Shield Therapeutics (STX ) has entered into an exclusive licence agreement for its iron-deficiency product Accrufer® with the Canadian group KYE Pharmaceuticals.
To date, Accrufer®/Feraccru®, has been approved for use in the United States, European Union, UK, Switzerland, and Australia and has exclusive IP rights until the mid-2030s.
As part of the agreement, the Company outlined that KYE will both undertake and be responsible for all costs, both clinical and regulatory, related to activities required to achieve marketing authorisation and commercialisation of Accrufer® in the Canadian market.
Under the terms of the deal, the London-listed pharmaceutical company, which will be responsible for all manufacturing costs of goods sold in Canada, will receive an upfront payment of £0.15m and is eligible to receive £0.85m in development and sales milestones.
This will comprise £0.25m upon regulatory approval of Accrufer® by Health Canada and up to £0.6m in milestone payments upon the achievement of specified calendar net sales targets.
Meanwhile, Shield said it will also receive double-digit royalties on net sales of Accrufer®.
Greg Madison, Chief Executive Officer for Shield, said: “This Agreement for the development and commercialisation of Accrufer® in Canada gets 2022 off to a great start for Shield.
We are dedicated to growing sales of Accrufer®/Feraccru® and bringing this important product to patients around the world with iron deficiency. Securing a commercial partnership for Canada is an important part of our strategy and we feel that KYE is the right partner. We look forward to supporting KYE’s efforts to bring Accrufer® to the market in Canada.”
Madison hailed Shield’s “significant progress” on its commercial launch of Accrufer® which it achieved over the last 12 months by establishing “important geographic partnerships” and successfully securing payer coverage “with several large pharmacy benefit managers.”
Commenting on the deal, Doug Reynolds, President of KYE Pharmaceuticals, added: “Iron deficiency is highly prevalent worldwide and a public health concern in Canada. Accrufer® will be the first oral prescription only therapy available in Canada to treat patients who continue to suffer from low iron despite attempts at treatment with currently available agents.
He added. “This agreement is very much aligned with our strategy to bring innovative medicines to the people of Canada and KYE is proud to be partnering with Shield.”
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.
Last month, Shield said it had made substantial progress by securing payer coverage in the US ‘with several large pharmacy benefit managers’ (PBMs), including Express Scripts and Optum, providing the Company with access to approximately 40 million commercial patients.
Commenting at the time of the update, CEO, Madison said: “We have made significant progress over the past few months in the US, by securing reimbursement for Accrufer® among several large pharmacy benefit managers. Gaining coverage of Accrufer® among payers is a critical step for adoption, and we expect to further expand that coverage in 2022.
He said, “Our clinical message has been well received during the initial stages of our launch, and we continue to expand awareness of Accrufer® among health care professionals.”
Shield has told investors that its 2H21 outlook will be dominated by the launch of Accrufer® in the US with its focus being on building awareness among healthcare providers, initiating prescriptions for appropriate patients, and extending patient access through payer groups.
In Europe, Feraccru® sales are expected to continue to ‘grow steadily’ in Germany, the UK, Scandinavia and Belgium whilst progress is made on pricing and reimbursement elsewhere.
Meanwhile, in the Chinese market, the Group said ASK Pharm will start the Phase III study required for approval while Shield will start recruiting patients into the paediatric study.
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