< PreviousM&A ROUND-UP 10 Pharma Business International www.pbiforum.net the most advanced of which are next- generation pneumococcal vaccines. Affinivax has developed the Multiple Antigen Presenting System (MAPS), a technology that supports higher valency than conventional conjugation technologies, enabling broader coverage against prevalent pneumococcal serotypes and potentially creating higher immunogenicity than current vaccines. Affinivax’s most advanced vaccine candidate (AFX3772) includes 24 pneumococcal polysaccharides plus two conserved pneumococcal proteins (compared to up to 20 serotypes in currently approved vaccines). A 30-plus valent pneumococcal candidate vaccine is also in pre-clinical development. Dr Hal Barron, chief scientific officer and president R&D, GSK, said: “The proposed acquisition further strengthens our vaccines R&D pipeline, provides access to a new, potentially disruptive technology, and broadens GSK’s existing scientific footprint in the Boston area.” The transaction, anticipated to close in the third quarter of 2022, follows GSK entering into an agreement to acquire Sierra Oncology, a late-stage biopharmaceutical company focused on targeted therapies for the treatment of rare forms of cancer, for $55 per share of common stock in cash representing an approximate total equity value of $1.9 billion. Bristol Myers Squibb - Turning Point Therapeutics Bristol Myers Squibb and Turning Point Therapeutics, meanwhile, have announced a definitive merger agreement under which Bristol Myers Squibb will acquire Turning Point Therapeutics in a $4.1 billion deal. Turning Point Therapeutics is a clinical- stage precision oncology company with a pipeline of investigational medicines designed to target the most common mutations associated with oncogenesis. Turning Point Therapeutics’ lead asset, repotrectinib, is a next-generation, potential best-in-class tyrosine kinase inhibitor (TKI) targeting the ROS1 and NTRK oncogenic drivers of non-small cell lung cancer (NSCLC) and other advanced solid tumours. Repotrectinib has been granted three Breakthrough Therapy Designations from the US Food and Drug Administration. In the Phase 1/2 TRIDENT-1 clinical trial, longer duration of response has been observed in the landmark analysis with repotrectinib than with existing ROS1 agents in first-line NSCLC. “The acquisition of Turning Point Therapeutics further broadens our leading oncology franchise by adding a best-in-class, late-stage precision oncology asset,” said Giovanni Caforio, 08-11.qxp_Layout 1 10/06/2022 14:59 Page 3Pharma Business International 11 www.pbiforum.net M&A ROUND-UP © stock.adobe.com/Atmosphere M.D., Board chair and Chief Executive Officer, Bristol Myers Squibb. “With this transaction, we are continuing our strong track record of strategic business development to further enhance our growth profile.” ADVANZ PHARMA - Intercept Pharmaceuticals Though more modest, also notable is ADVANZ PHARMA, a UK pharmaceutical company with a strategic focus on specialty and hospital pharmaceuticals in Europe, signing an agreement with Intercept Pharmaceuticals, to acquire the majority of Intercept’s subsidiaries and operations in Europe, Canada, and all other markets outside of the US. This includes the ex-US rights to commercialise Ocaliva (obeticholic acid) for primary biliary cholangitis (PBC), a progressive autoimmune disease that damages the bile ducts in the liver. Intercept is a US-based biopharmaceutical company centred on the development and commercialisation of novel therapeutics to treat progressive non-viral liver diseases. Under the terms of the agreement, Intercept will receive an upfront consideration of $405 million as well as an additional payment of $45 million from ADVANZ PHARMA contingent upon receipt of an extension of paediatric orphan exclusivity in Europe. “This acquisition is transformational for ADVANZ PHARMA,” said Steffen Wagner, CEO at ADVANZ PHARMA. “Acquiring this high-quality rare disease business outside of the US grows our position as a partner of choice for specialty and hospital pharmaceuticals in Europe, and we are thrilled to welcome Intercept’s dedicated and experienced team, which will bring additional capabilities to us for the benefit of patients.” Hikma Pharmaceuticals - Custopharm Hikma Pharmaceuticals, the multinational pharmaceutical company, meanwhile, has completed its acquisition of Custopharm from Water Street Healthcare Partners, following approval from the US Federal Trade Commission, for an initial cash consideration of $375 million on a debt and cash-free basis, with a further $50 million in contingent consideration payable upon the achievement of certain commercial milestones. Hikma is the second-largest supplier by volume of generic sterile injectable medicines used by US hospitals and health care providers. The combination with Custopharm enhances Hikma’s R&D capabilities and pipeline and expands Hikma’s differentiated US portfolio to close to 130 commercialised injectable medicines – a more than fivefold increase over the last decade. 08-11.qxp_Layout 1 10/06/2022 14:59 Page 4PROCESS. CONTROL AND AUTOMATION 12 Pharma Business International www.pbiforum.net Streamlining the process 12-15.qxp_Layout 1 10/06/2022 15:00 Page 1Pharma Business International 13 www.pbiforum.net PROCESS. CONTROL AND AUTOMATION Keeping up with changes in manufacturing can be difficult, especially with the world changing so much thanks to COVID. P harmaceutical manufacturing remains one of the most automated and refined of industries in the world, more by necessity than anything else. With stringent hygiene requirements, the human element has been removed from the production line at key points, and this has led to efficiency that other industries have been slow to pick up. Even the food and drink industry, which runs similar hygiene and sanitation protocols as pharmaceutical, still boasts human involvement in manufacturing, with the UK in particular falling behind European and global rivals to embrace robots and automated production lines. Costs in investment and keeping up with this automation have made maintaining lines difficult, however. There is always new technology, and with old machines becoming outdated or inefficient by comparison, there is often a need to push further, lest the competition do so in your place. Contract manufacturing has become a popular alternative as a result, essentially allowing pharma giants to outsource their manufacturing needs. Outsourcing production used to be a risky prospect, 14 Á © stock.adobe.com/Mike Mareen 12-15.qxp_Layout 1 10/06/2022 15:00 Page 2PROCESS. CONTROL AND AUTOMATION 14 Pharma Business International www.pbiforum.net something that was only considered as a last-minute resource in a situation where an influx of demand, or a problem with your own production line had taken place. Nowadays however, with the increased technological development – and as a result the more affordable access to technology – outsourcing pharma production is not as risky a prospect as it once was. In fact, it’s now a booming industry. Mostly handled by CMO’s (Contract Manufacturing Organisations), the healthcare CMO market is booming rapidly. This has led to many major pharmaceutical firms making the choice to utilise CMO’s for 100% of their production capabilities, greatly reducing staff costs and other overheads. When it comes to the CMO industry, major players are the US and Europe, who have a large number of healthcare CMO’s within their territory. Germany, Italy and the UK are particularly active in the EU – with Germany having a clear lead in terms of the sheer number of CMO’s that specialise in the pharmaceutical industry. This is expected to be a compound factor of pharma giants making increased use of CMO’s. But the figure is also strengthened by the ending of a number of patents which will likely see a flurry of suppliers seeking to provide now un- patented drugs at much lower rates. The advantages of contract manufacturing, or outsourcing in general, extend beyond the variable costs of manufacturing and into overheads in staff, maintenance and even property. No manufacturing means no factory, saving space and rental costs. Of course, becoming fully reliant on outsourced manufacturing comes with its own issues, namely that of flexibility and dependency, but so long as a company does not put all their eggs in one basket, this risk is mitigated. With how fast the manufacturing industry moves, it is tempting to place the burden of keeping up on another. While it will never be as profitable in simple terms to outsource – the contract manufacturer has to make a profit somewhere, after all – pharma companies can invest the money they would have spent on capital, investment and maintaining a facility, into R&D instead, investing in the creation of new drugs that might keep them more profitable in the future. As such, while the approach is not © stock.adobe.com/Microgen 12-15.qxp_Layout 1 10/06/2022 15:00 Page 3Pharma Business International 15 www.pbiforum.net PROCESS. CONTROL AND AUTOMATION inherently as profitable in itself, it can be more sustainable in the long run. As well as the ongoing issues that producers and processors have been facing for many years now – including staff shortages and the continuing skills gap – more challenges have arisen over the last twenty-one months. Namely, social distancing measures and self- isolation. The impact COVID has wrought on the supply chain, at a time when Brexit was seriously impacting seasonal labour, cannot be overstated. Despite a relative return to normal, coronavirus remains a very real concern for many companies with the constant fear that production can be impacted, or halted entirely, due to an on-site outbreak or a high number of staff self-isolating. However, these issues can be mitigated and managed with the use of collaborative robots. These robots – often termed ‘cobots’ – are cost-effective, safe and flexible to deploy, making them an increasinglypopular option in pharma processing and materials handling. Added to this is the fact that, as the name suggests, they are collaborative, designed to share a workspace with humans. They can allow even small and mid-sized companies to automate where before it would have been prohibitive. Although cobots have far-reaching applications and capabilities across the entire industrial spectrum, where the industry is concerned, they are ideally suited to work alongside humans in delicate processes such as pick and place – though a risk assessment will need to be undertaken first. With all that in mind, many have touted cobots as the future of pharma factories. Looking at the data, it’s hard to disagree. Research from Interact Analysis found that in 2018, global revenues from cobot production exceeded $550 million – an almost sixty per cent increase over 2017. The market researcher forecasts that revenues for cobots will reach $5.6 billion in 2027, accounting for almost one-third of the total robotics market. There’s no single solution to meeting the ongoing challenges facing the industry. However, automation and smart technologies can not only boost efficiency and output but can also help to reduce carbon emissions. Now, more than ever, automating is affordable and within reach for smaller firms. The future is indeed now. © stock.adobe.com/gen_A 12-15.qxp_Layout 1 10/06/2022 15:00 Page 4TRAINING AND SKILLS DEVELOPMENT 16 Pharma Business International www.pbiforum.net T he skills shortage is being hailed as the biggest threat of 2022. In a post-pandemic world, we’ve come out into an economy where job openings are common and skilled applicants are less available than ever before. Combine this with the Great Resignation, which has seen many people move on due to pressures from Covid or just better offers elsewhere, and you have a scenario where many companies are struggling to find qualified and skilled staff for key positions. Worse still, retaining staff becomes increasingly difficult when their value increases. After all, if a company is struggling to fill a position, then they may turn to headhunting to poach staff directly or increase their wage offerings and put themselves in greater competition against your company if you cannot do the same. There’s no magic solution to that and no real way to force an employee to stay if they want to move on, which means many businesses will have to deal with – or currently are dealing with – the challenge of finding skilled employees to hire for certain positions. If your business has the resources necessary to offer the greatest packages and attract the best talent, great, but those who cannot afford to break the bank to hire the best, may need to create the perfect candidate instead. This is nothing overly new in the pharmaceutical industry. Businesses in the sector have been providing bursaries, scholarships and putting talented people through universities for years now. However, the squeeze is still being felt even on this level, and there are many lower-qualification jobs involved in pharma that don’t require degrees. These Training the ideal candidate With skills shortages and the great resignation squeezing recruitment pools and agencies alike, pharma businesses may want to look to creating their own ideal candidate rather than waiting for one to show up. 18 Á 16-19.qxp_Layout 1 10/06/2022 15:01 Page 1Pharma Business International 17 www.pbiforum.net © stock.adobe.com/Halfpoint 16-19.qxp_Layout 1 10/06/2022 15:01 Page 2TRAINING AND SKILLS DEVELOPMENT 18 Pharma Business International www.pbiforum.net jobs are being squeezed just as tightly as high-level R&D or management positions, resulting in pressure at every level of the supply chain. Online training saw a massive boom during the lockdown period for the obvious reasons of its convenience and viability in a working-from-home landscape. While this was a great way to upskill staff during a time when productivity and work hours were low, every business owner understands what it can achieve. Training can help improve staff and give business leaders valuable skills they need to run a company. This is all applicable and very easily understood, but what many are missing out on is the potential online training has to solve the recruitment crisis gripping the sector by replacing, or supporting, in-house training already undertaken, by online courses tailored to the particular role. Businesses already run in-house training as an everyday part of hiring a new employee – but this, often day or several days long training wherein fire drills, company practice and more are explained, could easily be expanded into an outsourced, online training program designed to teach valuable skills the job requires. This could take part prior to a candidate starting with the company, or as part of their introductory term with the company and could be tailored theoretically to any position or role, used either to strengthen key skills, teach valuable qualifications or even shore up weaknesses in a candidate. This may not be an ideal solution of course, the ideal would be that a candidate comes with every skill necessary to fill the role, but in today’s world where this simply isn’t happening, and where companies are fighting tooth and nail for a limited pool of skilled candidates, alternatives must be found. It may soon not be enough to simply wait for the right candidate or 16-19.qxp_Layout 1 10/06/2022 15:01 Page 3Pharma Business International 19 www.pbiforum.net TRAINING AND SKILLS DEVELOPMENT even to wait for the ones you are pushing through university to come through. Ironically, merging or acquiring another company might be one of the better ways to source high-quality staff now – which sounds ridiculous on its own; the idea of buying a firm just to hire some decent employees – but considering that acquisitions would also bring with it valuable IP, patents or expertise, it can be something of a bonus to an already profitable business move. It is, of course, an expensive one, and not exactly the first option for many businesses. Training and skills development must therefore remain the main source of skilled candidates – and this is something that will have to be expanded as the skills shortage continues to get worse. One of the reasons why training courses are so often cut by companies is because the results of them can seem intangible. Like so many other departments or initiatives, the budgets of these are cut first compared to profit-making venture. This is obviously a flawed way of thinking that will have to change in the long run, but perhaps the flaw is also in the idea that performance is difficult to quantify. It should not be. Targets and KPI’s have existed as far back as businesses have, and employees being trained to perform better should be able to show a measurable and quantifiable increase in productivity. If training is necessary to enable an employee to work in a role at all then it should already be easily quantified – the training has allowed the employee to take the position and has therefore worked – but if the training course is to upskill in areas such as sales, conflict resolution or health and safety, then managers must find other ways of measuring how successful it has been, but they must work to quantify this rather than simply write it off as too difficult, as has all too often been the excuse in the past. © stock.adobe.com/Me studio 16-19.qxp_Layout 1 10/06/2022 15:01 Page 4Next >