Viridian Therapeutics has announced a major licensing agreement with Kissei Pharmaceutical Co., Ltd. that could generate up to $385 million for the development and commercialization of two thyroid eye disease (TED) therapies in Japan. The deal provides Kissei with exclusive rights to develop and commercialize veligrotug and VRDN-003, both anti-insulin-like growth factor-1 receptor (IGF-1R) antibodies designed to treat patients with TED.
Financial Terms and Structure
Under the agreement, Viridian will receive an upfront cash payment of $70 million, with the potential for an additional $315 million in development, regulatory, and commercial milestone payments. The company will also earn tiered royalties on net sales in Japan ranging from the 20s to mid-30s percent. Kissei will assume responsibility for all development, regulatory, and commercialization activities and associated costs in Japan.
"After running a very competitive partnering process, we are thrilled to partner with Kissei to bring these potential best-in-class medicines to TED patients in Japan," said Steve Mahoney, Viridian's President and CEO. "Kissei has an established strong track record of successfully developing and commercializing in-licensed, rare disease medicines."
Therapeutic Candidates and Clinical Progress
Both veligrotug (formerly VRDN-001) and VRDN-003 target the IGF-1R pathway in treating TED, an autoimmune condition characterized by inflammation, growth, and damage to tissues around and behind the eye, often causing swelling, discomfort, and double vision. VRDN-003 represents a potential best-in-class, subcutaneous, half-life extended anti-IGF-1R antibody with the same binding domain as veligrotug.
Veligrotug has demonstrated strong clinical performance in two global phase 3 clinical trials, THRIVE and THRIVE-2, which reported positive topline data and met all primary and secondary endpoints in evaluating efficacy and safety in patients with active and chronic TED. Meanwhile, VRDN-003 is currently being evaluated in two ongoing global phase 3 pivotal clinical trials, REVEAL-1 and REVEAL-2, as a subcutaneous therapy for TED treatment.
Strategic Partnership Rationale
Mutsuo Kanzawa, Chairman and CEO of Kissei, expressed enthusiasm for the collaboration, stating: "As we seek to further expand our pipeline in rare and intractable diseases, we are very excited by the potential of veligrotug and VRDN-003 to address the significant unmet needs of TED patients in Japan, based on veligrotug's strong and consistent phase 3 clinical data in THRIVE and THRIVE-2."
The partnership combines Viridian's antibody discovery and protein engineering expertise with Kissei's established presence in rare disease development and commercialization in Japan. Kissei focuses on rare/intractable diseases, urology, and nephrology/dialysis, making it well-positioned to advance these TED therapies in the Japanese market.
Company Portfolios and Future Prospects
Beyond its TED portfolio, Viridian is also advancing a novel portfolio of neonatal Fc receptor (FcRn) inhibitors, including VRDN-006 and VRDN-008, which have potential applications in multiple autoimmune diseases. The Waltham, Massachusetts-based company specializes in discovering, developing, and commercializing potential best-in-class medicines for serious and rare diseases.
Kissei Pharmaceutical, based in Japan, operates under the management philosophy of "contributing to society through high-quality, innovative pharmaceutical products" and maintains a strong R&D focus on bringing innovative pharmaceuticals to patients worldwide through drug discovery and licensing activities.
The collaboration represents a significant validation of Viridian's TED program and provides substantial financial resources to support continued development while establishing a pathway for Japanese patients to access these potentially transformative therapies.
