< PreviousM&A ROUND-UP 10 Pharma Business International www.pbiforum.net to its transplant portfolio. Rezurock is a recently FDA-approved, first-in-class treatment for chronic graft-versus-host disease (cGVHD) for adult and paediatric patients twelve years and older who have failed at least two prior lines of systemic therapy. Also announced in August was Amgen’s acquisition of Teneobio – a privately held, clinical stage biotechnology company developing a new class of biologics called Human Heavy-Chain Antibodies – for up to $2.5 billion. The deal sees Amgen acquire all outstanding shares of Teneobio at closing in exchange for a $900 million upfront cash payment, as well as future contingent milestone payments to Teneobio equity holders potentially worth up to an additional $1.6 billion in cash. The acquisition includes Teneobio’s proprietary bispecific and multispecific antibody technologies, which will enable significant acceleration and efficiency in the discovery and development of new molecules that have the potential to treat a wide range of important diseases across Amgen’s core therapeutic areas. Amgen said that these platforms complement its existing antibody capabilities with the addition of a heavy- chain only platform that allows a streamlined, sequence-based discovery approach for target binders, as well as Teneobio’s novel T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform. The acquisition will also add TNB-585, a Phase 1 bispecific T cell-engager for the treatment of metastatic castrate-resistant prostate cancer (mCRPC), and several preclinical oncology pipeline assets with the potential for near-term IND filings. TNB-585 complements Amgen’s existing prostate cancer portfolio, which includes acapatamab (formerly AMG 160) and AMG 509, both in Phase 1. David M. Reese, Executive Vice President of R&D at Amgen, said the deal will “strengthen our ability to develop innovative medicines to treat patients with serious illnesses and to bring to market best-in-class products, particularly with respect to multispecific and bispecific medicines directed against targets in a wide range of diseases across our core therapeutic areas.” © Shutterstock /nitpicker 08-11.qxp_Layout 1 12/10/2021 13:45 Page 3Pharma Business International 11 www.pbiforum.net M&A ROUND-UP More movers and shakers in the top ten with Pfizer’s $2.26 billion acquisition of Canadian clinical stage immuno- oncology company Trillium. The company’s portfolio includes biologics that are designed to enhance the ability of patients’ innate immune system to detect and destroy cancer cells. Its two lead molecules – TTI-622 and TTI-621 – block the signal-regulatory protein α (SIRPα)–CD47 axis, which is emerging as a key immune checkpoint in haematological malignancies. In September 2020, as part of the Pfizer Breakthrough Growth Initiative (PBGI), Pfizer invested $25 million in Trillium and Jeff Settleman, Senior Vice President and Chief Scientific Officer of Pfizer’s Oncology Research & Development Group, was named to Trillium’s Scientific Advisory Board. Established in June 2020, PBGI’s goal is to provide funding for scientific research as well as access to Pfizer’s experts to ensure the continuity of clinical programs that could be of potential strategic interest for Pfizer. Pfizer has committed to providing up to $500 million in total funding to the PBGI. Lastly this issue is the announcement that Grifols, the Spanish pharmaceutical and chemical manufacturer, is acquiring Tiancheng Pharmaceutical Holdings, the largest shareholder of German biotech, Biotest, to increase patients’ access to plasma therapies for $1.289 billion. Alongside this transaction, Grifols launched a voluntary public tender offer to all outstanding ordinary and preferred shareholders to acquire in cash Biotest’s remaining ordinary and preferred shares. This acquisition will significantly reinforce Grifols’ industry capabilities by enhancing its plasma-derived medicines access, pipeline and sales presence. Moreover, it will provide access to new scientific and industrial capabilities. It will also improve Grifols’ plasma economics and revenue per litre bringing innovative plasma proteins to drive revenue growth and margin expansion. In parallel, Grifols will also expand and diversify its plasma sourcing through the addition of twenty-six European plasma centres and strengthen its operations and revenues in EMEA (Europe, the Middle East and Africa) region. The transaction is subject to regulatory approvals and other conditions. It is expected to close by the end of the first semester of 2022. © Shutterstock /JHVEPhoto 08-11.qxp_Layout 1 12/10/2021 13:45 Page 4SUPPLY CHAIN 12 Pharma Business International www.pbiforum.net Two of the biggest supply chain concerns for pharmaceutical companies – doubly so since the pandemic – are its fleet and the constant threat of counterfeits. Pharmaceutical companies are dependent on their fleet to transport ingredients and finished products from warehouses to suppliers and stockists. As one of its most expensive assets, its fleet needs to be constantly evaluated and new technology is helping to safeguard the bottom line. But far from the cost of the fleet alone, a company must also factor in expenses such as fuel, maintenance and repairs. Pharmaceutical sales fleets are a formidable sector in their own right, with the combined fleets in Europe and the UK totalling 300,000 vehicles. To put that in perspective, the average size of a pharma sales fleet is around 1,000 vehicles which can be as much as five times higher for the largest fifteen companies. Much like the rest of the pharmaceutical industry itself, sales vehicles are evolving. However, as newer models enter the market, older, lower- end vehicles hold less value to a company, meaning they need to be sold to make way for the next generation of models. For fleet managers, this tipping point has come at an ideal time, as they embrace new technologies enabling them to track and manage the data that comes from their drivers and vehicles like never before. The way in which managers look at their fleets has Securing the supply chain 12-15.qxp_Layout 1 12/10/2021 13:46 Page 1Pharma Business International 13 www.pbiforum.net SUPPLY CHAIN © Shutterstock /DoorZone changed, allowing them to scrutinise every phase of a vehicle’s life span – from point of purchase to everything in between. This allows them to know exactly when the time is right to sell a vehicle on or get real time feedback on a new addition to a fleet. The transportation of pharmaceuticals and other medicines requires an efficient and specialised logistical network. Although many ambient over-the-counter medicines are packaged in such a way that requires minimum interference or additional protection, many other pharma products has specific transportation needs. As some of these products and their materials are temperature and light sensitive, the transport must reliably conform to these needs, from a temperature controlled environment to the expert handling of goods, not to mention the health and safety requirements. Embracing new technology is driving the entirety of the pharmaceutical supply chain into industry 4.0. Some of the most exciting and important developments are taking place in the transport and logistics side of the divide, from integrating tracking software and utilising mobile applications, logistics are evolving alongside the industry itself. While companies must be cognizant of their fleet, they cannot be blind to other supply issues – especially where counterfeits are concerned. Pharmaceuticals rank within the top ten categories for counterfeit goods – an issue that has only worsened in the wake of the pandemic with counterfeit COVID 14 Á Pharmaceutical sales fleets are a formidable sector in their own right, with the combined fleets in Europe and the UK totalling 300,000 vehicles. 12-15.qxp_Layout 1 12/10/2021 13:46 Page 2SUPPLY CHAIN 14 Pharma Business International www.pbiforum.net treatments being sold online. Far from simply erring on the side of caution, traceability is a means of monitoring products as they move through the supply chain, and compiling statistics and information which can be called on in the event of theft. As counterfeiters turn to ever more cunning methods of production and use online websites and social channels to sell their products, traceability is necessary for safeguarding the industry and, more importantly, keeping consumers and patients safe. Supply chains in general have become more complex and multidimensional with the influx of new technologies, equipment and with the interconnectedness of an omnichannel approach. With the Internet of Things (IoT) continuing to gain momentum, it’s likely that supply chains will continue to benefit from a greater degree of efficiency and traceability. Yet the emergence of a more complex supply chain brings with it the greater challenge of tracking products. The presence of new tech and software requires an updating of the existing processes, itself a time-consuming effort, but also one that can leave room for accidents and problems to occur. There also exists the challenge in keeping track of the staggering number of products that are processed every day. To meet these challenges, pharmaceutical manufacturers are turning to and investing in product security initiatives such as serialisation. This involves coding products with a unique signature at the item level during production. Doing so ensures that © Shutterstock /Shidlovski 12-15.qxp_Layout 1 12/10/2021 13:46 Page 3Pharma Business International 15 www.pbiforum.net SUPPLY CHAIN products can be tracked as they journey through the supply chain – and be marked off as they move from the production floor to a warehouse etc. – and offering manufactures and suppliers some extra safeguards against theft. Furthermore, it adds a further defence against counterfeits, as bogus medicines will be lacking the coded signature. Adhering to market compliance can be a herculean task for pharmaceutical companies as regulations can differ from one market to another for legislative or conflicting regulatory reasons. Staying abreast of the regulations in any given country or territory, then, is an absolute must. For some companies, staying compliant is more than just good practice, but rather the opportunity to create value beyond compliance. This is a novel approach in as much as most pharmaceutical companies approach traceability in terms of how to comply rather than how to comply and create value. Ergo, traceability can help to offer brand differentiation as well as gain a competitive edge. Fortunately, the majority of the global medicine supply is now covered by one or more track and trace regulations. That means that companies serving global patients will face complex serialisation, traceability, verification and government reporting regulations. So for many companies, serialisation may well be one of the biggest operational challenges they face but doing so will help to implement a stronger, more impregnable pharmaceutical supply chain, one where counterfeit products are on the decline. © Shutterstock /Zapp2Photo 12-15.qxp_Layout 1 12/10/2021 13:46 Page 4ANIMAL HEALTH 16 Pharma Business International www.pbiforum.net Innovations in animal health 16-19.qxp_Layout 1 12/10/2021 13:47 Page 1Pharma Business International 17 www.pbiforum.net ANIMAL HEALTH © Shutterstock /Liudmyla Guniavaia The animal health sector continues to expand and biopharmaceutical companies are innovating - seeing new vaccines, cancer treatments, and alternatives to antibiotics come to fruition. The animal healthcare industry is expanding as awareness grows around animal health issues and their impact on people and the planet. This comes alongside pet ownership and health expenditure increases (especially in the wake of the pandemic pet boom), longer pet lifespans, rising livestock production, and crises such as African Swine Fever - for which there is no cure or effective vaccine. Manufacturers/biopharmaceutical companies continue to invest in research and development, creating new and more effective treatments for both companion and livestock animals, and minimising the threat of disease by strengthening immunity, prevention, and enhancing diagnosis. As animal diseases constantly evolve this is vital. Scientific advances and emerging technologies including AI and stem cell therapy meanwhile are presenting more opportunities to predict, prevent, diagnose, and treat animal illnesses rapidly and safely. All in on innovation: vaccines, antibiotics, and cancer treatments take centre stage New vaccines, and innovations in development, are a key tool in deadly disease prevention, are reducing antibiotic use, and as a result, antimicrobial resistance, protecting the public, and halting the transmission of zoonotic diseases particularly. The increasing focus placed on developing novel vaccines can be seen with the £40 million UK Animal Vaccine Manufacturing and Innovation Centre being established for vaccines to prevent zoonotic diseases. Steps forward for the industry include the breakthrough of mRNA vaccines, 18 Á 16-19.qxp_Layout 1 12/10/2021 13:47 Page 2ANIMAL HEALTH 18 Pharma Business International www.pbiforum.net which provide a genetic code to act as instructions and show the immune system how it can recognise and fight a disease. In safely preparing the body to fight viruses without needing to use the virus itself, vaccines can be produced more efficiently, with less risks, at lower costs. Heat resistant vaccines are another important innovation, addressing how vaccines are typically required to be kept at cold, and sub-zero temperatures until administered, hindering the roll out of vaccines in areas where refrigeration is not possible and in tropical countries. Heat-resistant vaccines, then, remaining effective at room temperature, are cutting costs and bolstering animal health in many regions. This can be seen with these vaccines eradicating diseases like rinderpest. Simultaneously the case for responsible antibiotic use is growing, with figures from 2020 showing a 34.6 per cent overall decline in sales of antibiotics for animal health purposes since 2011 in twenty-five European countries. This comes as a result of over a decade of efforts to boost disease prevention and improve animal health management through better hygiene practices, biosecurity measures, vaccine use and nutrition. New innovations are taking on antibiotics, providing alternatives, and reducing need for use. Bacteriophages for instance - a type of virus that infects bacteria and destroys the host cells - continue to be researched. Targeting specific bacteria, bacteriophages cannot be applied using a blanket approach, meaning that though they have a long history, viable products are yet to hit the market. Confidence can be seen in bacteriophages, however, with Proteon Pharmaceuticals recently landing an investment of €21 million to accelerate the commercialisation of its bacteriophage products, which seek to minimise reliance on antibiotics within aquaculture and livestock farming. The bacteriophage cocktails take on Pseudomonas and Aeromonas infection © Shutterstock /Pressmaster 16-19.qxp_Layout 1 12/10/2021 13:47 Page 3Pharma Business International 19 www.pbiforum.net ANIMAL HEALTH in finfish aquaculture, and the firm’s product development pipeline offers solutions for the prevention of AHPND in shrimp production. Cold and ambient plasmas are also being researched as substances that can destroy harmful pathogens without leaving residues. Studies suggest plasmas - applied using a laser-like device to a targeted area - could be used to prevent and treat microbial infections without damaging tissue or risking antimicrobial resistance. Cold plasma is already being utilised at Cummings Veterinary Medical Center to treat skin wounds in animals. Other innovations in development include antimicrobial peptides, broad-spectrum antimicrobial molecules produced in almost all animals as part of the immune system, nanotechnology to deliver antibacterial substances, and immunotherapies, making use of an animal’s natural defences against a bacterial infection. Of course the last of these has been an important research area in human cancer treatment and much of this work has been harnessed for use in animals. ELIAS Animal Health, for example, brought technology over from a human health company to improve the survival times and quality of life for dogs being treated for cancer. It has since completed multiple clinical trials for novel treatments, launching a new trial of cancer immunotherapy treatment for canine oral melanoma this year. It builds on promising results reported last year for an osteosarcoma study. While many breakthroughs are being made in animal health, with one in five farm animals lost to disease each year there remains much work to be done. Meanwhile, those in the industry face a competitive landscape, rising product development costs, and stringent regulation. © Shutterstock /plutmaverick 16-19.qxp_Layout 1 12/10/2021 13:47 Page 4Next >