Vectura is a UK-based pharmaceuticals business that provides product formulation and development services for inhaled pharmaceuticals as well as developing devices to deliver drugs across dry powder inhalers (DPIs), pressurized metered dose inhalers (pMDIs), and smart nebulizers.

The company employs more than 400 people at its Chippenham, UK headquarters, and at its other UK sites in Cambridge and London, as well as in Switzerland and Germany.

Vectura has a rich heritage as an inhalation product development company, and in 2019 announced that it was to become a leading player in the inhalation segment of the contract development and manufacturing organization (CDMO) market, offering formulation and development services to companies ranging from small innovator biotechs to large pharma.

Contract Pharma had the chance to sit down with Vectura’s Chief Executive Officer, Will Downie, who joined Vectura in November 2019, to talk about how the company has aligned its services with the needs of the development market, and the current nature of the inhaled-drug market.

Contract Pharma (CP): What was the strategy behind changing from a development company into a CDMO service provider?

Will Downie: Over the course of the last twenty years, Vectura has leveraged its inhaled drug development and inhalation device capabilities to establish a number of strong partnerships with pharmaceutical companies. Since 2012, our formulation and device technology has contributed to the success of 11 inhaled medicines, launched by our partners and licensees, generating $10 billion in sales. In 2018 these products were used by 9 million patients worldwide.

Our business model to date has been to co-invest in the development of products with our clients, making money through a series of milestones and royalties; as well as developing our own products. We will no longer be doing the latter and we will focus solely on being a CDMO service provider, as well as working with our current partners.

The rationale behind this is that we can use our deep scientific knowhow and world-class technology to move more robustly into the outsourcing space and diversify our customer base. We hold an enviable position, having deep expertise in both pharmaceuticals and delivery devices, so the focus will remain within this field, but working with a wider number of molecules and across a broader range of disease states.

CP: What is the current state of the inhaled drug industry, and the pipeline of new products coming through?

Downie: The market is very buoyant and growing. Industry data reveals that there are over 300 molecules¹ within the drug development pipeline today that require an inhaled route of delivery. For Vectura, with the expertise we can offer, there is real interest in about 70% of these molecules which sit in the pre-clinical to phase II stages and likely need some assistance and development work to make them commercially-viable products.

It is important to note that the molecules currently in development are not limited to respiratory diseases such as asthma and COPD. There are a number of opportunities for delivery of drugs through the lungs for therapies targeting indications from CNS and endocrinology disorders, to oncology and pulmonary vascular diseases.

We know that the CDMO market as a whole is growing and corresponding outsourcing rates are increasing, especially for smaller innovator companies where the outsourcing rates are particularly high, as their business model is almost entirely virtual. With this increase in outsourcing, there is a continued need for innovation, as companies look to differentiate their products and meet payor demands. What we see as a real opportunity for Vectura is that the drive for innovation is opening up the route of inhalation delivery of products to be broader than just respiratory medicine, and there is a need for both the optimization of complex combination drug products and the development of complex generics going forward.

CP:  What are the current trends within the industry, and what challenges does it face? How is Vectura looking to address these?

Downie:  In the broad healthcare environment, we are seeing a number of trends which touch upon our part of the industry. Firstly, digital health is becoming prevalent on the high street, and the combination of smart devices and pharmaceuticals will continue to become even more important in the future. We can also see that personalized medicine has at last become a reality, and product development is now being undertaken to treat smaller sub-populations of patients, orphan disease states, and in some cases, even individual patients. Finally—and this is by no means a new phenomenon—looking at all the development pipelines of biopharmaceutical companies, there is a steady increase in the number of large molecules coming to market and being developed.

The challenges in drug development are well documented, and as molecules become more complex, issues around bioavailability and solubility need to be overcome. This is not unique to inhaled drugs, but the science around inhaled product development and device technology is very challenging, and the barrier to entry in the market as a service provider is very high.

As a company, we work with customers at any stage of their drug development cycle after drug discovery, all the way from pre-clinical formulation stage to late stage commercial scale up. By partnering with customers with early development molecules, we can help them to optimize their chances of success as they move through clinical trial development. During the development process we can also utilize our device technology expertise to create the optimal delivery platform for the drug product, with patient compatibility and compliance in mind at all times.

The experience we have, with over two decades of formulation and device technology development, is a massive advantage in overcoming the current challenges, and the eleven products launched to date bear testament to this. Looking forward, we foresee that the drivers in the inhaled drug arena will be to meet the need for effective particle engineering and formulation of large, as well as complex small, molecules. In addition, ensuring devices deliver drugs in ways that allow for the growing focus of patient centricity and increased adherence to be met. There is a current digital drive to combine devices with smart phones and apps so that dosages can be tracked and accurately prescribed, and there is a need to adapt nebulizers in the future in order to become “smart” and deliver product to the lungs more effectively. Additionally, the industry needs to look at current dry powder inhalers and find ways to increase their deliverable payloads.

Vectura has always had the philosophy of developing simple devices to overcome complex challenges, and provide excellent compatibility for patients and increasing probability of success for our customers.

CP: What are the future plans for Vectura and what especially excites you about your relatively new role?

Downie:  Our ultimate mission at Vectura is to improve the lives of patients who can benefit from the successful delivery of medicines through an inhaled route of administration.
The switch to being a CDMO will allow us to demonstrate our expertise in a much broader inhalation market and move away from our more historical narrow product development focus. The change in focus will see us continuing to invest in areas where we can differentiate our capabilities and technologies against competitors, but will as a consequence diversify our customer base.

The heart of our company lies in the world-class expertise of our scientific and engineering staff, who are adept at working across the spectrum of pharmaceutical development and device technology. Having the expertise in both offers simplicity for clients and allows us to forge true partnerships throughout a product’s lifecycle.

The ability to combine drug development and device technology is rare in the marketplace today. Our expertise in helping clients with formulation and device solutions, together with connected digitization, can unlock the potential of our clients’ product challenges. 

Sources

1. Global Data pipeline analysis (July 2019) – “Respiratory” includes infectious disease assets Small & medium-sized respiratory companies excludes companies with significant in-house inhalation capabilities: Astra Zeneca, GSK, Bayer, Novartis, BI, Pfizer, Chiesi, Orion 1 Contract development and manufacturing organization.

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Will Downie was appointed Chief Executive Officer of Vectura in November 2019. Prior to joining Vectura, Will spent ten years as the senior vice president, global sales and marketing at Catalent. In this role, he led the commercial effort and had responsbility for global sales, marketing and commercial operations activities. During his tenure, he developed an outstanding track record in helpin drive the long-term growth of the company, as well as positioning Catalent as one of the leading brands in the pharmaceutical services space.