< PreviousM&A ROUND-UP 10 Pharma Business International www.pbiforum.net AbbVie - Aliada Therapeutics Meanwhile, AbbVie is set to acquire Aliada Therapeutics, a biotechnology company advancing therapies using a novel blood-brain barrier (BBB)-crossing technology to address challenging central nervous system (CNS) diseases. Aliada’s lead investigational asset utilizing this delivery technology, ALIA-1758, is an anti-pyroglutamate amyloid beta (3pE-A?) antibody in development for the treatment of Alzheimer’s disease. Under the terms of the agreement, AbbVie will acquire all outstanding Aliada equity for $1.4 billion in cash, subject to certain customary adjustments. Roopal Thakkar, M.D., Executive Vice President, Research and Development and Chief Scientific Officer, AbbVie, said: “Neuroscience is one of our key growth areas and we are committed to driving innovation in this field to address critical unmet needs for patients living with seriously debilitating neurological diseases such as Alzheimer’s disease. This acquisition immediately positions us to advance ALIA-1758, a potentially best-in-class disease-modifying therapy for Alzheimer’s disease. In addition, Aliada’s novel BBB-crossing technology strengthens our R&D capabilities to accelerate the development of next- generation therapies for neurological disorders and other diseases where enhanced delivery of therapeutics into the CNS is beneficial.” Aliada is advancing therapeutic candidates using its Modular Delivery (MODEL) platform, engineered for high- precision CNS drug delivery. The novel BBB-crossing technology targets transferrin and CD98 receptors (TfR and CD98) which are highly expressed in brain endothelial cells. By engineering highly optimized TfR or CD98 binders, this platform is designed to deliver different types of biological cargoes into the brain, including therapeutic antibodies and genetic medicines such as siRNA. ALIA-1758 utilizes TfR to transport a 3pE-A? antibody across the BBB to enable degradation and elimination of amyloid beta plaques, a pathological hallmark of Alzheimer’s disease. This investigational candidate is currently in a Phase 1 clinical trial to assess its safety and tolerability in healthy participants. Lundbeck - Longboard Pharmaceuticals Furthermore, Lundbeck is to snap up Longboard Pharmaceuticals in a $2.6 billion deal. Longboard is a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases. Its lead asset, bexicaserin, has shown Pharma Business International 11 www.pbiforum.net M&A ROUND-UP encouraging anti-seizure reduction to date in preclinical and clinical studies, with its next-generation superagonist mechanism specifically targeting 5-HT2C receptors, which support bexicaserin’s potential to offer a highly differentiated and best-in-class profile. Bexicaserin is now being evaluated in a global phase III clinical program (the DEEp Program). Charl van Zyl, President and CEO of Lundbeck, said: “This transformative transaction will become a cornerstone in Lundbeck’s neuro-rare franchise, with a potential to drive growth into the next decade. Bexicaserin addresses a critical unmet need for patients suffering from rare and severe epilepsies, for which there are very few good treatment options available. With this acquisition, we continue to execute on our Focused Innovator strategy, transforming the lives of patients suffering from severe brain disorders.” Roche - Poseida Therapeutics Finally, Roche has entered into a definitive merger agreement to acquire Poseida Therapeutics, a public clinical-stage biopharmaceutical company pioneering donor-derived CAR-T cell therapies, in a $1.5 billion deal. Based in San Diego, California, Poseida’s R&D portfolio includes pre-clinical and clinical-stage off-the-shelf (also referred to as allogeneic) CAR-T therapies across several therapeutic areas including haematological malignancies, solid tumours, and autoimmune disease, as well as manufacturing capabilities and technology platforms. The transaction builds on an existing partnership between Roche and Poseida following a collaboration and licence agreement established in 2022, which focuses on developing off-the-shelf CAR-T cell therapies to address medical needs of patients with haematological malignancies. The joint vision of Poseida, Roche and Genentech, a member of the Roche Group, is to deliver the next generation of off-the-shelf CAR-T cell therapies with increased potency and favourable safety at a scale that can potentially reach more patients and enable broad commercial use. Levi Garraway, Head of Product Development and Chief Medical Officer at Roche, said: “This exciting acquisition will allow us to drive further progress in allogeneic cell therapy while leveraging the successful existing partnership with Poseida. We are very encouraged by the early clinical data, and this acquisition builds on our joint progress to catalyse the development of potentially first and best-in-class cell therapies in oncology, immunology and neurology.” These represent just a handful of the deals announced since our last issue, with M&A core to pharmaceutical companies’ continued success. © stock.adobe.com/greenbutterflyEND OF YEAR SUCCESS STORIES 12 Pharma Business Internationalwww.pbiforum.net W hile the COVID-19 pandemic pushed the pharmaceutical industry into the spotlight only a few years ago, setting it up to be the star of the 2020s, the accelerated growth it brought has since waned. Dealing with the effects of this status change, and a drop in government support post- pandemic, 2024 placed a further raft of challenges on pharma businesses, from regulatory changes to high inflation and interest rates, geopolitical uncertainty, supply chain problems, talent shortages and more. It is perhaps no surprise that the year has seen news of layoffs and a need to reduce costs. In these tough conditions, though, resilient businesses have made their mark, pharma has kept making breakthroughs, and transformation has been rife. Research released in 2024 has revealed rapid growth in the market and research environment in emerging economies such as Brazil, China, and India, but the boon for these regions has come with a gradual migration of activity away from other areas, particularly Europe. European involvement in clinical trials, for example, has declined, with fewer developers choosing to test drugs in the region, even though global clinical trials have showcased a welcome increase by 38% in the last decade. A new report by IQVIA for the European Federation of Pharmaceutical Industries and Associations (EFPIA) and Vaccines Europe, shows that the European Economic Area’s share of commercial trials – those sponsored by a pharmaceutical company – reduced from 22% in 2013 to 12% in 2023. On the other hand, China has doubled its number of commercial trials since 2018, now accounting for an 18% share of global commercial clinical trials. Concurrently, R&D spending in China and the US, according to new research published by EFPIA, is outpacing Europe. Potential bright spots appeared in 2024 for pharma in Europe, however, with support for the industry growing. July saw the publication of the Political Guidelines for the Next European Commission 2024-2029, which included a focus on a life sciences strategy and a European Biotech Act to streamline the Looking back at 2024 2024 has certainly been another challenging year, but amidst the doom and gloom there have also been bright spots. 15 ÁPharma Business International 13 www.pbiforum.net END OF YEAR SUCCESS STORIES © stock.adobe.com/AddMeshCubeEND OF YEAR SUCCESS STORIES 14 Pharma Business International www.pbiforum.net © stock.adobe.com/littlewolf1989Pharma Business International 15 www.pbiforum.net END OF YEAR SUCCESS STORIES process of bringing biotech from lab to market. Since then, Denmark and Sweden have themselves launched ambitious new and updated life science strategies. Life sciences are also being backed elsewhere, with the UK’s recent budget including measures to improve its competitiveness, with key announcements being a £520m life sciences innovative manufacturing fund and investment in R&D. As pharma recovers from the many challenges of 2024, public attention is being brought to the industry as drugs like Ozempic and Wegovy hit headlines, alongside global concern over antibiotic resistance and mpox outbreaks. New polling data from the 2024 UK Pharma Reputation Index indicates public familiarity with the industry has reached a high, with one in four of respondents reporting substantial awareness of the sector (in 2020, one in seven had the same level of familiarity). This is an important step with familiarity strongly linked with the longstanding challenge of public trust. There is much work still to be done, however, as despite 71% of members of the public agreeing that the industry produces effective medicines and vaccines, opinions are divided on whether pharmaceutical profits benefit society, meaning better communication is required to inform on how profits fuel future discoveries. Overcoming antibiotic resistance and incentivising new drugs has been a crucial topic this year, and progress has been made as the UK’s NHS pushed forward its Antimicrobial Products Subscription Model after a pilot. The initiative will see the NHS pay an annual subscription fee to companies to access novel antibiotics and simultaneously help overcome the lack of incentives to develop antimicrobials, where due to a need to minimise their use in the face of resistance drug companies cannot rely on sales to gain a return on their investment. Under the Model, pharmaceutical firms are to receive a guaranteed return for access to their products. The scheme will see a drug’s value to the NHS assessed to be placed into one of four bands, attracting subscription fees of £5m to £20m per year for England (access can also be extended to Scotland, Wales, and Northern Ireland). Following the pilot’s subscription contracts for antibiotics with Pfizer and Shionogi, in August the NHS tendered contracts with an estimated value of almost £1.9bn over 16 years for new antimicrobial medicines. Similar approaches are on the cards in other countries, such as the PASTEUR Act in the United States, while the EU is proposing a voucher, where developing a critical antimicrobial extends the patent a pharma company has on another drug. 2024 has additionally seen steps forward in sustainability, as businesses implement Environmental, Social and Governance (ESG) initiatives, improve energy efficiency, invest in renewable energy, greener packaging and waste management, and embrace sustainable sourcing. Uniting the industry in efforts to boost sustainability, in May the World Business Council for Sustainable Development (WBCSD), in partnership with GSK, convened the pharma sector — including AstraZeneca, Bayer, Novartis, Novo Nordisk, Roche and Takeda — to develop a ‘Roadmap to Nature Positive’ offering sector-specific guidance. A draft ‘Overview’ released in October highlights the key nature-related dependencies and impacts of the pharmaceutical sector as well as impactful actions companies should take to drive progress toward a nature-positive future. Actions include reducing water use by establishing sustainable water management practices, reducing pollution risk from active pharmaceutical ingredients through product innovation and education programs, reducing the release of emissions, sourcing responsibly, improving supply chain traceability and transparency, accelerating use of alternative lower impact materials, and reducing solid waste through product design, innovative manufacturing and circular business approaches. Following consultation, the Roadmap is to be published in early 2025. A further area seeing successful strides in the pharma industry in 2024 is Artificial Intelligence (AI), as it streamlines drug discovery, development, data analysis and decision making, amongst other aspects of the sector. With pharma giants unveiling new pacts with AI companies, more AI-designed treatments advancing into the clinic, and firms announcing numerous AI assistants, such as InstaDeep and BioNTech’s Laila lab assistant automating routine and complex tasks, the year also saw the Nobel Prize in chemistry co-awarded to Co- founder and CEO of Google DeepMind and Isomorphic Labs, Sir Demis Hassabis, and Google DeepMind Director, Dr. John Jumper, for their work developing AlphaFold, an AI system that predicts the 3D structure of proteins from their amino acid sequences. David Baker was also co-awarded for his work on computational protein design. AlphaFold has been used by more than two million researchers to advance work from enzyme design to drug discovery and has been hailed as a demonstration that AI will make science faster and help to understand disease and develop therapeutics. Though the pharma industry will continue to face deep-rooted challenges as we enter 2025, there is much to look forward to as innovation continues, new partnerships are established, new technology brings transformation, and novel therapeutics are discovered, trialled and approved.FINANCE AND INVESTMENT 16 Pharma Business International www.pbiforum.net © stock.adobe.com/Anoo Financial Pharma Business International 17 www.pbiforum.net FINANCE AND INVESTMENT instability The markets have been so erratic in the last few months that one has to wonder if the bubble won’t burst in a manner that will be looked back at in the history books. R ussia and Ukraine continue warring while Israel makes enemies of every country around it and natural disasters strike Spain. Meanwhile, Donald Trump wins the presidential election and right-wing politics takes an uncomfortable lurch to the extreme. None of this is good for business at any time but coming off the back of sky-high inflation and now talk of tariffs, it’s likely to send markets into difficult times, especially if you work within the US or Middle East. It’s not a good time for finance in any industry, but at times when people’s bank balances are under pressure, it’s often the case that expensive medicines, and the companies who produce them, come under the crosshairs for what people see as profit-making off life-saving products. And it is. There’s little point pretending otherwise if you’re in the pharma industry. Geopolitical pressure is putting a strain on many countries, most recently of all Israel and Palestine, but before that Ukraine and Russia. Putin’s threats of escalation after utilising an ICBM and bringing North Korea into the mix does not have investor confidence in the Europe (eastern-Europe especially) trending at high levels. Last year we spoke of 18 ÁFINANCE AND INVESTMENT 18 Pharma Business International www.pbiforum.net global-economic uncertainty, and the harsh reality is that it’s only gotten worse in the last 12 months. In the UK, the taxes on the sale of drugs to the NHS have risen to high levels, with the service under incredible stress, and the UK already uses bargaining power to force drugs to be sold to the NHS at low prices. This situation makes it very difficult for smaller pharma companies to compete and raise money. While there are some success stories to be had, such as 1nhaler raising £2 million from angel and seed investors to develop their single-use sustainable inhaler, the fact that they have to seek out investment from individual investors rather than more typical sources is telling. The rules are changing and people are having to seek investment from the ever- increasing wealth of the 1%, likely because a lot of the money that governments and banks and private equity groups would have had before is being syphoned out by those people (and corruption) to pad the pockets of select individuals. Pharma Business International 19 www.pbiforum.net FINANCE AND INVESTMENT © stock.adobe.com/Orhan Çam When other companies are struggling for finance, however, this is often where larger ones swoop in. The struggles of smaller companies to not only raise money but to compete for quality recruits is crippling them and may well be crippling innovation on a global scale. We don’t want to tie money to progress but it’s often the case that high demand draws talent, and there are worries that the financial pressures on the industry may cause investors to back out, which will mean less capital to throw at emerging diseases, potentially pushing back research against illnesses like cancer and heart disease and costing the lives of millions. Pharmaceutical research has never been cheap, but investors are looking for big returns, and with governments across the world imploding with their own dramas and petty squabbles – identity politics and culture wars – it’s hard to say if this will get any better. The industry can only hope that cooler heads prevail, but the US’s next president suggests that won’t be the case.Next >