< PreviousM&A ROUND-UP 10 Pharma Business International www.pbiforum.net MiroBio’s proprietary discovery platform and entire portfolio of immune inhibitory receptor agonists. MiroBio’s lead investigational antibody, MB272, is a selective agonist of immune inhibitory receptor B- and T-Lymphocyte Attenuator (BTLA) and has entered Phase 1 clinical trials, with the first patient dosed. MB272 targets T, B and dendritic cells to inhibit or blunt activation and suppress an inflammatory immune response. MiroBio’s I-ReSToRE platform (REceptor Selection and Targeting to Reinstate immune Equilibrium) has the potential to be used to develop best-in- class agonist antibodies targeting immune inhibitory receptors, a novel approach to the treatment of inflammatory diseases. The I-ReSToRE platform supports identification and development of therapeutics that utilize inhibitory signalling networks with the goal of restoring immune homeostasis for patients. Gilead anticipates advancing additional agonists derived from MiroBio’s I-ReSToRE platform, including a PD-1 agonist, MB151, and other undisclosed early-stage programs, over the next several years. “We are excited to be joining Gilead,” said Eliot Charles, chairman of MiroBio. “MiroBio has a deep understanding of checkpoint receptor signaling and a proprietary approach to select and generate superior agonist antibodies. Combining this with Gilead’s drug development and therapeutic area expertise will allow us to fully explore the potential of checkpoint agonist antibodies for patients with autoimmune disease.” Vertex - ViaCyte Furthermore, Vertex Pharmaceuticals has entered into a definitive agreement to acquire ViaCyte, a privately held biotechnology company focused on delivering novel stem cell-derived cell replacement therapies as a functional cure for type 1 diabetes (T1D), for $320 million in cash. Reshma Kewalramani, M.D., Chief Executive Officer and president of Vertex, said: “VX-880 has successfully 08-11.qxp_Layout 1 15/08/2022 09:16 Page 3Pharma Business International 11 www.pbiforum.net M&A ROUND-UP demonstrated clinical proof of concept in T1D, and the acquisition of ViaCyte will accelerate our goal of transforming, if not curing T1D by expanding our capabilities and bringing additional tools, technologies and assets to our current stem cell-based programs.” Vertex’s VX-880, an investigational allogeneic stem cell-derived, fully differentiated, insulin-producing islet cell therapy for T1D, has already achieved proof-of-concept with promising safety and efficacy results from an ongoing Phase 1/2 study which continues to enrol and dose patients. The acquisition of ViaCyte provides Vertex with complementary assets, capabilities and technologies including additional human stem cell lines, intellectual property around stem cell differentiation, and Good Manufacturing Practice (GMP) manufacturing facilities for cell-based therapies that could speed up Vertex’s ongoing T1D programs. It also presents access to novel hypoimmune stem cell assets via the ViaCyte collaboration with CRISPR Therapeutics. AstraZeneca - TeneoTwo AstraZeneca has announced an agreement to acquire TeneoTwo, including its Phase I clinical-stage CD19/CD3 T-cell engager, TNB-486, currently under evaluation in relapsed and refractory B-cell non-Hodgkin lymphoma. The acquisition of TNB-486 aims to accelerate the development of this potential new medicine for B-cell haematologic malignancies, including diffuse large B-cell lymphoma and follicular lymphoma. Building on the success of Calquence (acalabrutinib), TNB-486 further diversifies AstraZeneca’s haematology pipeline that spans multiple therapeutic modalities and mechanisms to address a broad spectrum of blood cancers. AstraZeneca will acquire all outstanding equity of TeneoTwo in exchange for an upfront payment of $100 million on deal closing. Under the terms of the agreement, AstraZeneca will make additional contingent R&D-related milestone payments of up to $805 million and additional contingent commercial- related milestone payments of up to $360 million to TeneoTwo’s equity holders. The transaction is expected to close in the third quarter of 2022, subject to customary closing conditions and regulatory clearances. Pfizer - Global Blood Therapeutics Finally, Pfizer and Global Blood Therapeutics have entered into a definitive agreement under which Pfizer will snap up GBT, a biopharmaceutical company dedicated to the discovery, development and delivery of treatments that provide hope to underserved patient communities, starting with sickle cell disease (SCD). The transaction complements and further enhances Pfizer’s more than 30- year heritage in rare hematology and reinforces the company’s commitment to SCD by bringing expertise and a leading portfolio and pipeline with the potential to address the full spectrum of critical needs in this underserved community. Pfizer intends to continue to build on the companies’ shared commitment to and engagement with the SCD community. Under the terms of the transaction, Pfizer will acquire all the outstanding shares of GBT for $68.50 per share in cash, for a total enterprise value of approximately $5.4 billion, including debt and net of cash acquired. © stock.adobe.com/Rido 08-11.qxp_Layout 1 15/08/2022 09:16 Page 4PACKAGING 12 Pharma Business International www.pbiforum.net P ackaging plays a profound role in impeding counterfeit pharmaceutical products, the presence of which can spell economic damage to manufacturers and pose health risks for patients and consumers. Track and trace technology has emerged as one of the biggest advances in the battle against counterfeit products and as a means of strengthening the supply chain. A track and trace system works by printing a unique identification code onto each product after it has been packaged, which allows the individual product to be tracked from production to end consumer. This process shares more than a passing resemblance to blockchain, however blockchain is still very much in its infancy and is far from commonplace. Track and trace, on the other hand, is already offering manufacturers a robust and reliable means of following their products through the supply chain and ensuring their validity at all times. Together, the two technologies could well create one of the securest supply chains, which the pharmaceutical industry is in need of. Currently, counterfeits are rife, putting drug makers out of pocket and patients at risk. One of the biggest advantages of track and trace technology is that it can be easily integrated into a product supply chain, The war against counterfeit drugs The war against counterfeit drugs The counterfeit drugs market is one of the largest in the world and yet many who take them are unawares of their illegal nature. Packaging may well be the solution to making customers aware of the problem. 14 Á 12-15.qxp_Layout 1 15/08/2022 09:18 Page 1Pharma Business International 13 www.pbiforum.net PACKAGING © stock.adobe.com/ Владимир Солдатов 12-15.qxp_Layout 1 15/08/2022 09:18 Page 2PACKAGING 14 Pharma Business International www.pbiforum.net offering a means for companies of all sizes to sure up their supply chain. For this reason, it’s entirely understandable why a system of this kind is gaining an increasingly large presence in the marketplace, with growth only tipped to grow in the future. In fact, it will be worth $3.93 billion by 2023. 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. There are some hindrances to future growth, however, with hesitation among manufacturers regarding the security features of track and trace packaging chief among them. There’s also a reticence over the high cost involved in implementing a new system, with many companies struggling to justify the expenditure for an issue that may not have affected them directly. Counterfeit 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 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. 12-15.qxp_Layout 1 15/08/2022 09:18 Page 3Pharma Business International 15 www.pbiforum.net PACKAGING © stock.adobe.com/denisismagilov 12-15.qxp_Layout 1 15/08/2022 09:18 Page 4TEMPERATURE CONTROL 16 Pharma Business International www.pbiforum.net Unyielding integrity Unyielding integrity T he role of temperature control in the pharmaceutical supply chain is utilised right across the life cycle of a medical or drug product. From manufacture to the delivery to an end user or patient, many of the products and substances are temperature sensitive, requiring specific parameters to stay stable, active and predictable. Currently, the global pharmaceutical cold chain logistics industry is worth $159.9 billion but, according to the latest figures, the industry is forecast to reach $585.1 billion by 2026. This substantial growth is being driven by strict requests for the increase in biologics in international life sciences shipments and demand in the wake of the COVID-19 pandemic. Despite the surge in growth, emerging market challenges, from regulatory requirements to partner selection, put roadblocks up. The last decade has seen an upsurge in the number of logistics hubs worldwide, creating a more connected, around-the- clock pharmaceutical supply chain. As biologics become ever more fragile and sensitive to a greater number of environmental factors, the industry needs to forge links for the sector’s overall wellbeing. Combining specialist packers with a temperature-controlled fleet, for example, will help alleviate the stress of product contamination or breakages whilst also ensuring sensitive materials stay within the desired temperature parameters. 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. 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 Maintaining the cold chain is vital to ensure the efficacy of vaccines and vital medical products. As well as an upsurge in growth over the last decade, the sector was called on in the safe delivery and transportation of COVID-19 vaccines, and this pressure has not yielded with further pandemic fears in the future. 18 Á 16-19.qxp_Layout 1 15/08/2022 09:20 Page 1Pharma Business International 17 www.pbiforum.net TEMPERATURE CONTROL © stock.adobe.com/Grispb 16-19.qxp_Layout 1 15/08/2022 09:20 Page 2TEMPERATURE CONTROL 18 Pharma Business International www.pbiforum.net 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. 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. As the single biggest vaccination programme ever, the transportation and distribution of the myriad COVID-19 vaccines was a trial by fire for the pharmaceutical cold chain. Each vaccine may have had a different profile, but what unites them all is the need for cold chain storage. This ranges from around – 16-19.qxp_Layout 1 15/08/2022 09:20 Page 3Pharma Business International 19 www.pbiforum.net TEMPERATURE CONTROL 70°C during specialised shipping to around 2 to 8°C when administered. This challenge was faced across the developed world and saw cold chains stretched to their breaking point and, in some cases, beyond. 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/serjiob74 © stock.adobe.com/Felipe Caparrós 16-19.qxp_Layout 1 15/08/2022 09:20 Page 4Next >