Shield Therapeutics Looking At US Options For Feraccru
Executive Summary
The UK biotech has revised its business strategy over the past year, and Shield's CEO believes the company's lead product for iron deficiency is now well positioned to compete with current and potential entrants in the therapeutic sector.
Shield Therapeutics plc has emerged from a rollercoaster ride in 2018 and is now in "good shape", with a cash runway that extends into 2020 and a US PDUFA date for its lead product, Feraccru (ferric maltol) in mid-2019. The company is now evaluating US commercialization options for Feraccru, it announced on Jan. 24.
Shield highlighted several positives over the past 12 months in a year-end business and unaudited trading update, which included a positive re-analysis in March 2018 which reversed an initial negative analysis of top-line data from a US Phase III study of Feraccru; the signing of a European commercialization partner, Norgine, for Feraccru which is already achieving sales growth; and the acceptance of a US marketing application for the product by the US FDA.
That said, the initially negative data analysis in Feb. 2018, and the associated sharp decline in Shield's share price, set the stage for subsequent business changes at Shield. "It's all about capital," Shield CEO Carl Sterritt commented to Scrip in an interview.
Leading the changes was the cutting back of its sales and commercialization team to preserve cash resources, after the initial negative analysis of top-line data from the US AEGIS-CKD study in patients with iron-deficiency anemia in chronic kidney disease (CKD) (see sidebar).
And at the end of March, Feraccru's label in the EU was extended to include the treatment of all adults with iron deficiency, with or without anemia. Previously, Feraccru was only approved and marketed in Europe for the treatment of iron-deficiency anemia in adult patients with inflammatory bowel disease. "This massively increased the commercial opportunity for Feraccru in Europe, from a few 100,000 patients to tens of millions," noted Sterritt.
However, the label change, and the positive re-analysis of data from the US Phase III study, made little difference to Shield's depressed share price and inhibited the company from raising capital to build a team to increase promotion and the company's share of voice in the market. In September 2018, Norgine signed on as the European licensee for Feraccru, and has been a "top class partner," Sterrit said.
Norgine started promoting Feraccru in the UK and Germany in December 2018, and has already put 80 sales rep in the field, four times more than Shield deployed, and further launches are expected in other EU markets in 2020. Feraccru has also gained attractive levels of reimbursement in Sweden and Finland, enabling further commercial roll out by licensee AOP Orphan in those markets, Shield added.
In the US, the FDA has accepted the marketing submission for Feraccru for the treatment of iron deficiency, with a PDUFA date of July 27, 2019. However, with the prolonged shutdown of federal government operations in the US, there may be some risk of delay to this review, Shield noted. The company is assessing its options for commercializing Feraccru in the US, which includes identifying a licensing partner, and in other countries around the world.
Sterritt acknowledged that a new class of oral anemia agent, the hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHI) are nearing the market, but believes their introduction represents an opportunity for Shield. (Also see "AZ/FibroGen's Roxadustat Superior To Epoetin-Alfa In Chronic Renal Disease With Anemia" - Scrip, 20 Dec, 2018.)
In CKD patients, patients treated with HIF-PHIs will likely still require supplemental iron and may prefer oral rather than intravenous options. So this new class of agent is likely to be a "market amplifier," he noted.