Swedish inhalation company Iconovo offer a faster way to the inhalation market by developing ready-to-use inhalation products, consisting of both the device itself and the dry-powder formulation(s) to go with it. The company’s four inhalation platforms address a huge market worth 14 billion USD in product sales annually. Now, with the recent regulatory approvals of GSK’s Trelegy Ellipta in asthma from the FDA and Novartis’s Enerzair Breezhaler in asthma from the European Commission, Iconovo’s market potential has expanded even further.
Iconovo targets two indications spanning huge markets: asthma and chronic obstructive pulmonary disease (COPD). In fact, according to WHO, more than 339 million people suffered from asthma globally in 2016, and the prevalence for COPD was estimated at 251 million cases during the same year. The Lund-based med tech company use their inhalation expertise to develop generic versions of both inhalation devices and dry-powder formulations resembling those developed by large pharmaceutical companies.
CEO presents Iconovo’s business strategy
Johan Wäborg, CEO at Iconovo, recently held a presentation at Erik Penser Bank’s Company Day, explaining the company’s inhalation platforms and business model.
He emphasized that the development process for innovative products typically is very time-consuming and often involves high-risk projects and swollen development costs. However, development timelines for generic (inhalation) products are significantly shorter. Iconovo has optimized this concept as they develop the inhalation products in advance, while the generic pharma companies run the pharmacokinetic trials and market registration once outlicensed to them by Iconovo. This working methodology reduces the risk and costs and minimizes the time to market. An earlier entry onto the market means higher market share and larger revenue streams.
According to Wäborg, a partnership with Iconovo could mean cutting the time of product development down by three to four years. In turn, through such partnerships, Iconovo receives revenue in the form of milestone payments and especially royalties from the market sales.
So far, Iconovo has signed four royalty agreements within the company’s proprietary inhalation platforms – ICOcap, ICOres, ICOone and ICOpre – which, together, address a total market worth 14 billion USD in product sales annually. Two of these platforms, ICOpre and ICOcap, recently expanded their market potential thanks to two new regulatory approvals for products targeted by these platforms.
ICOpre is the biggest investment to date
ICOpre is the company’s latest inhalation platform and the biggest and most important strategic investment so far for the company. It is a pre-metered dry-powder inhaler that is designed to be able to combine products, and it contains two times 30 individually-sealed doses for a month’s supply and has a dose counter that checks the number of remaining doses.
This platform is being developed to target the global market, with a specific aim set on the valuable US market. The inhalation device is similar to the Ellipta inhaler from GSK, but with an improved design that avoids Iconovo from infringing any Ellipta patents. Like Trelegy, ICOpre has multiple compartments which makes it suitable for mono, duo or triple drugs and thereby also multiple combination therapies.
The Ellipta portfolio is highly valued as analysts forecast 4.5 billion USD in sales in 2023. However, the patent for the Ellipta portfolio expires in 2025, which means that there will be an opening for generic versions. Iconovo’s aim is to find a collaboration partner that Iconovo can help get to the market as the first or one of the first generic versions of Ellipta in 2025.
FDA approval of Ellipta product for new indication
Last month, the FDA approved GSK’s Trelegy Ellipta as a maintenance therapy for asthma, making it the first once-daily, triple-drug inhaler approved for this indication. The approval means that Trelegy Ellipta can now be used for the treatment of both asthma and chronic obstructive pulmonary disease (COPD) in the US.
This is good news for Iconovo and especially its inhalation platform ICOpre because the approval increases the platform’s market potential and opens up opportunities in the longer term for Iconovo.
In fact, according to GSK’s financial report for the second quarter of 2020, Trelegy Ellipta generated 254 million USD in sales for the company – a 58 per cent increase from the same time period last year.
Increased market potential for ICOcap
In July, Iconovo announced that they had signed their fourth royalty agreement – a 20-year royalty agreement with BNC Korea which covers the development of two generic formulations of Novartis’s Ultibro Breezhaler and Seebri Breezhalerto be used in Iconovo’s ICOcap – a recently CE-marked capsule-based dry powder inhaler that is designed to be both robust and easy to use. BNC Korea has the exclusive right to market, sell and distribute the formulations in an Asian territory with over 2.7 billion inhabitants.
According to Novartis’s financial report 2019, Ultibro and Seebri together generated 548 MUSD in sales during the financial year. During the summer, Novartis received an approval from the European Commission for Enerzair Breezhaler as a maintenance treatment for asthma not adequately controlled with a maintenance combination of a long‑acting beta2‑agonist (LABA) and inhaled corticosteroid (ICS). Just like with the FDA’s approval for GSK’s Trelegy Ellipta in Asthma, this approval expands Iconovo’s market potential in the long term even further.
Overall, Iconovo’s business model, while it does not come without risks, according to analysts, is a strong model as it can rely on a large market potential covered by the company’s vast product portfolio, and it can expect rising profit margins in the long term.
Experts in the medtech community are taking notice of Iconovo’s potential; in fact, in August, the company was recognized by the magazine Medtech Outlook with Top Drug Delivery Device company 2020 award for being one of 10 companies that are at the forefront of providing drug delivery device solutions. It will be exciting to follow Iconovo in its journey as it continues its development.
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.