< PreviousM&A ROUND-UP 10 Pharma Business International www.pbiforum.net cells through precise targeting using molecules such as antibodies, peptides or small molecules. This approach has many potential advantages compared to traditional radiotherapy including minimising damage to healthy cells and enabling access to tumors not reachable through external beam radiation. The Fusion pipeline of RCs includes their most advanced programme, FPI- 2265, a potential new treatment for patients with metastatic castration- resistant prostate cancer (mCRPC). FPI- 2265 targets prostate-specific membrane antigen (PSMA), a protein that is highly expressed in mCRPC, and is currently in a Phase II trial. The acquisition brings new expertise and pioneering R&D, manufacturing and supply chain capabilities in actinium-based RCs to AstraZeneca. The announcement of the acquisition followed hot on the heels of AstraZeneca’s agreement to snap up Amolyt Pharma, a clinical-stage biotechnology company focused on developing novel treatments for rare endocrine diseases. The proposed $1.05bn deal is set to bolster the Alexion, AstraZeneca Rare Disease late-stage pipeline and expand on its bone metabolism franchise with the addition of eneboparatide (AZP-3601), a Phase III investigational therapeutic peptide with a novel mechanism of action designed to meet key therapeutic goals for hypoparathyroidism. Novo Holdings - Catalent Catalent and Novo Holdings, a holding and investment company responsible for managing the assets and wealth of the Novo Nordisk Foundation, have entered into a merger agreement that will see Contract Development and Manufacturing Organization (CDMO) Catalent acquired for $16.5bn. Novo Holdings intends to sell three Catalent fill-finish sites and related assets acquired in the merger to Novo Nordisk. Kasim Kutay, CEO of Novo Holdings, said: “We are excited to partner with Catalent as it enters a new phase of growth and accelerates its mission to develop, manufacture and supply products that help people live better and healthier lives. With our expertise and track record of investing in high quality life sciences businesses, we believe Catalent is a very good strategic fit. We are excited to support the company’s stakeholders in the years ahead, especially employees and customers as they work to develop new products to benefit patients. As engaged investors committed to productive relationships with all our partners, we look forward to working with the Catalent team to realise the company’s full potential. Importantly, our acquisition of Catalent is aligned with our mandate to invest in high quality life sciences companies for the benefit of the Novo Nordisk Foundation’s mission and philanthropic causes.” Moreover, Novo Nordisk recently agreed to acquire Cardior for up to €1.025bn. Cardior is a leader in the discovery and development of therapies that target RNA as a means to prevent, repair and reverse diseases of the heart. The company’s therapeutic approach targets distinctive non-coding RNAs as a platform for addressing root causes of cardiac dysfunctions with an aim to Pharma Business International 11 www.pbiforum.net M&A ROUND-UP achieve lasting patient impact. The agreement includes Cardior’s lead compound CDR132L, currently in phase 2 clinical development for the treatment of heart failure, and is an important step forward in Novo Nordisk’s strategy to establish a presence in cardiovascular disease. Genmab - ProfoundBio Finally, Genmab has agreed to acquire ProfoundBio in a $1.8bn deal. ProfoundBio is a privately-owned clinical- stage biotechnology company developing next-generation antibody-drug conjugates (ADCs) and ADC technologies for the treatment of certain cancers, including ovarian cancer and other folate receptor alpha (FR?)-expressing solid tumors. The transaction will broaden Genmab’s mid- to late-stage clinical pipeline and complement its already validated suite of proprietary technology platforms. The acquisition will give Genmab worldwide rights to ProfoundBio’s portfolio of next- generation ADCs, which consists of three clinical and multiple preclinical programs including rinatabart sesutecan (Rina-S), a potential best-in-class, clinical-stage, FR?-targeted, Topo1 ADC, currently in Phase 2 of a Phase 1/2 clinical trial, for the treatment of ovarian cancer and other FR?-expressing solid tumors. In addition, the combination of ProfoundBio’s novel ADC technology platforms with Genmab’s proprietary antibody platforms will potentially create new opportunities to generate and develop new medicines with the potential to transform the treatment of cancer and improve the lives of patients. These represent just a few of the deals revealed since our last issue, with M&A in the pharma industry picking up pace. © stock.adobe.com/NuthawutTRANSPORT AND LOGISTICS 12 Pharma Business International www.pbiforum.net Given the importance of the transport industry to just about any country, logistics groups are asking if it isn’t time for a more direct line between government and industry. L ogistics and supply lines have come under pressure recently, especially in western countries. The system was stretched and tested during the COVID pandemic with the need to keep shelves stocked with food and hospitals with vaccines, masks and other equipment, and it seems lessons weren’t learned as much as everyone would have wished. In recent months, repeat instances of supply chain issues have damaged several industries – primarily retail and food and drink, but the reasons behind them relate mostly to quality and availability of transport infrastructure, and could therefore happen again for pharma. If this were to occur during another emergency or Governance and transport Governance and transport Pharma Business International 13 www.pbiforum.net TRANSPORT AND LOGISTICS © stock.adobe.com/AdriFerrer pandemic, the consequences could be dire. In the UK, logistics groups are calling for a Logistics Minister so that the industry can have a direct line to governance, and this is an intriguing idea. There’s no arguing that logistics and transport isn’t one of the most important parts of the running of any country. In times of peace, a good transport system ensures timely arrival of food, medicine and goods. In times of war, it’s a necessity to ship supplies to front lines, and often becomes a target of enemy attack. Given its strategic importance, therefore, it seems odd that many countries around the world have been content to leave the logistical element out of government. Roles such as health and education obviously do deserve to have strong roles in a country’s government, but so does the one industry that ensures people get what they need to survive. Having a more active relationship between governments and the logistics 14 ÁTRANSPORT AND LOGISTICS 14 Pharma Business International www.pbiforum.net industry could also help with worldwide initiatives to reduce carbon emissions. Fossil fuels remain a thorny subject for many, especially in a time when economies are doing poorly and it’s tempting to reach for the quickly profitable fossil fuels over long-term investments. The transport and logistics industries have been struggling with the problem of green transport for a long time now, and a lot of this struggle is made worse because various governments don’t communicate well with the industry. Having someone who can act as a direct line and port of call for the industry to discuss with government officials would alleviate the problem, or at least increase understanding. Case in point, one of the largest couriers, DHL, provided a target of spending 7 billion euros on sustainable measures and decarbonisation by 2030, but has only spent 440 million euros so far. While DHL themselves blamed the slow uptake on a lack of measures, those in the logistics industry have said the fault lays more on an unwillingness to Pharma Business International 15 www.pbiforum.net TRANSPORT AND LOGISTICS spend, and customers’ willingness to pay a premium for sustainable transport. Simply put, governments and environmental groups are demanding lower carbon emissions without any thought for whether customers will actually be willing to pay for it, leaving companies who do comply and do their best to reduce their emissions to lose business to greedier companies who do not. There are solutions to this such as taxing the companies that don’t more or offering incentives to those that do, but governments tend to have other things that are more “vote-winning” and thus of higher importance to focus on. Many transport companies are calling on governmental support to further push the issue, but the true need the industry faces might be in greater scrutiny on supermarkets and retailers who are happy to claim they are doing all they can to decarbonise, but at the same time refuse to deal fairly with their logistical suppliers. These companies are unlikely to budge for anything but a threat to their reputations and profits. © stock.adobe.com/Virtual Art StudioLABELLING, CODING AND MARKING 16 Pharma Business International www.pbiforum.net A s the product of a highly regulated industry, the medicines and drugs the public receive must be secure and identifiable, meeting requirements for unique labelling, whether that be on a capsule or box. Labelling, coding, and marking, then, are vital in the pharmaceutical sector, facilitating traceability and integrity as products move through the supply chain, and play a critical role in preventing counterfeiting, a problem that the World Health Organization (WHO) estimates costs the global pharma industry $75 billion USD a year. More intelligent labels have been put forward as a solution to counterfeiting, bolstering classic markings and labelling with both overt and covert anti- counterfeiting capabilities. Overt solutions, visible to the eye and difficult to replicate, range from colour-shifting and pearlescent inks, creating effects recognised easily by distributers, to tamper evident labels and holographic labels utilising sophisticated graphics requiring high end printing. Furthermore unique 2D and QR codes are a useful tool to authenticate and track products, scanned to give access to verification data. The codes act as an identifier, enabling name of product, pharmaceutical form, strength, size, type of packaging, country of origin, serial numbers, date of manufacture and expiration, manufacturer’s information, et al. to be specified. Covert solutions, meanwhile, becoming visible with specific tools, include UV and infrared light-reactive inks, thermochromic inks that display particular images under severe temperature changes, barcodes and digital watermarking with cryptic images detected with a tailored device, and taggants, invisible molecular or optical symbols added to inks and coatings, that become visible with specialised lab equipment. Combinations of these are recommended to combat counterfeiters. RFID (radio frequency identification)- enabled labels are also coming to the fore, allowing digital visibility and monitoring due to their trackable nature, from manufacturer to shelves and homes, improving upon serial numbers and barcodes. These labels also provide product users with a more interactive experience, offering access to extra product information, videos, apps, and mobile product authentication. While key in ensuring true products reach patients, drug manufacturers’ labelling, coding, and marking processes must themselves present accurate, legible content on packaging that adheres to regulation. From warnings to font size to marking on vials, stringent control is essential. Any error exposes companies to costly recalls, fines, fees, and serious financial, legal, and safety implications, as well as a damaged reputation that takes time and money to repair. It can be a life-or-death issue, with one small typo on a label able to cause significant harm, for example mis- instructing the user on how a product should be used, leading to unwanted side effects, medication interactions, and even hospitalisation. Patients need to be able to trust that medications being taken will be administered correctly and that labels present complete accuracy. Adding complexity and room for error in Safe and secure Labelling, coding, and marking are key in the pharmaceutical sector - to product traceability, integrity, and safety. 18 Á© stock.adobe.com/highwaystarzLABELLING, CODING AND MARKING 18 Pharma Business International www.pbiforum.net labelling is the continually expanding amount of content that needs to fit on drug labels and changing regulatory requirements and standards. Meanwhile companies must comply with regulations from multiple geographies, creating further difficulties. Not being in compliance with local guidelines can see inventory become unsellable and wasted - a major cost. To overcome these issues, an efficient, holistic labelling solution is required. Label management must become more organised and make use of the latest technology. Ensuring that labelling is considered on an enterprise-wide level helps in this, with labels conversely being managed in isolation, using different software, manual data input, and changes being made as needed, inefficient, stunting opportunities to scale operations quickly, but thankfully coming to an end. Siloed labelling commonly leads to errors, with manufacturers maintaining multiple labelling solutions with no connectivity to make sure vital data is accurate. Addressing labelling on an enterprise-wide level however gives access to consistent, accurate, up-to- date, approved label content. This approach may see labelling integrated with WMS, ERP, and product lifecycle management systems. With label updates constant, enterprise-wide systems make alterations easy where siloed systems see changes made in isolation, with separate templates, and additional administrative burden and opportunity for error and Pharma Business International 19 www.pbiforum.net LABELLING, CODING AND MARKING miscommunication. Enterprise-wide approaches reduce variability, don’t need separate templates for updates, allow label updates to be managed from one location, and updated information from other enterprise systems can automatically extend to labels if the right integration is in place, with a simple update in an ERP system, for example, preventing hours spent changing different label templates. In some cases automated updates can be facilitated. To create an enterprise-wide system, a solution based in the cloud is key, allowing quick access for new users and quick connection for sites in different locations, providing company data, product information, and controlled labelling. Automation is also useful in preventing and identifying labelling, coding, and marking mistakes, while enabling compliance, safety, and efficiency. The potential for a mislabelled product, whether this involves missing information, content mistakes, incorrect translations, or malfunctioning barcodes, is increased when relying on humans to spot errors. With careful inspection a necessity, automation provides a solution. Automated computer systems inspecting different types of pharmaceutical labels can discover errors not obvious to the naked eye and do so at a rapid speed and high rate of accuracy, boosting efficiency. This enables more thorough checks to be performed at every stage of manufacturing and distribution. © stock.adobe.com/nordrodenNext >