< PreviousM&A ROUND-UP 10 Pharma Business International www.pbiforum.net chronic kidney disease. The $1.8 billion acquisition will bolster AstraZeneca’s cardiorenal pipeline by adding CinCor’s candidate drug, baxdrostat (CIN-107), an aldosterone synthase inhibitor (ASI) for blood pressure lowering in treatment- resistant hypertension. Baxdrostat represents a potentially leading next- generation ASI as it is highly selective for aldosterone synthase and spares the cortisol pathway in humans. The opportunity also brings the potential for combination with Farxiga and complements AstraZeneca’s strategy to provide added benefit across cardiorenal diseases, where there is a high unmet medical need. Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca, said: “Acquiring CinCor supports our commitment to cardiorenal disease and further strengthens our pipeline with baxdrostat. Excess levels of aldosterone are associated with hypertension and several cardiorenal diseases, including chronic kidney disease and coronary artery disease and being able to effectively reduce this would offer a much-needed treatment option for these patients.” Marc de Garidel, CEO, CinCor, said: “We are excited about the proposed acquisition of CinCor Pharma by AstraZeneca as we believe it offers the prospect of accelerating the development timeline and expanding the breadth of benefits patients with cardiorenal diseases might obtain from baxdrostat, if approved.” Chiesi Farmaceutici - Amryt Pharma Chiesi Farmaceutici, the international, research-focused biopharmaceuticals and healthcare group, is set to acquire Amryt Pharma, a global, commercial- stage biopharmaceutical company focused on acquiring, developing, and commercializing novel treatments for rare diseases, in a $1.5 billion deal. Marco Vecchia, Chief Executive Officer of Chiesi Group, said: “With this transaction, we are further expanding our commitment to people living with rare diseases, the majority of which still have no cure or approved treatment. This addition of the Amryt portfolio, as well as their expertise, will help us on our journey to bring medicines to patients, no matter how rare their condition may be. We look forward to working with Amryt towards a successful closing of the transaction. Amryt has steadily brought innovative products to new markets and, by adding them to the Chiesi portfolio, we hope to make them available to even more patients who may require them.” Dr. Joe Wiley, Chief Executive Officer of Amryt Pharma, said: “I am incredibly proud of what Amryt has accomplished for patients, their families, healthcare professionals and shareholders since we established our business in 2015. In less than 8 years, we have built from the ground up, a high growth and globally respected company in the biotechnology industry and the rare disease space. These accomplishments are a testament to the Amryt team’s commitment and © stock.adobe.com/Azeemud-Deen Jacobs/peopleimages.com 08-11.qxp_Layout 1 10/02/2023 14:25 Page 3Pharma Business International 11 www.pbiforum.net M&A ROUND-UP passion for patients that are impacted by rare and orphan diseases. Chiesi is aligned with Amryt’s commitment and passion and I believe Chiesi will further maximise the value of Amryt’s current portfolio and pipeline and most importantly, will accelerate our ability to reach more patients in need globally.” Ipsen - Albireo Ipsen has made a $952 million swoop for Albireo, an innovator in bile-acid modulators to treat pediatric and adult cholestatic liver diseases. The anticipated acquisition will enrich Ipsen’s rare disease portfolio and pipeline. The lead medicine in Albireo’s pipeline is Bylvay (odevixibat), a potent, once- daily, oral, non-systemic ileal bile acid transport inhibitor (IBATi). Bylvay was approved in 2021 in the US for the treatment of pruritus in patients three months of age and older with progressive familial intrahepatic cholestasis (PFIC), and in the EU for the treatment of PFIC in patients aged six months or older. Pruritus is one of the most prominent and problematic manifestations of the disease, often resulting in severely diminished quality of life. Bylvay has orphan exclusivity for the approved indications in PFIC in the US and EU. “We are excited about the potential of Albireo’s assets and scientific expertise, which we gain through this acquisition, and we believe this is a compelling growth opportunity for Ipsen,” said David Loew, Chief Executive Officer of Ipsen. “Our Rare Disease franchise is strengthened with Bylvay, which, in addition to being the first- approved treatment in PFIC, has two further indications being investigated in rare liver conditions that are underserved. Additionally, Bylvay and the clinical and preclinical novel bile acid transport inhibitors in Albireo’s portfolio complement our own pipeline in liver disease.” BioNTech - InstaDeep BioNTech has entered into an agreement to snap up InstaDeep, a global technology company in the field of artificial intelligence (AI) and machine learning (ML), in a £562 million deal. The acquisition supports BioNTech’s strategy to build world-leading capabilities in AI- driven drug discovery and development of next-generation immunotherapies and vaccines to address diseases with high unmet medical need. “Since the inception of BioNTech, we have focused on leveraging computational solutions to create personalized immunotherapies that can reach a wide patient population,” said Prof. Ugur Sahin, M.D., CEO and co- founder of BioNTech. “The acquisition of InstaDeep allows us to incorporate the rapidly evolving AI capabilities of the digital world into our technologies, research, drug discovery, manufacturing, and deployment processes. Our aim is to make BioNTech a technology company where AI is seamlessly integrated into all aspects of our work.” © stock.adobe.com/Mucahiddin 08-11.qxp_Layout 1 10/02/2023 14:25 Page 4LABORATORIES 12 Pharma Business International www.pbiforum.net Advancing technology Advancing technology © stock.adobe.com/BrunoWeltmann 12-15.qxp_Layout 1 10/02/2023 14:25 Page 1Pharma Business International 13 www.pbiforum.net LABORATORIES With recent advances in technology combining with a shrinking workforce, more and more labs are looking to ways to cut back on staffing through digitalisation. T he last few years have marked a push for digitalisation in labs due to three major components – firstly, COVID-19 and the pandemic forced many to work from home, and more to become sick and not be able to work at all. Secondly, the recovery and economic situation has combined to make an already noticeable problem with recruitment more of an issue. Finally, the industry has become leaner after the investment boom of last year, and many are looking to make their labs work harder and more affordably. All these issues combined are leading labs to look at ways to minimise the need for employees – not with a view of cutting numbers, but with aims to let existing staff tackle greater workloads. The focus across the whole pharma industry at the moment is that of getting the most out of existing assets as possible. It has become a requirement for labs to be digitally enabled and globally connected to support the future of the pharmaceutical industry and allow for innovation, and there is a plethora of different technologies (hardware and software) being utilised to transform labs, particularly Internet of Things (IoT) technology, artificial intelligence (AI)/AI-powered analytics, automation, and robotics. These connected, digitalised, ‘smart’ labs come with a wealth of benefits, from simplifying data management and processes, increasing efficiency, and boosting quality 14 Á 12-15.qxp_Layout 1 10/02/2023 14:25 Page 2LABORATORIES 14 Pharma Business International www.pbiforum.net control to enhancing the skills and capabilities of professionals. Depending on your laboratory requirements, digital transformation will have different scopes. Digitalisation is set to have a major impact on the R&D lab of the future, as highlighted by Deloitte who envision an interconnected ecosystem of data, platforms, instruments, and advanced analytical tools supporting scientists across teams and geographies to quickly discover breakthrough therapies. This lab is able to optimise and advance value- stream processes from target identification to preclinical development via digital innovation. To achieve this, labs need to implement a number of tools. Machine intelligence for instance is set to empower researchers, changing human-led scientific methods, and when inserted into research processes facilitates faster analysis of molecular structures and identification of promising compounds. AI in the future lab can be applied to knowledge graphs to automate target identification and validation, cutting down time spent screening molecular libraries to uncover lead molecules. AI algorithms and machine learning, which continuously learn and adapt, can guide researchers as they identify, process, and test molecules and therapies. Furthermore, AI-based computational chemistry toolkits allow scientists to delve into novel spaces and expand the pool of potential structures to consider as drug candidates, growing development pipeline size, and AI is a critical tool for efficiently and accurately reviewing data, discovering patterns, and improving analysis. The automation of lab processes is also important to smart labs - especially labs with repetitive and high-throughput processes - through physical and digital robots, taking on sample and buffer prep, pipetting, and standard analytical testing for example, with high precision, reliability, and repeatability, minimising manual work, saving time and reducing potential for human error, particularly in steps at higher risk of variability, as well as freeing up scientists to focus on activities such as result interpretation, decision making and creative discussions. Of course, automation is © stock.adobe.com/Gorodenkoff 12-15.qxp_Layout 1 10/02/2023 14:25 Page 3Pharma Business International 15 www.pbiforum.net LABORATORIES present already, primarily partial automation, with just the most routine processes fully automated - those that bring the best return on investment. Looking at a fully automated lab, liquid handling systems and robotic arms can perform the assays and transfer containers between different devices, and other labs go even further, requiring no human interaction, with robotic arms taking samples from storage, transferring them to an analytical device, and the scientist checking data. Meanwhile to enhance the work of staff, digital assistants with augmented reality (AR), virtual reality (VR), natural language processing (NLP), and computer vision can enable hands-free work, presenting a lab procedure’s steps, notes from prior experiments, and record video and audio observations. Digital transformation in labs also means an improvement in how we interact with enormous amounts of data and control experiments. Embracing IoT (a system of internet connected objects with sensors, processing ability, software, and other technologies that exchange data over a wireless network), for instance, research platforms and smart instruments can clean, store and upload real-time data to cloud platforms automatically, and this data can be used to gain AI-driven insights that help companies discover and develop new medicines while reducing costs as well as harness information from instruments, process sensors et al. for workflow optimisation and process management. IoT allows connectivity and effortless access to, and sharing of, data and insights as needed, across organisations and geographies, strengthening collaborative work with cloud tech connecting global teams. Moreover, the use of IoT sees it help remote teams monitor and control experiments and equipment. This can be done around the clock, enabling more flexibility and creating agile teams. With digitalisation - the use of intelligent, connected systems - becoming the new normal for labs, those that do not upgrade their facilities will lose out to competitors who are able to get therapies to market quicker with reliability and strong quality control. 12-15.qxp_Layout 1 10/02/2023 14:25 Page 4MICROBIOLOGY AND R&D 16 Pharma Business International www.pbiforum.net W hen we look at the microbiology sector in the last few years it’s clear to see that there has been a loss of faith in big pharma – driven primarily by conspiracy theories, politicians, and misinformed public seeking to shift the blame. This has led to increased focus on labs, especially those dealing with potentially harmful contaminants, and the smallest breach or accident can soon end up being a worldwide talking point. We have seen this all too much already with Chinese labs and the propensity for the US public to blame them for any little thing. It stands to reason then that a big talking point going forward is that of Contamination Control Strategies (CCS), and how those working with microbes can react to a potential breach in a manner to maintain safety and hygiene. In a recent report by the UN, the pharma industry was also listed as one of the three biggest risk factors for future superbugs and a repeat of the COVID-19 pandemic, alongside agriculture and health pollution. When it comes to CCS it seems that many companies, riding high off the successful pharma sector economy, might have slacked on safety precautions. While the industry is heavily regulated that doesn’t mean every lab adheres to those regulations, and it can get even more confusing when those regulations change from country to country. The microbiology industry is also changing rapidly on account of new discoveries, but also new technologies including AI-integration, digitalisation, and blockchain. While the automation and serialisation are useful in places, the technology still isn’t advanced enough to replace all involvement by humans. For instance, automated colony counters for 18 Á The changing world of microbiology There’s a lot of change going on in microbiology, and a lot of it is adapting to the changing circumstances going on around the world. 16-19.qxp_Layout 1 10/02/2023 14:26 Page 1Pharma Business International 17 www.pbiforum.net MICROBIOLOGY AND R&D © stock.adobe.com/ ink drop 16-19.qxp_Layout 1 10/02/2023 14:26 Page 2MICROBIOLOGY AND R&D 18 Pharma Business International www.pbiforum.net agar plates still have limitations when it comes to mixed cultures and merged colonies. All of this is causing the skillsets of microbiologists to need to change as well, causing a focus on new talent and upskilling that, while beneficial for the industry, means that a lot of new staff are being hired that might not be familiar with CCS policies. This temporary lapse creates a potential flashpoint for accidents to happen. The introduction of new regulation hasn’t made matters any easier – such as last year’s EU GMP Annex 1. Adapting to these takes time and creates more confusion. It doesn’t help that microbiological focus is, in some ways, also shifting. There has been an ongoing transition from products based on small molecules to those based on large ones to cellular therapies. Because cellular products have short lifecycles, small batch sizes, and demanding analytical methods, the way in which labs work with them has to be overhauled. Furthermore, they almost all have microbial contamination risks, which loops back to the primary problem surrounding CCS and the fallout among the general public for even a minor contamination risk. All this additional data gleaned also needs to be processed, which means more digitisation, serialisation, and data storage. Microbiological labs are rather old-fashioned in many regards, which is odd given how scientific they are. Agar plates have traditionally been both the record and the proof, but now everything must be done online, securely, and through database systems. The introduction of IoT in labs is both a boon and a curse, for while it does allow for convenience in some regards, it also creates extra work, and a dependence upon technology that can at times fail or need repair. 16-19.qxp_Layout 1 10/02/2023 14:26 Page 3Pharma Business International 19 www.pbiforum.net MICROBIOLOGY AND R&D © stock.adobe.com/sarawutnam 16-19.qxp_Layout 1 10/02/2023 14:26 Page 4Next >