By Maryam Cockar
Date: Friday 06 Jan 2017
LONDON (ShareCast) - (ShareCast News) - AIM-listed pharmaceutical Shield Therapeutics saw "encouraging" demand for its oral iron product in the England and Germany.
The company said is seeing "very encouraging signals of demand" after only six months since the commercial launch of Feraccru, which treats of iron deficiency anaemia, in England and less than three months since the launch in Germany.
Since raising funds at the initial public offering in February 2016, the company has launched Feraccru, and has taken steps to transition from a research and development focused business into a commercial pharmaceutical company. It has done this through "very attractive pricing" for Feraccru in England and Germany, as well as increasing numbers of regional and local formulary and pricing and reimbursement approvals in England, a key activity to enable demand.
The company has made its first commercial sales to AOP, its central and eastern European partner, for Feraccru and towards the end of 2016 it filed a new drug approval application with the Swiss authorities, which translate to commercialisation in Switzerland during 2018.
In June Feraccru was launched in England and review processes within hospital and CCGs were slower than the company had initially hoped through the summer months immediately after the product became available commercially. The company has since focused on key subscriber locations and formulary and pricing and reimbursement approvals have come through.
While in Germany the company achieved more attractive pricing compared to the UK and clinician demand for Feraccru became more visible to the group much more rapidly due to a national pricing and reimbursement system.
The company plans to pursue an out-licensing strategy with licensing partners in a number of relevant, although non-core, territories.
Two phase three studies we are currently for Feraccru in order to achieve a broader label in Europe and giving access to the US market with approval from the Food and Drug Administration.
The company said that booked revenue in 2016 will be in line with market expectations and costs will be below market forecasts, due to a lower level of activity during the period in one of the phase three studies.
Chief executive Carl Sterritt, said: "The extensive formulary access and pricing and reimbursement process in the UK is undoubtedly frustrating and time consuming, however with Feraccru now becoming increasingly available to prescribers, I am encouraged at the signals of demand we are seeing in England. With no such P&R requirements in Germany, while it is early days, I am further encouraged that the opportunity we know exists for Feraccru is beginning to materialise in this very large pharmaceutical market.
"With a newly launched product, Shield remains well positioned to capitalise on this interest and deliver growth, initially through Feraccru, and, in the near to medium term, through our other pipeline assets as well as the planned acquisition or in-licensing of other complimentary products."
Shares in Shield Therapeutics were down 4.62% to 165p at 0850 GMT.
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