Pressure is mounting on American pharma major Gilead Sciences Inc not to go ahead with the exclusive status for a potential coronavirus drug as global infections inch close to the 800,000-mark and death toll climbs to 37, 830.
The biotech firm, as Moneycontrol wrote on March 24, is conducting Phase III clinical trials for remdesivir, an investigational antiviral drug it developed but never used for treating Ebola.
Responding to criticism that the “orphan drug” status will put remdesivir out of reach of most patients, Gilead chairman and CEO Daniel O’Day said in an open letter, “If it is approved, we will work to ensure affordability and access so that remdesivir is available to patients with the greatest need.”
More than 150 organisations and individuals, including Doctors Without Borders, on March 30 said it was "unacceptable for Gilead's remdesivir to be put under the company's exclusive control", news agency AFP reported.
"We are seriously concerned with Gilead's current approach to remdesivir, which may obscure access to this potentially critical treatment for COVID-19," it quoted their letter as saying, referring to respiratory illness caused by the coronavirus.
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The letter comes four days after London-based Financial Times reported that Gilead had asked US regulators to rescind “orphan drug” status for remdesivir.
The drugmaker said it was waiving all benefits of the status, which include significant tax incentives and control over prices for at least seven years in a de facto monopoly, the FT wrote.
Remdesivir on March 23 received the “orphan drug” designation from the Food and Drug Administration. The status is granted to a drug that shows promise in the treatment, prevention or diagnosis of a rare disease. These drugs are called orphan because they are commercially underdeveloped and production needs government support.
Gilead has already initiated Phase III clinical trials that involve randomised testing in hundreds of patients for a drug’s effectiveness. According to estimates, 70-90 percent of the drugs that go into Phase III successfully complete this make-or-break stage.
The results and data readouts of remdesivir’s Phase III trials are expected in April."Establishing the safety and efficacy of remdesivir, in partnership with regulatory authorities, is essential to potentially enabling the treatment of many more patients in the future. Multiple studies are ongoing, and we are on track to have initial data in the coming weeks," O’Day said.