Shield Therapeutics takes bold approach in the US

Shield Therapeutics PLC is a commercial-stage specialty pharmaceutical company delivering innovative speciality pharmaceuticals to address significant unmet needs in the treatment of iron deficiency and hyperphosphatemia.

The company’s lead product Feraccru^(R)/Accrufer^(R) is a novel, stable, non-salt based oral therapy and is approved in the United States, European Union, UK and Switzerland for the treatment of iron deficiency with or without anaemia in adults.

In Europe the product is marketed as Feraccru^(R) with commercialisation led by Norgine BV. In the USA the product is marketed as Accrufer^(R).

Shield also has an exclusive licence agreement with ASK Pharm who will lead development and commercialisation in China, Hong Kong, Macau and Taiwan.

Proactive Research has published a new note on Shield Therapeutics PLC (AIM:STX, OTCQX:SHIEF) ahead of the launch of iron deficiency drug Accrufer in the US.

In Europe, the drug is branded as Ferracru and marketed by partner Norgine.

Accrufer is an effective oral product to treat iron deficiency (anaemia), says Proactive analyst John Savin.

In addition, Accrufer is positioned against ineffective, if cheap, generic oral iron products that have significant gastrointestinal side effects.

Shield Therapeutics PLC (LSE:STX, FRA:1JS) said Jose A. Menoyo, M.D., is joining its senior executive team as vice president and chief medical officer with immediate effect, in a move that is expected to help the launch of its iron deficiency treatment Accrufer in the US.

Dr. Menoyo most recently served as head of US Medical Affairs at rare disease specialist Alexion Pharmaceuticals, Inc., which was acquired by AstraZeneca PLC (LSE:AZN) in July this year. In this role, Menoyo led the Medical Affairs and Health Outcomes and Research teams that supported several launches in the rare disease area.

Shield Therapeutics PLC (LSE:STX, FRA:1JS) (LSE:STX) said in its half-year results that the focus in the second half will be on the roll-out of its iron deficiency product Accrufer in the US.

The product was launched in the US on 1 July, so the only impact it had on the company’s results for the first six months of the year was as an expense as the company prepared for the launch.

Shield Therapeutics PLC (LSE:STX, FRA:1JS) (LSE:STX) new CEO Greg Madison talks to Proactive London about his strategy for the company and focus on driving the iron deficiency product Accrufer in the US.

The product was launched in the US on 1 July, so the only impact it had on the company’s results for the first six months of the year was as an expense as the company prepared for the launch.

During the second quarter of 2021, the company built up a sales force and started to contact key prescribers. Due to the ongoing impact of the COVID pandemic and the emergence of the delta variant in the US, face-to-face contact with clinicians has been limited in the initial phase of launch but discussions are taking place with payers regarding formulary placement of Accrufer and will continue over the next several months.

Shield Therapeutics is a UK-based company actively and directly marketing its approved product, Accrufer, in the US. In Europe, it is branded as Ferracru and marketed by partner Norgine. Accrufer is an effective oral product to treat iron deficiency (anaemia). Accrufer is positioned against ineffective, if cheap, generic oral iron products that have significant gastrointestinal side effects. This makes Shield one of the few UK companies to both achieve full FDA approval and to gain the maximum US-market profit from its R&D investments. This note looks at the current position of Accrufer ahead of potential trading updates and FY21 results over the next few months.