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Gilead says it is “aware of positive data” about remdesivir treatment for COVID-19 (caused by SARS-COV-2) but no details given; stock rises

2020-04-29

photo of book by Peter H courtesy of pixabay.com

Gilead pharmaceutical company announced this morning that it had received “positive results” from a trial of 800 patients with a placebo control in the treatment of COVID-19.  No further details were given at this time.  This was reported by multiple news sources including Bloomberg, CNBC, Fox Business, MarketWatch, the Boston Globe, and the New York Times.  The PharmaLetter, however, reported that an Indian group had urged the Indian Government to revoke Gilead’s patent on remdesivir:

On April 9, the Cancer Patients Aid Association (CPAA) wrote to the Health Ministry and the Pharma Ministry urging them to revoke the Indian patent granted to remdesivir. The CPAA wants the drug available to those in need at affordable prices. Remdesivir was granted a patent as recently as February 2020.

In a letter to the Prime Minister’s Office and the Commerce Minister, CPAA Founder YK Sapru said the patent needs to be revoked given the lack of novelty and inventiveness – the main criteria necessary for patent protection to be granted to a novel compound.

Remdesivir is an analogue of the nucleotide adenine, a basic building block of the virus’ genetic structure: its RNA (ribonucleic acid).  The virus depends on its genes to reproduce, and the genes consist of a long string (about 30,000 units) of ribonucleic acid building blocks.  There are four RNA bases: adenine, uracil, guanine, and cytosine.  These four bases are used in a code.  Each base is a part of a triplet, which codes for an individual amino acid.  Amino acids are linked up according to the code into proteins.

This coding system is ancient, going back well over a billion years to the beginning of life on Earth.  Some scientists think that ribonucleic acid chains functioned in primitive life forms as proteins do today, that is, as enzymes and structural parts of primitive cells.  This is controversial, but there is some good evidence that RNA formed the basis for a pre-protein life form billions of years old.  RNA and its descendant, DNA, are now used to store the information needed to produce proteins, which are essential elements of all living things on Earth.

Apparently, remdesivir, as an analogue of adenine, is incorporated by the growing RNA chain and causes a defect in structure or premature termination of the chain.  This stops the virus from creating new copies of itself and prevents the infection from spreading.  Whether remdesivir is patentable or not (and this is probably not a serious challenge to the patent), it is potentially quite useful in treating COVID-19.  Clearly, it needs to be administered as early as possible in the course of infection.  If given too late, it may not prevent the over-reaction of the immune system called a cytokine storm which appears to be the final killer late in the course of the most serious infections.

Gilead may or may not have a really good drug on its hands, but it seems to have mastered the art of publicity.  The company has pushed back against a Chinese study which appeared to show poor effectiveness, in part by challenging how the study was done and whether the drug was given early enough.  If the current study can withstand critical scrutiny, we will see dramatic rises in stock value.  Our question, going forward, is “How much will Gilead charge us (the US federal government and insurers) for administering remdesivir to patients who need it?”

If recent history is any guide, a lot of money will change hands.  Gilead’s previous money-maker was a drug for Hepatitis C which costs thousands of dollars per tablet.  Since hepatitis C is a major cause of disability, much of the cost is borne by Medicaid and Medicare, which are bankrolled by the US federal government.  Now that Congress is throwing trillions of dollars at relief for the pandemic, it has good reason to regret that it did not establish a drug-cost negotiation clause to its Medicare part D (prescription drug benefit) plans.

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