MindMed Announces Exclusive License Agreement With Catalent for Its Patented Zydis® Fast-Dissolve Technology for Use with MM-120
03 Agosto 2023 - 8:30AM
Business Wire
Mind Medicine (MindMed) Inc (NASDAQ: MNMD), (NEO: MMED),
(the “Company” or “MindMed”), 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.
About MindMed
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.
MindMed trades on NASDAQ under the symbol MNMD and on the
Canadian NEO Exchange under the symbol MMED.
Forward-Looking Statements
Certain statements in this news release related to the Company
constitute “forward-looking information” within the meaning of
applicable securities laws and are prospective in nature.
Forward-looking information is not based on historical facts, but
rather on current expectations and projections about future events
and are therefore subject to risks and uncertainties which could
cause actual results to differ materially from the future results
expressed or implied by the forward-looking statements. These
statements generally can be identified by the use of
forward-looking words such as “will”, “may”, “should”, “could”,
“intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe”,
“potential” or “continue”, or the negative thereof or similar
variations. Forward-looking information in this news release
includes, but is not limited to, statements regarding anticipated
benefits of incorporating the Zydis ODT delivery technology with
MM-120, grant of patents, the first expiration dates of patents, if
granted, the advancement of the MM-120 ODT formulation into pivotal
clinical trials, timing of results from the Phase 2b clinical trial
of MM-120 and the potential benefits of the Company’s product
candidates. There are numerous risks and uncertainties that could
cause actual results and the Company’s plans and objectives to
differ materially from those expressed in the forward-looking
information, including history of negative cash flows; limited
operating history; incurrence of future losses; availability of
additional capital; lack of product revenue; compliance with laws
and regulations; difficulty associated with research and
development; risks associated with clinical trials or studies;
heightened regulatory scrutiny; early stage product development;
clinical trial risks; regulatory approval processes; novelty of the
psychedelic inspired medicines industry; as well as those risk
factors discussed or referred to herein and the risks described in
the Company’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2022, the Company’s Quarterly Report on Form 10-Q for
the fiscal quarter ended March 31, 2023 under headings such as
“Special Note Regarding Forward-Looking Statements,” and “Risk
Factors” and “Management’s Discussion and Analysis of Financial
Condition and Results of Operations” and other filings and
furnishings made by the Company with the securities regulatory
authorities in all provinces and territories of Canada which are
available under the Company’s profile on SEDAR at www.sedar.com and
with the U.S. Securities and Exchange Commission on EDGAR at
www.sec.gov. Except as required by law, the Company undertakes no
duty or obligation to update any forward-looking statements
contained in this release as a result of new information, future
events, changes in expectations or otherwise.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230803173510/en/
For Media & Investor Inquiries, please contact:
Maxim Jacobs, CFA Vice President, Investor Relations and
Corporate Communications Mind Medicine (MindMed) Inc. ir@mindmed.co
media@mindmed.co
Mind Medicine MindMed (NASDAQ:MNMD)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Mind Medicine MindMed (NASDAQ:MNMD)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024