- Supply agreement supports Viridian’s
development of potential first- and best-in-class subcutaneous
therapies for treatment of thyroid eye disease (TED) -
- Ypsomed brings strong track record of
drug-device combination approvals engineered with its proprietary
YpsoMate self-injection technology -
Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology
company focused on discovering and developing potential
best-in-class medicines for serious and rare diseases, and Ypsomed
AG (SIX: YPSN), the leading developer and manufacturer of injection
and infusion systems for self-medication have signed a supply
agreement for Ypsomed’s customizable YpsoMate 2.25 autoinjector pen
device with a fill volume of 2.0 milliliters.
As part of the agreement, Ypsomed will customize and supply
YpsoMate 2.25 patient-administered delivery devices to support
Viridian’s development of investigational subcutaneous therapy
candidates for the treatment of thyroid eye disease (TED).
“Developing a subcutaneous therapy is an essential part of our
vision to offer the most comprehensive set of therapeutic options
to the TED community. Following our lead intravenous candidate, a
subcutaneous therapy would bring much needed convenience to care
givers and patients while potentially expanding the TED medicines
market,” said Scott Myers, President and CEO of Viridian. “Thus,
it’s critical that we continue to improve our therapy by packaging
it in a delivery device that is as convenient and user-friendly as
possible. We engaged in a rigorous selection process and concluded
that, based on its strong track record of drug-device combination
approvals in multiple disease areas, Ypsomed is the ideal partner
to supply such a device. We’re very much looking forward to working
with them.”
“We are very pleased that, together with Viridian, we may
provide people affected by TED access to an innovative drug,” said
Ulrike Bauer, Chief Business Officer Delivery Systems at Ypsomed.
“It shows that with our platform approach, we are able to quickly
and efficiently customize autoinjectors that optimally support
users in the administration of their medicine.”
About Viridian’s Thyroid Eye Disease Pipeline (VRDN-001,
-002, and -003)
Viridian’s lead product candidate, VRDN-001, is a differentiated
monoclonal antibody targeting the insulin-like growth factor-1
receptor (IGF-1R), a clinically and commercially validated target
for the treatment of thyroid eye disease (TED). In preclinical
studies, VRDN-001 was shown to be a full antagonist of IGF-1R, with
more complete receptor blockade than other anti-IGF-1R antibodies,
including the only currently approved TED therapy. Data from the
Phase 2 portion of the ongoing trial established clinical
proof-of-concept for VRDN-001 delivered intravenously (IV) in
patients with active and chronic TED. VRDN-001 was generally well
tolerated in the trial.
The THRIVE Phase 3 trial in patients with active TED is ongoing,
and the Company is currently recruiting for its second Phase 3
trial, called THRIVE-2, in patients with chronic TED.
The Company is also advancing three candidates (VRDN-001 SC,
VRDN-002, and VRDN-003) designed for administration as a
convenient, low-volume, subcutaneous (SC) injection for the
treatment of TED.
Viridian’s goal is to bring a best-in-class IV therapy followed
by a first- and best-in-class SC therapy to the market for the
treatment of the TED.
VRDN-001, -002, and -003 are investigational therapies that are
not approved for any use in any country.
About TED
TED is a serious and debilitating rare autoimmune disease that
causes inflammation within the orbit of the eye that can cause
double vision, pain, and potential blindness. TED is a progressive
disease consisting of an initial active phase, followed by a
transition to a secondary chronic phase. According to estimates,
more than 50,000 and 200,000 people suffer from active and chronic
TED, respectively, in the United States and Europe.
About Viridian Therapeutics
Viridian Therapeutics is a biopharmaceutical company focused on
engineering and developing potential best-in-class medicines for
patients with serious and rare diseases. Viridian’s expertise in
antibody discovery and engineering enables it to develop
differentiated therapeutic candidates for previously validated drug
targets in commercially established disease areas.
Viridian is advancing multiple candidates in the clinic for the
treatment of patients with thyroid eye disease (TED). The Company
is conducting two global Phase 3 trials called THRIVE and THRIVE-2
to evaluate the safety and efficacy of VRDN-001 in patients with
active or chronic TED. In addition to its program for intravenously
administered VRDN-001, the Company is advancing three candidates
for its subcutaneous strategy with the goal of providing a more
conveniently administered therapy to patients with TED. Viridian is
also developing multiple preclinical assets in autoimmune and rare
diseases.
Viridian is based in Waltham, Massachusetts. For more
information, please visit www.viridiantherapeutics.com. Follow
Viridian on LinkedIn and twitter.
About Ypsomed AG
Ypsomed is the leading developer and manufacturer of injection
and infusion systems for self-medication and a renowned diabetes
specialist with over 35 years’ experience. As a leader in
innovation and technology, it is a preferred partner of
pharmaceutical and biotech companies for pens, autoinjectors and
pump systems for administering liquid medications. Ypsomed presents
and markets its product portfolios under the umbrella brands mylife
Diabetescare directly to patients or via pharmacies and hospitals
as well as under YDS Ypsomed Delivery Systems in
business-to-business operations with pharmaceutical companies.
Ypsomed has its headquarters in Burgdorf, Switzerland, and operates
a global network of manufacturing sites, subsidiaries, and
distributors. The Ypsomed Group employs over 2,200 employees.
For more information, please visit www.ypsomed.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. These statements may be identified by the use of words such
as, but not limited to, "anticipate," "believe," "continue,"
"could," "estimate," "expect," "intend," "may," "might," "plan,"
"potential," "predict," "project," "should," "target," "will," or
"would" or other similar terms or expressions that concern our
expectations, plans and intentions. Forward-looking statements
include, without limitation, statements regarding our expectations,
strategies, plans and intentions. Forward-looking statements are
neither historical facts nor assurances of future performance.
Instead, they are based on our current beliefs, expectations, and
assumptions. New risks and uncertainties may emerge from time to
time, and it is not possible to predict all risks and
uncertainties. No representations or warranties (expressed or
implied) are made about the accuracy of any such forward-looking
statements. Such forward-looking statements are subject to a number
of material risks and uncertainties including but not limited to:
the potential efficacy and safety of VRDN-001, VRDN-002, and
VRDN-003 for the treatment of Thyroid Eye Disease (TED), the
results of ongoing or future clinical trials; the timing, progress
and plans for our ongoing or future research, pre-clinical and
clinical development programs; including the clinical trials for
VRDN-001, VRDN-002, and VRDN-003, our ability to develop a
subcutaneous formulation (SC); our plan regarding a lead SC
candidate and our expectations regarding a delivery device supply
partnership and other risks and uncertainties, including those
risks set forth under the caption "Risk Factors" in our Quarterly
Report on Form 10-Q filed with the Securities and Exchange
Commission (SEC) on August 8, 2023 and other subsequent disclosure
documents filed with the SEC. Any forward-looking statement speaks
only as of the date on which it was made. Neither the Company, nor
its affiliates, advisors, or representatives, undertake any
obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future events or
otherwise, except as required by law. These forward-looking
statements should not be relied upon as representing the Company’s
views as of any date subsequent to the date hereof.
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version on businesswire.com: https://www.businesswire.com/news/home/20231026854999/en/
Investors: Louisa Stone, 508-808-2400 Manager, Investor
Relations IR@viridiantherapeutics.com
Media: Matt Fearer, 617-272-4605 Vice President, Corporate
Communications Media@viridiantherapeutics.com
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