Shield Therapeutics (STX ) said it has entered into an exclusive licence agreement with the pharmaceutical company Korea Pharma which will enable it to market Accrufer® in Korea.
Under the terms of the agreement, Korea Pharma will undertake and pay for all activities to achieve marketing authorisation and then commercialise Accrufer® - Shield’s iron-containing medication for the treatment of adults with low iron stores – in Korea.
Shield, a commercial stage pharmaceutical firm which is focused on treating iron deficiency, will receive an upfront payment of £0.5m from Korea Pharma while the Company is also eligible to receive a further £1.5m upon first commercial sale of Accrufer® in Korea.
Meanwhile, Shield will also receive up to £4.0 million in milestone payments upon the achievement of specified cumulative sales targets. In addition, for the duration of the intellectual property in Korea, Shield will receive royalties of 15% of net sales of Accrufer®.
Under the agreement, Korea Pharma will be responsible for all clinical and regulatory costs and activities as well as all manufacturing and distribution costs of goods sold in Korea.
Greg Madison, CEO of Shield, described Korea Pharma as “a successful pharmaceutical company with an excellent track record of product development and commercial success.”
Korea Pharma, a prescription pharmaceutical firm focusing on CNS (central nervous system) and GI (gastro-intestinal) products, previously signed an agreement with global firm Norgine BV to distribute the world's first one-litre PEG (polyethylene glycol) bowel preparation drug.
To date, PLENVU® has been approved in the UK and in the US, and can be used for IBD patients. As a result, Korea Pharma has based its expansion into the IBD area on PLENVU®.
Korea Pharma has already secured a sales route for Accrufer® by securing Inflammatory bowel disease (IBD) patients who experience iron deficiency anemia frequently and plans to expand its business not only in the IBD area but also in the CKD area with Accrufer®.
Speaking on the exclusive licence agreement this morning, Madison commented: “This is a first step in broadening our geographical reach outside the US, Europe, and China. Iron deficiency is a prevalent issue globally, and this agreement will make our novel oral iron, Accrufer®, available, pending approval, to more patients with iron deficiency in Korea.”
View from Vox
At the end of June 2021, Shield confirmed that it would launch Accrufer®, its iron-containing medication for the treatment of adults with low iron stores, in the US from 1 July 2021.
In 2020, the Group’s ‘most significant effort’ has been finding a route to the US market for Accrufer®. After discussions with potential partners, Shield decided to go with a self-launch, a move which it believes can generate greater value for shareholders than with a licence deal.
The Board anticipates that rising sales of Accrufer® in the US should result in the Company’s monthly cash flow turning positive between 15-18 months after the initial launch as well as hold the potential for net sales to reach $100 million in the third year after launch.
Shield previously stated that the US market opportunity for Accrufer® is ‘substantial and growing’ and in Shield's head-to-head study, Accrufer® was identified to be a credible alternative to IV therapy particularly for maintaining haemoglobin levels over the long term.
Potential sales estimates for Accrufer® in the US are forecasted to exceed $100 million from the third year following launch and to reach $300 million-$400 million by years five to six.
Despite shares having more than halved in recent months following the news that STX would not be signing a US marketing deal before the end of 2020, STX’s Directors believe its recent fundraising fulfils the necessary requirements for a Shield-led US launch of Accrufer®, a pathway they view as having the potential to generate significant returns for shareholders.
In addition, last month’s news that the company had acquired an additional listing on OTCQX market is expected to increase STX’s visibility to US investors ahead of Accrufer®’s launch.
Reasons to STX
Shield Therapeutics is focused on commercialising its lead product, Feraccru®/Accrufer®, a novel, non-salt based oral therapy for adults with iron deficiency with or without anaemia.
Proven and Approved
The Group’s Feraccru®/Accrufer® product has been approved for use in the United States, European Union, UK and Switzerland and has exclusive IP rights until the mid-2030s.
Feraccru® is commercialised across the UK and European Union by Norgine B.V. and the Company is currently in the process of evaluating commercialisation options for the US market, including the potential launch of Accrufer® in the US by Shield.
Shield also has an exclusive licence agreement with Beijing Aosaikang Pharmaceutical to develop and commercialise Feraccru®/Accrufer® in China, Hong Kong, Macau and Taiwan.
Follow News & Updates from Shield Therapeutics here: