Iconovo has invested heavily in developing a new pre-metered dual cavity inhaler under the name ICOpre. The company is now presenting the inhaler to the outside world for the first time at the international Respiratory Drug Delivery 2021 conference. Details of the design, function and development process of ICOpre will be presented at a workshop at the RDD conference.
Iconovo develops complete inhalation products, i.e., inhalers and associated dry powder formulations, which are licensed to pharmaceutical and generic companies. This means that customers do not have to carry out complex and costly stages in the development process, leading to a faster way to the inhalation market together with lower risk and lower cost.
The fourth and latest addition to Iconovo’s family with inhalation platforms is the pre-filled dual cavity inhaler ICOpre. Yesterday, the company announced that ICOpre will be shown publicly for the first time at a workshop at the Respiratory Drug Delivery 2021 (RDD)virtual conference, which will take place 4-7 May. During the workshop, ICOpre will be used as an example of how Iconovo’s conceptcan help overcome challenges when developing generic inhalationproducts.
ICOpre is a significant investment
Iconovo made the decision to develop this new inhalation platform in 2019. Even then, the company had announced that the new platform would be a generic version of GlaxoSmithKline’s Ellipta, both in terms of inhaler and powder formulations, and that the platform would be intended for a global market including the US.
»This is the biggest and most important investment in Iconovo’s five-year history. With the ICOpre-platform we will be able to reach, not only the European market, but also the very valuable US market.« – Orest Lastow, CTO Iconovo
Since then, Iconovo has made significant progress in the development of ICOpre. The development started in the first quarter of 2020, and, after less than 12 months of development, excellent in vitro equivalence with the original Ellipta was achieved. According to Iconovo, ICOpre has been developed in Iconovo’s own laboratories by experts in inhaler engineering, powder formulations and analytical characterisation.
Workshop at RDD 2021
The newly developed inhaler will now be presented to the outside world for the first time at the RDD conference. This is a large international conference for researchers, regulators, business professionals and suppliers active in pulmonary and nasal drug administration.
At the conference, Iconovo will arrange a workshop with the theme ”Development of a Generic Dry Powder Inhaler Platform for a Global Market.” During the workshop Iconovo will present the design, different features and development process of ICOpre.
The idea of the workshop is to use ICOpre as an example to show how an integrated development process can accelerate the development time of a complete inhalation product. Dr Orest Lastow, CTO of Iconovo, founder and inventor of Iconovo’s inhalers, will show an on-demand video on ICOpre that can be seen by participants at RDD.
The ICOpre design
ICOpre is a pre-metered dual cavity dry powder inhaler with 30 doses individually sealed and protected by aluminum foil. A dose counter shows the number of remaining doses and the exterior of the inhaler has a Scandinavian design according to the company. The inhaler is operated in three steps: open-inhale-close. Each dose comes from two compartments that are inhaled simultaneously, which makes ICOpre suitable for mono, duo or triple products.
ICOpre is designed to be operated in the same way as GSK’s Ellipta, however, ICOpre is based on aproprietary mechanism with an injection-molded disk and cavity opening. Thanks to its unique technical solutions, ICOpre is not limited by Ellipta’s patent protection, which lasts until 2030. This minimises the risk of patent infringement and enables Iconovo to obtain patent protection for ICOpre for 20 years. The first twopatent applications for ICOpre were filed in February 2021.
Great market potential for generic products of Ellipta
The idea is that ICOpre will become an AB-rated (therapeutic equivalent) substitute for GSK’s Ellipta portfolio,which currently consists of five inhalation products: Relvar/Breo, Anoro, Incruse, Trelegy andArnuity. Total sales of these products are expected to increase to 4.9 BUSD by 2025.
GSK has patent protection for both the inhaler and the drug substances in the inhalation products. When the patents and market exclusivity for the drug substances expire, a major market opportunity is opened up for generic products.
Ready for five launches
Iconovo is carrying out the parallel development of generics for all Ellipta products and plans to out-license these products to a potential partner, which is expected to take place in H1 2022. Iconovo aims to be ready for launch at the time of patent expiry for each of the products in the Ellipta portfolio.
The first patent that expires concerns Breo/Relvar in 2025 in the US. Iconovo plans to launch a generic Breo/Relvar product in the valuable US market soon after that patent expiration. According to Iconovo, such a product has a sales potential of at least 100-150 million USD. However, the main launch is expected for 2030 with the launch of a generic Trelegy, the best-selling inhalation product in the Ellipta portfolio.
The presentation of ICOpre at RDD is a stepping stone towards finding suitable partners and eventuallylaunching up to five generic products that are expected to create great value for Iconovo.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.