An increasing trend in global medicine spending
One of the most interesting stories (and our most-read industry news piece) from 2019 was about a report entitled ‘The Global Use of Medicine in 2019 and Outlook to 2023’ from the IQVIA Institute for Human Data Science (NC, USA). The report set to assess the impact of drug launches, take a look at the current state of medicine use and provide predictions on future trends in the pharmaceutical industry – on a global scale. One of the key takeaways from this report was that global spending on medicines reached US$1.3 trillion in 2018 and we can expect to see an increasing trend throughout to 2023, where it is forecast to exceed US$1.5 trillion. This represents a 3–6% increase in annual growth over the next 5 years; the key drivers of this will be from the growing US market (4–7%), as well as pharmerging countries (such as China and India) who are expected to see a 5–8% growth in annual sales.
Novel research driven by grants
In June, we saw The Institute for Research in Immunology and Cancer (IRIC) of the Université de Montréal (UdeM; QB, Canada) awarded CAD$10 million as part of a grant to develop new cancer-fighting drugs. In this, over the next 4 years, they plan to work with Bristol-Myers Squibb (BMS; NY, USA) and seven other academic research centers to translate the range of academic research into therapeutic solutions. The grant was provided by the government of Quebec’s Fond d’accélération des collaborations en santé (FACS), as part of their efforts to support the key players in the drug discovery field. As cancer research develops and evolves, it is important to successfully translate this research into effective therapies for patients. It will be interesting to see what comes from the next 4 years of work and how the research efforts from these academic institutions will be utilized alongside the knowledge and programs developed by BMS.
Taking a trip across the pond, in the UK we saw NovaBiotics (Aberdeen, Scotland) awarded a grant of GB£1.8 million, to develop their first-in-class antifungal compound, Novamycin. Development of this antimicrobial peptide has the potential to combat life-threatening and drug-resistant bloodstream and tissue fungal infections – for which there is a clear and urgent need to develop new therapies. As part of the UK’s 5-year strategy to tackle antimicrobial resistance, Innovate UK (Swindon, UK) ran a competition – on behalf of the Department of Health and Social Care (DHSC) – a Small Business Research Initiative, in which a total of GB£10 million was to be invested into several projects around the UK.
From manufacture to R&D: expanding China’s research efforts
We wrote about the news that AstraZeneca’s (Shanghai, China) plans to continue their work advancing global research and development in China – building on their long-standing commitment in the country. As part of this, they announced their plans to begin work on three, large-scale initiatives in China. These programs will be based at the Global R&D Centre (Shanghai, China), focusing primarily on China’s needs – the diseases prevalent in this region and other parts of Asia. This project set to not only advance R&D in China but also looks at the wider picture of creating partnerships both internally and externally, as China is currently seeking to move their industry beyond manufacturing and towards a greater proportion of their efforts being involved in R&D. AstraZeneca’s choice to expand their work in China is explained not only by rapid growth seen in China’s research industry but also because China accounted for 21% of AstraZeneca’s global sales.
Drug discovery during a disease outbreak
Following the Ebola outbreak that occurred in the Democratic Republic of Congo, the US Department of Health and Human Services announced they will be providing the funding to support the manufacture of the investigational Ebola vaccine (V920), from Merck (NJ, USA). This approval came before full marketing licensure was obtained from the US FDA but considering the conditions – this being the second-largest Ebola outbreak on record – the normal process was expedited. Under the terms, Merck is set to receive US$23 million over the next year to support the manufacturing process. At the time of this announcement, approximately 200,000 people had been vaccinated through compassionate use – an investment of this value will ensure all those that need it receive it.
In 2015, we saw the Brazilian government report on a large outbreak, which was soon identified as the Zika virus. Not only has this virus rapidly emerged as a pandemic but consequences of the injection are set to have long-term public health implications. Many have been working to develop novel treatments to target this virus – for which there are currently no approved treatment options. Hence, as an unmet clinical need, vaccine development for this infection needs to happen at a faster pace than seen with the typical drug discovery timeline. This year, Moderna (MA, USA) received Fast Track Designation for mRNA-1893, their preventative investigational prophylactic Zika vaccine. This designation was based on preclinical data that demonstrated the vaccine protected against transmission of Zika virus during pregnancy in mice. With this status from the US FDA, the company will be able to expedite the review process, with close communication between the company and the FDA to ensure patients can access the drug sooner.
From support to marketing approval
Prior to marketing approval, the US FDA often looks to its independent advisory boards and committees to provide recommendations on drugs that protect public health but also respect the standard requirements that need to be met. In March, we saw the approval of a nasal spray – SPRAVATO™ (esketamine) – indicated for treatment-resistant depression. A month before this decision was announced, we reported on the news that two US FDA committees have given their support of the approval of Spravato. The Psychopharmacologic Drug Advisory Committee, which reviews any data concerning both safety and efficacy of drug products that relate to psychiatry, and the Drug Safety and Risk Management Advisory Committee voted to recommend this treatment – voting 14:2 (with one abstain). They based their decisions on data from Phase I–III studies, which provided both short- and long-term supportive data that was clinically meaningful. As mentioned, the outcome of this vote led to the approval of Spravato, making it the first mechanism of action in 30 years that targets this disease.
The exclusive rights to Berubicin, a malignant glioblastoma drug developed by MD Anderson Cancer Center (TX, USA), were acquired by CNS Pharmaceuticals (TX, USA) in November. The compound is a powerful anthracycline, a class of powerful chemotherapeutic designed to damage the DNA of an enzyme crucial for cell proliferation. Importantly, this drug is the first of any anthracycline with the ability to cross the blood–brain barrier. At the time of the acquisition, CNS announced they would also be applying for orphan drug status from the FDA. Since then, this designation has been granted for glioblastoma and, additionally, they have received positive results from the first clinical trial where 44% of patients showed a clinical response. If success is seen in future trials, approval, along with the orphan drug designation, would provide them with 7 years of marketing exclusivity in the US.
In 2020, Novartis (Basel, Switzerland) will be adding inclisiran into their portfolio, following the acquisition of The Medicines Company (NJ, USA). This potentially transformative cholesterol-lowering drug could become one of the largest products for Novartis – leveraging their capabilities within this field, in the US and globally. This drug has the potential to aid the 50 million people worldwide with atherosclerosis cardiovascular disease (ASCVD) or familial hypercholesterolemia (FH), for whom the current therapeutic approaches do not sufficiently lower levels of LDL cholesterol (LDL-C). U$S9.7 billion is the price set for this merger, which The Medicines Company are set to receive at the end of the first quarter of 2020 when the transaction is expected to close.
Expanding markets in the UK
The medical cannabis market has seen real growth over the past few years. With the legalization of the product in various US states, are we seeing Europe follow along in this trend with the expansion of their medical cannabis market? Canopy Growth (ON, Canada), a cannabis-focused company, have continued their growth in this industry outside of the US as they formed Spectrum Biomedical UK (Buckinghamshire, UK) – which has the same aims as Canopy but for UK patients with severe unmet needs. This new company is a joint venture between Canopy Growth and Beckley Canopy Therapeutics (Oxford, UK). This new launch, along with the new legislation passed in November of 2018 that certain doctors can prescribe medical cannabis to patients with symptoms ranging from chronic pain to chemotherapy-induced nausea, means that more patients groups are set to receive the necessary.
Research published by the Cell and Gene Therapy Catapult (London, UK) highlighted the leading position of the UK in the development and manufacture of new cell and gene therapies. In the past 2 years, there has been a 26% increase in the proportion of clinical trials for studies utilizing modified therapies – to 73%. This growth can, in part, be attributed to the increase in commercial investment and increased confidence in the potential of these therapies from the life sciences industry as a whole. Surges in areas like this are important as they are will form the basis of research that will address the healthcare challenges we are currently facing and will face in years to come.