Gilead (GILD) is now working in consultation with regulatory authorities to establish additional expanded access programs for remdesivir, the company’s investigational medicine for Covid-19, says the company CEO Daniel O’Day.
According to O’Day, the programs enable hospitals or physicians to apply for emergency use of remdesivir for multiple severely ill patients at a time. In particular, new US sites have been initiated while the European Medicines Agency announced that it has provided EU member states with recommendations on implementing expanded access programs for remdesivir in their countries.
In addition to the expanded access programs, Gilead continues to provide remdesivir on an individual compassionate use basis for children and pregnant women. More than 1,700 patients have now been treated through these programs.
However as the CEO points out, remdesivir is still an investigational medicine and has not been approved by regulatory authorities anywhere in the world. “The safety and efficacy are not yet known so… multiple clinical trials for remdesivir are underway, involving thousands of patients with COVID-19 across the world” he said.
Nonetheless, the company has decided to quickly ramp up production, explaining “As soon as we knew that remdesivir may have potential in treating the novel coronavirus, our teams began to establish a supply chain for large-scale production. Then, as now, there were many unknowns… [but] we made the decision to invest and scale up regardless.”
As a result, GILD has now managed to reduce the end-to-end manufacturing timeline from approximately one year, to around six months. Its current existing supply amounts to 1.5 million individual doses- which equates to about 140,000 treatment courses. “Gilead is providing the entirety of this existing supply at no cost, to treat patients with the most severe symptoms of COVID-19” says the CEO.
Looking forward, the company has now set an ambitious goal of producing more than 500,000 treatment courses by October and more than 1 million treatment courses by the end of this year.
From an investing perspective, analysts are cautiously optimistic about Gilead’s potential. TipRanks reveals that the stock has a Moderate Buy analyst consensus with a $77 average analyst price target (2% downside potential). Shares in Gilead have soared 20% year-to-date, leaving some analysts concerned that much of the remdesivir opportunity has now been priced in. (See GILD’s stock analysis on TipRanks)
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