North East pharmaceuticals firm Shield Therapeutics says a decision which doubles its lead drug’s shelf life will support its US expansion.
The Gateshead company’s main drug, which treats iron deficiency anaemia, was first launched in Europe under the Ferracru brand in 2019 but is now available in the US and other countries outside Europe as Accrufer. Now the firm has announced that US Food and Drug Administration (FDA) has approved the extension of the expiration for Accrufer from 36 months to 48 months.
The move will, it says, aid its growth in the US, where the product was launched last year, having taken four years to get through the approval process.
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Greg Madison, CEO of Shield Therapeutics, said: “Over the past year, we have doubled the shelf-life or time to expiry for Accrufer from 24 to 48 months. Not only does this confirm the stable and robust nature of the capsule formulation of Accrufer, but also provides additional supply chain flexibility and simplifies global logistics as we continue to support our growing US business and our license partners across the globe.”
In July Shield secured a $10m loan from a major shareholder after seeing a strong start to the new financial year and a “transformational” 2021.
The company issued its half yearly report to shareholders last month, in which it hailed the US launch of Accrufer, which marked its one-year anniversary in July, saying Shield had built a high-performance executive leadership team and launch-savvy commercial organisation.
In the six months ended June 30 2022 total US prescriptions increased by around 350% compared to the previous half year, and with 20 million people in the US with anaemia, it said it was even more confident about the potential for Accrufer to become the oral iron treatment of choice.”
Revenue in the first six months of 2022 amounted to £2m, up from £500,000, while losses widened from £7.3m to £11.8m. Selling, general and administrative expenses meanwhile rose from £6.1m to £11.9m.
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