💊 Moderna's patent loss; Making drugs for kids; Fighting climate change for children

#477 | GSK goes green; Bird flu goes to Croatia; Bayer's cancer drug goes back home

Hello, and welcome back to The Kable. In Nigeria, the diphtheria outbreak shows no signs of relenting. The state of Kano is at the centre of the outbreak, accounting for 86% of a total of roughly 10,000 confirmed cases nationwide. Over 600 fatalities have been reported, making this outbreak far more severe than the last major one in 2011, which claimed 21 lives. To fight this catastrophe, the European Union (EU) has released €1 million (~N847 million) in humanitarian funding.

In another showcase of China’s growing cooperation with Africa, last month, Ethiopia’s Armauer Hansen Research Institute (AHRI) inked an MoU with China’s BGI Genomics to enhance AHRI’s genomics and precision medicine capabilities. AHRI aims to become a leading centre in genomics and bioinformatics, serving not only Ethiopia but also neighbouring countries in Africa.

Kenya is set to officially launch its second pharmaceutical microbiology lab today! With the objective of dealing with substandard and falsified medicines, the lab set up by the Mission for Essential Drugs and Supplies (Meds), with an investment of KES 100 million, will fortify testing for microbial contamination and drug quality, efficacy, and safety.

In Nigeria, the NCDC has launched its Strategy and Implementation Plan 2023-2027, saying that it requires N50 billion to implement it over the next five years. The plan includes 7 goals, 41 objectives, and 225 activities to transform public health security. This includes a digital transformation agenda with aspirations for high-quality public health informatics. Additionally, after conducting its inaugural Joint External Evaluation (JEE) in 2017, Nigeria has conducted its second one, raising its score for health security capabilities from 39% to 54%. While this progress is promising, the Director-General of the NCDC highlights that significant gaps still exist – he pointed specifically to the problem of antimicrobial resistance (AMR), which is documented to be a bigger problem than HIV, malaria, and tuberculosis combined in Africa. Currently, Nigeria is finalising its own second National Action Plan for AMR (NAP 2.0).

Still in Nigeria, a public health physician at the University of Ilorin Teaching Hospital suggests that the country records about 590,000 new cases of tuberculosis, which accounts for over 10% of deaths, annually.

Now for a quick stop in the Middle East. London-headquartered Huma Therapeutics has received Saudi FDA Class C certification for its disease-agnostic Software as a Medical Device (SaMD). This platform already has Class IIb regulatory certification in the EU and Class II 510(k) in the USA. The ready-to-use platform will reduce the time and cost for other companies to bring regulated SaMD products to market.

Meanwhile, US-based Allure Global is high on its South American victory. Anvisa, the Brazilian health regulatory agency, has cleared Allure to sell CBD products in Brazil.

In another North-South American collab, US-based IGC Pharma yesterday announced a Master Cooperation Agreement with the University of Los Andes to develop and adopt generative AI solutions into its drug R&D processes. Particularly, IGC will leverage the private Colombian university’s support to streamline clinical trial efficiency, enhance early detection methods for Alzheimer’s, and improve drug interaction analysis.

The Asian Development Bank (ADB) has approved a $350 million loan to support the Indonesian Ministry of Health in the implementation of a nationwide primary care transformation programme. This intervention aims to increase access to quality gender and climate-responsive primary care services.

South Korea’s SK Biosciences has entered a development licensing agreement with Hilleman Laboratories Singapore to jointly develop a low-cost second-generation Zaire ebolavirus vaccine. They aim to increase production process productivity and improve product thermostability, both of which would help rapidly roll out shots and improve access.

The US FDA is warning consumers not to consume any Neptune’s Fix products, sold with claims that they boost brain function and treat anxiety, depression, pain, and other conditions. The FDA says these products contain Tianeptine, a potentially dangerous unapproved opioid-like antidepressant. The alert comes after several reports of adverse events, including seizures and loss of consciousness leading to hospitalisation. Though approved in Europe, Asia, and Latin America, it is not approved for any medical use in the US.

The Massachusetts-based biotechs BeiGene and Ensem Therapeutics have announced an agreement for the former to acquire an exclusive global license to an Investigational New Drug (IND) application-ready oral cyclin-dependent kinase 2 (CDK2) inhibitor. BeiGene believes this phase 1-ready product complements its internally discovered phase 1 CDK4 inhibitor and strengthens its early development pipeline in breast cancer and other solid tumours. Ensem stands to make up to $1.33 billion from this deal.

Merck (MSD) is picking up Massachusetts-based preclinical biopharma Caraway Therapeutics in its latest acquisition. Caraway’s focus is on genetically-defined neurodegenerative disorders and rare diseases. If all goes according to plan, Merck could end up shelling out as much as $610 million. Merck’s drug portfolio and pipeline are dominated by oncology, but in 2019, it had committed up to $576 million to acquire Calporta Therapeutics, which targeted the ion channel TRPML1, like two of Caraway’s programmes. Calporta’s programmes are not listed in Merck’s pipeline or financial reports, and it's unclear what happened to them. But this new acquisition could be Merck’s way to fill that gap.

Even though AI-designed drugs haven’t exactly been the breakthroughs the industry hoped they would be, pharma and biotech companies continue to flock to AI to hasten things along in the painfully stretched-out drug R&D process. Now Roche subsidiary Genentech is partnering with Nvidia in the hope that the computing giant can help the biotech to improve its machine learning (ML) technology to accelerate its discovery of new drug candidates. The collab will also support Genentech’s ‘lab in a loop’, where experimental data feeds computational models, which then uncovers patterns to make new experimentally testable predictions to allow for iterative development of therapies.

Bayer is voluntarily recalling one lot of the cancer drug Vitrakvi after finding microbial contamination during routine stability testing. Vitrakvi is indicated for the treatment of NTRK gene fusion-positive solid tumours, which means that patients on the drug are likely immunocompromised. Though there is little data about the effects of the contaminant in question, Penicillium brevicompactum, there is a reasonable probability that ingesting the drug from the affected lot may result in invasive fungal infections of the blood or potentially life-threatening pneumonia. There have been no reports of related adverse events so far.

GSK is going green. The pharma giant is set to start phase 3 trials of a low-carbon version of its metered dose inhaler, Ventolin, in 2024. If successful, the next-gen propellant could cut greenhouse gas emissions from its use by about 90%. That could amount to a considerable emissions reduction, as 35 million patients globally rely on the inhaler, which accounts for almost half of GSK’s carbon footprint.

And finally, bird flu has come for poultry in Croatia.