North East pharmaceutical firm Shield Therapeutics is set to achieve a four-year mission to launch its lead product in the US within days.
The Gateshead firm’s main drug treats iron deficiency anaemia and is called Ferracru in the UK and Europe where it has been available since 2016, having gained approval to sell on the continent on the same day as the company's launch on the AIM market.
However, its attempts to launch in the US – as Accrufer– were hampered during the FDA approval process.
Now, however, the company has announced that Accrufer will be available in all parts of the US from July 1 - news which sent shares up 5.5% in early trading.
The firm said: “Launch stocks of Accrufer are currently being distributed through the wholesaler channels and will be available to doctors and other prescribers in all parts of the US by July 1, 2021.
“A sales force including 30 sales representatives has been recruited and trained and will be starting to contact key prescribers during next week.”
The Gateshead Design Centre-based firm was forced to make job cuts back in 2018 when setbacks halted its initial attempts to get into the US market.
It failed to reach initial FDA targets as part of a study into its efficacy - but further analysis of the results of the study, which involved 168 patients, later showed they had been skewed by a number of patient-specific events which adversely impacted the study.
Now the firm is on the cusp of huge growth after finally gaining US approval, while also helping millions of people with iron deficiency anaemia.
Having halted plans to team up with a commercial partner to launch Accrufer in America with its own team, the company has previously predicted it will increase from 30 to 60 reps by the end of this financial year and around 90 by 2023.
Industry experts also say Accrufer could rack up sales of as much as $300m five years after going on sale in the US, delivering significant returns for shareholders.
Greg Madison, CEO of Shield, added: “We are pleased to make Accrufer available to physicians and their patients in the US. Iron deficiency and iron deficiency anemia are significant challenges for millions of patients.
“Accrufer represents a novel form of oral iron which offers clinical effectiveness while being well tolerated in clinical trials, and has the potential to be a significant advance for those patients in the US.”
