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CanSino vaccine first to gain approval as Gilead reveals remdesivir price

U.S. insurers will pay $3,120 per course for antiviral, CanSino COVID-19 vaccine approved for military personnel

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CanSino received “military specially-needed drug approval” in China for its vaccine, making it the first vaccine to be authorized for use albeit in a limited population.

The announcement came as Gilead Sciences Inc. (NASDAQ:GILD) announced a price of $3,120 per treatment course of remdesivir for private insurers in the U.S., with the price for certain federal agencies and developed countries about $800 less.

CanSino Biologics Inc. (HKEX:6185) said that on June 25, its Ad5-nCoV vaccine received Military Specially-needed Drug Approval in China, which is valid for one year and limited to military use only.

While CanSino did not disclose specific data from the vaccine’s Phase II trial, it said the adenoviral vector vaccine showed a good safety profile and high levels of humoral and cellular immune response.

In a May 22 Lancet publication, CanSino reported data from its Phase I trial evaluating single immunizations with three doses of Ad5-nCoV in 108 individuals. The mean neutralization titer in the high dose group was 34 -- well below FDA’s recommended titer of 160 for convalescent plasma (see “Vaccine Yields Neutralizing Antibodies”).

Pricing remdesivir

Gilead Chairman and CEO Daniel O’Day said in an open letter on Monday that for governments of developed countries, the price of remdesivir will be $390 per vial, for a five-day, six-vial treatment course cost of $2,340. In the U.S., private insurance companies will pay $520 per vial.

Gilead spokesperson Sonia Choi told BioCentury that four federal agencies -- Veterans’ Affairs, Indian Health Services, Department of Defense and the Coast Guard -- are eligible for the $2,340 price. Other government direct purchasers, such as the Federal Bureau of Prisons, will be eligible for the price once the drug is on the Federal Supply Schedule. Medicare and Medicaid are not direct drug purchasers.

The company has deals with generics manufacturers to supply the antiviral at a much lower price in developing countries.

“At the level we have priced remdesivir and with government programs in place, along with additional Gilead assistance as needed, we believe all patients will have access,” O’Day wrote.

He also disclosed that Gilead has partnered with HHS to manage allocations to U.S. hospitals until the end of September. The agency has secured more than 500,000 treatment courses, representing 100% of Gilead’s projected July production, and 90% of the pharma’s August and September production.

BioCentury discussed the therapy’s price on the latest BioCentury This Week podcast, arguing that Gilead has done the biopharma industry a favor by giving remdesivir a Goldilocks price.

The Institute for Clinical and Economic Review would appear to disagree.

Last week, ICER published an updated pricing model for remdesivir that estimated the therapy could be cost effective if priced at $4,580-$5,080. However, the price benchmarks were calculated assuming remdesivir has a mortality benefit, which the antiviral has yet to demonstrate in a placebo-controlled trial.

In NIH’s ACTT trial, remdesivir did not lead to a statistically significant survival improvement; the antiviral arm had a mortality rate of 7.1%, vs 11.9% for placebo.

In his letter, O’Day does not claim a survival benefit from remdesivir, but points to the ACTT trial’s finding that the therapy shortened time to recovery by an average of four days. Earlier discharge would result in hospital savings of about $12,000 per patient, he said.

When ICER considered the cost-effectiveness of remdesivir based solely on its benefit of shortening time to improvement, but without a mortality benefit, it estimated a benchmark price of $310 per treatment course.

Remdesivir is the only therapy authorized in the U.S. for COVID-19, with EMA approval expected soon. More than 640 therapies and vaccines are in development for the novel coronavirus, according to BioCentury’s COVID-19 Resource Center (see “Data Bytes”).

Over 200 trials have completion dates before Sept. 1, according to ClinicalTrials.gov and the Chinese trial database (see “Clinical Scorecard for COVID-19”).

Separately Monday, Altimmune Inc. (NASDAQ:ALT) said it is receiving $4.7 million from the U.S. Army Medical Research & Development Command to cover the entire cost of a Phase I/II trial of its COVID-19 therapeutic, T-COVID. The study is expected to start in the coming weeks, with data expected in 4Q20.

The company expects the therapy to be used in an outpatient setting to protect patients from progressing to severe disease and hospitalization.

The single-dose intranasal immune modulator was developed with the biotech’s replication-deficient adenovirus 5 vector technology.

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