Vicore and Nippon Shinyaku Enter into an Exclusive License Agreement to Develop and Commercialize C21 in Japan

2024-02-09 | Regulatory

  • C21 is a potentially transformative therapy for the treatment of idiopathic pulmonary fibrosis (IPF)
  • Vicore to receive USD 10 million upfront and is entitled to up to USD 275 million in milestones in addition to tiered royalty payments
  • Nippon Shinyaku has been granted exclusive rights to and will be responsible for development of C21 in Japan
  • Vicore retains rights to develop and commercialize C21 in all markets outside of Japan

Stockholm, February 9, 2024 – Vicore Pharma Holding AB (publ), unlocking the potential of a new class of drug candidates, angiotensin II type 2 receptor agonists (ATRAGs), today announced it has entered into an exclusive licensing agreement with Nippon Shinyaku Co. Ltd., a leading Japanese pharmaceutical company, to develop and commercialize Vicore’s drug candidate C21 in Japan.

Under the terms of the agreement, Vicore will receive an upfront payment of USD 10 million and is entitled to potential development and commercial milestone payments up to a total of USD 275 million. Vicore is eligible to receive tiered royalties extending into the low 20s based on annual net sales of C21 in Japan. Nippon Shinyaku holds the exclusive right to develop and commercialize C21 in Japan focusing initially on the treatment of idiopathic pulmonary fibrosis (IPF). Nippon Shinyaku will be operationally and financially responsible for development of C21 in Japan and will contribute Japanese patients and sites to the global late-stage development of C21 at its expense. Vicore retains all rights to C21 in the rest of the world.

C21 is an oral therapy being developed for treatment of IPF and has been granted orphan drug designation by the U.S. Food and Drug Administration and European Medicines Agency. Although IPF affects approximately 34 000 patients in Japan, treatment options are very limited. In the Phase 2a AIR study, C21 demonstrated transformative potential by safely and effectively stabilizing or improving lung function in previously untreated individuals with IPF. A global Phase 2b ASPIRE study is planned to initiate in the first half of this year.

“This partnership is an important milestone in the development of C21”, said Ahmed Mousa, CEO of Vicore. “Nippon Shinyaku is an ideal partner that brings expertise in rare disease together with a strong track record of successfully partnering with leading companies to bring innovative treatments to the Japanese market. We look forward to working with the Nippon Shinyaku team and leveraging their expertise to successfully develop and commercialize this product in Japan.”

“IPF is a disease with a high unmet medical need,” said Toru Nakai, President & Representative Director of Nippon Shinyaku. “I am delighted to enter into an agreement with Vicore to develop this extremely promising therapy for the Japanese market. C21 will be an important addition to the Nippon Shinyaku portfolio of therapies for rare diseases.”

Renexes LLC served as an advisor to Vicore in connection with the transaction.

For further information, please contact:
Ahmed Mousa, CEO, tel: +1 607 437-0235, ahmed.mousa@vicorepharma.com  
Hans Jeppsson, CFO, tel: +46 70 553 14 65, hans.jeppsson@vicorepharma.com

About Nippon Shinyaku
Based on Nippon Shinyaku’s business philosophy, “Helping people lead healthier, happier lives,” we aim to be an organization trusted by the community through creating unique medicines that will bring hope to patients and families suffering from illness. Please visit our website (https://www.nippon-shinyaku.co.jp/english/) for products or detailed information.

About Vicore Pharma Holding AB (publ)
Vicore is an innovative clinical-stage pharmaceutical company unlocking the potential of a new class of drugs with disease-modifying potential. The company is establishing a portfolio in respiratory diseases, including idiopathic pulmonary fibrosis (IPF). C21 is a first-in-class orally available small molecule angiotensin II type 2 receptor agonist (ATRAG) currently in phase 2a development for IPF. Almee™ (an investigational medical device in clinical development) is a digital therapeutic based on cognitive behavioral therapy created to address the psychological impact of living with pulmonary fibrosis. Using its unique expertise in ATRAG chemistry and biology, Vicore is further fueling its pipeline with several new therapies across additional potential indications. The company’s shares (VICO) are listed on Nasdaq Stockholm’s main market. For more information, see www.vicorepharma.com.