One of Iconovo’s goals is to launch future inhalation products in the US, the world’s largest pharmaceutical market. The company has several products in the pipeline directed towards this ambition, including the generic versions of GSK’s Ellipta portfolio in ICOpre and AstraZeneca’s Symbicort in ICOres. There are also significant opportunities in the US for the development projects in the business area that Iconovo calls innovative inhalation products. On Monday, the news came that the company’s quality system (QMS) meets the requirements set by the FDA’s Quality System Regulation, which is a prerequisite for launching inhalation products on the US market.
Iconovo develops complete inhalation products, i.e. inhalers and associated drug preparation. The company’s product portfolio includes four inhalation platforms – ICOres, ICOcap, ICOone and ICOpre – that are licensed to customers for the development and sale of generic and innovative inhalation products.
Upcoming launches on the growing US market
Iconovo has several ongoing customer projects with planned launches in the coming years and with some of the products it aims for the valuable US market. Total sales of inhalation products in the US are expected to grow over the next few years, partly due to an increased prevalence of respiratory diseases, an increasing geriatric population, and favourable reimbursement models.
Generic Relvar in ICOpre with significant sales potential
Iconovo plans to launch a generic version of GlaxoSmithKline’s Relvar Ellipta in ICOpre in the US after the patent for the pharmaceutical substance expires in 2025.
ICOpre, Iconovo’s latest major investment, is a pre-filled inhaler with 30 doses that are individually sealed. The company’s plan is to develop five dry powder formulations for ICOpre in order to offer generic versions of GSK’s Ellipta portfolio for the treatment of COPD and asthma. The Ellipta portfolio consists of five products that had total sales of 3.5 billion USD in 2020. The sales are expected to increase to 4.9 billion USD by 2025, and the products are likely to dominate the inhalation market over the next 10 years. Iconovo has opened up the possibility to take advantage of this market space through the development of ICOpre.
According to Iconovo, a market share of 10-15 per cent volume at a 25 per cent discounted price would give a sales potential of 100-150 million USD for Relvar Ellipta alone. The big launch awaits in 2030 when Iconovo plans to launch a generic Trelegy Ellipta.
US included in the extended license agreement with Amneal
Within the same time frame as Relvar, there are also plans to launch a generic Symbicort in ICOres in collaboration with the US pharmaceutical company Amneal. The original agreement with Amneal covered sales in Europe, but also Canada, Australia, Russia and some smaller emerging markets. In May, the contract was extended to the US and China, thus covering about 90 per cent of the total global Symbicort market, of which about a third is US sales.
Iconovo believes that the agreement with Amneal can generate future annual royalty revenues of 110–220 million SEK. The project is in the final phase, and Amneal has begun the set-up of commercial manufacturing.
Potential in the US in new business area
Iconovo now has three collaborations in a relatively new business area that they have chosen to call innovative inhalation products. The strategic area was initiated at the end of 2020 in connection with the signing of a license agreement with Monash University for the development of inhaled oxytocin in ICOone in maternal health. Since then, Iconovo has also entered into a license agreement with ISR Immune System Regulation for the development of inhaled Covid-19 vaccine in ICOone, as well as a development agreement with Swedish Respiratorius for the development of a new drug for COPD and asthma.
The Monash University and ISR projects initially target developing countries where there is a great need for such products, but the US may also become relevant in the future. According to Roger Lassing, Iconovo’s Vice President Business Development, the market for innovative products is large in the US due to higher prices and faster acceptance of innovative products compared to other countries.
Progress in quality work
In order to launch in the US, Iconovo must comply with the requirements of FDA regulations for medical devices. As part of this, Iconovo announced on Monday that the company’s quality system has been upgraded to meet the requirements of the Quality System Regulation (QSR 21 CFR 82), which will benefit the company’s development projects and ambitions to reach the US market according to CEO Johan Wäborg:
»Iconovo have global ambitions for our inhalation platforms and US is the biggest pharma market in the world. Compliance with the US regulations is a key component to advance existing projects and will unlock even more opportunity in our partnering and business development process.«
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