Madam Therapeutics

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Antibiotic resistance may rise after COVID-19, as doctors struggle to treat secondary infections. New antibiotics are urgently needed, but development is falling behind.

Mother wearing a green homemade protective face mask and putting one to her daughter at home during the coronavirus Covid-19.

As the Covid-19 pandemic moves across the world, it may drag a second slow-motion pandemic behind it. Even though Covid-19 is a viral illness not affected by antibiotics, early data from hospitals shows that very high proportions of patients—more than 90 percent in some cohorts—are being treated with those drugs to cure or protect against secondary infections during respiratory illnesses or hospitalization. That’s being accompanied by an unmeasured but possibly huge number of people taking antibiotics on their own.

Those parallel phenomena mean that Covid-19 could whomp up antibiotic resistance, pathogens’ adaptive ability to defend themselves against drugs intended to kill them. Resistance is already a crisis: It causes an estimated 700,000 deaths around the world each year, almost four times the death toll from the novel coronavirus so far. Diminishing the power of antibiotics could undermine an important part of the medical response to Covid-19.

“In the context of Covid-19, antibiotics should be considered as important as protective gowns or facemasks,” says Adam Roberts, a microbiologist and antibiotic discoverer at the Liverpool School of Tropical Medicine in an interview with WIRED magazine. “We do not expect healthcare workers to go into hospital situations without the correct protective equipment. Nor should we expect clinics to do their job without the appropriate antibiotics. It is part of our defense for any pandemic situation.”

Madam Therapeutics endorses this view, and therefore works in parallel on the development of new antibiotics, as well as new treatment for the corona virus, both based on it’s peptide based antimicrobial platform.

Source: WIRED magazine

Why Madam Therapeutics focuses on developing its SAAPs as treatment for both the Corona virus as well as superbugs during the COVID-19 crisis

Young woman wearing protective face mask, she sitting in bus transportation in the city.

We’re all focused on the coronavirus, but there’s another, major threat still lurking: superbugs. And the pandemic is a stark reminder of the need to be prepared for public health crises, particularly the growing danger of antibiotic-resistant bacteria, says Pew in new analysis

Fact: We need new antibiotics. Superbugs killed 160,000 Americans in 2010—and unless we take action, they’re expected to kill 10 million people per year by 2050.

But there aren’t enough antibiotics in the development pipeline. “According to Pew’s most recent assessment of the antibiotic pipeline, far too few drugs are in development with even the potential to treat the most dangerous superbugs,” writes Pew

Why are we talking about antibiotics in the context of a virus? “Antibiotics are needed to protect COVID-19 patients who have weakened immune systems (and who may be on ventilators) and are therefore at risk for secondary bacterial infections. Likewise, antibiotics are also critical for patients fighting cancer, receiving dialysis, undergoing surgery, and requiring countless other medical treatments and procedures,” Pew explains.

This is why Madam Therapeutics is developing peptides from it’s SAAP both as antiviral compounds targeted to fight COVID-19, as well as the secondary bacterial infections.

New York Times: The Ganges River in India Brims With Dangerous Bacteria

The Ganges river in India is living proof that antibiotic-resistant bacteria are almost everywhere. The river offers powerful insight into the prevalence and spread of drug-resistant infections, one of the world’s most pressing public health problems. Its waters provide clues to how these pathogens find their way into our ecosystem.

According to the New York Times, annual tests by scientists at the Indian Institute of Technology show that antibiotic-resistant bacteria appear while the river is still flowing through the narrow gorges of the Himalayan foothills, hundreds of miles before it encounters any of the usual suspects that would pollute its waters with resistant germs.

Other studies confirm the danger. An article in Lancet Infectious Diseases found that about 57 percent of infections in India with Klebsiella pneumoniae, a common bacterium, were carbapenem-resistant.

More reading: https://www.nytimes.com/2019/12/23/health/ganges-drug-resistant-bacteria.html and https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(18)30072-0/fulltext

CDC report: every 15 minutes someone in the USA dies of a drug-resistant superbug

Antimicrobial resistance rates are rising with an alarming rate.

Every 15 minutes, someone in the United States now dies of a superbug that has learned to outsmart even our most sophisticated antibiotics, according to a new report from the US Centers for Disease Control and Prevention.That’s about 35,000 deaths each year from drug-resistant infections, according to the landmark report. This is twice the number of deaths since 2013.

People in the United States are misusing antibiotics, study says. The report places five drug-resistant superbugs on the CDC’s “urgent threat” list — two more germs than were on the CDC’s list in 2013, the last time the agency issued a report on antibiotic resistance.

Companies like Madam Therapeutics are developing solutions that could help these patients, but we need to be allowed to use these drugs and get reimbursed appropriately, as otherwise development cannot be paid.

Antibiotic Awareness Week: getting the risk-reward ratio right for R&D to fight superbugs

Each November, World Antibiotic Awareness Week (WAAW) aims to increase global awareness of antibiotic resistance and to encourage best practices among the general public, health workers and policy makers to avoid the further emergence and spread of antibiotic resistance.

During this week, there is heightened attention for the fact that new antibiotics are imperative to overcoming the threat of AMR. Yet approvals for new antibiotics have declined for many years. The last new class of antibiotics was introduced in the 1980s. While the pharmaceutical industry has been extremely successful in introducing transformative new therapies in general, it is exiting the field of antibiotics. In this area, the classic business model – high-risk research with reward in case of success – simply does not work.

Experts agree that incentives for innovations are needed; and there are a number of initiatives underway. So far, governments have focused on push incentives such grants, tax credits or public-private collaborations. These are designed to lower the risks that come with the early stages of research and development. But the bankruptcy of the antibiotic-focused biopharmaceutical company Achaogen shows that subsidizing research is not enough. Solutions are needed along the whole value chain to crack the AMR problem.
 
There is a slow but positive shift in the policy landscape acknowledging the need for broader, more sustainable solutions, including market-based pull incentives. For example, in July 2019, the United Kingdom launched a pilot program to reimburse companies based on how valuable their drugs are to the National Health Service (rather than on the quantity of antibiotics they sell). And in the United States, the Centers for Medicare & Medicaid Services is also making changes to the way it reimburses hospitals for antibiotics and the treatment of AMR.
 
This is a good start, but given the exponential threat to life that AMR poses, it is not enough; we need to go a lot further to get the risk-ratio right and ensure the continued investment we need to find and develop new antibiotics.
 
This is an abbreviated version of a story originally published (in German) in the print edition of Frankfurter Allgemeine Zeitung (FAZ) on October 29, 2019.


Peptide Antibiotics Market to Observe Strong Evolution by 2029

A new Research Report on the Peptide Antibiotics Market offers in-depth analysis of market trends, drivers, restraints, opportunities etc.

Along with qualitative information, this report includes the quantitative analysis of various segments in terms of market share, growth, opportunity analysis, market value, etc. for the forecast years.

The report written by market watcher Market.us contains key statistics on the market status and is a helpful source of guidance and direction for firms and individuals interested in the industry.

The report begins with the industry forecast and market structure and then further forecasts several segments and sub-segments of the global peptide antibiotics market. The report contains a summary of the technologies involved in the production, application and much more. It also carries in-depth case studies on the various countries which are actively involved in the Peptide Antibiotics Market production.

It also brings to light high-growth segments of the global peptide antibiotics market and how they will progress in the coming years. The overviews, SWOT analysis, and strategies of each vendor in the peptide antibiotics market provide a better understanding of the market forces and how those can be utilized to create future opportunities.

Major market players that are mentioned in the report as deeply involved in the market are Novartis, GlaxoSmithKline, Eli Lily, Pfizer and last but not least Madam Therapeutics!

We are proud that the report validates what the management of Madam Therapeutics has believed since day 1: the peptide antibiotics market will experience a surge over the next few years.

Want to be part of our adventure? Please write to investors@madam-therapeutics.com

New reimbursement models in the US and UK ignite the development of new antimicrobials

Over last few years, raising funds for AMR product development has been problematic for companies like Madam Therapeutics. Funding prospects have been cumbersome due to the fact that antibiotics are generally less profitable than drugs used to treat chronic diseases; for example, the net present value of drugs used in oncology is three times higher than that of antibiotics. This is explained by the high costs of development as well as relatively low success rates: only 1.5% of antibiotic compounds identified in preclinical research reach the market. Moreover, the market expects limited expected revenues in terms of price and volume of sales, because of (a) low prices, due to the availability of generic alternatives, (b) limited volumes, due to increasing stewardship requirements for some new antibiotics; (c) the risk of resistance developing and resulting in their decreased effectiveness; and (d) the short duration of antibiotic treatment in comparison with treatment for chronic illnesses.

Fortunately, the funding landscape it is becoming considerably more favorable as a result of a combination of so-called push and pull instruments that now start to interact with each other in a synergistic way.

Fourteen US Democratic senators recently introduced a legislation proposition, the Affordable Medications Act, that includes provisions to set aside $2 billion for an Antibiotics Innovation Incentive Fund that would grant up to three awards for new antibiotic drugs over 10 years. In exchange for the market entry awards, drug developers would relinquish patent and market exclusivity rights.

In addition, the UK NHS has recently announced that it will test the world’s first ‘subscription’ style payment model to incentivize pharmaceutical companies to develop new drugs for resistant infections. We believe these initiatives by the US and UK will make a very big difference in the interests of pharma companies and professional investors to get back in this development space.

As board member of the BEAM Alliance, Remko van Leeuwen anticipated that other countries and economic communities as the EU will follow the example set by the US and the UK.

It Starts with One…..

The theme of the BIO Convention that is held in Philadelphia this week is “It Starts with One.” BIO is the biggest biotech industry gathering on earth, and expects to break their own records by hosting 50,000 One-on-One Partnering meetings. Leonie de Best, CBO at Madam Therapeutics is in Philadelphia this week, where she will engage with investors and potential collaboration partners during a selection of those many One-on-One Partnering meetings.

Recent events bring the problem of ‘market failure’ back on the political agenda

The traditional drug development pathway doesn’t seem to be sufficient for antibiotics. Take the case of Achaogen, a San Francisco biotech that won one of the first antibiotic approvals in decades last year. Despite its novelty, plazomicin (Zemdri) generated sales less than $1 million; Achaogen filed for bankruptcy just a few weeks ago.

The financial challenges underline one of the ironies around antibiotics: Although they’re sorely needed, they will only be most effective if they’re used sparingly — for the most critical of cases.

Experts agree that it’ll involve a public-private partnership: Government entities, investors, and the industry will have to work together to find better treatments.

Madam Therapeutics is actively pursuing such public-private partnerships, such as the recently established AMR-Global partnership.

In a recent interview, Harvard economist Amitabh Chandra argued that rewarding companies for their drug’s overall efficacy, and broader impact on global health, might allow them to ultimately profit enough that they’ll want to invest in the initial research and development in the first place.

More ideas on market incentive instruments are discussed in the same publication on the website of StatNews.

Madam Therapeutics is member of the BEAM Alliance. This Alliance has written various position papers on this problem, whcih can be found via the site of the BEAM Alliance

AMR-Global kicks-off in Utrecht

On April 18th 2019 the AMR-Global coalition kicked-off at a first workshop in Utrecht.

AMR-Global aims at sustainable and collaborative research with input from various knowledge domains and industry sectors. AMR-Global is anticipated to conduct broad research terrains. Using a system approach, we aim to make an essential contribution to improving the health of humans, animals and the environment globally, by including critical factors such as local value, affordability, sustainability and health market- and health system uptake.

As ‘coalition building’ public private partnership, AMR-Global seeks to expand on relationships with academia and companies within and outside of the Netherlands, and together prioritize our innovation agenda. The meeting was intended to discuss how we can become an inclusive and multidisciplinary International Health Coalition with the intent to graduate from ‘coalition building’ to ‘fully operational’ public private partnership. 

Madam Therapeutics will contribute to this initiative with knowledge and expertise. We will make an active contribution to jointly look for financial resources with the other partners in AMR-Global. By doing so, we contribute to the goal of AMR-Global, which is to reach a target group in low and middle income countries and to give them access to our resources when they need them, and to do so in a responsible way.

A 2nd workshop has been planned for July 9th