MSD launches novel antibiotic RECARBRIO®▼ (imipenem/cilastatin/relebactam) in the UK but concerns about patient access to future generations of novel antibiotics remain

MSD launches novel antibiotic RECARBRIO®▼ (imipenem/cilastatin/relebactam) in the UK but concerns about patient access to future generations of novel antibiotics remain

• MSD is launching a novel antibiotic in the UK but warns that without further action on the part of policymakers to fix the so-called ‘broken’ antibiotic market, patient access to future generations of antibiotics could be jeopardised.

• MSD welcomes UK’s antibiotic subscription pilot but calls on Government and the NHS to go further and faster in enacting more widely applicable and appropriately funded reforms.

HODDESDON, UK – 18th November 2020 – MSD (trade name of Merck & Co., Inc., with headquarters in Kenilworth, N.J., U.S.A.) has today - during World Antimicrobial Awareness Week - announced the launch of its novel antibiotic in the UK. The news follows authorisation of the medicine by the European Commission earlier this year for the treatment of infections caused by aerobic Gram-negative organisms in adults with limited treatment options1. The medicine addresses some of the critical “priority pathogens” identified by the World Health Organisation (WHO)1,2, but news of its launch in the UK is accompanied by concerns that more action is needed to guarantee patient access to future generations of novel antibiotics.

Whilst addressing COVID-19 is a priority, at least 700,000 lives are lost each year globally due to drug-resistant infections3; a number that is only expected to increase as bacteria evolve new mechanisms of resistance to antibiotics. Yet the WHO has warned that the global pipeline of innovations is ‘insufficient to tackle the challenge of increasing emergence and spread of antimicrobial resistance’ (AMR).4 Without effective antibiotics, routine surgical procedures or cancer chemotherapy could be deemed too risky to undertake in future due to the possibility of infection.5

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Date Material code: GB-TIX-00009 of Preparation: October 2020

It can take 10-12 years and over £1 billion to develop a new medicine.6 However, upon launch, new antibiotics are typically held in reserve until resistance has emerged to older treatments.7 The absence of a predictable and sustainable return on investment in antibiotic research and development has led to a dramatic fall in the number of large companies involved in antibiotic research and development.7 To bolster what is now a fragile global pipeline of antibiotics, over 20 biopharmaceutical companies recently launched a new $1 billion AMR Action Fund designed to help innovators bring forward new antibiotics through late-stage clinical trials; a welcome intervention, but one that needs to be matched by government action if access to future generations of novel antibiotics is to be secured.

David Peacock, Managing Director of MSD in the UK and Ireland commented: “The world risks losing the most powerful tool in medicine: antibiotics. AMR is an urgent threat that, over time, could affect us all and have public health and economic consequences even greater than COVID-19 – unless we act now. Current reimbursement frameworks simply do not support the level of sustained R&D investment that is needed to tackle AMR. Whilst the UK’s efforts to pilot a new subscription model of antibiotic reimbursement is a step in the right direction, its scope is limited, and it remains unclear if the overall level of funding attributed to this scheme will prove sufficient to incentivise much needed investment.”

“As one of the few remaining large research-based pharmaceutical companies still undertaking antibiotic research, we are aware that we cannot solve this issue alone. That is why we recently committed to invest $100m in the AMR Action Fund, to help innovators bridge the gap between the laboratory and patients. However, even this historic intervention on the part of industry won’t be enough to save the global pipeline of antibiotics unless governments enact market-based reforms, and fund these to a degree that is commensurate with the scale of the threat to public health. With the UK due to assume the Presidency of the G7 in 2021, there exists an opportunity to go further and faster at home and in so doing set the standard for what is also needed abroad.”

In a randomised, controlled, double-blind, phase 3 clinical trial of adult patients with infections caused by imipenem-nonsusceptible Gram-negative bacteria, favourable overall response was observed in 71% imipenem/cilastatin/relebactam and 70% colistin+imipenem/cilastatin patients (90% confidence interval [CI] for difference, –27.5, 21.4), which was the primary endpoint. Forty seven patients were randomized 2:1 to received 5-21 days imipenem/cilastatin/relebactam or

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Date Material code: GB-TIX-00009 of Preparation: October 2020

colistin+imipenem/cilastatin. Favourable overall response was defined by relevant endpoints for each infection type in the microbiologic modified intent-to-treat population.

8 The most common adverse events were pyrexia (13%), increased aspartate aminotransferase (13%), increased alanine aminotransferase (11%), and nausea (11%). Drug-related adverse events were reported in 16% of imipenem/cilastatin/relebactam vs 31% of colistin+imipenem/cilastatin patients.8

For more information, please see the Summary of Product Characteristics for this medicine, available online at https://www.medicines.org.uk/emc/product/11675

In February 2020, imipenem/cilastatin/relebactam was authorised by the European Commission to treat infections due to aerobic Gram-negative organisms in adults with limited treatment options. On 15th October 2020 the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending authorisation of imipenem/cilastatin/relebactam for the treatment of hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP) in adults and for the treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with HAP or VAP, in adults.9 The CHMP positive opinion will be considered by the European Commission. If the European Commission affirms the CHMP opinion, it will grant the centralised marketing authorisation with unified labeling that is valid in the 27 countries that are members of the European Union, as well as the United Kingdom and the European Economic Area members, Iceland, Liechtenstein and Norway.