< PreviousM&A ROUND-UP 10 Pharma Business International www.pbiforum.net development-stage therapeutic candidates in gastroenterology, dermatology, and cardiology, including etrasimod, an oral, selective sphingosine 1-phosphate (S1P) receptor modulator currently in development for a range of immuno-inflammatory diseases including ulcerative colitis, Crohn’s Disease, atopic dermatitis, eosinophilic esophagitis, and alopecia areata. “We are excited to add the impressive experience and pipeline of Arena Pharmaceuticals to Pfizer’s Inflammation and Immunology therapeutic area, helping us further our purpose of developing breakthroughs to change the lives of those with immuno-inflammatory diseases,” said Mike Gladstone, Global President & General Manager, Pfizer Inflammation and Immunology. Eagle Pharmaceuticals – Acacia Pharma Group Eagle Pharmaceuticals is to acquire Acacia Pharma Group by way of a scheme of arrangement for €94.7m. The proposed transaction has been approved by the boards of directors of both companies and is expected to close in late Q2 2022, subject to approval by Acacia’s shareholders and the sanction of the High Court of England and Wales and customary closing conditions for transactions of this type. Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals, said: “We are delighted to announce that we have agreed to terms for the proposed acquisition of Acacia Pharma. This will be a very important acquisition for us, both financially and strategically.” AbbVie – Syndesi Therapeutics SA AbbVie has completed the acquisition of Syndesi Therapeutics SA, which will help to expand AbbVie’s neuroscience portfolio. This acquisition gives AbbVie access to Syndesi’s portfolio of novel modulators of the synaptic vesicle protein 2A (SV2A), including its lead molecule SDI-118. The mechanism is currently being evaluated for the potential treatment of cognitive impairment and other symptoms associated with a range of neuropsychiatric and neurodegenerative disorders, such as © stock.adobe.com/ Sundry Photography 08-11.qxp_Layout 1 08/04/2022 14:28 Page 3Pharma Business International 11 www.pbiforum.net M&A ROUND-UP Alzheimer’s disease and major depressive disorder. Under the terms of the agreement, AbbVie will pay Syndesi shareholders a $130 million upfront payment with the potential for Syndesi shareholders to receive additional contingent payments of up to $870 million based on the achievement of certain predetermined milestones. Pfizer – ReViral Pfizer is looking to increase its presence in the respiratory market with the acquisition of ReViral, a UK based pharmaceutical company specialising in respiratory viruses. The agreed deal comes to a total value of $525 million. “At Pfizer, we have a strong heritage in, and commitment to, fighting infectious diseases, most recently evidenced by our delivery of the first authorized vaccine and oral therapy to combat COVID-19.” chairman and CEO Albert Bourla said, “We’re continuing to grow our pipeline – through our own research-and- development efforts, such as our investigational RSV vaccine programs, as well as strategic investments in companies like ReViral – with a focus on end-to-end capabilities to help protect patients from severe illness, hospitalization, and death.” Emmes – Casimir The Clinical Research Organisation, Emmes, has further bolstered its capabilities with another acquisition – this time of fellow CRO Casimir. The move should set Emmes apart as an industry leading CRO in matters of rare and orphan diseases, as well as clinical research and drug development. This marks Emmes’ fourth acquisition since 2019, and may not yet be their last. Emmes Chief Executive Officer Dr. Christine Dingivan said: “This is another exciting step for Emmes in just over a year, as we continue to add new biopharma clients and deepen our innovative research capabilities. The combination of Casimir and Emmes will further differentiate our global rare disease center of excellence, Orphan Reach™. We plan to continue and accelerate the groundbreaking work of Casimir in neurodegenerative and neuromuscular conditions with remote data capture and patient outcome standardization.” © stock.adobe.com/Kathy images 08-11.qxp_Layout 1 08/04/2022 14:28 Page 4TRANSPORT AND LOGISTICS 12 Pharma Business International www.pbiforum.net T he transport industry is facing a double whammy of issues in recent times, none more pressing than the war in Ukraine and the effect it has had on fuel prices across the world. The price of fuel spiking has put everyday commuters into untenable situations, so it’s obvious to say that businesses who make their income around transportation are suffering far worse. While some countries, notably Germany, have announced that they have secured a deal with Qatar for more oil, the UK was unable to boast the same after a meeting in the UAE, and even then, the UAE has stated it will not be increasing oil production, leaving the world hooked on Russian imports. The fuel duty was recently cut by 5p in the UK, a historically significant move since fuel duty had been frozen for the last twelve years. The cut has been claimed as insignificant by commuters, but logistics bosses had a warmer reception to the decision, with the Institute of Export and International Trade welcoming the decision. IOE&IT director general Marco Forgione said the measures would have a significant impact for traders that move goods by road. “Traders moving goods by road will welcome the cut in fuel duty announced by the Chancellor – it will make a difference to costs in what is a tough environment.” An industry under siege An industry under siege Rising fuel costs and staff shortages have put the haulage industry in an impossible situation – are alternative fuel sources the only way out? 12-15.qxp_Layout 1 08/04/2022 14:30 Page 1Pharma Business International 13 www.pbiforum.net TRANSPORT AND LOGISTICS Similar sentiments were echoed by Richard Smith, Managing Direction of the Road Haulage Association (RHA), who said: “We welcome Rishi Sunak’s 5p per litre cut in fuel duty and hauliers and coach operators will benefit, but with fuel prices increasing at an alarming rate, it is essentially a short-term fix.” In a later interview, Richard Smith hinted that the long-term solution would be a 15p per litre rebate for “essential users” of fuels, which would naturally include the logistics and transport industry. There has been little indication as of yet that more will come for the industry but other countries in the EU will almost certainly face pressure to make similar cuts facing the unprecedented rise in fuel costs. In France, the decision has already been announced to provide €400 million in aid to French hauliers. “The aid will concern more than 500,000 vehicles and will be paid out quickly to strengthen the cash flow of companies,” said employers’ organisations the Fédération Nationale des Transporteurs Routiers (FNTR) and Transport et Logistique (TLF). German haulage associations are calling for a similar package and also a summit with economic ministers to find a solution to what is rapidly becoming an impossible business position, especially 14 Á © stock.adobe.com/malp 12-15.qxp_Layout 1 08/04/2022 14:30 Page 2TRANSPORT AND LOGISTICS 14 Pharma Business International www.pbiforum.net for SMEs. They are also calling for payment terms to haulage firms to be shortened, forcing companies to pay hauliers sooner in an effort to alleviate pressure on cashflow. All of this ties back solely to the issue of fuel, and if a full embargo on Russian imports is imposed as the EU is deliberating at the time of writing, then the matter will only get worse. While schemes and initiatives are in place for alternative-fuel vehicles such as electric or gas, the infrastructure isn’t there yet. Perhaps the current crisis could have been mitigated if more had been done to explore that in times of plenty, but hindsight is 20-20 and the expenses were hard to justify for many in the industry. While hydrogen fuel is being tested in many countries, and Germany has even arranged a deal to transport liquid hydrogen from the UAE, this is unlikely to be much relief for smaller businesses who cannot afford the large investment in hydrogen-fuelled vehicles. That said, even assuming the war in Ukraine should suddenly be fixed and prices return to normal, it has only shown how volatile they are to Russian action, and many countries are looking to rid their dependency on Russian energy entirely. As such, the investment in alternative fuels, while painful, might be a necessity all the same. The issue of rising fuel costs compounds a further issue the industry is facing; that of the shortage of HGV drivers. That problem of staff shortages is even less likely to go away despite plans to “bridge the gap” and train more people to become hauliers. Such has been said for a hundred other sectors including STEM sciences, medicine and teaching, and it’s unlikely that the initiatives will achieve much more in that regard than bandaging the wound. Questions then must be asked on what can be done within the industry to appeal to potential employees to take up the profession. If the issue is of cost and wages then it’s unlikely the spiking fuel prices will allow for better pay, but if it is something else that drives people away then perhaps that can be addressed. Even if it should, rising costs of wages within the EU may add unhelpful pressure. In a controversial move last month, P&O Ferries sacked over 800 workers via Zoom call, in a decision that their 12-15.qxp_Layout 1 08/04/2022 14:30 Page 3Pharma Business International 15 www.pbiforum.net TRANSPORT AND LOGISTICS employers admitted they had known to be in violation of employment law, so that they could all be replaced with foreign agency workers who are paid below minimum wage. This decision was made, according to employers at P&O, because there was no viable alternative to their survival, but what some may seem as necessary action is likely only to poison sentiment against haulage and logistics companies at an already difficult time. While pharmaceutical companies may have the funds necessary to keep things running, problems may appear if the infrastructure necessary to transport said goods to a final destination falls apart. One solution may be for pharma companies to look at hiring their own fleets, their own supply chain, but then that runs into the same hiring and staffing issue that many are facing already. The answer may well be in the hands of the transport firms themselves, who will have difficult questions ahead about whether they want to remain subject to the volatility of fuel prices, or if it isn’t worth a larger investment in alternative fuels for a chance at a more stable market. © stock.adobe.com/Maksym Yemelyanov © stock.adobe.com/Image'in 12-15.qxp_Layout 1 08/04/2022 14:30 Page 4LABELLING, 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 are ready for use. 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 © stock.adobe.com/nordroden Safe and secure Labelling, coding, and marking are key in the pharmaceutical sector - to product traceability, integrity, and safety. Safe and secure 16-19.qxp_Layout 1 08/04/2022 14:30 Page 1Pharma Business International 17 www.pbiforum.net LABELLING, CODING AND MARKING 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 18 Á © stock.adobe.com/highwaystarz 16-19.qxp_Layout 1 08/04/2022 14:30 Page 2LABELLING, CODING AND MARKING 18 Pharma Business International 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 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 © stock.adobe.com/ I Viewfinder © stock.adobe.com/Aksana 16-19.qxp_Layout 1 08/04/2022 14:30 Page 3Pharma Business International 19 LABELLING, CODING AND MARKING easy where siloed systems see changes made in isolation, with separate templates, and additional administrative burden and opportunity for error and 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. Labelling, coding, and marking processes must be able to keep up with high-speed production lines and constant demand to cut turnaround times. The COVID-19 pandemic added fresh pressure, and a need for advanced solutions with new lines for packaging vaccines installed or existing ones reconfigured in response to the crisis. It is crucial that pharmaceutical companies have the right solutions for the job, with leaders in the industry making use of advanced technology able to bolster productivity. 16-19.qxp_Layout 1 08/04/2022 14:30 Page 4Next >