< PreviousM&A ROUND-UP 10 Pharma Business International www.pbiforum.net immune system and direct it toward cancer cells. Nerio’s small molecule inhibitors will be an important addition to Boehringer Ingelheim’s portfolio with the potential to act as a single agent therapy and, importantly, in combination with many cancer therapies already being developed in-house. “Securing the rights to Nerio Therapeutics’ novel checkpoint inhibitors creates a broad panel of exciting new cancer treatment combination opportunities. This brings us a major step closer to our vision of transforming the lives of people living with cancer,” said Paola Casarosa, Member of the Board of Managing Directors at Boehringer Ingelheim with responsibility for the Innovation Unit. Johnson & Johnson - Yellow Jersey Therapeutics Moreover, Johnson & Johnson has successfully completed the acquisition of Yellow Jersey, a demerged subsidiary of Numab Therapeutics to secure the global rights to NM26, a novel, investigational first-in-class bispecific antibody, in an all- cash transaction of approximately $1.25 billion. NM26, which is ready to enter Phase 2 studies in atopic dermatitis (AD), targets two clinically proven pathways, IL-4R alpha subunit (IL-4R?) and IL-31, which trigger Th2-mediated skin inflammation and skin itch, respectively. “NM26 is designed to help different subpopulations of patients by targeting two disease-driving pathways, which is key when treating a heterogeneous disease like AD,” said David Lee, Global Immunology Therapeutic Area Head, Johnson & Johnson Innovative Medicine. “We are excited about the potential this represents to transform the standard of care for AD, as well as other inflammatory skin diseases involving Th2 inflammation and itch.” Agilent - BIOVECTRA Finally, Agilent Technologies has signed a definitive agreement to acquire BIOVECTRA, a specialized contract development and manufacturing organization (CDMO), for $925 million. BIOVECTRA produces biologics, highly potent active pharmaceutical ingredients, and other molecules for targeted therapeutics. The acquisition builds on Agilent’s CDMO specialization in oligonucleotides and CRISPR therapeutics in three key areas: it expands Agilent’s portfolio of services, with BIOVECTRA offering sterile fill-finish services, pDNA and mRNA capabilities, and lipid nanoparticle (LNP) formulation; it adds rapidly growing modalities, with BIOVECTRA bringing expertise in antibody drug conjugates (ADCs), highly potent active pharmaceutical ingredients (HPAPIs), and GLP-1; it brings world-class capabilities to support gene editing, with BIOVECTRA’s capabilities in biologics combined with Agilent’s expertise in gRNA providing customers with a single source for gene-editing technology. “We look forward to welcoming BIOVECTRA to Agilent,” said Agilent President and CEO Padraig McDonnell. “The company has an outstanding record of innovation, and its employees share our commitment to providing integrated biopharma solutions that continuously deliver more value to customers.” McDonnell continued: “Plus, BIOVECTRA’s manufacturing capabilities further expand Agilent’s end-to-end biopharma offerings into new growth vectors, including workflows that seamlessly integrate analytical instrumentation, consumables, and a wide range of lab services.” These deals represent just a few of those since our last issue, amidst a bustling dealmaking landscape. Pharma Business International 11 www.pbiforum.net © stock.adobe.com/ Thaakirah/peopleimages.comPackaged PACKAGING 12 Pharma Business International www.pbiforum.net© stock.adobe.com/ Artinun Packaging’s rather surprising role in combating counterfeit drugs remains an important facet for the industry. Pharma Business International 13 www.pbiforum.net PACKAGING C ounterfeit drugs and other medical products continue to plague the pharmaceutical sector and put patients at risk. The financial damage can also be significant, and so a reliable solution needs to be implemented in order to eradicate this illegal trade. Track and trace has frequently proven its ability to strengthen the supply chain, prove effective for manufacturers and keep patients safe from unregulated and potentially harmful products. It proves that packaging will remain critical going forward, as track and trace systems become more commonplace. Outside of track and trace, anti- counterfeit tabs and holographic displays can be used to let consumers 14 Á14 Pharma Business International www.pbiforum.net © stock.adobe.com/ Sergey RyzhovPACKAGING Pharma Business International 15 www.pbiforum.net know the product they are using is legitimate. However, this relies on the consumer being aware of the trick used – and thus will call on extensive marketing and informational campaigns to inform them. This can be as simple as adverts and promotional material advising customers to “always look for the seal” or something of a similar nature, and this can help clamp down on counterfeit goods that make it through to customers. Counterfeiters will always be upgrading their own equipment to match that of manufacturers, so it’s important to stay one step ahead and monitor the situation. Without knowing what the counterfeiters are doing, there is little way to impede them. Some of the most significant developments to the packaging industry aren’t whole machines, but rather sensors. Given the fast pace of the supply chain, it’s better if products can be scanned and sent to the correct vehicle and destination faster. Sensors and barcode scanners come in here to great effect, drawing from SCM software to identify where the product is stored, where it needs to go and how many boxes, pallets or crates need to be shipped. Working in conjuncture with sensors is the use of offline case marking. Implementing such a strategy greatly reduces the human error which in turn bolsters efficient practices and decreases the risk of damaged goods and loss. The ability to mark-up secondary packaging offline meets a growing need for traceability in today’s pharmaceutical market. For many manufacturers, this is represented by increased levels of traceability and to crack down on counterfeit goods. After all, if end of line packaging can be stamped with seals of approval, then it reduces the risk of damage, and knowing where any product is going and from which distribution facility is integral to mitigating the fallout of a product recall. The biggest driver behind this growth, other than the obvious outlined above, is that there is an increasing awareness for secure and reliable products from consumers and patients. A similar state of affairs is being seen in the food industry, where consumers are better informed than they have ever been. Thanks in part to the internet – especially social media – consumers are actively engaging with the supply chain and taking a deeper, keener interest in the products and services they use and buy. Elsewhere, technological evolution and the more widespread deployment of packaging equipment and machinery is enabling smaller companies to integrate track and trace systems into their supply chain. Then, of course, there are government regulations to consider. Unsurprisingly, governments the world over are keen to end the scourge of counterfeit goods, especially when it comes to food and medicines. Legislation and new regulations will increasingly prioritise track and trace systems, if not make them a legal requirement going forward. © stock.adobe.com/ fotofabrikaTEMPERATURE CONTROL 16 Pharma Business International www.pbiforum.net Cold opportunities Cold opportunities Pharma Business International 17 www.pbiforum.net TEMPERATURE CONTROL © stock.adobe.com/ StellaPattaya W here cool air is present, there also exists the possibility of moisture build-up which can lead to all manner of issues such as damp or a build-up of ice. This not only presents a safety hazard for workers but can also severely limit the functionality and efficiency of processing equipment and lead to costly repairs. Ensuring a thorough washdown can help, as can investing in dehumidifying technologies. The transport and distribution of temperature- sensitive goods presents a more challenging situation as it involves moving goods from one strictly controlled environment to another. To facilitate this changeover, manufacturers will The need for temperature-controlled logistics in both the food and pharma sectors has caught the attention of mainstream transport companies looking to diversify their offering or expand their capabilities. Many of these companies are integrating cold trucks into their fleets, while some of the biggest players, such as FedEx and UPS, have entire branches dedicated to healthcare logistics. 18 Álikely have temperature controlled loading bays, ensuring a constant temperature from the production and packing lines. Curtain walls will help to maintain this consistency, creating a barrier to ensure that cold air stays inside its designated area whilst also allowing workers, forklift trucks and other vehicles to pass easily through. Loading bays themselves, however, are literal openings into the outside and so could quite easily scupper this carefully controlled environment. To compensate for this and maintain the cold integrity, manufacturers and logistics companies rely on hoods around the bay door opening. This means a truck or lorry can back into the bay and open its doors, creating a seal and ensuring that the exterior and interior temperatures don’t have a chance to meet and mingle. Pharmaceutical products can then be loaded without fear of thawing. New technology is opening up new frontiers and opportunities for cold chain logistics, from driverless vehicles to greener fuel options, blockchain technology and other means of tracking and tracing. Being able to track a shipment in real time allows a company to follow a product through the supply chain, so should a problem arise, such as a fault in manufacturing, the shipment can be immediately located and stopped before delivery, thus preserving the health of patients. It can also allow for insightful analytics so any detriments to efficiency can be identified and rectified. © stock.adobe.com/ serjiob74 18 Pharma Business International www.pbiforum.netTEMPERATURE CONTROL There are limitations to road haulage and although arguments to the contrary, driverless technology is unlikely to lessen the strain of congestion and road accidents – certainly not for the foreseeable future. The unpredictability of road infrastructure can also wreak havoc with tightly regimented schedules; so many pharmaceutical companies are increasingly turning towards ocean container lines to service their refrigerated supply chains. Air transport is an altogether more reliable and safer mode of transport, but it is losing a portion of market share from the global pharma products transport market due to a mixture of market challenges. There’s a lack of compliance, standardisation, accountability and transparency across the air transport supply chain, and annual product losses have been estimated as being anywhere between £2.5 billion and £12.5 billion. Though the market is vulnerable to regulatory challenges, the cold chain logistics industry is tipped for massive growth over the coming years. Along with logistics companies looking to diversify their offering and get in on the action, as well as the ever-expanding pharmaceutical industry, the future is looking cold indeed. © stock.adobe.com/ Borin Pharma Business International 19 www.pbiforum.netNext >