08.03.23
MindMed, biopharmaceutical company developing novel candidates to treat brain health disorders, has entered into a license agreement with Catalent to access Catalent’s Zydis orally disintegrating tablet (ODT) technology for the development of MindMed’s lead product candidate MM-120 (lysergide D-tartrate), a pharmaceutically optimized form of lysergide.
The agreement also provides MindMed exclusive rights to use the Zydis technology to develop all salt and polymorphic forms of lysergide in the U.S., UK, and EU 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, CEO 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."
Tom Hawkeswood, president, division head of pharma product delivery at Catalent said, "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. 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 4Q23. 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.
The agreement also provides MindMed exclusive rights to use the Zydis technology to develop all salt and polymorphic forms of lysergide in the U.S., UK, and EU 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, CEO 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."
Tom Hawkeswood, president, division head of pharma product delivery at Catalent said, "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. 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 4Q23. 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.