One afternoon in mid-June, I sat with Ethan*, a local islander, at Nauru’s boat harbour. He was speaking about how life had changed in the country since an asylum deal with Australia. Just a few years before my arrival in 2016, the small Pacific island had once again been financed to process the asylum claims of migrants attempting to reach Australia. If successful, refugees would be resettled locally around the island. Successive Australian governments had taken a tough zero-tolerance approach, making sure that anyone making their way by boat without documentation would “never settle in Australia”.
Not far from where we sat, placards covered the fence of a refugee resettlement compound, reading: “We’re refugees not criminals,” and “Freedom is a Right Not a Crime, We Want Justice.”
“The thing is none of them want to be here,” Ethan explained, “and we don’t know who these people are, they could be dangerous. Why else does Australia not want them?” These fears were echoed to me numerous times in Nauru. “I’m so worried about having the refugee children in our school,” Sandra, a teacher at Nauru’s only secondary school, said on another occasion. “We don’t want to touch or go too close in case they say we hit refugees. And natural things like kids pushing each other on the playground. The next day it’s in the Australian news”. This teacher’s fears were confirmed several months later, with headlines like: “Nauru Government Denies Refugee Children Are Abused in Schools.”
Such accusations of savagery against refugees draw on colonial tropes of Pacific islanders as cannibals. Major global media outlets have alleged that Nauru was a veritable heart of darkness, an “island of despair”, where refugees are “hacked with machetes” by the local population.
These sorts of representations have created a fractious context locally: one produced by sending asylum seekers, many with devastating pasts, to a vastly different region of the world from their intended destination.
The UK Rwanda policy
In January 2023, the UK’s High Court ruled on the lawfulness of the British government’s plan to deport asylum seekers to Rwanda. Under this £140 million agreement, undocumented migrants could find themselves sent to the East African country – 4,000 miles south-east of where they lodged their asylum applications. Once in Rwanda, they will have their asylum claims processed, and will be eligible for residency, not in the UK – their original destination – but in Rwanda.
The European Court of Human Rights (ECHR) in Strasbourg is expected to rule on the controversial policy by the end of the year. This proposed “outsourced” asylum policy directly mimics Australia’s so-called “Pacific Solution”, the impacts of which I have examined in my research. Since Australia’s Liberal prime minister, John Howard, at the turn of the century, boat arrivals have been the basis for copious media attention and resultant public anxiety in Australia. Controversial offshore policies in small Pacific islands like Nauru, combined with high-profile military and naval operations, are intended to reduce the number of people crossing the Indian Ocean.
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Now, like successive Australian politicians, UK Prime Minister Rishi Sunak is promoting the UK-Rwanda policy as a means of “stopping the boats”, but this time those crossing the English Channel from northern France. Just as Australian politicians stoked public anxiety, pursuing media attention and electoral gains, Suella Braverman, the UK home secretary, has called migrant boats from Calais “an invasion on our southern coast”. She also said: “I would love to have a front page of the Telegraph with a plane taking off to Rwanda, that’s my dream, it’s my obsession.”
I conducted long-term fieldwork in Nauru into the effects of the Australian government’s near AU$10 billion (about £5 billion) arrangement. I have also led anthropological fieldwork projects into similar outsourced asylum measures in regions as diverse as Guatemala, Jordan and Lebanon. What falls outside the global media headlines, from all sides of the political spectrum, is how these policies are realised in practice and whether or not they actually work.
I have interviewed migrants claiming asylum, as well as local residents, private security contractors and government officials. I found that these outsourcing schemes create a refugee industry economy that local populations become dependant on. For the asylum seekers and refugees, most with devastating pasts and equally hazy futures, being castigated to far off places not of their choosing all too often led to tragic instances of self-harm and suicide. In Nauru, the friction between different populations were apparent on a daily basis.
Australia’s ‘Nauru experiment’
The boat harbour is a popular spot for Nauruans and refugees alike. It is one of the few places where you can swim safely without the threats of currents or the jagged limestone pinnacles that pierce through the island’s coastal waters. It is also a place where I have long conversations with asylum seekers down from the island’s Regional Processing Centres (RPCs). The RPCs are tucked deep in the heart of coral atoll’s jungle. Many asylum seekers take advantage of the afternoon open centre hours at the RPCs to catch a bus down to the boat harbour.
“No, I can’t swim, but I just like to come here because it’s cooler than at the centres. The heat sticks to you up there,” Khadija, an Iranian asylum seeker says to me. “In Iran, we never have this kind of heat.”
Like the majority of Nauru’s new refugee population, Khadija stands out. She’s 20 and most of her life has been spent in Tehran then Jakarta: cosmopolitan, urban hubs at odds with small Pacific island climes. She, as with so many other asylum seekers I speak with in Nauru, took a boat from Indonesia in the hopes of reaching Australia to claim asylum. The financial cost and possible dangers were enormous. It cost AU$10,000 (just over £5,000) for the boat alone, she tells me. But she and her sister were escaping extreme domestic abuse.
Not far from us, on the concrete walls of the boat harbour, sit a group of Nauruan Community Liaison Officers, also dressed in distinctive fluorescent vests. They are tasked with dealing with conflicts that arise between refugees and locals now that refugees are being resettled on Nauruan visas around the island. Our conversation moves to some of these conflicts. Khadija tells me:
I have Nauruan friends, but no, I don’t want to be here. I’d never heard of Nauru before I came here. I was scared, I didn’t know where they were taking me.
Abdul, a friend of hers, catches wind of our conversation as he dries himself off with a towel nearby. “I don’t think anyone had heard of this place! I mean, why would we want to come here? It’s a dump!”
“Well, a lot of Nauruans have been kind, but there are no jobs here for us here. How can we set up lives? No one wants to be here,” Khadija says, worry lines coursing her face.
We speak about the latest Guardian Australia media report of Nauruans beating up a refugee. Abdul has a lot to say on the matter: “You never know. Sometimes it’s true, there are fights that happen. Sometimes it’s desperation. Refugees trying to bring media attention to their situation. This is all expected. Send people to a very different part of the world where they don’t want to be and see what happens.”
Khadija interjects: “And refugees here will also do anything to get to Australia. You can’t send people somewhere so different and not expect them to protest. It’s not nice for the Nauruans, but a lot of refugees don’t care about that.”
I think of the placards covering the fence of a nearby refugee resettlement compound and the doors of the Australian-funded refugee businesses (largely beauty salons and takeaways) that are all firmly closed in protest. I had been in conversation earlier that week with a group of Nauruans working at the RPCs, who had told me of “shit smeared on the walls” and “taps left on” from asylum seekers in desperate protest. Only a few years before I arrived in Nauru, one of the RPC buildings had been burned to the ground.
“It’s not just between locals and refugees,” points out Khadija. “It’s also between refugees, of course. I’m Shia. My sister and I were put together with someone who’s Sunni. They made life difficult for us. They had to move us to a different section.” Abdul nods, adding: “There was one guy who had to be moved to separate hotel accommodation because it got so bad.”
Secrecy, violence and segregation
The kind of secrecy, violence and segregation that Khadija and Abdul speak of underpins daily life in Nauru. Around the island, the destructive realities of outsourcing asylum are palpable.
Aziz, an Iraqi refugee, living in resettlement accommodation, tells me of the cries when he goes to sleep at night:
I hear my neighbour through the walls, I don’t know what he saw before he came to Nauru.
Marie, an Australian torture and trauma counsellor, told me “you can’t begin to help people work through trauma when it’s exacerbated by being in Nauru”. She says Nauru has never had the capacity or the infrastructure to effectively support asylum seekers and refugees.
Marie’s latter point is one I’ve heard several times. Prior to the Australian arrangement, Nauru had no history of refugee processing or resettlement. To make this outsourced arrangement a reality, the Australian government funded fly-in-fly-out Australian counsellors in addition to asylum legal support, interpreters, refugee adjudication and appeals tribunals, education and medics. However, counsellors like Marie were largely ineffective – palliative at best. Asylum seekers I spoke with described experiencing overwhelming powerlessness, depression, and identity crises because of the offshore arrangement.
Industry contractors I spoke with recounted similar stories of human suffering. Sarah, a facility manager from the Australian corporate management firm, told me of her recurring nightmares, having witnessed asylum seekers sewing their lips together in her work at the RPCs.
Vivian, a mental health counsellor to the Australian Immigration Department, made the damaging toll of working in Nauru explicit in our interview. She said:
The compromises that people are in, and every day going to work to do bad things to others is making them feel ill. I had a client who had breast cancer who said to me, ‘I believe that I will be punished for what I’m doing by getting my breast cancer back.’ It’s a toxic environment and it sends people mad.
Trevor, a security guard at the RPCs, described the hunger strikes he tried to resolve: “But it’s not just hunger strikes,” he added, visibly upset.
Self-immolation, self-harm, riots, arson, suicide, jumps from roofs, sewing lips. Asylum seekers are desperate not to be here and so many of them have been through all kinds of traumatic experiences I can’t even imagine before being sent here.
Sarah and Trevor are just some of the many industry contractors I spoke with who bear the scars of witnessing these devastating situations. In fact, lawsuits from past contracted Australian workers to Nauru still plague the Australian government.
Many locals were initially sympathetic to the plight of refugees. However, over the years, this sympathy turned to anger as Nauruans contended being represented as savages and human rights abusers in parts of the media and by certain refugee solidarity activists. “Look at this stuff they write … They haven’t even been here,” says Oliana, a Nauruan government worker.
A growing trend
The kind of outsourcing arrangement between Australia and Nauru seems outlandish, but it is not unique. It is part of a model of wealthier western countries funding poorer countries to carry out border enforcement. Australia is often cited as a case study of outsourcing asylum, but this system has historical precedents.
Asylum as a formal international legal procedure was institutionalised across the early 20th century. European governments sought increased control over the demographic makeup and political structure of their nation states. Some feared disproportionate numbers of undocumented migrant arrivals. It was in this climate that the international refugee agency – a precursors to the United Nations High Commissioner for Refugees (UNHCR) – pioneered systems of so-called burden-sharing.
In the early 20th century, the Nansen Office and Intergovernmental Committee on Refugees spearheaded moving refugees (largely Russians, Armenians, and Greeks) between countries. Just a few decades later, huge numbers of Jewish refugees sought to escape the atrocities of the second world war. Many European countries refused to provide sanctuary to Jewish refugees, referring to the “Jewish problem”.
Instead, countries as far flung as the Dominican Republic and Ecuador promoted themselves as destinations for Jewish refugees to attract political and economic support. The International Refugee Organization - UNHCR’s precursor, active between 1946-1952 - took this system of burden-sharing to new heights, relocating more than a million refugees from Europe to the Americas, Israel, South Africa and Oceania between 1947 and 1951.
As asylum seekers changed from eastern Europeans to Africans and Asians from the 1970s, the term “asylum seeker” attracted negative connotations in western political and media discourse. It became shorthand for economic opportunism, mass movements and threats to security. Tough measures on asylum, including intercepting migrants before arrival, soon become a touchstone for left and right-leaning governments alike.
Outsourced asylum models have since been adopted across the EU. There are agreements with eastern Europe, Turkey, north and East Africa, and Central Asia. The US has experimented with several of what are termed extra-territorial asylum processing schemes, including processing Haitian asylum seekers in Guantanamo in the 1990s, establishing facilities to assess asylum claims across Central America, funding local advertisements to dissuade migrants, as well as financing border enforcement and national asylum systems across Mexico and Central America.
Many Asian countries, including China, Japan, South Korea and Taiwan have implemented restrictive detention and temporary visa practices for African migrants, in particular. So-called transit regions, such as South Asia, eastern Europe and North Africa have also seen significant levels of funding and resources going into policing, detention, and other forms of immigration control.
The UK has toyed with different externalised border enforcement measures over the years. The Rwanda deal is one such arrangement. Sunak has said that he will do “whatever it takes to make the Rwanda plan work”, describing “illegal migration” as an “emergency”. In June 2022, the first flight of four asylum seekers from the UK to Rwanda was blocked after an injunction from the ECHR alleged it was a violation of civil and political rights.
Others question the efficacy of the £140 million Illegal Migration Bill that is designed for only a small number of asylum seekers: the Rwandan government has agreed to receive 200 asylum seekers a year across a five-year trial period. Meanwhile, Braverman has declared that relocating people to Rwanda is a “ground-breaking migration and economic development partnership” and “an innovative way of addressing a major problem” of “billions of” people coming [to the UK].
Anti-migrant protests outside asylum seeker housing in Knowsley and Dover in the UK have also led to concerns that the Conservative government is capitalising on xenophobic sentiments. As legal debates continue around the legitimacy of the arrangement, Sunak has put together legislation that would disallow anyone reaching the UK to claim asylum without prior clearance.
The legislation would extend the government’s ability to detain them beyond the current permissible 28 days. It would also enable their deportation to a third country, such as Rwanda – the only country that has agreed to such a strategy. The former home secretary, Priti Patel, attempted deals with countries including Ghana and Kenya, which were rejected locally.
But Rwanda has yet to experience the implications of the deal. Rwanda does have a recent failed history of taking asylum seekers through a similar arrangement. In agreement with Israel’s Netanyahu government, Rwanda received some 4,000 Eritreans and Sudanese between 2014 and 2017. At the time, Netanyahu marshalled a similar narrative steeped in racial bias around the country’s mistanenim or “infiltrators”. Israel paid the Rwandan government US$5,000 for every asylum seeker, each of whom received US$3,500 and their airfare. Almost all are thought to have left the country immediately. Yet, unlike the proposed UK-Rwanda deal, this coerced voluntary deportation scheme did not involve a long-term asylum processing and resettlement arrangement. Such a proposition presents far greater concerns: ones raised not just in Nauru but also across my other fieldwork sites.
US and Guatemala: conflicting refugee histories
Flores is a picturesque island village in Guatemala’s northernmost Petén region. Located deep in the jungle in Lake Peten Itza, it is a place where the concept of claiming asylum to – not from – was little heard of prior to 2010. I am sitting in Flores’ main church square for World Refugee Day in June 2022. It is a new event for the island, put together by UNHCR’s new Petén field office, to socialise Guatemalan residents in refugee protection. Under the slogan “Reborn in Guate”, UNHCR has devised a day-long programme of art, folklore, dance, music and poetry.
“We have to be careful with using the word refugees,” whispers Alessandra, a UNHCR official, as a group of young Honduran rappers take the stage. “Many people, particularly Indigenous Maya, still have such vivid memories of when they were refugees. We don’t want it to seem like anyone’s getting preferential treatment or that they accuse our new refugee arrivals of gaming the system”.
This goes back to Guatemala’s four decade-long civil war. From the 1950s to the 1990s, genocidal policies claimed the lives of hundreds of thousands of Indigenous Maya, or Maya Q’eqchi’. During this period, the US provided counter-insurgency training and military supplies to Guatemalan military and police, which heightened the escalation of violence.
In Santa Elena, just across the causeway from Flores, I have a long conversation with a local fruit market vendor, Estella, about this time. She was a young girl when the civil war broke out. Caught in the gunfire between guerrilla forces, she and her family, like so many Maya Q’eqchi’, eventually crossed the border to Mexico in the 1980s in hopes of survival. After nearly a decade living in different refugee camps in southern Mexico, she eventually returned to the Petén as a middle-aged woman in 1995, not long after the peace process negotiations.
“Most of my life, I was in fear of the military finding my family,” she says. “We moved between refugee camps in Mexico, almost every year it felt like. Chiapas, Campeche, Quintana Roo,” she slowly counts the different states on her fingers, adding:
We never knew if the Mexican government was on our side or if we might be handed over to the Guatemalan army. The Guatemalan army was always coming into Mexico, looking for guerrilla soldiers in the camps. We knew that if they found us, we would be killed without any mercy, we’d seen this happen to others.
All those years spent living in exile in refugee camps before returning to the Petén, gives Estella pause when discussing the new refugee programmes. “It confuses me. These people aren’t refugees. They haven’t been through the kind of suffering we have,” she says. “Many Maya never got their land back and still live as refugees in Guatemala. They have all these programmes for the new refugees, and make such a big deal about them, they even get a month of accommodation, but we Maya experience so much inequality that has never been resolved.”
Guatemala still has one of the most unequal systems of land tenure in the world. The violence of the civil war resulted in the loss of livelihoods for many Maya, including huge unemployment that lingers to this day. Oil palm plantations, taking over great swaths of north-eastern Guatemala that are home to Q’eqchi’ communities, are continuing to fuel displacement. Substantial numbers of Guatemalans are also deported back from the US and Mexico each year (almost 100,000 migrants in 2022 alone), compounding these tensions.
It is for this reason that the Guatemalan government avoids calling resettled regional migrants refugees. Officials I speak with at Guatemala City’s Migration Institute emphasise avoiding the term. Not only does it evoke traumatic memories for many, but the government fears public perceptions of preferential treatment of US-funded, regional refugees.
Yet, Guatemala is visibly promoting itself as an asylum destination, as the World Refugee Day celebrations make clear. In our conversation, Estella references the posters that cover Santa Elena’s central bus station. At her recommendation, I go to look at the almost tourist-style advertisements that stretch dramatically across the façade of the arrivals hall. One is fringed with stick figures of people running for safety and the logos of UNHCR and El Refugio de la Niñez, Guatemala’s national refugee support agency. At its centre, it features a family holding hands as they clamber over train tracks. In large blue font, with the words “danger”, “protection”, and “refugee” highlighted, it reads:
“If your life is in danger, and you cannot return to your country, you can ask for protection as a refugee in Guatemala. We can help you!”
Around another corner in the terminal, signs point towards a small office, the Attention Centre for Migrants and Refugees. Inside, I see a small team of Guatemalan social workers with leaflets explaining the process of claiming asylum in Guatemala.
These efforts constitute the US’ latest outsourced asylum strategy. As part of a regional approach begun in 2017, known as the Regional Comprehensive Protection and Solutions Framework (or its Spanish acronym MIRPS). Guatemala, together with Mexico and other Central American countries (Belize, Costa Rica, El Salvador, Honduras and Panama) is steadily developing the capacity to receive and support asylum claims in the country. Santa Elena is a way station for Honduran migrants making the long journey up to the US. Heightened US-funded border enforcement further south along Guatemala’s main land borders has also pushed more people to pass through the northern Petén border, where I conducted my research.
Migrants are encouraged to claim asylum for Mexico or Central America, rather than making their claims to the US. Limitations at the US-Mexico border, combined with the exorbitant costs and danger of making the crossing undocumented, are pushing more migrants to applying for asylum regionally. Claiming asylum in Guatemala or other third countries might soon be a legal requirement. In 2023, the US Supreme Court issued a hotly contested proposed rule known as the “transit ban” – asylum seekers who pass through a third country en route to the US-Mexico border must claim asylum there first.
But very few migrants are interested in claiming asylum locally. Like the UK-Rwanda deal, the US plan also functions largely as spectacle. Although the numbers of asylum claims filed to Guatemala’s new National Commission for Refugees is increasing, only 634 refugee visa holders and 1,410 asylum-seekers reside in Guatemala.
Memories of exile
Estella’s confusion at the visible effects of outsourcing asylum in Guatemala foreshadows additional dynamics that the UK-Rwanda deal might produce. Like Guatemala, Rwanda is also a country with a tragic history of producing refugees. The 1994 Rwandan genocide led to the massacre of next to a million people. Horrific numbers of women were sexually assaulted. Over two million Rwandans fled to neighbouring countries in Africa’s Great Lakes region including Tanzania, Uganda, Burundi, and the Democratic Republic of Congo (DRC). Following the end of the civil war, an estimated 1.3 million Rwandan refugees returned after over two years in exile. As with Guatemala, memories of exile and return are ever-present in Rwanda. Outsourcing asylum to regions with pre-existing local refugee populations can incite the tensions voiced by Estella and others I spoke with.
Unlike Guatemala, Rwanda does have a history of formal refugee protection outside of the return of its own citizens. Almost 164,000 refugees live in refugee camps or urban areas in Rwanda. However, these refugees are from surrounding East African regions, such as the DRC and Burundi. Those asylum seekers who have received notices of intent from the UK Home Office (making them at risk of being sent to Rwanda) are largely from the same countries as those I met in Nauru: Afghanistan, Iran and Syria. These are countries that are ethnically and linguistically distinct to Rwanda.
Even in the US asylum arrangement with Guatemala, most refugees given residency there are from surrounding Spanish-speaking countries. Here, the emphasis is on developing a viable regional resettlement framework. That the UK is considering sending asylum seekers from far different regions to a country still raw from its own refugee dynamics does not bode well. It was the cultivation of ethnic hierarchies between Tutsis and Hutus under Belgian colonial rule that resulted in the 1994 Rwandan genocide in the first place.
A toxic policy with little returns
My fieldwork findings from Nauru and Guatemala paint a bleak picture of the impacts of outsourcing asylum, relevant to the UK-Rwanda arrangement. The British government is setting up for similar entrapment in a costly operation, totals that in Australia financially spiralled to an estimated AU$9.65 billion (over £5 billion) since July 2013.
Rwanda is a country that, unlike the UK, does not have a substantial Middle Eastern diaspora. The Rwandan government will require enormous investment to support new populations from well outside the East African region. The British government – and ultimately taxpayer – will end up shouldering these costs. Sustaining the operations in the face of ongoing activism and High Court pushbacks will require evermore Rwandan investments to ensure its international legal compliance. Rwanda, like Nauru, will have major challenges to contend with too, including education, social integration, housing capacity, and mental health and trauma-related concerns.
As a migration governance strategy, the UK-Rwanda deal makes little sense. It will cost the British taxpayer far more than the economic and social benefits of integrating the small number of migrants into the British workforce.
Since the post-war era, international migration worldwide has remained stable, as a percentage of the global population it stands at 3.6%. This is a fraction of the world’s population, meaning that most people migrate within countries, rather than across borders. The majority of irregular migrants to the UK are visa over-stayers and not those who take a boat across the English Channel. Typically, it is also not the poorest people who migrate. Taking a boat is an expensive endeavour and migrants require considerable resources to migrate, particularly across international borders.
‘A laboratory experiment gone wrong’
A new deal was finally struck for Nauru after almost a decade of indecision as to how to end the arrangement. It came amid a backdrop of deepening civil unrest, a series of tragic self-immolations, and a Guardian Nauru Files campaign that made global headlines. The Australian government arranged with the Obama administration a deal in which 1,250 refugees from Nauru and Manus Island would be resettled in the US.
These resettlement places were still honoured when Donald Trump entered office in 2016, as part of what Trump notoriously described as the “dumb, dumb deal”. Hamid, an Afghani refugee acquaintance in Nauru, sent me an email at the time. He expressed his excitement about his upcoming move to the US, but also his fear at the racism he might encounter. Like Hamid, most refugees have since been resettled across the US, Canada, and eventually through the long-standing New Zealand offer. But 60 refugees remain in Nauru, with the country still marred in refugee protests locally.
Heated debates continue in Australia. In March, the Albanese Labor government, the Liberal Party and the One Nation Party voted against the Green Party’s Migration Amendment Evacuation to Safety Bill 2023. This bill called for those refugees held in Nauru to be moved to Australia, while the Australian government pursued further resettlement options.
Nauru remains funded by the Australian government with the possibility that these operations might be restarted in the future. In October 2022, the Australian government awarded an AU$422 million (roughly £230 million) contract with the US-based private prison contractor, Management and Training Corporation, until September 2025 to hold refugees in Nauru.
Instead of debating the legitimacy of asylum, countries could benefit from providing work rights to migrant populations. The UK is well prepared for meeting these integration needs. Because of centuries of migration (much wrought through colonialism) the UK has already invested significant resources into supporting newcomers keen to integrate into the labour market. The Oxford Migration Observatory recently found that higher net migration reduces pressure on government debt over time. Incoming migrants are generally younger and of working age than the wider population. This means that they are more likely to work and contribute to public finances.
Not only is this shown to support migrant livelihoods, but it can also benefit the economies of sending and receiving countries in the long-term. These kinds of boosts to the economy and the labour market are much-needed in the post-COVID-19 and post-Brexit labour environment.
Back to 2016 and I am sitting in a senior Australian bureaucrat’s office in Canberra, discussing the standstill underway with the Nauru arrangement. I ask what the future holds for the offshoring policy. “Most politicians want it to end, but they’re unsure how to do it without losing face,” he replies.
Protests, many refugees on suicide watch, hunger strike, people sewing their lips together, no one interested in integrating locally in Nauru, it frankly just isn’t sustainable. It was never meant to be.
He pauses, adding: “Not to mention, ethically. It’s a laboratory experiment gone wrong.”
All names have been changed to protect the identities of those involved.
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Julia Morris does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.depression unemployment covid-19 government debt army trump treatment therapy unemployment oil south korea iran africa mexico japan canada european europe uk france eu china
NYC biotech LB Pharmaceuticals eyes $75M for new take on decades-old schizophrenia drug
As Karuna Therapeutics wraps up its FDA approval request for what could be the first new type of schizophrenia drug in decades, another East Coast biotech…
As Karuna Therapeutics wraps up its FDA approval request for what could be the first new type of schizophrenia drug in decades, another East Coast biotech is raising $75 million to test an adjusted version of a decades-old medicine for the disorder next year.
LB Pharmaceuticals has secured about $35 million so far and expects another $40 million in the round, according to an SEC filing on Thursday. Per the financial document, its board includes directors associated with Vida Ventures, Pontifax, Deep Track Capital and TCGX, a crossover firm that has invested in multiple nine-figure biotech financings in recent months, including Carmot Therapeutics, Alkeus and Upstream Bio.
LB declined to comment.
The New York City biotech plans to run a Phase II trial of a chemically differentiated form of amisulpride, a D2 and D3 antagonist that has been available in Europe and more than 50 countries for decades, according to an investor deck from June. Sanofi marketed it as Solian, which generated €135 million in sales in 2002 for the French Big Pharma. It’s since become available as a generic.
LB’s board includes Piero Poli, CEO of Swiss drugmaker Rivopharm, which produces generic amisulpride. In February 2020, Acacia Pharma secured FDA approval for an IV formulation of amisulpride in certain postoperative patients with nausea, marketing it as Barhemsys.
With its methylated version of amisulpride, LB says its oral asset LB-102 has the potential to be more effective at lower doses by improving blood-brain barrier permeability, per the investor deck. Its new chemical structure gives LB-102 IP protection until “at least 2037.” LB has positioned the drug as a blockbuster treatment that could generate $1 billion or more in annual sales, pointing to antipsychotic prescriptions in the EU with an average price of $2,000 per month.
The drug is set to go into Phase II testing in adults with acute schizophrenia in the first quarter of next year, per the June document.
The company expects to enroll about 350 people at 25 sites, testing whether three doses of the drug are better than placebo based on the commonly used schizophrenia clinical trial measure known as PANSS, or Positive and Negative Syndrome Scale. Karuna’s M1/M4-preferring muscarinic agonist KarXT has passed two Phase III trials that use that measure, leading to massive financing hauls for the biotech and Cerevel Therapeutics. Boston-based Karuna plans to submit its approval request to the FDA this quarter. Meanwhile, Sumitomo and Otsuka’s ulotaront failed a Phase III on the PANSS test two months ago.
LB expects the study to focus on in-patients for four weeks. Pending the mid-stage results, the company would likely then take LB-102 into multiple Phase III trials in 2025, with plans to submit an NDA in 2028, per the June presentation. The company sees schizophrenia as the first step, with potential for studies in depression, bipolar depression and other indications.
The drug developer is led by a former family office manager, CEO Zachary Prensky. LB’s medical chief is Anna Eramo, who previously ran clinical and medical affairs at Lundbeck’s US operations and worked on the development of Rexulti, approved for schizophrenia and other indications. Science chief Andrew Vaino and chief financial officer Marc Panoff were previous executives at Retrophin.
Prensky co-founded LB with Vincent Grattan, a pharmacist who came across amisulpride in the 2000s while working on medication managements in multiple prisons. “As many are aware, correctional facilities are de facto mental health hospitals, and I wanted to make sure we were stocking the most reliable medications,” he told Psychiatric News in 2021.depression treatment testing fda medication europe eu
Dana-Farber, Brigham breakup could lead to a ripple effect for CGT clinical trials for cancer
Dana-Farber Cancer Institute announced on Sept. 14 that it is securing a new joint venture with Beth Israel Deaconess Medical Center, marking a breakup…
Dana-Farber Cancer Institute announced on Sept. 14 that it is securing a new joint venture with Beth Israel Deaconess Medical Center, marking a breakup of its decadeslong adult cancer care partnership with Brigham and Women’s Hospital.
The news shocked Brigham, which had been negotiating a partnership extension with Dana-Farber for the past 15 months, according to the Boston Globe.
There are around 20 ongoing cell therapy clinical trials under the Dana-Farber Brigham Cancer Center, which comprises 12 treatment centers with experts from Dana-Farber and Brigham working together. Brigham also has its own gene and cell therapy institute and a lab dedicated to next-generation, genetically-modified CAR-T cell therapies for cancer.
With the Dana-Farber contract set to end in 2028, concerns have been raised about the impact on current cell and gene therapy (CGT) studies and ones that are scheduled to start, due to the complex nature of the treatments involved.
Manufacturing CGTs is a skill- and labor-intensive process. Ori Biotech CEO Jason Foster told Endpoints News that hospitals and research centers often work together to make them on-site for clinical trials, with highly skilled experts from the specialty centers playing a key role. UK-based Ori develops technologies that automates CGT manufacturing.
At Dana-Farber Brigham Cancer Center’s cellular therapies program, cells are processed at an outside commercial facility or at the Connell and O’Reilly Families Cell Manipulation Core Facility.
When such partnerships come to an end, “that kind of [specialist] knowledge loss is something that will impact both the trajectory of [CGT] trials, but also the time it takes to get these products to patients,” Foster added.
These potential negative impacts on trials would only compound preexisting barriers to access to CGTs, including high costs and lengthy manufacturing processes. Estimates suggest that 25% of patients die while waiting for CAR-T treatments, according to ASCO Post.
Lee Buckler, senior vice president of advanced therapies at Blood Centers of America, told Endpoints in an email that collaboration between research institutes and healthcare providers was of significant — if not critical — value to the testing of CGTs.
A Brigham spokesperson said that the hospital is one of the largest recipients of NIH funding and does not expect any changes to trials already under agreement, adding it would continue to be a leader in the CGT space. “We are also planning for a new, state of the art Brigham facility which will include the medical oncology specialty,” the spokesperson said.
Dana-Farber did not respond to Endpoints before deadline.
Problems with CGT trials could be both the cause and the effect of partnership breakdowns. Buckler said that general hospitals are often reluctant to facilitate the kinds of clinical trial protocols associated with innovative CGTs, which may drive research centers to align with partners more willing to prioritize them.
Under the new partnership with Beth Israel, Dana-Farber plans to create a free-standing state-of-the-art cancer hospital, which it said would have the flexibility to “incorporate the innovations and technology in cancer care that Dana-Farber’s and BIDMC’s researchers and clinicians are developing every day.”
But a dedicated cancer hospital is not necessarily better at carrying out CGT trials than a general hospital with a tightly-integrated cancer specialty.
“I’ve seen general hospitals with tremendous capabilities and specific hospitals with tremendous capabilities — it really depends on the particular hospital,” Orgenesis CEO Vered Caplan told Endpoints in an interview. Germantown, MD-headquartered Orgenesis rolls out CGT mobile processing units and labs for cancer treatment to hospitals.
Regardless, the breakup means Dana-Farber must convince patients that its program with Beth Israel will provide at least the same quality care as the Brigham partnership, while Brigham must rebuild its specialist capabilities without Dana-Farber expertise.treatment testing clinical trials therapy uk
Zelensky Departs Washington Mostly Empty-Handed Amid Mood Shift In West
Zelensky Departs Washington Mostly Empty-Handed Amid Mood Shift In West
By all accounts, Zelensky came away from his Washington visit with…
By all accounts, Zelensky came away from his Washington visit with nothing new. Biden did announce a fresh $325 million aid package for Ukraine from already committed funds, but the hoped-for long range missile approval never came (however, more cluster bombs are being sent). And as we detailed Thursday, House Republican leadership once again failed to move forward on a mere procedural vote for the Pentagon funding bill, due in large part to GOP members rejecting Biden's proposed $24 billion more in Ukraine aid.
Thursday's package announced by Biden, as Zelensky visited the White House and Capitol Hill, was run-of-the-mill and entirely to be expected. "Today I approved the next tranche of U.S. security assistance to Ukraine including more artillery, more ammunition, more anti-tank weapons and next week, the first U.S. Abrams tanks will be delivered to Ukraine," Biden said.
As for the earlier in the day (Thurs.) meeting with Congressional leaders, House Speaker Kevin McCarthy explained when asked why the Ukrainian leader's request to address Congress was denied, "Zelensky asked for a joint session, we just didn't have time. He's already given a joint session."
Instead in a closed-door meeting, Zelensky later acknowledged he discussed with lawmakers "the battlefield situation and priority defense needs."
But if there is any level of consolation for Kiev, it's seen in the Pentagon announcement which came late in the day Thursday. Facing potential US government shutdown on Oct.1st, given at this point Congress is not expected to pass the 12 appropriations bills needed to fund government operations before next fiscal year, the Pentagon has said it will exempt its operations supporting Ukraine from a shutdown.
The military typically suspends any activities not deemed vital to national security during government shutdowns, thus the DoD is in effect saying Ukraine aid remains "vital to national security".
"Operation Atlantic Resolve is an excepted activity under a government lapse in appropriations," Pentagon spokesman Chris Sherwood told Politico, in reference to the operational name still used for actions supporting Kiev.
But Politico points out a potential shutdown would still negatively impact US support to Ukraine:
Sherwood noted that while DOD’s activities related to Ukraine will continue, furloughs and other activities halted under the shutdown could still have a negative impact.
"Training would happen, but depending on whether or not there were certain personnel that were not able to report for duty, for example, that could have an impact," said Pentagon spokesperson Brig. Gen. Patrick Ryder on Thursday.
This Pentagon exemption to keep Ukraine-related support active during a government shutdown seems to be the only significant thing Zelensky came away with.
Zelensky visited the US in person, made a speech at the UN, and came home with an amount of ammo so small the Pentagon won't give numbers and a handful of the worst air defense systems currently in use by a major power.— Armchair Warlord (@ArmchairW) September 22, 2023
In the Army we called this "getting thrown under the bus." pic.twitter.com/f8hFVstDud
It appears to have been the main object of discussion when Zelensky met with Secretary of Defense Lloyd Austin in Washington during the trip. The Pentagon said this was "to reaffirm the steadfast US support for Ukraine."
Meanwhile, Bloomberg takes note of Zelensky "showing the strain" amid increasing divisions among allies:
The Ukrainian president allowed a dispute with one of his biggest allies to spin out of control at the United Nations General Assembly this week, and that’s just a hint of the tensions building behind the scenes.
Zelenskiy has been leading his country through Russia’s brutal assault for 19 months, all the time fighting on another front to wring the weapons and finance he needs from his US and European supporters. Now he suspects that President Joe Biden’s commitment is wavering and other leaders may be taking their cue from the US, according to a person who met with him recently.
He grew very emotional at times during that discussion, the person said, and was scathing in his criticism of nations that he said weren’t delivering weapons quickly enough.
Washington's lackluster greeting of Zelensky this week (compared to how he was received in December 2022) came simultaneous to Poland declaring it will no longer arm Ukraine, amid a fierce diplomatic spat over blockage of Ukraine grain imports by Warsaw, to protect Polish farmers.
The Economist is also taking note of the significant mood shift among Western allies...
A "long war" indeed... given a G7 leader from a European country has told reporters this week that the West is prepared for a years-long war, something likely to last some six or seven years, according to the quote.
"A senior official from one European G-7 country said the war may last as much as six or seven more years and that allies need to plan financially to continue support for Kyiv for such a long conflict," Bloomberg wrote.
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