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Iconovo has recently made the strategic decision to invest heavily in developing a new inhalation platform – ICOpre. With this investment, the company hopes to be able to offer generic versions of GSK’s Ellipta portfolio, which is expected to have a market value of 5 BUSD by 2024. BioStock takes a closer look at the stakes involved for Iconovo in making this big bet.

GSK’s Ellipta is an inhalation device meant for treating respiratory diseases such as asthma and COPD and is one of the company’s top products. The device stormed the respiratory device market in 2013 and has since dominated thanks to the fact that it can be used in combination with a range of drug formulations. This gives patients the flexibility to use the same inhaler with new medicines as their disease progresses.

Ellipta dominates inhalation market

The Ellipta inhaler, along with the dry powder formulations that go with it, is expected to dominate the inhalation market for the next 10 years, and by some estimates, analysts expect the Ellipta range of products to be worth at least 5 BUSD in annual sales by 2024.

As they go uncontested on the market, the prices for Ellipta products are very high, thus not highly accessible to patients, but with Ellipta’s first patent expiring in 2025, there will be an opening for generic versions.

A big opportunity coming up for generic developers

Swedish Iconovo are experts in the inhalation device field for dry powder inhalers, in particular when it comes to developing generic products that are meant to mimic top mainstream inhalation products from big pharma companies. A big example is Iconovo’s ICOres budesonide/formoterol, which is a generic for AstraZeneca’s Symbicort Turbuhaler.

With Ellipta expected to take up so much of the inhalation market in the coming years, Iconovo spotted an opportunity to insert itself into this market space and generate significant future income by developing a generic version of GSK’s inhaler.

In fact, the Swedish medtech company announced late last year it would be making a huge investment in a new platform called ICOpre with that scope, and it would become the fourth platform offered by Iconovo along with ICOres, ICOone, and ICOcap. In the announcement, Iconovo mentioned that it aims to be ready with a generic version within three years, thus being ready by the time Ellipta’s first patent expires.

Great potential for Iconovo’s ICOpre

Iconovo is the only player, without a partnership, that can supply both an inhaler and a generic formulation of Ellipta. Considering that, and the high sales numbers expected for Ellipta, the big bet made by Iconovo has huge potential.

Just last year, sales for all Ellipta products, shot up by 13 per cent from the year before with total sales reaching 2.9 billion USD (£2.3 billion). The boost in sales was mainly driven by sales of Trelegy Ellipta, a combination of three molecules in a single inhaler that only needs to be taken in a single inhalation, once a day.

Trelegy Ellipta was approved by both the FDA and EMA in 2017 for treating COPD and is awaiting approval from both agencies for the treatment of Asthma. Its sales increased 26 per cent in Europe and 29 per cent internationally, corresponding to 653 million USD (£518 million) in 2019.

Financially set to manage investment

This investment by Iconovo is made possible by the 60 MSEK raised last year during a targeted share issue, which targeted large Swedish institutional investors like Andra AP-fonden, Fjärde AP fonden and Länsförsäkringar Fondförvaltning. This helped the company end 2019 with 89MSEK of cash on hand. And according to the latest interview with Iconovo’s Vice President Business Development, Roger Lassing, the company will need approximately 20MSEK of that to fully develop the ICOpre platform.

Top innovation at Iconovo

ICOpre will be intended for a global market, including the US, where Iconovo has already seen an opening since FDA approval of Mylan’s Advair generic product Wixela Inhub intended for the treatment of COPD and asthma. This was the first Advair generic inhaler product approved by the FDA, and indicates a strong willingness from FDA to make generic inhalers available for the US citizens.

With ICOpre being the fourth inhalation platform entering Iconovo’s portfolio, the company is showing its great strength in innovation as a medical device company. By developing both inhalers and inhalation powder, Iconovo has a clear advantage over its competitors as they can develop all parts of the final product inhouse. Thereby, Iconovo can offer generic company customers a full service while it brings significant benefits to Iconovo’s own product pipeline.

Strong product combined with strong IP

Furthermore, the company has demonstrated the ability to develop unique inhalation solutions yielding patent protections, thus not interfering with other companies’ patents, and keeping in line with Iconovo’s business strategy. The latest IP development came just last week when the European Patent Office communicated its intention to grant Iconovo a patent for the ICOres platform.

»This patent further strengthens the protection of ICOres and also clearly shows that our technology is unique and innovative. Approved patents in Europe are extremely important as Europe is the largest market for ICOres. This makes us a safer and thus a more attractive partner« — Orest Lastow, CEO of 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.

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