Who owns remdesivir, how much can they make, and how much does it cost?

[struggle4progress]

JONATHAN M. GITLIN - 4/29/2020, 4:50 PM

... remdesivir is owned by Gilead Sciences, a US biotechnology company. Gilead got its first patent for the drug in 2017 when the company was originally targeting it as a possible treatment for the Ebola virus. That didn't pan out, but as our earlier article explains, biochemical similarities in how the Ebola and SARS-CoV-2 viruses function led Gilead to see if remdesivir could be repurposed for treating COVID-19. Gilead's patents mean that it has a monopoly on the drug in the United States, so barring government intervention or Gilead licensing the patent to others, it's the only company that can manufacture it until 2037, at which point a generic version could be possible.

... Gilead announced in April that it had ramped up production of remdesivir at its factory in La Verne, California, in January, and by the beginning of April, it had already stockpiled enough to treat 140,000 patients, each over the course of 10 days. The company also said that it plans to produce enough remdesivir to treat 500,000 patients by October and a million patients by the end of 2020. (This explains why there was some outcry in March when it was revealed that Gilead had applied for something called "orphan drug status" for remdesivir, which is supposed to be reserved for rare diseases. Gilead withdrew that application.)

... As of today, we don't know how much Gilead intends to charge for remdesivir in the US or elsewhere. In CEO Daniel O'Day's April letter that revealed the existing stockpile, he wrote that the company "is providing the entirety of this existing supply at no cost, to treat patients with the most severe symptoms of COVID-19. The 1.5 million individual doses are available for compassionate use, expanded access, and clinical trials and will be donated for broader distribution following any potential future regulatory authorizations."

A recent study published in the Journal of Virus Eradication attempts to analyze the cost of manufacturing remdesivir. The authors looked at the chemical synthesis of the drug and concluded that a 10-day course for one person would cost $9, allowing for 20 percent losses during formulation, plus the cost of the vials, a profit margin, and tax. However, whether it costs Gilead that to actually produce the drug is unknown, and one needn't be a scholar of the US healthcare system to be skeptical that a novel treatment would end up being quite so cheap ...

https://arstechnica.com/science/2020/04/who-owns-remdesivir-how-much-can-they-make-and-how-much-does-it-cost/

[struggle4progress]

1. Potential Coronavirus Drugs May Cost as Little as $1, Study Says

By Jason Gale
April 10, 2020, 6:38 AM EDT

... “This pricing study shows clearly that potential medicines to treat COVID-19 are not at all expensive to produce and could be priced such that anyone who needs treatment should be able to access it,” said Jessica Burry, a pharmacist with medical aid group Medecins Sans Frontieres’ Access Campaign, in a statement.

https://www.bloomberg.com/news/articles/2020-04-10/potential-coronavirus-drugs-may-cost-as-little-as-1-study-says

[struggle4progress]

2. Remdesivir helps coronavirus patients -- but at what cost?

05/06/2020 01:44 PM EDT
Updated: 05/06/2020 01:51 PM EDT

Gilead has rocketed into the public consciousness with one of the most promising coronavirus treatments, but the company’s history of sky high drug pricing is drawing increasing scrutiny from Congress about how much it will charge for remdesivir and who will get access.

But Gilead, which suffered through a spate of bad publicity in 2015 for charging $84,000 for a hepatitis C drug, isn’t just under fire over the potential price of its coronavirus treatment. It’s under pressure from Wall Street investors to recoup the $1 billion investment in remdesivir, which has been proven to accelerate recovery from the coronavirus. How Gilead navigates financial pressures from investors and political pressures from Washington may very well determine the mass production and availability of one of the most promising coronavirus drugs on the market.

“An unaffordable drug is completely ineffective,” Democratic Reps. Lloyd Doggett (Texas) and Rosa DeLauro (Conn.) wrote to Health and Human Services Secretary Alex Azar last week, raising questions about remdesivir.

It’s not clear exactly how much the drug will cost. For context, one non-profit that evaluates drug costs says it costs about $9.32 to manufacture a 10-day course of remdesivir treatment for one patient. Calculating the cost of development and trials, the Institute for Clinical and Economic Review says Gilead could charge as little as $390 for the drug. But Wall Street analysts are on an entirely different page, suggesting a price between $5,000 to $10,000, leading to billions in profits ...

https://www.politico.com/news/2020/05/06/remdesivir-helps-coronavirus-patients-but-at-what-cost-240230

[dawg]

3. I have no medical training, but I *am* a biotech investor (i.e. "fool") ...

and I think Remdesivir is likely to prove helpful to many patients, but it is unlikely to be the game-changer we are all hoping for. Still, better than nothing. (And potentially a life-saver for some.)

[secondwind]

4. believe KUSHNER has ties to Gilead........... follow the money!

[struggle4progress]

5. Scaling up remdesivir amid the coronavirus crisis

by Lisa M. Jarvis
APRIL 20, 2020

... with cases worldwide at nearly 2.5 million, scrutiny of data coming out of clinical trials of the drug has reached fever pitch. When the health-focused news site Stat posted a story based on leaked video of a University of Chicago clinician talking optimistically about remdesivir’s possible effectiveness, it didn’t just prop up Gilead’s stock price; it lifted the entire stock market.

With each new anecdote, whether about an individual patient or a hunch from a doctor running a trial, the pressure on Gilead mounts. If any of the five late-stage clinical studies underway show that remdesivir works, Gilead will need to make a lot of it, and fast.

... One variable is the complexity of the molecule. The antimalarial hydrochloroquine, also being tested in COVID-19, is at the easy end of the spectrum. Making it in large quantities, if the need arises, will require little more than high-quality manufacturing capacity. Remdesivir, with its six chiral centers, is “a medium complexity project,” says Ian Davies, director of internal and external scientific relationships for the Princeton Catalysis Initiative ...

https://cen.acs.org/biological-chemistry/infectious-disease/Scaling-remdesivir-amid-coronavirus-crisis/98/web/2020/04

[struggle4progress]

6. Worth up to $4500 per patient

Andrew Dunn May 3, 2020, 12:39 PM

... The Institute for Clinical and Economic Review (ICER) ... said Friday a price of up to $4,500 per treatment course is justified for remdesivir ...

https://www.businessinsider.com/coronavirus-treatment-icer-pricing-analysis-on-gileads-remdesivir-2020-5

[struggle4progress]

7. Call for Indian government to revoke Gilead's remdesivir patent

29-04-2020

... 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 ...

Gilead filed a patent application for remdesivir in India in 2015, which was granted on February 18, 2020. The drug is currently in clinical trial stage and has not yet received marketing approval.

The CPAA said in its letter that the government has the power to revoke the patent in the public interest. Pointing out, "we have cogent grounds to state that the [Gilead] application ought not to have been granted a patent as it lacks novelty and inventive step," the CPAA said Application No '821"is not an invention and is not patentable under the Patents Act" ...

https://www.thepharmaletter.com/article/call-for-indian-government-to-revoke-gilead-s-remdesivir-patent

[nykym]

8. The big question is

Are tRUMP and his brood of grifter buying up the stock or getting kickbacks?

[struggle4progress]

9. $10 or $4,500?

By Josh Nathan-Kazis
May 4, 2020 9:37 am ET

What will be the cost of a course of treatment of remdesivir, the Gilead Sciences therapeutic authorized by the Food and Drug Administration on Friday to treat Covid-19?

In a report issued Friday, the Institute for Clinical and Economic Review, an influential research group that issues recommendation on drug pricing, suggested that Gilead could charge around $4,500 for a treatment course, based on a model that takes into account the cost-effectiveness of the drug ...

https://www.barrons.com/articles/gilead-stock-covid-19-drug-cost-treatment-icer-recommendation-mortality-51588599356

[struggle4progress]

10. Gilead's drug pricing in the crosshairs again

By Ron Leuty – Staff Reporter, San Francisco Business Times
May 4, 2020, 5:37pm EDT

... Patient advocacy groups have slammed the company for the cost of its HIV-fighting drugs, which have extended the lives of AIDS patients and include the only two FDA-approved HIV prevention drugs, while insurers and other payers have criticized Gilead for its $1,000-a-pill hepatitis C drugs that were the first to essentially wipe out the underlying virus ...

On Thursday, watchdog Public Citizen noted that remdesivir must be "reasonably priced" to prevent rationing of treatment for severe Covid-19 patients and to relieve stress on public health care budgets.

"Gilead's vague assurances are not enough," the group said, adding that the U.S. government should license Gilead's patents and Congress should enact "reasonable" pricing legislation. "This is the company that gave us the $1,000 pill. Remdesivir has benefiited at every stage from taxpayer funding, totaling a minimum of $60 million" ...

https://www.bizjournals.com/sanfrancisco/news/2020/05/04/gileads-drug-pricing-in-the-crosshairs-again-in.html

[SharonAnn]

11. For readers of "The Handmaid's Tale", the name "Gilead" has unfortunate connotations.

[AntiFascist]

12. The Wuhan Institute of Virology is also seeking a patent...

http://www.iprdaily.com/article/index/15372.html

The Wuhan Institute of Virology, part of the China Academy of Sciences, has applied to patent the use of Gilead Sciences’ remdesivir to treat the current coronavirus outbreak.

The company has partnered with Chinese health authorities to run a Phase III clinical trial to assess remdesivir for treatment of the virus.
...
The Wuhan Institute submitted the patent application jointly with the Military Medicine Institute of the People’s Liberation Army Academy of Military Science. Researchers with both organizations noted in a paper published in Nature’s Cell Research this week that both remdesivir and chloroquine, used to treat malaria, may be effective in stalling the coronavirus.

“Even if the Wuhan Institute’s application gets authorized, the role is very limited because Gilead still owns the fundamental patent of the drug,” said Zhao Youbin, a Shanghai-based intellectual property attorney at Purplevine IP Service Co. “Any exploitation of the patent must seek approval from Gilead.”

The Wuhan Institute indicated it filed the patent application on January 21, but also noted it would temporarily drop the patent claims if it had the opportunity to collaborate with foreign biopharma companies to battle the epidemic.

[AntiFascist]

15. I didn't realize until now that the Military Medicine Institute of the People's Liberation Army...

Academy of Military Science was involved in coronavirus-related research, but this may be interesting to note:

https://www.defenseone.com/ideas/2019/08/chinas-military-pursuing-biotech/159167/

...
Biology is among seven “new domains of warfare” discussed in a 2017 book by Zhang Shibo <张仕波>, a retired general and former president of the National Defense University, who concludes: “Modern biotechnology development is gradually showing strong signs characteristic of an offensive capability,” including the possibility that “specific ethnic genetic attacks” <特定种族基因攻击> could be employed.

The 2017 edition of Science of Military Strategy <战略学>, a textbook published by the PLA’s National Defense University that is considered to be relatively authoritative, debuted a section about biology as a domain of military struggle, similarly mentioning the potential for new kinds of biological warfare to include “specific ethnic genetic attacks.”

[genxlib]

13. I am as cynical as the next guy

But how about we wait to see what they are charging before we stampede the castle?

Just a thought.

I actually know someone who works for them pretty high up and the thought is that it will be affordable. I am not sure we have the same concept of affordability but I am encouraged enough to wait.

Even if they were greedy, it doesn't mean they are suicidal. If they come out wrong on this one, it could turn the tide on a whole bunch of reforms and oversight they don't want. It is probably in their best long term interest to just be the good guy here and make a decent but not obscene profit.

[safeinOhio]

14. Big Pharma spent millions

lobbying Congress to extend patent dates. Then made billions on that investment.

We have the best government money can buy.