Shield Therapeutics doing its homework ahead of launch next month of Accrufer in the US

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Shield Therapeutics PLC (LON:STX) said it remains on track to launch Accrufer, its iron deficiency treatment, in the US by the end of next month.

The commercial-stage pharmaceutical company said that since it tapped the market in March, preparatory work on the launch has accelerated dramatically.

In an update on its US preparations, the company said it has established a US subsidiary and set up the necessary operating essentials for the launch. Work is in progress on the product supply chain and logistics and all being well, launch stocks should be in its US wholesaler’s warehouses by mid-June.

Agreements have been signed with providers for product warehousing and distribution, Shield said.

On the marketing side, market research has been carried out and a fully integrated marketing plan including both personal and non-personal promotion has been devised.

Shield is working alongside a well-established contract sales organisation and together they have built a scalable sales team that will be working to build awareness and educate health care providers on the clinical value of Accrufer.

Shield is planning to launch initially with 30 sales representatives. The recruitment should be completed by early June and the representatives will then be trained and ready to promote Accrufer at the time of the launch.

Information about Accrufer will be made available to healthcare professionals online and through a team of medical science liaison (MSL) employees, Shield revealed.

The wholesale acquisition cost price for Accrufer in the US has been set at US$500 per pack; each pack contains 30 days’ supply at two capsules per day.

National account managers are already actively engaging payer organisations to provide their patients with access to Accrufer. This process is underway but it will take 12-18 months before Shield has comprehensive coverage across a large proportion of payers and its sales forecasts in the early months take account of this.

“A huge amount has been achieved in the last two months since the fundraise completed and I am very grateful to all Shield employees, and in particular to Brian Groch and his US team, for the efforts they are making to prepare for launch. This is a very exciting time for Shield and I am looking forward immensely to the Accrufer launch and the large opportunity available,” said Tim Watts, the chief executive of Shield.

Broker Peel Hunt said the most important part of this morning’s release from Shield was confirmation that the launch will take place in the first half of this year.

” At the recent fundraising to support US self-commercialisation, Shield had indicated an assumed net US net price per pack (ie after discounts and rebates) of $250 as a basis for its illustrative sales scenarios at the time. Today’s release states that the headline price before rebates and discounts (the “WAC”) has been set at $500 per pack, implying a rebate/discount of c.50%, which is consistent with our experience of these types of products in the US,” Peel Hunt said. 

“The release also summarises steps taken to date to build out the promotion effort, which include hiring 30 sales reps – this is ongoing and due to complete by early June to facilitate training. Payer organisations are currently being engaged to establish reimbursement and coverage for Accrufer; Shield states this process is likely to take 12-18 months and that its sales forecasts for the early months of launch reflect this – we believe this is important for investors to note when calibrating their own expectations for the early period of the US Accrufer launch. In all, we see this release as a reassuring confirmation that the US launch plans remain on track. Whilst supportive, we would not expect a significant reaction to this update,” the broker said, as it reiterated its “buy” rating.

Shares in Shield were up 2.9% at 59.5p in mid-morning trading.

— adds broker comment and share price —

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