- 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231026854999/en/