See also a UN announcement covered in the NYT, and an article in Business Week. Here, here.
See articles in The Economist here, here, podcast series here, March 2019 London conference here. (With the conference see also an "Economist Article Kit," here.)
See article in MedCity News here.
https://www.ft.com/content/4da1c6e4-603d-11e9-9300-0becfc937c37
See also:
Axios, October 2018: The Antibiotics Market is Falling Apart
https://www.axios.com/antibiotic-drug-resistance-market-c712e575-0d34-4c9e-b81c-ce1844f59242.html
Pew Foundation, April 2019: The Antibiotic Market is Broken - And Won't Fix Itself
Jointly with IDSA. Appeared at this link, and also in THE HILL.
https://www.pewtrusts.org/en/about/news-room/opinion/2019/04/10/the-antibiotic-market-is-broken-and-wont-fix-itself
Pew to Congress, re ABx, February 2019
https://www.pewtrusts.org/en/research-and-analysis/speeches-and-testimony/2019/02/05/groups-urge-congress-to-act-on-antibiotic-resistance
Pew "Drug Spending Initiative" (not specific to Abx), 2017/2018
https://www.pewtrusts.org/en/projects/archived-projects/drug-spending-research-initiative
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We ignore the disaster in the antibiotics market at our peril
Financial Times April 21, 2019
There is no viable path for new drugs, however valuable they are to society
To go beyond early-stage research and initial small-scale trials, biotechs need private capital to step in
Jeremy Farrar - Wellcome Trust
Achaogen is not a company most people have heard of. It is not a household name, barely has an international presence and most of us have never used one of its products. The few who have probably don’t know the company either, even if its product saved their life. And yet its recently announced bankruptcy is one of the most significant — and worrying — corporate failures of this decade.
In the global struggle against superbugs, Achaogen is a biotech at the front line. Its failure is the latest symptom of an ailing antibiotics market. Decades of disinvestment have left perilously few companies active in antibiotic development. Those remaining are often dependent on support from philanthropic or public funders — such as the Wellcome Trust, the medical research charity, or the US government.
This support has catalysed an exciting crop of biotechs that are now driving antibiotic innovation. But to go beyond early-stage research and initial small-scale trials, they need private capital to step in. Without external investment, small biotechs cannot carry prospective drugs through the complex and expensive later-stage trials they must pass.
Against the odds, Achaogen appeared to have succeeded. Its antibiotic, plazomicin, was approved by the US Food and Drug Administration in 2018 for treating complex urinary tract infections caused by drug-resistant bacteria. It is a vitally needed drug and just one of the many new antibiotics we need to replace drugs that are rapidly losing their effectiveness against superbugs.
Achaogen was a leading example of what could be achieved by a smart start-up working in partnership with government and philanthropic funders. (Wellcome supported Achaogen with early research and development for the plazomicin programme, was later an investor in its IPO and still indirectly holds a small amount of stock). A handful of other companies followed, some making it all the way to market.
Private investors backing such companies counted on revenues being buoyed either by growing need for their products or by governments responding to the calls to fix the market. Instead, a disaster is unfolding. With limited resources behind it, and facing a tough marketplace, plazomicin has struggled to gain market share even as an alternative to colistin, a cheap, 50-year-old antibiotic with severe side-effects.
In the year before filing for bankruptcy protection last week, Achaogen’s stock lost more than 95 per cent of its value. It closed research and development programmes, laid off staff and even auctioned lab equipment online in desperate efforts to stay afloat. It is not alone. Ten of 12 antibiotics launched in the US in the past decade (not all of them breakthrough products) are achieving US sales of less than $100m a year. This barely covers the cost of keeping them on the market, let alone recouping investments.
The tragedy is not that investors have lost their money. Rather, it is the signal that there is no viable route to market for new antibiotics, however valuable they may be to society. Capital-starved smaller companies will fold. Innovation will die on the vine. Money already invested by governments and charities will be squandered.
Despite agreement about what is wrong, our political leaders have chosen not to address the problem. This is unacceptable. Governments must send an immediate signal to companies and investors that the future is not as bleak as the present. The UK government has announced a limited new pricing model pilot, paying developers upfront for antibiotics used by the National Health Service, based on the value of the drugs to the service rather than quantity. But there will be a two-year delay before it is implemented and possibly no fresh funding from the Treasury.
We need real change now. The amounts that need to be injected are high — about $1bn per drug. That’s a hard sell for politicians, but it reflects the value of antibiotics. The cost could be shared among countries: for the UK to contribute 5 per cent, for example, of an additional $1bn a year for antibiotic development would cost about 6p per person per month. This is a problem we can afford to solve.
If leaders are afraid to deliver these types of market incentives, we need to offer a plan B — finding creative new models to stabilise the antibiotics market and stimulate private sector innovation without exposing public funders to all the risk. If we do not act, the biggest losers will not be the investors, staff and shareholders of companies such as Achaogen, but patients and the public.
The writer is director of the Wellcome Trust
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https://thehill.com/opinion/healthcare/438165-the-antibiotic-market-is-broken-and-wont-fix-itself
The antibiotic market is broken and won't fix itself
BY ALLAN COUKELL AND HELEN BOUCHER, OPINION CONTRIBUTORS — 04/10/19 07:30 AM EDT
PEW & IDSA
Over the past year we’ve watched two troubling trends escalate. First, patients increasingly face — and their doctors struggle to treat — infections that do not respond to existing antibiotics. Second, major pharmaceutical companies are backing away from developing new antibiotics. Last July, Novartis became the third major pharmaceutical company in 2018 alone to announce that it would end antibiotic research and development. Other companies that haven’t eliminated antibiotic R&D have significantly reduced it.
In short, just as the world needs new and novel antibiotics, the research needed to find them is shrinking in size and scope.
Antibiotics play a central role in modern medicine — one that goes beyond treating infections that were routinely fatal before the drugs came on the scene in the mid-20th century. The discovery of penicillin and the drugs that followed also made possible surgery, chemotherapy, dialysis, and other procedures that we now take for granted. They also help protect at-risk patients such as children, seniors, and people who have underlying conditions, such as cystic fibrosis, that weaken the immune system.
The Pew Charitable Trusts and the Infectious Diseases Society of America, together with more than 20 leaders in antibiotic research and development, have joined forces to push for swift action in the face of the growing challenge posed by the combination of increasing resistance to antibiotics and decreasing efforts to find urgently needed new antibiotics. In a letter recently sent to members of Congress, our organizations called on policymakers to commit to advancing a set of economic incentives to make antibiotic development viable again.
Providing economic incentives to pharmaceutical companies might seem like a hard sell at a time when high drug prices are a top concern of the public and policymakers. Our two organizations share this concern, and Pew has been working to address the problem. However, antibiotics are unlike other drugs. As companies reduce or eliminate their research efforts, the antibiotic market is less likely to produce new therapies to meet the threat of increasingly resistant infections, and physicians will have fewer tools to cure infections and protect patients as they undergo medical procedures.
At least nine authoritative commissions and reports have come to the same conclusion, recommending “pull incentives” to reward the development of urgently needed antibiotics by increasing the return on a drug once it comes to market. We believe that the U.S. approach to pull incentives must:
1. Address the greatest public health needs
The focus should be on stimulating the development of novel antibiotics to treat the most dangerous threats.
2. Align with efforts to improve stewardship and surveillance
Antibiotics must be used appropriately so as not to accelerate the emergence of resistance.
3. Provide predictability
Any incentive needs to be structured in a way that ensures it will be available when an antibiotic developer meets eligibility criteria.
4. Stabilize the market
Measures must be put in place to ensure that companies that have recently developed promising new antibiotics, often with the support of public funds, have an incentive to continue producing them.
According to one estimate, to fix the antibiotic market, a package of pull incentives needs to be worth an additional $1 billion in revenue for each qualifying antibiotic that a company develops, on top of sales earnings. The full amount would not need to come from the U.S., nor would it need to come exclusively from public sources. The U.S. contribution should be proportionate to the U.S. share of the global pharmaceutical market.
At a time when the cost of pharmaceuticals in the U.S. is already high, we do not suggest pull incentives lightly. But the antibiotic market is different from other drug markets in two important ways. When a new antibiotic is approved, public health requires that it be held in reserve as long as possible to slow the development of resistance.
This means that new antibiotics often face anemic initial sales. For example, Allergan’s Teflaro — one of the very few drugs effective against multidrug-resistant pathogens that have been identified by the Centers for Disease Control and Prevention as serious threats to public health — garnered average annual sales of $130 million from 2016 through 2018. Contrast that figure with the $1.4 billion in sales generated last year by the 20th best-selling cancer drug, and it isn’t surprising that Allergan announced plans last year to divest its anti-infectives business unit.
The second way in which antibiotics differ from other medications is that as bacteria develop resistance, existing drugs lose their effectiveness, making it inevitable that new antibiotics will be needed. When antibiotic development stands still, the options for patients go backward.
CDC data show that tens of thousands of Americans die each year because of resistant infections. The situation could quickly become exponentially worse if new, resistant mutations emerge. Indeed, alarming new types of antibiotic resistance have recently been identified — enabling pathogens to evade some of our most powerful antibiotics and spread quickly.
Private-sector investment in antibiotics has been falling for several decades, and there is no indication that the trend will slow. Public programs that support aspects of antibiotic development before they reach the market (often referred to as “push incentives”) — such as those of the Biomedical Advanced Research and Development Authority, the National Institutes of Health, and the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) program — have been important steps forward, but not enough. We need to fundamentally change how the market for new antibiotics works.
We cannot afford to wait or hope any longer. Ensuring that the U.S. has effective antibiotics is not a luxury; it is a necessity for protecting medical advances, preventing the spread of drug-resistant pathogens, and saving lives. Congress must act now.
Allan Coukell directs health programs for The Pew Charitable Trusts. Helen W. Boucher, M.D., is director of the Tufts Center for Integrated Management of Antimicrobial Resistance at Tufts Medical Center, professor of medicine at Tufts University School of Medicine and a member of the Infectious Diseases Society of America board of directors.
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