in the marketplace and continue to expand our intellectual property estate. If granted, based on our current and ongoing applications that incorporate the Zydis ODT platform, MM-120 would benefit from numerous patents with first expiration dates beginning in 2042.”
“Catalent has a proven track record in working with partners to bring novel therapies through the clinic and to market quickly and we look forward to working with MindMed in the development of this potentially life-changing new product candidate,” said Tom Hawkeswood, President, Division Head of Pharma Product Delivery at Catalent. “The Zydis technology platform has been shown to be very versatile and effective in developing easy-to-administer dose forms for innovators, and its superiority over other ODTs has been illustrated by its use in the launch of more than 36 products in over 60 countries.”
MindMed is currently conducting a Phase 2b trial evaluating MM-120 for the treatment of generalized anxiety disorder (GAD) with topline data expected in the fourth quarter of 2023. This Phase 2b trial is a multi-center, parallel, randomized, double-blind, placebo-controlled, dose-optimization study. The participants are randomized to receive a single administration of 25 µg, 50 µg, 100 µg or 200 µg of MM-120 or placebo. The primary objective is to determine the reduction in anxiety symptoms four weeks after a single administration of MM-120, compared across the five treatment arms. Key secondary objectives, measured up to 12 weeks after the single administration, include assessments of anxiety symptoms, safety and tolerability, as well as other measures of efficacy and quality of life. More information about the trial is available on our website (mindmed.co), the trial website (anxietyresearchstudy.com) or on clinicaltrials.gov (identifier NCT05407064). 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.
MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders.
Businesswire | August 01, 2023
Harrow a leading U.S. eyecare pharmaceutical company, today announced the completion of the transfer to Harrow of the New Drug Application (NDA) for VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5%, a fluoroquinolone antibiotic eye drop for the treatment of bacterial conjunctivitis caused by susceptible strains of organisms. The U.S. commercial rights to VIGAMOX werepurchasedby Harrow in January of 2023, and VIGAMOX is the fourth FDA-approved ophthalmic product from that acquisition to have completed the NDA transfer process and become commercially available under the Harrow name.
“Having now completed the NDA transfer of VIGAMOX, we are excited to begin the implementation of the market access, marketing, inventory management, national sales detailing, and other brand‑leveraging strategies that we have developed during this transfer period,” said Mark L. Baum, Chief Executive Officer of Harrow. “With an exceptional record of safety and efficacy, VIGAMOX is a well-known, reliable, and trusted product by U.S. eyecare professionals, many of whom regard VIGAMOX as the preferred broad-spectrum topical antibiotic to treat patients for bacterial conjunctivitis (sometimes referred to as 'pink eye') as well as many other common bacterial-based infections.”
Product orders for VIGAMOX can be made directly through Harrow’s dedicated customer service ordering partner, Cardinal’s Cordlogistics, which includes a wholesaler distribution system encompassing McKesson and AmerisourceBergen.
About VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5%:
INDICATIONS AND USAGE
VIGAMOX® is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species*, Micrococcus luteus*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri*, Streptococcus pneumoniae, Streptococcus viridans group, Acinetobacter lwoffii*, Haemophilus influenzae, Haemophilus parainfluenzae*, and Chlamydia trachomatis.
Efficacy for this organism was studied in fewer than 10 infections.
IMPORTANT SAFETY INFORMATION
VIGAMOX® is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication.
Warnings and Precautions
Hypersensitivity Reactions –Hypersensitivity and anaphylaxis have been reported with systemic use of moxifloxacin.
Prolonged Use –May result in overgrowth of non-susceptible organisms, including fungi.
Avoid Contact Lens Wear –Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.
The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1%-6% of patients.
Nonocular adverse events reported at a rate of 1%-4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis.
Harrow Health, Inc. is a leading eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic pharmaceutical products for the U.S. market. Harrow helps U.S. eyecare professionals preserve the gift of sight by making its comprehensive portfolio of prescription and non-prescription pharmaceutical products accessible and affordable to millions of Americans each year.
Businesswire | July 26, 2023
Nexus Pharmaceuticals announced it has received U.S. Food and Drug Administration (FDA) approval for Sterile Water for Injection, USP in 10mL and 20mL Single-Dose Vials.
According to the FDA and the FD&C Act, the product is considered bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Sterile Water for Injection USP, of Hospira, Inc. Furthermore, the FDA has granted CGT (competitive generic therapy) designation for the 20mL presentation of sterile water for injection.
“We are proud to be a force for change in the pharmaceutical industry, and we are grateful to the FDA for recognizing the importance of this critical-need product,” said Aman Ahmed, Director of Government Relations and International Sales at Nexus. “The approval of this product is an important step in continuing our efforts to alleviate drug shortages and bring pharmaceutical manufacturing back to the U.S.”
Nexus Pharmaceuticals’ Sterile Water for Injection will be available in cartons of 25 vials.
About Sterile Water for Injection, USP
Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection.
This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
About Nexus Pharmaceuticals LLC
Nexus Pharmaceuticals LLC., a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor intensive, and more streamlined in practice. Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they’re needed most.