The Global Antibiotic Research & Development Partnership (GARDP) today announced a major step in its efforts to bridge global gaps in access to innovative, critically needed antibiotics.

Under a sublicense agreement with GARDP, India-based Orchid Pharma will manufacture cefiderocol, an antibiotic for difficult-to-treat, gram-negative bacterial infections developed by Japanese drugmaker Shionogi. The agreement will enable Orchid to produce the drug cheaper and make it available in low- and middle-income countries (LMICs), many of which are confronting rising rates of antimicrobial resistance (AMR) with a limited arsenal of antibiotics.

The agreement builds on a partnership between GARDP, Shionogi, and the Clinton Health Initiative (CHAI) announced last year, under which Shionogi agreed to grant GARDP the license for cefiderocol. CHAI will work with Shionogi to transfer technology and convey essential manufacturing information to Orchid and other sublicensees to help reduce manufacturing costs, which will make the drug more affordable—pending local authorization or national regulatory approval—for the 135 LMICs that don't currently have access to it.

"We welcome Orchid to this programme and are confident that together we will continue to make strides toward increasing access to medications for people living in low- and middle-income countries," Takuko Sawada, director and vice chairperson of Shionogi's board, said in a company press release.

Reducing the access gap

Cefiderocol was approved by the US Food and Drug Administration in 2019 and the European Medicines Agency in 2020 and is on the World Health Organization Model List of Essential Medicines. It's considered an important weapon against carbapenem- and multidrug-resistant infections, but to date has only been commercially available in high-income countries.

"Access is one of the least talked about issues in the global AMR crisis," said GARDP executive director Manica Balasegaram, MRCP, MSc. "We can effectively offset the burden of antibiotic resistance by reducing the access gap between high- and lower-income countries so that the right antibiotics are affordable and available for appropriate use."

Access is one of the least talked about issues in the global AMR crisis.

A source from India's National Institute of Virology (NIV) said today that two fatal Nipah virus infections have been confirmed in Kerala state, with testing under way for two suspected infections in members from the same family, Reuters reported today.

An unnamed official from NIV told Reuters that one person died at the end of August and the other died in September and that the results have been sent to India's health ministry.

A media report from India said the deaths involve patients from Kozhikode district. The story quoted a local health official, who said samples from four family members were sent to the NIV for testing.

Previous outbreaks

In 2018, an outbreak in India's Kozhikode district led to 17 deaths and was connected to fruit bats found in a family farm's well. In 2019, the country reported another outbreak in Kochi district, also in Kerala state. In 2021, the country reported an isolated case from Kozhikode district, which involved a 12-year-old boy who died from his infection, according to the World Health Organization (WHO).

Nipah virus, a paramyxovirus, is found in South and Southeast Asia. The disease has a high case-fatality rate, between 45% and 75%. The natural reservoir is fruit bats.

Nipah virus is one of the WHO's priority diseases for research and development and is a key target of the Coalition for Epidemic Preparedness and Innovations (CEPI) for furthering the development of countermeasures against emerging infectious diseases.

A genomic and epidemiologic analysis of data from the 2022 mpox outbreak estimates that 1.3% of men who have sex with men (MSM) in Portugal were infected. 

Led by researchers from Portugal's national institute of health, the study involved the sequencing of 54.2% of the country's 495 confirmed mpox cases. Viral samples were obtained from May 4 to September 16, 2022.

Among the 447 patients with demographic data, 99.1% were men, 96.5% were MSM, 44.1% were aged 30 to 39 years, 28.4% were aged 20 to 29, and 20.4% were 40 to 49. A total of 42.9% of the patients with HIV information (168 of 392) were HIV-positive.

Sex networks, saunas fed mpox spread

Portugal was one of the first countries to report mpox cases in 2022. An estimated 62% of the country's cases were reported, and 1.3% of MSM were infected. Sexual networks and superspreader gatherings such as at saunas played a critical role in mpox spread.

In April, the R_t (expected number of infections caused by an infected person in a population in which some people might be immune) was 2.25, peaking at 2.70 in May. In total, 182 genetic subclusters were identified globally, with 78.3% including at least two Portuguese sequences, which made up 66.6% of sequences from Portugal. There was a link between travel-related countries and those with a high percentage of sequences in Portuguese subclusters.

Our findings highlight genomic epidemiology as a tool for the real-time monitoring and control of mpox epidemics, and can guide future vaccine policy in a highly susceptible population.

Of the 399 cases with information on probable transmission routes, 95.2% identified sexual contact, 3.3% cited nonsexual contact, and 0.5% reported healthcare-associated spread.

"Our findings highlight genomic epidemiology as a tool for the real-time monitoring and control of mpox epidemics, and can guide future vaccine policy in a highly susceptible population," the study authors wrote.

The global mpox outbreak began in May 2022, with 88,600 confirmed infections and 152 deaths reported in 113 countries across all world regions by August 2, 2023. As of January 10, 2023, 951 mpox cases had been confirmed in Portugal.