💊 Merck goes to Korea for AI; Lilly plunks down big bucks; Achieving health equity in Africa

#462 | CHAI reflects on the HIV market; Interpol cracks down on illegal drugs; Pig hearts don't lead to everlasting wins

Hello, and welcome back to The Kable for another eventful life sciences day. Yesterday, South Korea’s Daewoong Pharmaceutical announced that it has inked an MoU with Merck Life Scienceto build an AI-based drug development platform.

In the first INTERPOL story we’ve ever carried, the results of a major operation to crack down on illicit medicines across 89 countries were announced yesterday. Operation Pangea XVI has resulted in 72 arrests globally, the seizure of potentially dangerous pharma products worth over $7 million, 325 new investigations, and the closure of over 1,300 criminal websites. Fun fact: erectile dysfunction medications are still the most seized medicine worldwide. Psychotherapeutic meds came a close second.

The WHO and the Italian Embassy in Libya have inked a One Health agreement to prevent and control arboviral (vector-borne) and zoonotic diseases in Libya. The WHO and partners will support improvements in disease surveillance and detection, upgrades to central and peripheral lab capacities, simulation exercises to test Libya’s preparedness to detect and respond to disease threats, and more.

Meanwhile, the WHO has cause for celebration! The organisation yesterday announced three historic milestones – the elimination of visceral leishmaniasis as a public health problem by Bangladesh, the interruption of leprosy transmission by the Maldives, and the elimination of rubella by the Democratic People’s Republic of Korea.

But in not-so-promising tidings, dengue appears to be everywhere. The Indian capital city of Delhi has reported over 5,000 dengue cases till mid-September this year. There have been concerns about a lack of transparency in issuing dengue data in the capital city, but already numbers are the highest in five years. Incessant rainfall may be to blame. For the rise in dengue, that is; not for the lack of transparency.

Still in India, Zydus Lifesciences is acquiring the UK-based LiqMeds Group, which specialises in oral liquid products. Zydus paid  £68 million (~₹690 crores) upfront and will shell out yearly earn-outs until 2026, based on the achievement of certain milestones.

Elsewhere in Asia, US-based startup AnHeart Therapeutics has entered a $40 million exclusive license agreement with Japan’s Nippon Kayaku. Nippon will market and distribute AnHeart’s next-gen ROS1 tyrosine kinase inhibitor, Taletrectinib, for the treatment of ROS1-positive non-small cell lung cancer, in Japan. AnHeart is also entitled to potential milestone and royalty payments in the future.

Across the Pacific, the US FDA has been happy with progression-free survival being the primary and surrogate endpoint for new cancer drug approvals. But with new classes of oncology drugs emerging, the agency is pushing oncology drug developers to include overall survival data more frequently.

Coming to marketing approvals, the US FDA has given Amgen the green signal for its biosimilar version of J&J’s blockbuster psoriasis treatment Stelara for multiple inflammatory diseases. But because of a legal settlement between J&J and Amgen, Amgen’s biosimilar will only be launched in 2025.

In big bad news for Big Pharma Bayer, a California jury has ordered the company to pay $332 million in damages to a man who claims his cancer, non-Hodgkin lymphoma, was due to exposure to Bayer’s Roundup weed killer. Of the $332 million, $7 million are compensatory damages, while the rest are punitive damages. Yes, Bayer intends to appeal the decision. No, this isn’t the first Roundup trial Bayer has lost.

Arrowhead Pharmaceuticals has been working with J&J’s Janssen since 2018 on a hepatitis B medicine JNJ-3989. As Janssen began to shrink its infectious disease portfolio earlier this year, Arrowhead has been uncertain about the future of its partnership. But no more. Now, GSK has acquired exclusive global rights to JNJ-3989. GSK intends to combine the siRNA therapeutic with its own late-stage therapy Bepirovirsen to develop a potentially more effective treatment. GSK will stand to pay up to $1 billion in upfront and potential milestone payments to both Janssen and Arrowhead. 

China-based Burning Rock Biotech and Germany’s Boehringer Ingelheim have inked a master service agreement in oncology companion diagnostics. The partnership is focused on advancing clinical trials of Ingelheim’s MDM2-p53 antagonist, Brigimadlin, and the development of companion diagnostics for Chinese patients.

Eli Lilly is shelling out $200 million upfront to acquire option rights to several of Verve Therapeutics’ drug programmes, including for cardiovascular diseases, from Verve’s partner Beam Therapeutics. Additionally, Lilly will invest $50 million in Beam equity, plus $350 million more, contingent on the achievement of certain milestones.

Gilead Sciences’ subsidiary Kite, which specialises in CAR-T, is partnering with California-based Epic Bio to use epigenetic editing to engineer T cells and develop next-gen cell therapies.

Biotech Vect-Horus has entered an exclusive global license agreement with Novo Nordisk to develop targeted therapeutics using Vect-Horus’ VECTrans platform technology. Vect-Horus will receive an upfront payment, plus up to $327 million in milestone payments across three programmes.

Pfizer’s cuts continue. This time, some clinical programmes, including cancer and dermatology trials, are getting axed.

The latest in a never-ending layoff season: J&J’s DePuy waves bye-bye to 67 workers in Colorado.

In the US, the infant mortality rate rose 3% last year, marking the largest increase in 20 years. The CDC’s report revealed larger increases in two of the leading causes of infant deaths: maternal complications and bacterial meningitis.

In Europe, meanwhile, dengue is making its presence felt like never before. Nature outlines the causes, trends, and risks posed by the situation.

A few weeks ago, we told you about the second person ever to get a pig heart transplant. Unfortunately, the transplant recipient has now died, 6 weeks after undergoing the experimental procedure.

Yesterday, we celebrated the Saudi FDA’s achievement of ML4 status from the WHO. Today, we celebrate the landmark listing of Singapore’s Health Sciences Authority, Korea’s Ministry of Food and Drug Safety, and the Swiss Agency for Therapeutic Products as the first three WHO-Listed Authorities! This means that the regulatory authorities comply with all the indicators and requirements specified by the WHO based on established benchmarking and performance evaluation.

The FAO, the WHO, and the WOAH have launched an all-new free online course on joint responses to zoonotic disease outbreaks.

And finally, in an update that is hardly surprising, a University of Sydney-led study has found that many WHO-recommended antibiotics are less than 50% effective in treating childhood infectionslike pneumonia, sepsis, and meningitis. ☹ Southeast Asia and the Pacific are home to the most seriously affected regions.