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 8,00,000-mark and death toll climbs to 37,830.
The biotech firm 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.
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% 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.
Remdesivir has demonstrated in vitro (test tube) and in vivo (in body) activity in animal models against MERS and SARS, which are also coronaviruses that are structurally similar to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), as the coronavirus has been named.
The company said the limited preclinical data on MERS and SARS indicated that remdesivir may have potential potency against SARS-CoV-2.
Once commercially available, the medicine’s price, particularly for countries such as India, will remain a key question. In their letter, the NGOs claimed that Gilead Sciences held primary patents of remdesivir in more than 70 countries.
Remdesivir evolved from research in the mid-2010s to test compounds against new viruses. While early results from tests done on animals showed promise as a potential treatment against Ebola, but a large Phase III trial in the Democratic Republic of the Congo showed it wasn’t very effective in preventing deaths from the virus.
These experiments have now assumed prominence, as MERS and SARS viruses mirror genetic similarities to SARS-CoV-2.
Researchers expect the FDA to fast track the approval, with the US accounting for most confirmed cases globally at more than 160, 700. More than 3,000 people have died in the country, according to John Hopkins University that is tracking global coronavirus cases.