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Saturday, October 10, 2020

Who's the huckster for the profiteering of Big Pharma? Who would you guess?

Where to start a post like this one? It could be direct. A followed by B followed by C, and you get the drift even if slowly because you are slow. That's no fun.

Build a theme, then cap a theme? Let's try.

NYT rightly reported ["Opinion" actually] back in March 2020, 

Drug Companies Will Make a Killing From Coronavirus

Unless we fix the system, American taxpayers will get gouged on a vaccine they paid to produce. -- By Mariana Mazzucato and Azzi Momenghalibaf

Ms. Mazzucato is a professor at University College London and the author of “The Value of Everything.” Ms. Momenghalibaf is a senior program officer at the Open Society Public Health Program.

[...] Since the 2003 SARS outbreak, the United States has spent nearly $700 million of taxpayer money on coronavirus research — more than any other country — through the National Institutes of Health. Yet the question right now for Americans — thousands of whom are forced to ration their insulin and face astronomical bills for live-saving drugs — is not only when these treatments and vaccines will become available, but at what price.

As the world’s leader in public financing of biomedical research, the U.S. government has the opportunity to set a precedent to ensure that medicines developed with public funding are accessible and affordable to the public; this will have enormous implications not only how for we deal with the coronavirus, but also for the crisis of unaffordable medicines in America.

 Health Secretary Alex Azar recently said that he could not guarantee coronavirus treatments or vaccines would be affordable, despite taxpayers’ significant investment in their development. Faced with public backlash led by the House speaker, Nancy Pelosi, Mr. Azar backtracked, although details on how the administration would keep prices down remain unclear.

One way was spelled out in a letter sent on Feb. 20 by 46 lawmakers: It demands that coronavirus vaccines and treatments developed with taxpayer money should be produced without giving an exclusive license to private manufacturers.

Yet that is not how our system works.

No shit, Sherlock. We all know who is evil and how, and the wonder is the brigands get away with it in our U.S. of A. Against US. The politicians owned and in bed with Big Pharma are: Against US. And so it happens. Back to NYT content - as to how the system works in good and rugged capitalist social Darwinism ways and means:

Yet that is not how our system works. Instead, the government grants exclusivity to pharmaceutical companies to conduct later stage drug development on publicly funded inventions, without requiring that these drugs be widely affordable or accessible. These exclusive licenses allow drug companies to enjoy a monopoly and charge exorbitant prices for medical technologies developed with public funds.

We are once again handing over the fruits of publicly funded research to for-profit corporations with no strings attached.

Under a deal struck with Regeneron Pharmaceuticals, the federal Biomedical Advanced Research and Development Authority agreed to pay 80 percent of the costs of developing and manufacturing coronavirus treatments — without any requirement that the final products be affordable. Regeneron has the two highest-paid executives in the pharmaceutical industry.

Similarly, another promising experimental drug to treat coronavirus, remdesivir, was developed with the help of taxpayer-funded research. Gilead Sciences, famous for its price gouging of other medicines developed with public funding like Truvada for PrEP and Sovaldi, owns the exclusive rights to remdesivir. In the case of coronavirus vaccines, nearly every candidate in development involves public-private partnerships that builds off publicly funded research, like Johnson & Johnson and Sanofi’s collaborations with the government’s biomedical research authority.

Despite Democratic lawmakers’ [half-hearted, all for show and toothless] push for stronger access and affordability protections for coronavirus vaccines and treatments, the pharmaceutical lobby got these protections removed from the coronavirus spending bill recently approved by Congress, which included $3 billion in federal funding for research and development of coronavirus vaccines, tests and treatments.

The National Institutes of Health pours $40 billion annually into health innovation, and it is on track to spend billions more for Covid-19. In fact, N.I.H. funding contributed to every one of the 210 new drugs approved by the Federal Drug Administration from 2010 to 2016.

Yet the pricing of medicines does not reflect this contribution. While the reasons for this are varied, including the lobbying power of the pharmaceutical industry, it reflects an entrenched but misguided belief that the private sector is the primary driver of innovation and should reap all the rewards. Recent studies show that large pharmaceutical companies like Johnson & Johnson and Pfizer are focusing less and less to research — instead acquiring smaller biotech firms with promising drug candidates that rely on public funding — and spending more on strategies to inflate executive pay, such as share buybacks.

The United States needs a system where public and private sectors work together. This is not about bashing Big Pharma; it is about reclaiming the focus on health and the public interest in an industry that has for too long been driven by profiteering.

 

 Mentioned in there, Regeneron, the firm with this Wikipedia page, stating in part:

Marketed products

Arcalyst (rilonacept) for specific, rare autoinflammatory conditions. Approved by the FDA in February 2008.

Eylea (aflibercept injection) approved by the U.S. Food and Drug Administration (FDA) in November 2011,[4][20] to treat a common cause of blindness in the elderly. Eylea is reported to cost $11,000 per year for each eye treated.[21]

Zaltrap (aflibercept injection) for metastatic colorectal cancer approved by the FDA in August 2012.[22]

Praluent (alirocumab) indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein (LDL) cholesterol. Approved by the FDA in July 2015,[23] It is reported to cost $4,500 to $8,000 per year.[24]

Dupixent (dupilumab injection) is for the treatment of adolescent and adult patients' atopic dermatitis. Approved by the FDA in March 2017.[25] It is reported to cost $37,000 per year.[21]

Kevzara (sarilumab injection) is an interleukin-6 (IL-6) receptor antagonist for treatment of adults with rheumatoid arthritis. Approved by the FDA in May 2017.[26] Trials commenced in March 2020, to evaluate the effectiveness of Kevzara in the treatment of COVID-19.[27][28]

Libtayo (cemiplimab injection) is a monoclonal antibody targeting the PD-1 pathway as a checkpoint inhibitor, for the treatment of people with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative surgery or curative radiation. Approved by the FDA in September 2018.[29]

REGN-EB3 is a drug made of three antibodies, developed to treat deadly Ebola virus.

Technology platforms

Trap Fusion Proteins: Regeneron's novel and patented Trap technology creates high-affinity product candidates for many types of signaling molecules, including growth factors and cytokines. The Trap technology involves fusing two distinct fully human receptor components and a fully human immunoglobulin-G constant region.

Fully Human Monoclonal Antibodies: Regeneron has developed a suite (VelociSuite) of patented technologies, including VelocImmune and VelociMab, that allow Regeneron scientists to determine the best targets for therapeutic intervention and rapidly generate high-quality, fully human antibodies drug candidates addressing these targets.[30]:255–258

Financial performance

Financial Year Revenue Ref
2012 $1.4 billion [31]
2013 $2.1 billion [32]
2014 $2.8 billion [33]
2015 $4.1 billion [34]
2016 $4.8 billion [35]
2017 $5.8 billion [36]
2018 $6.7 billion [37]
2019 $7.8 billion [38]

Key people

The company was founded by CEO Leonard Schleifer and scientist George Yancopoulos. They are reported to hold $1.3 billion and $900 million in company stock, respectively. Both are from Queens, New York.[21]

Schleifer was formerly a professor of medicine at Weill Cornell Medical School. Yancopoulos was an assistant professor at Columbia University. Yancopoulos was involved in each drug's development.[21]

 

 That Wiki fn.21 points to a Forbes July 2018 item, stating in part:

Sipping a lemon-flavored VitaminWater at a sprawling complex of laboratories and offices in Tarrytown, New York, Leonard Schleifer, the 66-year-old cofounder of Regeneron Pharmaceuticals, is, as usual, criticizing the pricing practices of other drug companies. (He once told the chief executive of Pfizer: "You're not entitled to a fraction of the GDP.")

"It's not simply about just growing your earnings per share by raising your price," Schleifer says. "So, yes, I'm glad I've been outspoken, because I think that I am trying to prevent what is still at risk of happening: If the industry does not behave properly, the government is going to step in."

Look who's talking. Regeneron, like other biotech firms, spends giant sums to find new cures, and it charges accordingly. Its big seller, the eye drug Eylea, costs $11,000 a year per eye. A newer Regeneron product, Dupixent, treats skin rashes; that one can run $37,000 a year. A cholesterol treatment costs $14,000 a year. Even more insane: These eye-catching prices really are cheap by pharma standards.

In a letter sent to Forbes after this story's original publication, Schleifer wrote that Regeneron believes in "responsible pricing." He points out that Regeneron submitted to external review to come up with a fair price for both Dupixent and its cholesterol treatment. "These were unprecedented steps that set a shining example of how it is possible to make great medical advances and provide those advances at a fair price."

It took Regeneron 24 years to make back the billions investors poured into it. Now it's making good money, $1.2 billion last year on sales of $6 billion. Wall Street values the company at $37 billion.

Schleifer and his cofounder, scientist George Yancopoulos, both kids from Queens, have made fortunes for themselves: $1.3 billion for Schleifer, mostly in Regeneron shares, and $900 million for Yancopoulos, making him one of the richest research chiefs ever, in any industry.

But Regeneron, whose shares are down 40% from their 2015 peak, isn't quite living up to expectations. Regeneron has brought to market six drugs, all co-invented by Yancopoulos, but only Eylea is a big hit. Eylea generates $6 billion in annual global sales. Bayer, which markets it outside the U.S., gets about 20% of that. The drug represents 80% of Regeneron's revenue.


Always attuned to profitable opportunity, the company writes of collaboration

Our entrepreneurial culture and history as one of the industry’s longest-standing biotech companies fosters a high-science mindset, nimble decision-making and highly collaborative relationships.

We follow the science, rather than limiting our innovations to any one therapeutic area. We are open to collaboration opportunities with the potential to offer important benefits to patients, representing a true scientific or medical advance. In particular, we consider:

  • Novel platforms that enable next-generation therapeutics
  • Technologies for antibody discovery and development against new / challenging targets
  • New approaches that enhance activity of tumor-directed antibodies
  • Biomarker discovery and validation
  • Drug delivery or formulation technologies that improve the efficacy / safety profile, address a CMC or supply challenge or enhance patient convenience or compliance
  • Studying the potential of combinations pairing our pipeline molecules with other innovative clinical-stage therapeutic candidates
  • Collaborations with leading academic groups to advance our efforts in human genetics, animal model development, target discovery, target validation and antibody discovery

 

 That's all great, but who's picking up the check? Who pays, while collaborative profits roll in? That is hard to pin down, as is the part federal dollars add to the value of the firm and its products, with the federal government getting zero say and zero return on its essentially "given away" tax revenue to privateers. The firm jumped the Covid-19 train to maximize its chances, per a June 2020 press release:

https://investor.regeneron.com/news-releases/news-release-details/two-science-publications-highlight-potential-regn-cov2-anti

So, in the Covid-19 money-hunt, got their dog in the hunt, Science accepting papers, so it is not fly-by-night speculation and hand waving - but real, and

How to market stuff?

To the headline, Who's the huckster? Don't waste time with Hollywood celebrities with nice teeth and fine faces, go top rank, as Lincoln Project explains:


And what's the price, when Medicare pays for it for seniors; or when private insurance pays for those lucky enough to be insured with coverage for it, and what's the fate of those without coverage, without Medicare for All, and up the creek without a paddle that way - well, does the huckster care about them, or are they like war dead to him, suckers and losers?