What does the current state of the development pipeline for inhaled drugs look like?
Drug development in general is in a strong phase, with FDA approval numbers also being very healthy. Looking at inhaled drugs specifically, the sector is showing encouraging numbers, with over 300 molecules in development that require an inhaled route of administration. The majority of these are in the pre-phase II stage which, for Vectura, is especially promising, as the services we offer to innovators in terms of formulation and device development can have the most impact on a development program at this stage.
What disease targets are most applicable to inhaled dose forms?
Obviously, respiratory diseases are suitable for inhaled doses, as the drug can get directly to the required site of action. There are significant unmet patient need that remain in the treatment of asthma and chronic obstructive pulmonary disease (COPD) as well as the less common respiratory diseases such as cystic fibrosis, bronchiolitis obliterans, idiopathic pulmonary fibrosis and pulmonary arterial hypertension. However, it would be wrong to think that the inhaled route is restricted only to respiratory diseases; it has long been used for delivery of other drugs – most notably antibiotics - and there are also opportunities to use it for drugs to treat diabetes, migraine or Parkinson’s disease.
Vectura has a history of developing its own drugs, how will it now be able to meet the needs of customers it was in competition with?
Vectura’s history in partnering with developers has led to many successes. There are 11 commercial products on the market that we have developed with our partners, and that represents about $10 billion in sales over the last 10 years or so. We will, of course, continue to support our existing partners in their programs, but it is this success and expertise that we can demonstrate to new customers that can be leveraged to accelerate their inhaled drug programs through the clinical phases and towards commercial launch. The needs for different sized customers will obviously not be the same, depending on their own in-house capabilities and whether programs involve small molecules, biologics, complex combinations or generic products. For small pharma companies, we offer the regulatory knowledge, guidance and expertise - which they may not have in house - that they can take advantage of to ensure decisions made at each step of development are geared towards the ultimate goal of approval. The larger companies may have this, and so look to capitalize on our scientific capabilities, and collaborating with our experts to develop the drugs of the future.
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What sets Vectura apart from other CDMOs in this area?
One of the challenges with inhaled dose design is that it is not easy! The challenges are very specialized and this means that focus and expertise are absolutely key to overcome them. The research and development team we have at Vectura is committed to being at the forefront of science and innovation. What sets us apart from many competitors is that we have specialist knowledge in product and formulation development, as well as technology solutions across a range of platforms, including dry powder inhalers (DPIs), pressurized meter dose inhalers (pMDIs) and smart nebulizers. By having the skills to develop both the drug and delivery device, innovators can turn to us as a single development partner and simplify their supply chain.
For innovators looking for a partner in this area, they need to assess a CDMO’s experience and track record, and look into the company’s ethos, and can they be trusted? At Vectura, we believe our record speaks for itself. We have worked, and continue to work, with companies of all sizes around the world, and apply our expertise to each project to guide our clients and partners towards success. Our device and formulation development services are fully supported by our medical, regulatory, device vigilance and pharmacovigilance teams to accelerate programs and ensure the smoothest path to product approval.