Madam Therapeutics

News Archive

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

New study confirms that antimicrobial resistance shows no signs of slowing down

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.

Source Euractive

Patent on SAAPs issued in an increasing number of countries

An increasing number has now published the patent for our SAAP family of compounds. Today we have received notification of the assignment of our patent in Turkey

Genes linked to antibiotic-resistant superbugs found in Arctic

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.

Source: https://www.theguardian.com/society/2019/jan/28/genes-linked-to-antibiotic-resistant-superbugs-found-in-arctic

Remko van Leeuwen features in video from Holland Bio

On January 24th, HollandBIO celebrated with its members and relations its first lustrum during the HollandBIO Year Event in the heart of Amsterdam. The event for the Dutch biotech sector was once again full of innovation, inspiring entrepreneurship and a healthy dose of humor. The opening video made it clear at a glance how the life sciences sector already contributes to a sustainable and healthy society, what innovations are on the horizon and the important role of HollandBIO to clear away the obstacles biotech frontrunners on their way from lab to meet society. Remko van Leeuwen, CEO from Madam Therapeutics is one the entrepreneurs that were selected to talk on their passion for biotech. Remko van Leeuwen, as well the other
entrepreneurs look back at the first five years HollandBIO and, of course, ahead: in the next five years, HollandBIO will once again be full of enthusiasm to pave the way for biotech innovations.

UK announces at World Economic Forum in Davos that it will trial a new payment model for antibiotics


BBS news announced today that the drugs advisory body in the UK, the UK National Institute for Health and Clinical Excellence, and NHS England will trial a new payment model that means pharmaceutical companies that development new antibiotics will be paid for drugs based on how valuable the medicines are to the NHS, rather than by the quantity of drugs sold.

Health Secretary Matt Hancock, launched the government’s 20-year vision at the World Economic Forum at Davos, Switzerland. “Antimicrobial resistance is as big a danger to humanity as climate change or warfare. That’s why we need an urgent global response”, he argues.

Traditionally, drugs companies are paid for the amount of antibiotics they sell. This has led to a “market failure” where companies are incentivised to sell existing antibiotics, rather than innovate and develop new treatments for infections where they are most needed.

By changing to a model where companies are paid based on how valuable the medicines are to the NHS, the UK government anticipates that companies will start to invest in the development of new, high-priority drugs.

Developing such new, high-priority drugs to fight bacterial infections is precisely what Madam Therapeutics has been doing since its start in 2011. The executive board from Madam Therapeutics welcomes this critical step by the UK government, and hopes that other European and other governments will follow soon.

Source: BBC News



Madam Therapeutics has been selected for a pitch at the upcoming edition of Innovation for Health.

Innovation for Health has announced today that Madam Therapeutics has been selected for a pitch at the upcoming edition of Innovation for Health on 14 February in Rotterdam. We are amongst 10 companies that are developing an healthcare innovation, and will get the opportunity to pitch our company and innovation to key players and decision makers in Health & Life sciences sector on 14 February at Innovation for Health and Global Investor Forum in Rotterdam!

More info https://www.innovationforhealth.nl/start-up-pitches