Viridian Therapeutics Secures $385 Million Deal with Kissei for Thyroid Eye Disease Therapies in Japan
核心洞察
Viridian Therapeutics has entered into an exclusive licensing agreement with Kissei Pharmaceutical (搜索) for veligrotug and VRDN-003 in Japan, receiving $70 million upfront with potential milestone payments up to $315 million.
Both drug candidates are anti-IGF-1R (搜索) antibodies targeting thyroid eye disease (搜索), with veligrotug having demonstrated positive results in phase 3 THRIVE trials and VRDN-003 being a subcutaneous, half-life extended formulation.
The collaboration leverages Kissei's expertise in rare disease development and commercialization in Japan to address significant unmet medical needs for TED (搜索) patients.
Viridian Therapeutics has announced a major licensing agreement with Kissei Pharmaceutical (搜索) Co., Ltd. that could generate up to $385 million for the development and commercialization of two thyroid eye disease (搜索) (TED (搜索)) 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 (搜索) (IGF-1R (搜索)) 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 (搜索) 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 (搜索) pathway in treating TED (搜索), 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 (搜索). 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 (搜索) 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 (搜索) therapies in the Japanese market.
Company Portfolios and Future Prospects
Beyond its TED (搜索) portfolio, Viridian is also advancing a novel portfolio of neonatal Fc receptor (搜索) (FcRn (搜索)) 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 (搜索), 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 (搜索) program and provides substantial financial resources to support continued development while establishing a pathway for Japanese patients to access these potentially transformative therapies.