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.
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.
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.
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.
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.
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
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.
Data released this week by the European Centre for Disease Prevention and Control (ECDC) and European Food Safety Authority (EFSA) reveal that antimicrobials used to treat diseases that can be transmitted between animals and humans, such as campylobacteriosis and salmonellosis, are becoming less effective.
Vytenis Andriukaitis, EU Commissioner for Health and Food Safety,
said: “The report released today should ring–again–alarm bells. It
shows that we are entering into a world where more and more common infections
become difficult–or even sometimes impossible–to treat. However, ambitious
national policies in some countries limiting antimicrobial use have led to a
decrease of antimicrobial resistance. So before the alarm bells become a
deafening siren, let’s make sure that we increasingly act all together, in
every country and across the public health, animal health and environment
sectors under the One Health approach umbrella.”
According to the report, which refers to 2017 data, resistance to
fluoroquinolones (such as ciprofloxacin) is so high in Campylobacter
bacteria in some countries that these antimicrobials no longer work for the
treatment of severe campylobacteriosis cases.
Most countries reported that Salmonella in humans is increasingly resistant to fluoroquinolones. Multidrug resistance (resistance to three or more antimicrobials) is high in Salmonella found in humans (28.3%) and animals, particularly in S. Typhimurium.
Madam Therapeutics believes that an integral, multi-sectoral, multidisciplinary, and global approach to control these – often life-threatening – infections is essential. This means that the world needs to combine forces to work on sustainable usage of antimicrobials through stewardship programs, development new antimicrobials, and development of new rapid detection platforms to diagnose AMR infections. Madam Therapeutics is contributing to such an integral approach through the development of novel effective antimicrobial agents and strategies to limit and counteract the development of resistance will be developed. Only when used in combination, these innovations will have a major impact by preventing AMR development and the associated costs for health care systems. Madam Therapeutics is therefore actively involved in public private collaborations that promote such an integrated approach.
Genes associated with antibiotic-resistant superbugs have been discovered in the high Arctic, one of the most remote places on earth, showing the rapid spread and global nature of the resistance problem. This reported by the English newspaper the Gardian. The discovery of these genes, possibly carried by birds or humans, shows rapid spread of crisis
The genes were first identified in a hospital patient in India in 2007-8, then in surface waters in Delhi in 2010, probably carried there by sewage, and are now confirmed in soil samples from Svalbard in the Arctic circle, in a paper in the journal Environment International. They may have been carried by migrating birds or human visitors, but human impact on the area is minimal.
While the genes, called blaNDM-1, have been identified in soil on the Norwegian archipelago, the presence of superbugs has not. The genes can confer on bacteria resistance to carbapenems, which are antibiotics of last resort for the treatment of human diseases.
Antibiotic resistance threatens a global “apocalypse”, England’s chief medical officer, Dame Sally Davies, has warned, and last week the health secretary, Matt Hancock, called it a bigger threat than climate change or warfare. Common operations could become life-threatening and rapidly spreading and evolving diseases could overcome our last medical defences, reversing nearly a century of remarkable progress in human health.
Madam Therapeutics is developing new medicines that aim to overcome the problem of antimicrobial resistance. Madam Therapeutics is a One-Health company, with different development programs for human health, as well as animal health. Our lead molecules are SAAP-148 for use in infections in humans, and p10 for treatment of infections in animals.