Gilead ramps up production of experimental Covid-19 treatment amid criticism over access

In response to intensifying demand, Gilead Sciences (GILD) has been ramping up production of its experimental remdesivir treatment that is being tested to combat the novel coronavirus.

The drug maker now has 1.5 million individual dosages that could be used for more than 140,000 patients and is supplying the medicine, which is being made available through clinical trials and special access programs, at no charge.

“Providing our existing supplies at no charge is the right thing to do, to facilitate access to patients as quickly as possible and in recognition of the public emergency posed by this pandemic,” Gilead chief executive officer Daniel O’Day wrote in an open letter released Saturday night. He added the 1.5 million doses will be donated for “broader distribution” following any potential future regulatory approvals.

In coming months, the company expects to increase supplies as raw materials become available and, as a result, has set an “ambitious goal” of producing more than 500,000 treatment courses by October and more than 1 million by the end of this year. Toward that end, Gilead said it is building a “geographically diverse” group of suppliers to expand global capacity for raw materials and production.

There is some evidence remdesivir, which previously failed to show benefit in Ebola virus patients, benefits Covid-19 patients, and the company has been working with researchers and several governments to get several clinical trials running. Results are expected this month.

Meanwhile, there has been growing demand from physicians and patient families who are clamoring for a treatment, but have been frustrated by insufficient supplies of the Gilead medicine. On Friday, for instance, a European Medicines Agency committee issued a statement encouraging Gilead to make remdesivir available “in a fair and transparent way” to European Union countries that wish to participate in clinical trials or treat patients as part of compassionate use programs.

The company, which has a history of stirring controversy over pricing for its medicines, has been on the defensive this past month over access to remdesivir. In the absence of a useful treatment for Covid-19, the medicine is generating enormous attention as researchers and government officials around the world struggle to find a therapy for the pandemic.

Last week, though, Gilead cut back a so-called compassionate use program that was providing remdesivir to Covid-19 patients who were not enrolled in clinical trials. After receiving thousands of requests, the company had provided the medicine to more than 1,500 patients, but was unable to keep up with demand, a Gilead spokesman explained.

Instead, the company switched gears and — except for pregnant women and children — began offering the medicine only through what it calls an expanded access program. The goal with this program is to make it possible for hospitals and physicians to apply for emergency use for “multiple severely ill patients at a time” as part of clinical trials and, importantly, collect patient data. So far, Gilead has treated about 1,700 patients.

The process for the shift, though, generated criticism as families who complained Covid-19 patients fell through the cracks and were suddenly ineligible to receive the medicine. For instance, Michael Goldsmith, 34, was already a patient in Hackensack University Medical Center in New Jersey, and placed on a respirator on March 20, but was denied expanded access, even though the hospital participates in a trial.

“They didn’t tell us why he was excluded from the trial, but bureaucratic snafus concerning eligibility prevented him from getting the medicine,” said Jack Stroh, his father-in-law, who organized a petition drive and contacted lawmakers to lobby Gilead. He added that, over the last few days, Goldsmith has shown slight improvement since being given a Roche (RHHBY) drug called Actemra.

A Gilead spokesman told us the company cannot comment on individual cases.

The drug maker has also been under pressure to ensure that remdesivir — assuming it proves effective and is approved by regulators to combat Covid-19 — is accessible should the drug win regulatory approval.

Last week, more than 150 advocacy groups issued an open letter urging the company not to enforce and claim exclusive rights on patents, as well as regulatory and trial data, or other types of exclusivity anywhere in the world. They also asked the company to make publicly available all data, sample products, and know-how needed for generic development, among other things.

The missive was issued after Gilead last month asked the Food and Drug Administration to rescind orphan drug designation for remdesivir following criticism that it unfairly pursued a lucrative monopoly.

The designation, which offers a drug maker seven years of marketing exclusivity, drew immediate condemnation from consumer advocates because orphan status is reserved for medicines targeting rare diseases that afflict 200,000 or fewer people. The law does allow drugs treating more common illnesses to be classified as orphan if the designation is granted before that threshold is met.

But earlier this year, the World Health Organization noted the number of cases was expected to grow exponentially in coming weeks. And consumer advocates have noted there were numerous indications earlier this year — at the time Gilead sought orphan designation — that the novel coronavirus was quickly becoming a pandemic and likely to claim countless victims.

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