💊 BioNTech acquires AexeRNA; Shionogi, Apnimed make a baby; EFPIA says nein to new pharma rules

#465 | Salt as guilty as sugar; The science of exercise; Turmeric yellow, toxic fellow

Hello, and welcome to a brand new week with the same ol’ Kable. Today's delightfully short and sweet edition begins with news of the Director General of the Africa CDC, Dr Jean Kaseya's visit to South Korea’s SK Bioscience last week to discuss vaccine localisation in Africa. Under its core strategic Glocalisation Project, SK Bioscience intends to transfer R&D and manufacturing capabilities to countries with insufficient vaccine infrastructure, supporting the Partnerships for African Vaccine Manufacturing under this initiative.

The WHO and the Korea International Cooperation Agency (KOICA) Ghana have agreed to pilot a new project to strengthen efforts against antimicrobial resistance (AMR) in Ghana. Titled Partnership for Health Security in Ghana, this Government of Korea-backed project will be implemented in the Northern region of Ghana with funding worth $100,000. The project will provide practical guidance, capacity building, and support to selected health facilities to implement antimicrobial stewardship (AMS) interventions. The project, to be implemented over 17 months starting November 2023, also includes the development of AMS guidelines and a training manual for the country.

In Kenya, the Ministry of Health has proposed stringent measures for people selling herbal medicine under the Kenya Drugs Authority Bill. Non-adherence to these measures could result in a fine of up to Ksh100,000, imprisonment of up to one year, or both.

Rwanda and the Global Fund are discussing enhancing their partnership to strengthen the healthcare sector in Rwanda. The Global Fund is committed to supporting the country’s Four by Four initiative to prepare the healthcare workforce.

Meanwhile, Zimbabwe is experiencing a severe shortage of medicines at public hospitals. Underfunding is to blame.

Over in the pharmacy of the world, pharma exports grew 5% in the first half of this financial year. The total pharma exports were worth $13,361 million. The US, the UK, and Brazil were the top three importers, with Indian pharma exports to these countries touching $4142 million, $370 million, and $336 million, respectively. This growth has been driven by greater demand, an increase in export scale-up of mid-level pharma companies in India, and clearance of pending site inspections by the US FDA.

In neighbouring Bangladesh, the latest daily numbers indicate 13 dengue deaths and 1,638 dengue hospitalisations.

In Balochistan, Congo virus fever – which has no vaccine or specific treatment – has caused a troubling situation. The tick-borne illness has claimed 16 lives, including that of a doctor, so far. The province has issued a red alert. It has also introduced measures, including anti-viral spray at dairy farms as cattle and other livestock carry such ticks.

Back in India, Natco Pharma is at the receiving end of another Form 483, outlining 8 observations concerning its Telangana plant, from the US FDA.

The beginning of the end is here. At least, that’s what the European Federation of Pharmaceutical Industries and Associations (EFPIA) claims. The European Commission (EC) proposed a major overhaul to pharma rules in April this year. Proposed measures include shortening the time a new medicine remains patented in the hope that this would reduce the cost of medicines for EU citizens as cheaper generics become available more quickly. But the industry group says that this could see Europe’s share in global R&D contract by a third, from 32% to 21%, by 2040 - that is €2 billion ($2.15 billion) per year in lost R&D investments. About 20% of projects to develop regulatory data protection (RDP) reliant medicines would become economically unviable in Europe. EFPIA says the EC has not conducted a competitiveness impact assessment. If the proposed rules become law, they would speed up the negative innovation trend in the EU. Small- and medium-sized enterprises would be hit the hardest. Small biotech companies have already moved to the US and China, according to the EPFIA.

Japan’s Shionogi and the US’ Apnimed are setting up a JV, Shionogi-Apnimed Sleep Science, to address sleep disorders. The JV will combine Shionogi’s capabilities in small molecule drug discovery and Apnimed’s expertise in obstructive sleep apnea and capabilities in translational medicine. Apnimed’s most advanced development programmes are not included in the JV.

BioNTech has acquired AexeRNA and its novel lipid nanoparticles for mRNA medicines. Though AexeRNA has not much to boast of in terms of lab infrastructure or staff scientists, it does have recent Nobel laureate Drew Weissman as one of several scientific co-founders.

With its eyes set on the American oncology market, Pierre Fabre Laboratories is expanding its partnership with Atara Biotherapeutics. In a deal worth over $640 million, Atara has sold its marketing rights to T-cell immunotherapy Ebvallo in North America, APAC, and LatAm to Pierre Fabre. Ebvallo has already been approved by the European Commission to treat patients two years of age and over with Epstein‑Barr virus-positive post‑transplant lymphoproliferative disease (EBV+ PTLD). In 2021, Pierre Fabre had acquired marketing rights to Ebvallo in Europe, the Middle East, Africa, and certain other emerging markets.

We can count on Pfizer for our daily dose of cost-cutting news. As part of its $3.5 billion cost-cutting plan, the company is laying off 200 employees at its plant in Kalamazoo, Michigan, from where Pfizer’s first Covid-19 vaccines were shipped out. Pfizer is blaming the lower-than-expected demand for its Covid vaccines and antivirals.

More layoff news from Siemens Healthineers, where 300 workers are going to be laid off from the diagnostics division in New Jersey, USA. This news comes amidst conjecture that Siemens is exploring new options for the diagnostics division, potentially even a sale.

Unfortunately, bird flu has been back to making a daily appearance in The Kable lately. As cases in the US rise, the state of Arkansas – the third biggest producer of chickens raised for meat in the US – has reported its first outbreak in a commercial flock this year.

And finally, South Asia’s high rates of lead poisoning have a sinister cause: that rich yellow colour of turmeric. The Economist writes about how countries like India can learn from Bangladesh to make turmeric lattes less deadly.