< PreviousM&A ROUND-UP 10 Pharma Business International www.pbiforum.net announcement. “Longer term, we plan to continue to invest in and connect the capabilities across the combined company to further help our customers accelerate innovation and drive productivity, while driving further value for our shareholders.” Last up in the billion-dollar bracket this issue is Carlyle Group’s announcement that it will – through which its affiliate Murano Bidco, a recently founded company indirectly controlled by Carlyle Europe Partners V Fund – acquire all issued and to be issued ordinary shares of Vectura for $1.36 billion. The deal is anticipated to conclude in the third quarter of this year. Vectura is a UK-based company focussed on providing inhaled drug delivery solutions that aid its partners to deliver their treatments to patients. The company has a portfolio of thirteen inhaled and eleven non-inhaled products that are commercialised by its partners with royalty streams globally. It also has a partnered portfolio of therapies that are currently in the clinical developmental stage. “Vectura has made strong progress since embarking on its new strategy in 2019 to become a leading inhalation- focused CDMO whilst continuing to deliver strong financial and operational results in its royalties and product supply businesses,” said Vectura Group Chairman Bruno Angelici. “While the Vectura directors remain confident in the long-term fundamentals of the Vectura Group, we believe that this is an attractive offer for Vectura shareholders, which secures the delivery of future value for Vectura shareholders in cash today.” Be sure to check in with our next issue for the all the biggest deals taking place in the pharmaceutical space. 08-11.qxp_Layout 1 10/06/2021 09:54 Page 3Pharma Business International 11 www.pbiforum.net M&A ROUND-UP © Shutterstock /photofriday 08-11.qxp_Layout 1 10/06/2021 09:55 Page 4ANTIVIRALS EXPOSÉ 12 Pharma Business International www.pbiforum.net treatments Promising 12-15.qxp_Layout 1 10/06/2021 09:55 Page 1Pharma Business International 13 www.pbiforum.net ANTIVIRALS EXPOSÉ © Shutterstock /Lightspring While vaccines are rolled out, the importance of antivirals in treating COVID-19 should not be forgotten. Pharma Business International shines a light on recent developments showing promise. Antivirals are currently available for a handful of infections, primarily focused on those caused by HIV, herpes viruses, hepatitis B and C viruses, influenza A and B viruses. But now, in light of the past year, treating COVID-19 has become the centre of conversations surrounding the development, as well as repurposing, of antivirals in hopes of lessening the impact of infections by interrupting the virus’ ability to multiply. Highlighting this, the UK government recently launched a COVID-19 Antivirals Taskforce to identify treatments for patients who have been exposed to COVID-19 to stop the infection spreading and speed up recovery time. The taskforce will search for the most promising novel antiviral medicines that can be taken at home and support their development through clinical trials to ensure they can be rapidly rolled out to patients as early as the autumn. The taskforce will also look at opportunities to onshore the manufacture of antiviral treatments and it is aiming to have at least two effective treatments this year, either in a tablet or capsule form, that the public can take at home following a positive COVID-19 test or exposure to someone with the virus. The government’s move comes as it looks to establish another “vital tool to combat any future increase in infections and limit the impact of new variants, especially over the flu season later this year.” The antivirals could be used alone or in combination with one another in order to increase effectiveness and reduce the risk of further mutations. The taskforce’s aim to have at least two effective treatments this year, however, may well prove to be difficult with antivirals challenging to create. It tends to take years to develop and approve these drugs, with a discovery pipeline involving a sedulous process to identify chemical compounds that target 14 Á 12-15.qxp_Layout 1 10/06/2021 09:55 Page 2ANTIVIRALS EXPOSÉ 14 Pharma Business International www.pbiforum.net a virus, and testing efficacy and safety. Moreover, viruses are diverse and hold less targetable protein building blocks. In getting the drug to its target, entering infected cells, there is also collateral damage to consider and overcome. Attacking a virus outside of cells is also hard due to the virus shell. As the pandemic continues, there has been positive and negative news for antiviral treatments, with some treatments in clinical trials. Disappointingly, while the drug remdesivir had been thought to be showing promising results for those hospitalised due to coronavirus, after a clinical trial, WHO established that it had no substantial effect on survival chance. Subsequently, the European Society of Intensive Care Medicine has recommended that it not be used routinely to treat patients with COVID-19. On the other side of the spectrum, progress is being made by a number of organisations. Scientists from the University of Bristol, for example, have formed a new biotech company (Halo Therapeutics) that is developing ground- breaking and newly patented potential treatments for coronavirus after the team found that exposing the SARS-CoV-2 virus to a free fatty acid called linoleic acid locks the virus’s spike protein into a closed, non-infective form, stopping it in its tracks. The company is now preparing to make an application to start clinical trials with infected patients. If proven to be effective, the antivirals could be used at the first sign of COVID-19 symptoms, or if people have been in contact with someone with the virus, preventing the virus from taking hold and stopping further transmission. Lab studies indicate the antiviral will work against strains including the contagious UK, South African, and Brazilian variants by preventing the virus from penetrating cells in the nose, throat, and lungs. The treatments under development include a nasal spray and an inhaler. Additional positive news recently came from a team of scientists from Australia and the US, who have developed an experimental direct- acting antiviral therapy capable of reducing viral load by 99.9 per cent. The next-generation antiviral approach used gene-silencing RNA technology - siRNA (small-interfering RNA) - to attack the virus’ genome directly, stopping the virus from replicating, as well as lipid nanoparticles to deliver the siRNA to the lungs, 12-15.qxp_Layout 1 10/06/2021 09:55 Page 3ANTIVIRALS EXPOSÉ Pharma Business International 15 www.pbiforum.net the critical site of infection. Co-lead researcher, Professor Nigel McMillan, from Menzies Health Institute Queensland, said: “Treatment with virus-specific siRNA reduces viral load by 99.9 per cent. These stealth nanoparticles can be delivered to a wide range of lung cells and silence viral genes. Treatment with the therapy in SARS-Cov-2 infected mice improved survival and loss of disease. Remarkably, in treated survivors, no virus could be detected in the lungs.” The treatment is designed to work on all betacoronaviruses, like the original SARS virus (SARS-CoV-1), as well as SARS-CoV-2 and any new variants that may arise as it targets ultra-conserved regions in the virus’ genome. Also in the pipeline, Pfizer’s CEO has stated that its oral antiviral pill for COVID, to be taken when the illness is initially detected, could be ready by the end of 2021. The drug, PF- 07321332, is currently in phase 1 clinical trials. To prevent replication, protease inhibiters - which have been effective in treating HIV and hepatitis C - in the drug bind to viral enzymes. The candidate has demonstrated potent in vitro anti-viral activity against SARS-CoV-2, as well as activity against other coronaviruses, indicating potential for use in the treatment of COVID-19 as well as future coronavirus threats. Ridgeback Biotherapeutics and Merck’s new pill, molnupiravir, meanwhile, is further ahead. Researchers have found that the small molecule drug completely suppresses virus transmission in 24 hours. Molnupiravir, for non-hospitalised patients, is now in advanced phase 2/3 clinical trials after being tested to be successful in ferrets. Another promising candidate, Roche and Atea’s oral, direct-acting antiviral, AT-527, is also in phase 3 trials. With extensive mortality due to respiratory failure as a result of SARS-CoV-2, it is clear effective antiviral treatments are needed and must continue to be developed, and that vaccines - which not everyone will be able to take or respond to - and frequent testing alone are not enough, especially if considering variants and future coronaviruses. While the complexity, cost, and time involved in developing new antiviral drugs saw the reuse of existing drugs arise as the initial focus for treating the novel coronavirus, a renewed push is stimulating and supporting new treatments. 12-15.qxp_Layout 1 10/06/2021 09:55 Page 4THERAMEX Q&A 16 Pharma Business International www.pbiforum.net 1) What sets Theramex apart from other pharmaceutical companies? Our exclusive dedication to women’s health enables us to drive excellence in the care of women at every stage of their lives. We see first-hand how women may be under-served by healthcare systems and we are working hard to address care gaps driven by insufficient knowledge and poor patient awareness of contraception, menopause, osteoporosis, and fertility. Ultimately, we are working to empower women to contribute to making educated decisions regarding their health. 2) Why the focus on women’s health, and are there particular areas of focus within this? For far too long women have put the needs of others before themselves. As women advance through their lives, their healthcare needs may change from contraception or fertility treatment to the menopause and osteoporosis. For each stage we want to ensure that women understand their options and are empowered to make healthcare decisions which will suit the way they live. We currently operate in four therapeutic areas and there are many opportunities to add products, and new therapy areas, to support women with other aspects of their health. Osteoporosis We aim to make a big difference in the availability of treatments which support the prevention and management of osteoporosis. Osteoporosis is a disease which affects more than 200 million people worldwide1 and one-in-three post-menopausal women will have a bone fracture at some point in their lifetime.2 Despite this, 60–85% of women over 50 years of age with osteoporosis do not receive treatment.3 The significant risks to health caused by this disease are often overlooked by women and their healthcare providers, and most diagnoses come after a fracture occurs. Menopause For any woman, the menopause is a significant change which can have a big impact on them and their families. Women are post-menopausal for one- third of their lives.4 And 80% will experience menopausal symptoms, with half of these symptoms being moderate to severe.4 It is believed that more than a third of women visiting a GP to discuss the menopause are prescribed anti- depressants rather than HRT (hormone replacement therapy).5 Theramex is dedicated to improving healthcare professional (HCP) education to address this need for change. In addition, we are continually working with women, our partners, and HCPs, to bring forward affordable and effective treatments which will help in the management of the often-debilitating symptoms of the menopause. Contraception At any one time, 78% of women require support to achieve or prevent a pregnancy. Many of these women do not seek-out preconception advice and care.6 We are committed to supporting women who desire effective contraception that is suited to their lifestyle. We understand the need to balance the prevention of unwanted pregnancies with quality of life considerations, such as acne, weight gain, and cardiovascular risk. We also know the importance of women choosing and changing contraception at various life stages and the value of being well informed about their options, so they can make their choices with confidence. 3) How has Theramex negotiated the pandemic? At a time when many companies were reducing their workforce, Theramex added nearly 100 positions, seeing a Q&A Robert Stewart, CEO, Theramex We recently spoke with Robert Stewart, CEO of Theramex, a global speciality pharmaceutical company solely committed to supporting the health needs of women through every stage of life. Robert Stewart, CEO of Theramex 16-17.qxp_Layout 1 10/06/2021 09:56 Page 1Pharma Business International 17 www.pbiforum.net THERAMEX Q&A 77% growth in its employment base (from January 2019). We expanded our business by launching new affiliates and adding new distributor relationships, and now sell product in 57 markets around the globe. This has been possible because we have a clear purpose, there is a real need for our products, and we are continually investing in growth. We are not big pharma. We are very focused, extremely agile, and readily adaptable to the changes and challenges of the evolving world. During the pandemic, we worked incredibly hard and made decisions quickly. We ensured that our supply-chain could continue to operate well so that treatments remained available for patients, and we made sure that our employees were safe. We diverted stock as needed and manufactured new product to support UK HRT shortages. Our employees quickly adapted to the digital environment and continuously connected with customers to work through the pandemic. With caution, the darkest days of COVID appear to be behind us. I’m incredibly proud to be part of the pharma industry, which responded with safe and effective vaccines, and lifesaving treatments. Now, as we move into brighter days, we are out looking for new innovative products to bring to the women who need them. 4) What is your long-term vision for women’s health and how will Theramex lead the way to improve women’s health? In a modern society, women must have access to the knowledge needed to make informed decisions about their health. They also need access to a range of therapies which will suit their lifestyles. I believe in an inverted organisational structure where we are able to ensure that the leadership of the organisation is positioned to support sales teams, often with the closest view of customer needs, with the best products and tools. We are building an exciting portfolio which is strongly focused on reducing the burden of treatment and increasing quality of life. Alongside this, every day we are connecting with more and more HCPs to ensure that they have up-to-date information, enabling them to talk with confidence to patients about their conditions and treatment options. More than half (50.6%) of the UK’s population is female7 and nearly two thirds of women (59%) make health care decisions for others. In fact, nearly all (94%) working mothers with children under 18 make healthcare decisions for others. Despite this, many women (58%) lack confidence in their ability to make good health care decisions for themselves and their families.8 Today, the empowerment of women quite rightly has a high profile. We are beginning to see women setting a health and wellness agenda for themselves and their families, including choosing their own treatment regimens. The healthcare industry must support this move and Theramex is determined to be at the forefront of this exciting change. Caring for women throughout their lives is what defines Theramex and, because we care, we aim to be the leading global company in women’s healthcare. To find out more, visit www.theramex.com This article is intended for those working within the pharmaceutical industry sector References 1. Noh JY, et al. Molecular mechanisms and emerging therapeutics for osteoporosis. Int J Mol Sci. 2020; 21, 7623 DOI: doi.org/10.3390/ijms21207623 2. IOF Compendium of Osteoporosis. 25th September 2019. www.osteoporosis.foundation/sites/iofbonehealth/files/2020-01/IOF-Compendium-of- Osteoporosis-web-V02.pdf Last accessed: June 2021 3. IOF Broken Bones Broken Lives. A roadmap to solve the fragility fracture crisis in Europe. www.osteoporosis.foundation/sites/iofbonehealth/files/2019- 06/1.%202018_EU6_Report_BrokenBonesBrokenLives_English.pdf. Last accessed: June 2021 4. Newson L. Best practice for HRT: unpicking the evidence. British Journal of General Practice, 2016; 66 (653): 597-598. DOI: doi.org/10.3399/bjgp16X687097 5. Survey shows menopausal women being prescribed ‘inappropriate’ antidepressants. https://www.healtheuropa.eu/survey-shows-menopausal-women- being-prescribed-inappropriate-antidepressants/94110/ Last accessed: June 2021 6. Public Health England Guidance. Health matters: reproductive health and pregnancy planning. www.gov.uk/government/publications/health-matters- reproductive-health-and-pregnancy-planning/health-matters-reproductive-health- and-pregnancy-planning. Last accessed June 2021 7. Office for National Statistics. Female versus male population. www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/population estimates/articles/overviewoftheukpopulation/january2021. Last accessed: June 2021 8. Harvard Business Review.The Health Care Industry Needs to Start Taking Women Seriously. www.hbr.org/2015/05/the-health-care-industry-needs-to-start- taking-women-seriously. Last accessed: June 2021 HQ_MEDIAKT_004137 - Date of Preparation: June 2021 16-17.qxp_Layout 1 10/06/2021 09:56 Page 2LOGISTICS & DISTRIBUTION 18 Pharma Business International www.pbiforum.net Maintaining 18-21.qxp_Layout 1 10/06/2021 09:57 Page 1Pharma Business International 19 www.pbiforum.net LOGISTICS & DISTRIBUTION It’s vital to ensure that products stay at the correct temperature throughout the process, and that accurate information is available across the often extensive supply chain. That’s especially the case in the pharmaceuticals sector where products can often be compromised by changes to temperature. Both the pharmaceutical and the food industry face similar challenges in this regard, with their respective products being highly susceptible to the slightest changes in temperature. This is hardly news to the pharmaceutical industry, and every manufacturer in the world likely already has some form of careful temperature control system in place. But that doesn’t seem to stop the wastage that occurs as a result of variances in temperature. So what has been going wrong? For many companies, problems seem to occur in the supply chain, or on distribution lines. While the product is still in the primary manufacturing facility the process is much more regulated and controlled, but it is easier to achieve that in a state-of-the-art facility where the process is mostly automated. At the hand-over point between manufacturing facility and distribution, there is obviously a point where human elements need to get involved, be it in end-of-line packaging, or materials handling. These points of transference from one part of the supply chain to another represent significant breach points in the temperature integrity of pharmaceutical products and should have particular attention attributed to them. When it comes to distribution centres which play a key role in the supply chain towards the retail market, the costs of temperature control systems can quickly scale out of control. Therefore, it’s important at all times to focus on methods of efficiently maintaining temperature levels, with as little ambient loss of temperature as possible. At the end integrity © Shutterstock /V irrage Images When it comes to maintaining the temperature integrity of pharmaceutical products, it’s best to look at the supply chain – and in particular storage and distribution centres. 20 Á 18-21.qxp_Layout 1 10/06/2021 09:57 Page 2Next >