JAPAN – Swedish biotech company Vicore Pharma has secured an exclusive licensing agreement with Nippon Shinyaku for the Japanese rights to itsidiopathic pulmonary fibrosis (IPF) therapy, C21. 

 Under the terms of the deal, Nippon will pay an initial US$10 million upfront, with potential milestone-based payments totaling up to US$275 million. 

The agreement grants Nippon exclusive rights to develop and commercialize C21 in Japan, with Vicore positioned to receive tiered royalties based on annual net sales of the therapy. 

 Nippon will assume responsibility for all operational and financial costs associated with developing C21 in Japan, including contributions to Japanese trial sites and patient enrollment in the global late-stage development of the therapy. 

News of the partnership has sparked significant investor interest, driving Vicore’s stock up by over 18% in trading following the announcement.  

With a market cap currently standing at Skr1.7 billion (US$162 million), Vicore’s innovative IPF therapy continues to garner attention and support in the market. 

C21 functions as an angiotensin II type 2 receptor agonist (ATRAG), activating the protective arm of the renin-angiotensin system (RAS).  

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This therapy has received orphan drug designation from both the US Food and Drug Administration and the European Medicines Agency for the treatment of IPF, highlighting its potential to address critical unmet medical needs in the field. 

Trial records success amid Russia-Ukraine war 

The Phase IIa AIR trial (NCT04533022) evaluating C21 has shown promising results, with participants demonstrating stabilized lung capacity and increased forced expiratory volume after 36 weeks of treatment. 

 Despite disruptions caused by external factors such as the Russia-Ukraine war, the trial successfully enrolled 60 participants, paving the way for further development. 

Now, Vicore plans to initiate a global Phase IIb ASPIRE trial in the first half of 2024, aiming to build upon the positive outcomes observed in previous studies. 

 Moreover, C21’s therapeutic potential extends beyond IPF, with ongoing research exploring its efficacy in addressing conditions such as Covid-19 recovery and endothelial dysfunction in type 2 diabetics. 

The Phase II ATTRACT trial (NCT04880642) investigating C21 in hospitalized Covid-19 patients has yielded encouraging results, indicating a 40% reduction in the risk of requiring oxygen therapy at the end of treatment. 

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