Biostock published October 9th an article about Iconovo that can be found in its entirety below

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.

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.

Award-winning company

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.

Read the article at the Biostock webpage

The Q2 report released by Iconovo last week underlines an impressive first half of 2020 for the inhalation device company. Besides reaching several important milestones, Iconovo has made significant moves to put more focus on business development and strengthen its market position internationally. BioStock spoke with the company’s CEO Johan Wäborg to discuss the highlights from the report.

With the release of their Q2 report, it is clear that Lund-based Iconovo have high ambitions as it intensifies its focus on business development.

Business development focus

The medical device company develops not only inhalers but also dry powder formulations to be used with their inhalers for the treatment of respiratory diseases such as asthma and COPD. Through its four proprietary inhalation platforms – ICOresICOoneICOcap, and ICOpre – Iconovo has established a strong product portfolio giving the company the opportunity to insert itself into a growing global market, and the company has taken several steps to reach that goal.

During Q2, Iconovo hired a new CEO, Johan Wäborg, whose vast business development experience will be essential for Iconovo’s future growth. The new hire came at a difficult time globally with a pandemic causing several countries to shut down their economies, thus drastically reducing business in general.

Important milestones reached

However, under its new leadership, Iconovo weathered the storm well as it was able to keep business development discussions active by holding virtual meetings with potential customers and partners, thus sustaining a positive momentum. Not only that, but the company has been able to grow internally as well.

In the meantime, the company has achieved a series of important milestones, including the all-important CE-marking of one of its platforms, ICOcap, which can now be used in clinical trials across Europe and can be purchased directly from Stevanato, one of Iconovo’s manufacturing and distribution partners. Read more.

Push towards international markets

One of the most relevant highlights of the Q2 report has been Iconovo’s push to establish itself in international markets both through IP protections and distribution agreements. The first half of the year has seen Iconovo make several moves eastward.

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In July, Iconovo announced it had signed a regional licensing agreement with BNC Korea for the development of two inhalation capsule formulations for ICOcap: the generic forms of Novartis’s Ultibro and Seebri. The territory covered by BNC Korea represents about 15 per cent of total sales of the two formulations, giving Iconovo a substantial business opportunity. 

Iconovo’s ICOcap is a capsule-based dry powder inhaler designed to be robust, but also easy to use and able to handle different capsule sizes. The device is available in two versions and has the same function and performance as Boehringer Ingelheim’s capsule-based dry powder inhaler HandiHaler and Novartis’s dry powder inhaler Breezhaler.

The inhaler has recently received CE marking and can now be purchased from Iconovo’s manufacturing and distribution partner Stevanato Group to be used in clinical trials.

Read more

So far, 2020 has brought several advancements for the Swedish dry powder inhaler company Iconovo. A major stepping stone was the change of CEO in April. With Orest Lastow transitioning from CEO to CTO, to optimize the output of his expertise in the field, Iconovo has recruited Johan Wäborg for the CEO position bringing valuable business development experience to the company’s leadership. BioStock was able to get in touch with Johan Wäborg to learn more about his vision for the company.

Iconovo is a medtech company that offers the development of ready-to-use inhalation products – inhalers in combination with dry powder formulations. The company’s inhalation products are primarily intended for the treatment of asthma and chronic obstructive pulmonary disease (COPD) – two very common respiratory diseases.

Over the years, the company has developed a broad product portfolio including four inhaler platforms, through which Iconovo is able to insert itself into a growing global market. Three of the platforms are already fully developed and available for customization to suit administration of different inhalation powders: ICOresICOcap and ICOone. All of these have seen continued progress in terms of updates during the first half of 2020 despite a pandemic disrupting businesses across the globe.

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2020 has been a year of intellectual property expansion for dry powder inhaler developer Iconovo

Much of that expansion has come within Sweden and the EU, but recently the company has received the notice of intention to grant a patent from the Chinese Patent Agency regarding Iconovo’s reservoir-based inhalation device, ICOres. The new patent will protect the technology used in many of Iconovo’s projects like the project concerning a generic version of Symbicort.

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Iconovo’s expertise in developing inhalers and inhalation platforms for treating respiratory diseases has been key to generating several important collaborations. The latest comes in the form of a research partnership with Biofilms – Research Center for Biointerfaces at Malmö University and Swedish biotech Nanologica to develop an inhalation platform based on porous drug carriers. The collaboration could result in a breakthrough in inhalation therapy.

The lung infection caused by Mycobacterium tuberculosis, the bacteria that cause Tuberculosis (TB), is estimated to lead to 5,000 deaths each day, globally. In treating the disease, one of the major therapeutic challenges is to deliver a sufficiently high dose of the medication to the infected area of the lungs. In most cases, inhalation therapies are recommended, but reaching high enough doses is still an issue.

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Iconovo’s strong start to 2020 shows no signs of slowing down as we approach summer. The company just added a CE marking to the list of reached milestones, making the company’s capsule-based dry powder inhaler ICOcap authorized for use in clinical trials by European customers. BioStock takes a closer look.

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The Lund-based inhaler experts Iconovo are on the front lines of the fight against asthma, and they recently announced a new partnership dedicated to the development of ICOres budesonide/formoterol, the generic for AstraZeneca’s Symbicort, which is currently on the market for the treatment of asthma. BioStock was able to talk with Iconovo’s CEO Johan Wäborg to discuss the implications of the partnership and what it means for the ongoing battle against asthma.

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As Iconovo solidifies its product development and takes aim at a global market, a new analysis by Danske Bank indicates that the inhaler development company represents a significant market opportunity, thanks to its scalable business model in particular. The analysis values the company at 78-101 SEK per share – at least a 32 per cent increase from the current share price.

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