Asthma is a chronic inflammatory respiratory disease, which currently impacts more than 339 million people globally and is recognized as a condition of major public health importance by the WHO1. It is estimated that by 2025, there could be a further 100 million asthmatic patients worldwide.
In the US the condition affects 1 in every 12 people, and in Europe there are around 10 million people over 45 years of age living with asthma. A disease that affects all ages and all population groups, it is estimated that up to 1,000 people die as a result of asthma every day. According to WHO figures, over 417,000 preventable deaths were attributed to asthma in 2016, with 80% of deaths occurring in developing countries. And yet, this serious, chronic condition is very treatable. It is access to high quality medicines at an affordable price that is the major leveller when it comes to who receives treatment.
The price problem
The problem of access to treatment is not new and is one that has challenged patients, payers and the healthcare industry in equal measure. The development of inhaled medicines, at a sustainable and affordable price, is difficult because of the complexities involved in the development and manufacture of these hard-to-make combination products, which few companies have the necessary expertise for.
Thomas Storm, Global Program Head of the Respiratory portfolio at Sandoz explains: “Current treatment options for asthma are actually very good. The bigger challenge is ensuring universal and equitable access, and this is really where the generics industry can help. Reducing the cost, whilst maintaining the high quality of treatment needed for a condition that affects all ages and population groups, especially in the US where prices can be very high and can cost a patient several thousand USD per year2 – can have a major impact on the disease burden.”
In general, providing treatment via generic products for inhaled therapies is challenging, partly due to the very high regulatory requirements , partly due to the complexity of the technical and clinical development itself. This has resulted in the availability of only a limited number of inhaled generic products. Unlike for instance oral dosage generics, developing inhaled generic products comes with significant challenges requiring innovative solutions.
Due to the extensive and long-term capital investment requirements, as well as the level of scientific skill and know-how needed, only a few major players are currently active in this field. As a company, even through challenging times, Sandoz has maintained a commitment to building on its years of research, including navigating setbacks that required a rethink of its approach to developing respiratory medicines.
At Sandoz, we have the capabilities and know-how to develop complex generics and technically challenging products with long development cycles.
Thomas Storm explains why: “At Sandoz, we have the capabilities and know-how to develop complex generics and technically challenging products with long development cycles. We remain committed and fully engaged in an area where we also had major setbacks in the past. We have reinvigorated the development center for inhaled therapies and have expanded the capabilities we needed to ensure we have access to all required technologies to develop complex combination products.”
Enhancing the skills needed to be successful in both these areas is something Sandoz is looking to achieve this year. As a company, it is already committed to the research and development of complex generics, such as inhaled respiratory products, despite major setbacks in the past. Its continued focus on this therapy area, is why Sandoz remains a global player in inhaled respiratory medicine, continuously building the expertise and infrastructure needed to support this long-term commitment. Sandoz has been able to make significant advances by accessing device development capabilities for product development, and enabling strong collaboration between manufacturing and development teams, which are co-located on one vertically integrated site.
The value of generics
Cultivating a strong clinical team to drive the development of the respiratory portfolio was one advancement that has reinvigorated the company’s efforts, bringing clinical capability inside its scope of activity, rather than leaving it as an outsourced skill.
Front and centre of the Sandoz respiratory strategy is improving access across the board, firmly believing that lower prices increase availability, which in turn contribute to improving patient compliance.
Bill Brashier, Respiratory Clinical Development Group Head at Sandoz explains the impact of the economic burden of managing a life-long respiratory condition: “Asthma contributes to significant morbidity as well as mortality, due to non-compliance of treatment amongst patients, which can be driven by the high cost of inhaler devices. It may be that increasing the availability of less costly devices positively impacts compliance for this reason.
“Generic products have a significant impact on the health economics of many countries. An asthmatic patient in the US spends an average of $3500 per year on their condition, of which $1800 is spent on treatments. If a generic product can reduce that cost by a quarter, this would contribute to reducing the overall economic burden of managing the disease and more importantly, deliver better outcomes for patients.”
With millions of dollars of investment needed for the development of respiratory medicines, it pays to be in it for the long game, not only from a commercial perspective, but also to ensure patients are receiving the benefits of evolving generic products at a more affordable, or reduced price.
Hans Keegstra, Head of the Respiratory Development Center at Sandoz, explains the thinking behind the Sandoz strategy: “As a company, we take on the huge risks involved in the research and development of these challenging, difficult to make devices and combination products.
To be successful, what you need is clear; a good, integrated development site with strong clinical expertise, alongside strong commercial support to ensure the right level of investment.
“To be successful, what you need is clear; a good, integrated development site with strong clinical expertise, alongside strong commercial support to ensure the right level of investment. All of these are equally important and complicated. When you don’t have a good understanding of the mechanics of building an inhaler that is fit for purpose, manufacturing quality products at scale becomes problematic. Having the right distribution strategy is also key.
“All of these interconnected pieces are individually challenging but having them all readily available either within the Sandoz organisation or through our development partners in the device development area means we are well placed to deliver the products that patients need at a price they can afford. Failure often comes when one of these parts is missing and that’s a risk we’ve worked to mitigate effectively over the past few years”
A unique culture driving an ambition to deliver for patients
Leveraging the full spectrum of drug development is another improvement Sandoz has made. Bringing in more expertise in not only the clinical field but also technical capabilities has meant an increase in innovation, leading to greater opportunity for success.
Thomas Storm gives the background on how Sandoz has been thinking innovatively in this area: “We put a strong emphasis on modelling and using advanced modelling technologies to fully understand the link between the in-vitro characteristics of the product and the clinical outcomes. This is an area where Sandoz is really at the cutting edge of science, which is driving a lot of value by reducing the risk of failure in clinical studies. We have also established a strong collaboration with our partners in device development to fine-tune formulations and device characteristics to match those of the reference products. This is fundamental to generic product development and also what makes inhaled respiratory drug development so challenging.”
Despite the significant challenges associated with the development of generic respiratory products, the Sandoz team remains committed and determined to solve these issues to bring more cost-effective, high-quality and trusted medicines to the patients who need them.
Hans Keegstra explains why this is important to the people at Sandoz: “It’s actually a very nice challenge. This field of research is super complicated but solving problems is what excites us. I think we’re all problem solvers.”
Being able to have the right culture to do that is very difficult but once you’ve done it, you know that you’ve created something that is extremely valuable, not only for the company but for patients who rely on us to deliver something extraordinary.
Thomas Storm also takes an interesting view: “Most people who work in the field of inhaled medicine are really passionate about it. Globally, there are only a small number of people who know how to really do this well. It involves difficult cutting-edge science that requires the combined efforts of highly integrated, specialised teams of people who need to think differently to be successful, which is very engaging.
“Being able to have the right culture to do that is very difficult but once you’ve done it, you know that you’ve created something that is extremely valuable, not only for the company but for patients who rely on us to deliver something extraordinary.”
As for the continued determination to continuously improve and deliver better medicines for the patients that need them, Bill Brashier offers an interesting viewpoint on the drive to persevere and succeed at Sandoz: “We’re almost too enthusiastic. It keeps me on my toes for sure, but it’s also unique within the generics industry and that’s hugely motivating for everyone who works here.”