💉 GSK Nigeria to cease operations; Blackstone to bid for Cipla stake; Bavarian Nordic secures BARDA contract for smallpox/mpox vaccine
#399 | Depression raising dementia risk; Microbes keeping mosquitoes malaria-free; Getting diagnosed with climate change
Hello! Welcome back to The Kable. From R&D and workforce training to supply, today’s a good day for vaccine updates. For starters, the Africa CDC is collaborating with the Developing Countries Vaccine Manufacturing Network, or DCVMN, to organize fully-funded short-term training courses in vaccine tech transfer at Hilleman Laboratories in Singapore. You can find more details about the application process here.
The Africa CDC has deployed technical experts to work closely with South Sudan’s Ministry of Health to manage a suspected outbreak of viral haemorrhagic fever. They are conducting a risk assessment, developing a national response plan, and strengthening surveillance, lab and risk communication capacity.
Meanwhile, scientists are calling upon the African Union to prioritise mRNA vaccine tech transfer focused on equitable access and the open sharing of knowledge rather than supporting projects backed by IP-possessive Big Pharma.
The Bill & Melinda Gates Foundation, the Children’s Investment Fund Foundation, Pfizer, and Becton, Dickinson & Company have expanded their collab, which first began in 2014. Under this initiative, they will enable greater access to self-injectable contraceptives for millions of women in low- and lower-middle-income countries by delivering over 320 million doses of Pfizer’s Sayana Press by 2030. With this expansion, 23 more countries are eligible for the programme.
After Emergent BioSolutions bagged a BARDA contract for Ebola treatment production earlier this week, Bavarian Nordic is next in line to work with the US authority. Bavarian Nordic has secured a $120 million BARDA contract to produce smallpox/mpox shots for the US.
In the US, the National Institutes of Health has awarded The Access to Advanced Health Institute, or AAHI, $18 million to develop a single-dose thermostable RNA vaccine against chikungunya.
And finally, Ionis Pharmaceuticals is expanding its collaboration with Novartis. Under this expansion, Ionis has entered an at least $60 million license agreement with the latter to discover, develop and commercialise a novel cardiovascular disease medicine for patients with elevated lipoprotein(a).
In case you missed it, The Kable is collaborating with Pharmaconex, the beating heart of African pharmaceutical manufacturing that binds the entire supply chain in Egypt.
The 10th-anniversary edition of Pharmaconex cordially invites you to network with your peers across the African continent. And the icing on the cake? A free, year-long subscription to The Kable is all yours. Claim your free year.
Africa and West Asia will lead the worldwide pharma story in the forthcoming decade; this is your chance to get a headstart. Ensure you're in the know. Sign up for Pharmaconex today to claim your year of The Kable.
The Week That Was
For all you folks who didn't catch all our editions this week -
The week started with Africa CDC's grouse with the Pandemic Fund's first round of grant allocations because the selected projects in Africa benefit only 5 countries, representing less than 5% of Africa’s population. The Africa CDC is also unhappy that it could not apply for grants independently on behalf of African nations because it has not been recognised as an implementing entity.
In the ongoing cough syrup saga, a presidential task force in Gambia recommended that the Gambia government explore legal action against the Indian government, Maiden Pharmaceuticals and Atlantic Pharma.
In one of the biggest deals of the year, Biogen acquired Reata Pharmaceuticals for $7.3 billion. This came a week after the company announced its plans to let go of about 1,000 people.
On Tuesday, we brought you news of the US FDA getting by with a lil help from its friends in other countries. The agency had signed an agreement with the Swiss Agency for Therapeutic Products, also known as Swissmedic, to be an equivalent authority in determining GMP in January. The agreement is now in force, allowing both agencies to benefit from each other’s resources regarding pre- and post-approval inspections and regular GMP inspections.
Also, as a founding member of the International Coalition of Medicines Regulatory Authorities, the US FDA also completed its first collaborative assessment with the European Medicines Agency, or EMA, with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) acting as an observer.
Wednesday's edition included news of Emergent BioSolutions' 10-year, $704 million contract with BARDA to develop and scale up production of the Ebola treatment Ebanga.
There was also a study by the Botswana-Rutgers Partnership for Health, published in PLOS Global Public Health, in which researchers highlighted that cancer treatments which are effective in other regions and could have a significant impact in sub-Saharan Africa are not available or are difficult to procure in the region.
Meanwhile, news emerged that last week, the US FDA had handed India-based generics manufacturer Intas Pharmaceuticals a warning letter outlining several data issues at its side in Sanand. It's quite the list of issues. It’s no surprise that the facility’s products have been placed on an import alert.
And yesterday, we took a(nother) substantial look at Indian pharma's quality crisis. Indian regulators inspected Riemann Labs’ manufacturing unit based in the state of Madhya Pradesh and found violations in good manufacturing practices and good laboratory practices.
Also, Indian authorities’ risk-based inspections covering 162 factories and 14 public laboratories uncovered a long long list of concerns. “Poor documentation, lack of process and analytical validations, absence of self-assessment, absence of quality failure investigation"... there's lots more. It might be easier to list the things they are doing right.
The cherry on this cake was a Bloomberg News story about Synokem Pharmaceuticals. Its cheap generics, especially abortion pills, are used the world over. But more than 30 samples of drugs it has manufactured have failed quality tests conducted by regulators and researchers since 2018. Gates Foundation-funded non-profit DKT International distributes reproductive health products around the world, with Synokem supplying about a fifth of them. But neither DKT nor its funders have done anything in response to concerns about Synokem.
And finally, we had an immersive piece from Nature to give you the full lowdown on antimicrobial resistance and all the tools we have at our disposal to fight it.
Newsworthy
Blackstone wants a piece of India’s Cipla. Late last month, reports emerged of Indian drugmaker Cipla’s shareholders looking to sell part of their stake in the company to strategic investors. Their hope is to revamp the business, enhance capital allocation and improve operational efficiency. US-based private equity fund Blackstone, the largest in the world, wants to get in on this India action. The fund will submit a non-binding bid to acquire a 33.47% stake in Cipla next week. This move will also trigger an open offer for an additional 26% stake of Cipla; with full subscription of this, Blackstone could end up as the owner of up to 59.4% of Cipla. Last month, after that initial report, Cipla shares hit a record high; the company also posted a 45% growth in profit due to very strong sales. At current market value, this deal could end up being India’s largest private equity buyout, with a potential deal size of more than $6 billion.
(The Economic Times)
GSK Nigeria to turn out the lights. GSK has been in Nigeria since 1971. But things haven’t been looking up for the company in the West African country. With increasing competition from local companies and Indian and Chinese imports, its half-year sales this year dropped to 7.75 billion naira, compared to 14.8 billion naira for the same period last year. In 2018, GSK had said that it would scale back its operations in Africa. Instead of marketing medicines, it would adopt a distributor-led model in 29 sub-Saharan African countries.
GSK Nigeria yesterday said that given the cost of living crisis, rising business costs and a shrinking consumer base, it had no option but to cease operations. The company is working with advisors to outline next steps. It plans to submit a scheme of arrangement to Nigeria’s Securities and Exchange Commission; if approved, the scheme will lead to cash being returned to shareholders, barring its parent company GSK UK, which holds a 46.4% stake in the company. GSK Nigeria also announced that the Haleon Group has planned to terminate a distribution agreement and appoint a third-party distributor in the country.
(Reuters)
R&D
Depression --> dementia. If depression wasn’t making you sad enough, this research sure will. In a study published in JAMA Neurology, researchers followed participants from 1977 to 2018, assessing correlations between depression and dementia while adjusting for education, income, cardiovascular disease, diabetes, substance abuse disorders and some other factors. They found that individuals with a depression diagnosis had a 2.41 times higher risk of dementia than those who didn’t have depression. Whether the diagnosis was made in early, middle or late life made no difference to dementia risk. Poor men, they were found to be at a greater risk than women.
(JAMA Neurology)
Microbes against malaria. In another win against mosquitoes, researchers have discovered a naturally-occurring bacterium which can halt the development of the malaria parasite in their guts. Using microbes to control mosquitoes’ disease-carrying capacity isn’t new. The Wolbachia pipientis bacterium has proven to be useful against dengue fever. But a lot of these methods rely on genetically modifying bacteria, a process which comes with its own share of concerns.
In this new study, researchers were able to mess with mosquitoes’ ability to carry malaria without making any genetic interventions. Instead, they found that feeding a bacterial strain called Delftia tsuruhatensis TC1 to mosquitoes reduced the rate at which the malaria parasite infected them. And this also led to reduced transmission rates. Considering mosquitoes only need to eat a little bit of this microbe just once to develop this superpower, we reckon this is just what we need to take on the world’s malaria problem!
(Science)
Understanding STING. The signalling protein STING is important to the human immune system. It detects signs of danger in cells and activates various defence mechanisms in response to them. It achieves this by turning on at least three pathways – one which leads to interferon production, a second which is involved in recycling cell components, and a third which leads to the formation of a complex of proteins which activates inflammatory responses. While the first mechanism was well-understood, the other two weren’t.
That’s where these researchers from MIT and Harvard Medical School come in. They have discovered that STING also serves the function of acting as an ion channel which allows protons to leak out of the cell’s Golgi body. This gives it the unique ability to translate danger signals into ion flow. Considering how important STING is to the immune system, this finding could generate interest in developing drugs to activate or suppress STING activity, possibly to deal with infections, autoimmunity and cancer.
(Science)Â
The Kibble
The dance of dopamine. In a shocking twist of scientific discovery, researchers at Northwestern University have found that dopamine isn't just the "party animal" of the brain, obsessed with rewards. Nope, some dopamine neurons are more into dancing - specifically, they fire up when the body moves, and couldn't care less about rewards. This groundbreaking discovery opens new doors for understanding Parkinson's disease and brings a fresh perspective to the neurology scene. So, next time you feel the urge to dance like nobody's watching, you can thank that subtype of dopamine neurons for not being stuck in the "reward-only" mindset. They're the true rebels of the neurological world, daring to defy conventional wisdom!
(Nature Neuroscience)
Stop digging for gold. In an eye-catching (or perhaps nose-catching) study from the Netherlands, researchers have dug deep to find a connection between nose-picking and Covid. The findings are nothing to sneeze at, with habitual nose miners having a 17% infection rate compared to a 5.9% rate for those who keep their fingers out of the goldmine. While the evidence isn't rock solid, it seems that those who practice nasal excavation might be transferring the virus to their nose's mucosa. Glasses and beards get a clean bill of health, but nail biters are still warned to keep their hands to themselves. Next time you're tempted to go treasure hunting, just remember: Covid might be lurking in the depths!
(PLOS ONE)
Bottom line
A lesson in climate change and health. In the 1990s, two devastating hurricanes in Samoa led to a profound impact on the health and livelihood of the local community, wiping out entire villages and causing dozens of deaths. This tragic experience provided insights into how climate change can exacerbate existing health inequities. A local physician, who grew up witnessing the aftermath of the storms, has since applied her understanding of the connections between extreme weather and disease to her medical practice, emphasising the need to recognise climate impacts in patient treatment. The underfunded and understaffed medical system in Samoa struggles to address these challenges, despite being on the front lines of climate change's health impacts. This experience stands in contrast to more developed Western nations, which are only beginning to recognise and incorporate the health ramifications of climate change into medical education and practice. This story on Grist, while specific to Samoa, illustrates the complex intersection between climate change, public health, healthcare systems, and education, highlighting the urgent need for a globally coordinated response to these interrelated challenges.
(Grist)
Sailing into warmer waters. The oceans have reached their hottest recorded temperature, hitting an average of 20.96°C, surpassing the previous record set in 2016. This warming has serious consequences for the planet's health. Oceans are vital for climate regulation, absorbing heat and producing half of Earth's oxygen, but warmer waters can absorb less carbon dioxide, thus contributing to atmospheric warming. The rising temperatures can also accelerate glacier melting, leading to increased sea levels, and disrupt marine ecosystems by disturbing fish, whales, and other marine species. The broken temperature record has been linked to climate change and the burning of fossil fuels, with some connection to the newly started but still weak El Niño. Experts also emphasise that the oceans are under more stress than ever, from not only warming but also pollution and overfishing. The trend of marine heatwaves is expected to continue, further exacerbating these issues.
(BBC)
Oh, and Gopal Nair doesn't want you to see this.