Biostock published May 25th an article about Iconovo that can be found in its entirety below

Last week, Iconovo announced its financial targets for 2026. In five years, the company expects to have ten projects in development and five launched inhalation products that generate royalties. In addition, the goal is to enter into 1 – 3 new customer agreements per year on the way there. All in all, this is expected to generate sales of 200 million SEK and an operating profit of 100 million SEK in 2026. Iconovo also sees two potential upsides: royalty revenue from innovative inhalation products as well as from royalty revenue from generic Symbicort in the US.

Iconovo develops complete inhalation products (both inhalers and respective dry powder formulations) that are licensed to other pharmaceutical and generic companies.  In exchange, Iconovo receives milestone payments for development work and royalty revenues once the products have been launched.

The company has now presented its five-year goals for the business based on customers projects in Iconovo’s project portfolio, as well as the company’s goal of bringing in up to three new projects per year.

Five market launches ahead

Iconovo, together with its customers, expects to be able to launch five products in the next five years. First up is a generic version of Symbicort, developed together with Amneal and expected to launch in Europe in 2023. Next, Iconovo expects to launch a generic Ultibro and Seebri with BNC Korea, a generic version of Relvar in the US, and an undisclosed product developed in collaboration with Intas.

Sales of 200 million SEK and operating margin of 50 per cent

One of Iconovo’s financial targets is to achieve a turnover of 200 million SEK in 2026, which is significantly more than the turnover in 2020 (17.8 million SEK). In 2026, total revenues are expected to consist of ongoing revenues for development work in the company’s various projects as well as royalty revenues from the five launched generic products Symbicort, Ultibro, Seebri, Relvar and the product developed together with Intas.

Furthermore, Iconovo sets a goal of achieving an operating profit of 100 million SEK and thus an operating margin of 50 per cent.

Potential upsides

A potential upside in the sales target is royalty revenue from the area of innovative inhalation products. According to Iconovo, these products are less likely to reach the market than generic products and they also take longer to develop. However, an innovative project that Iconovo believes may reach launch within five years is the development of an inhaled Covid-19 vaccine together with ISR. If the project is successful, it could increase revenue by up to 100 million SEK in 2026.

Furthermore, a potential upside is royalty revenue from sales through Amneal in the US. Amneal’s decision tolaunch a generic Symbicort in the US will be based on a number of future events in the US and Europe. As aresult, Iconovo chooses to see it as a potential upside of 70 million SEK in 2026.

1/3 of the turnover from Iconovo Pharma

Last week, Iconovo announced that they are starting a new pharmaceutical division called Iconovo Pharma for the Nordic market. This was decided when Iconovo acquired the rights from Amneal to sell a generic Symbicort in the Nordic region.

The majority of the launched products will be sold in the Nordic region by Iconovo Pharma. According to the recently communicated business targets, sales through Iconovo Pharma are expected to account for one third of sales in 2026. The company estimates that the remaining two thirds will come from royalty revenues for generic inhalation products.

Virtual Capital Markets Day Wednesday, May 26

The financial targets for the next five years will most likely be mentioned at Iconovo’s Virtual Capital Markets Day on May 26 at 13:00-15:30. During the day, the audience will hear presentations from members of the management team as well as external guest speakers, such as the company’s customers ISR and Monash University regarding the projects for inhaled Covid-19 vaccine and inhaled oxytocin.

The digital event will focus on Iconovo’s transformation into a commercial pharmaceutical company as well as the potential in the company’s three strategic areas – generic inhalation products, innovative inhalation products and its own sales of generic inhalation products through Iconovo Pharma. According to the business goals, Iconovo will try to find a good mix of customer agreements in all three strategic areas in order to achieve a diversified product portfolio with both opportunities and risks.

High expectations for the next five years

Iconovo seems to have high expectations for the company’s growth over the next five years, given the recently communicated ambitious business goals. In five years, Iconovo is expected to have 50 employees, a doubling compared to today. According to Johan Wäborg, CEO, Iconovo is a company with high ambitions that is getting closer and closer to launch:

»Iconovo is a company with high ambitions. Now that we have increased the number of innovative projects in our pipeline in a short period of time and are getting closer and closer to launch, we think it is important to communicate financial goals« – Johan Wäborg, CEO 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.

Biostock published May 21th an article about Iconovo that can be found in its entirety below

The two Lund-based development companies Respiratorius and Iconovo have signed an agreement to develop an inhalation formulation and an inhalation product of Respiratorius drug candidate RES030-085 for the treatment of COPD and severe asthma. A first inhalation product based on Iconovo’s ICOone is intended to be used in a phase I clinical trial with the candidate. BioStock has spoken to the respective CEOs of the two companies to find out more about what this means.

Iconovo develops complete inhalation products consisting of both inhalers and dry powder formulations, while Respiratorius develops drugs for the treatment of chronic obstructive pulmonary disease (COPD), asthma and cancer. The companies will now work together to develop an inhalation product for the treatment of COPD and asthma based on Respiratorius’s candidate RES030-085 and Iconovo’s inhaler ICOone. The agreement between the two companies has a total value of SEK 3 million, of which SEK 200,000 will be paid to Iconovo upon signing the agreement.

COPD – a rapidly growing disease

COPD is a collective name for lung diseases that chronically reduce air flow in the respiratory tract associated with inflammation of the lungs, which leads to breathing problems. It is one of the fastest growing diseases and is the third leading cause of death in the world today. The respiratory treatment market accounts for almost 10 per cent of all drug sales worldwide, representing a market of approximately USD 90 billion in 2020, of which medicines for COPD accounted for more than half of this amount.

RES030-085 has anti-inflammatory and bronchodilating properties

Within the project RESP9000, Respiratorius is developing the drug candidate RES030-085, which, in preclinical studies, has been shown to provide complete relaxation of small airways isolated from human lung tissue regardless of how these have been contracted. This, combined with anti-inflammatory properties, distinguishes the candidate from other medicines available today.

The project is currently in preclinical phase, where the toxicological programme has recently been initiated. Another important piece of the puzzle to lay before taking the candidate into the clinical phase is the formulation of the substance. And here an important step is now being taken with the agreement with Iconovo.

Dry powder formulation and inhaler for phase I trial

According to the agreement, Iconovo will develop a dry powder formulation of RES030-085, as well as developing an inhalation product based on ICOone, which is intended to be used in a phase I trial – a work that is estimated to take about nine months to complete. ICOone is a dry powder inhaler with a low manufacturing cost and a simple design that makes it easy to use.

Iconovo has developed a total of four inhalation platforms – ICOone, ICOres, ICOcap and ICOpre. Within the collaboration between Iconovo and Respiratorius, the companies will also investigate which of Iconovo’s inhalation platforms would be best suited for a possible market launch of the product. If the project succeeds in reaching the important milestone, licensing agreements between the two companies will be discussed. 

 

Respiratorius and Iconovo comment on the agreement

For Respiratorius, an important piece is added to the preclinical puzzle, while for Iconovo it means that a third agreement has now been signed in the new strategic area for innovative inhalation projects.

Johan Wäborg, CEO Iconovo

BioStock has spoken to Johan Wäborg, CEO of Iconovo, and Johan Drott, CEO of Respiratorius, to learn more about the agreement. First up is Johan Wäborg:

First of all, what are your expectations for the collaboration with Respiratorius?

– Our expectations are that we will be able to quickly implement this first phase with good results and then be able to deepen our cooperation. RES-030-085 has shown very promising and unique results and we feel that the product could help many patients who currently need improved treatment.

 Why is the ICOone inhaler suitable for the phase I trial with Respiratorius drug candidate?

– ICOone is a simple disposable inhaler with very good performance. Almost no matter what substance we deliver with ICOone, we get a high lung dose. If a company wants to quickly enter clinical phase I trial with low risk and cost, ICOone is an excellent choice.

With the agreement with Respiratorius, you have already reached one of your business goals to enter into two new customer agreements in 2021. Is it time to reassess this goal?

– Two new customer agreements per year is a long-term goal that we set for the first time in 2021. We have now achieved this year’s goal, but we are not slowing down and are aiming for more agreements this year. We will see a variation over the years of between 1-3 deals. 2021 has started well in this regard.

Johan Drott, CEO Respiratorius

Johan Drott also takes a very positive view of the agreement that has now been concluded.

We start by asking you the same question – what expectations do you have for the collaboration with Iconovo?

– Iconovo possesses the experience and expertise that Respratorius needs to ensure an optimal product for clinical studies. We also see that it is important that the development work takes place with access to the type of inhaler that Iconovo can offer. 

When do you plan to start the phase I clinical trial with the drug candidate RES030-085, and what do you hope to show in the study?

– Phase I studies are primarily so-called safety studies; however, we also hope to be able to obtain some kind of preliminary data on the efficacy. The work on designing the study is not yet complete, but our thoughts are moving in that direction. We have a high pace in our work to be able to have approval as soon as possible to be able to start the study.

Why did you choose Iconovo as a development partner for the phase I clinical trial? 

– Iconovo’s knowledge is exactly what we are looking for, and we know that they have products that are well suited.

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.

Biostock published May 17th an article about Iconovo that can be found in its entirety below

Last week, Iconovo announced that the US and China have been added to the agreement with Amneal regarding sales of a generic version of Symbicort in the ICOres inhaler. The extended agreement covers 90 percent of the global Symbicort market, doubling the expected annual royalty revenue from Amneal. Iconovo also takes over the sales rights in the Nordic region for the generic product and therefore starts a new pharmaceutical division called Iconovo Pharma. BioStock reached out to the company’s CEO Johan Wäborg for a comment.

Iconovo develops complete inhalation products, i.e. both inhalers and associated dry powder preparations. One of the company’s inhalation products is ICOres, a multi-dose inhaler with two separate reservoirs. In addition, the inhaler provides visual feedback on the number of remaining doses and that the dose has been inhaled correctly.

Development project together with Amneal

Together with the US pharmaceutical company Amneal, Iconovo is developing a generic Symbicort in ICOres. The development project is now entering the final phase and Amneal has begun the set-up of commercial manufacturing.

Last week Iconovo announced that the agreement with Amneal has been extended to include the USA and China, two very valuable markets. The original agreement already covered sales in Europe, Canada, Australia, Russia and some smaller emerging markets.

Extended agreement doubles royalty opportunities

Under the expanded agreement, Amneal will have the rights to sell and market a generic ICOres Symbicort in markets covering about 90 percent of the total Symbicort market. The extended agreement leads to a doubling of the potential future annual royalty revenues to SEK 110 –220 million (USD 13.2 million – USD 26.4 million). Financially, the extended agreement with Amneal is an important event for Iconovo, according to CEO Johan Wäborg:

»We are very pleased to have been able to expand our agreement with Amneal. It is a very strong and positive signal that Symbicort in the ICOres inhaler is a product with great international potential. Financially, this is an important event for Iconovo« – Johan Wäborg, CEO of Iconovo 

Pharmaceutical division in the Nordics

With the new agreement with Amneal, Iconovo acquires the license to sell generic versions of Symbicort in the Nordic region. According to the company, the Nordic market for Symbicort amounted to SEK 800 million in 2020, which means that there is great market potential for Iconovo/Amneal’s generic version of Symbicort in ICOres. Iconovo estimates that they can reach a market share of 15-20 percent, which could generate revenues of between SEK 80 and 100 million per year, according to the company.

In connection with this, Iconovo starts the pharmaceutical division Iconovo Pharma, which will carry out marketing and sales of the generic product in the Nordic countries.

Iconovo’s CEO comments

Johan Wäborg, CEO of Iconovo

BioStock reached out to Iconovo’s CEO Johan Wäborg to learn more about the extended agreement withAmneal, as well as the newly started pharmaceutical company Iconovo Pharma.

First of all, how significant is the agreement with Amneal regarding ICOres?

– It is a very significant agreement in many ways. It is the one of our projects that is closest to launch, which is scheduled to take place in 2023 in Europe. In addition, Symbicort is a major product globally with approximately USD 3 billion in sales, so to get maximised global coverage is of great importance and increases the potential of our future royalty revenue.

You have also taken over the rights from Amneal to market and sell ICOres Symbicort in the Nordic market. What lead to this decision and what does it mean for Iconovo’s long-term strategy in the Nordic region?

– We have a unique position in the global inhalation market and extensive knowledge in the field of dry powder inhalation. Based on this position, we believe that establishing our own sales is a winning concept. Selling pharmaceuticals in selected markets is a way to maximize our share of the value chain and thus get even more value from our innovation.

– I have been involved in sales of pharmaceuticals and have also led Nordic pharmaceutical companies for most of my working life, it is my home ground, so expanding our strategy in this way feels obvious to me.

What is on the agenda for the rest of 2021? 

– We will continue to deliver towards our communicated goals, which among other things, means developing ICOpre with five preparations. We will also continue to deliver in our projects and support the projects that enter into clinical studies this year.

– We also have a goal of signing two new agreements this year. Already in March, we entered an agreement with ISR regarding an inhaled Covid-19 vaccine in ICOone. The extended agreement with Amneal is, of course, extremely important and partly new, but we will continue our quest for even more agreements this year.

Read the article at the Biostock webpage

Biostock published April 28th an article about Iconovo that can be found in its entirety below

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 concept can help overcome challenges when developing generic inhalation products.

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

Iconovo’s newly developed ICOpre

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 and Arnuity. 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.

Read the article at the Biostock webpage

Biostock published April 23th an article about Iconovo that can be found in its entirety below

ICOone is Iconovo’s single-dose inhaler for simple and cost-effective administration of vaccines and biomolecules. The first US patent has now been approved for the inhaler and thus the company has approved patents for ICOone in Sweden, Europe (EPO), India, and the USA. The patents for ICOone provide, among other things, strong protection for the Covid-19 vaccination opportunities that Iconovo is exploring together with ISR Immune System Regulation.

Iconovo, based in Lund, is a company with expertise in inhalers and dry powder formulations that has developed four inhalation platforms – ICOone, ICOcap, ICOres and ICOpre.

In March, a patent for ICOone was approved in India and Iconovo has now announced that the US Patent and Trademark Office also intends to approve a patent for ICOone. Iconovo’s CTO and founder Orest Lastow commented the importance of this new patent:

»This patent is a confirmation that ICOone is a very unique and innovative inhaler. With granted patents in USA, EU and India we now have a very strong protection on markets in great need of simple and cost-effective vaccination« – Dr. Orest Lastow, CTO Iconovo 

Exciting vaccine opportunities

ICOone

The approved patent in the US is not the only positive news for ICOone in April. At the beginning of the month, Iconovo entered into a collaboration with ISR Immune System Regulation for the development of Covid-19 inhalation vaccine in ICOone. The inhaler is intended for single use, and the manufacturing cost is very low, which makes it ideal for this purpose.

In addition, there are several advantages with dry powder vaccines, such as simpler administration and cheaper and smoother transport/storage without low temperature requirements. The use of inhaled vaccines eliminates the need for disposable syringes and thus avoids the build-up of hazardous waste with blood contaminated material. The simple design enables healthcare professionals, but also patients, to learn how to handle the inhaler with minimal training, making it very user friendly.

Oxytocin for postpartum bleeding

The patent for ICOone in the US will also provide immaterial protection for the use of the inhaler to develop inhaled oxytocin against postpartum haemorrhage (PPH). The drug product is currently being developed for a first clinical trial together with Monash University. In 2019, more than 3.7 million babies were born in the United States, which means that there is great market potential for the inhaled oxytocin against PPH in thecountry.

Iconovo also has pending patent applications for ICOone in China and Japan, two large and importantmarkets. With the first US patent for ICOone secured, Iconovo continues its work to strengthen patentprotection for its inhalation products on key markets.

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

Biostock published April 1th an article about Iconovo that can be found in its entirety below

Yesterday, Inhalation device company Iconovo, which offers complete inhalation products, signed an agreement with immunotherapy company ISR Immune System Regulation. The agreement concerns the development of an inhalation vaccine against Covid-19 in Iconovo’s disposable inhaler ICOone. The parties see significant potential for the product, which is expected to be tested thoroughly in humans in the second half of 2021.

Iconovo develops and outlicenses complete inhalation products with associated dry powder formulations based on the company’s four inhalation platforms – ICOcap, ICOres, ICOone and ICOpre.

Iconovo’s new agreement with ISR Immune System Regulation specifically applies to the single-use dry powder inhaler ICOone, making it particularly suitable for easy and cost-effective administration of vaccines.

Many benefits of inhalable vaccines

An inhaled dry powdered vaccine, like the one ISR develops, has many advantages over a liquid-based one, including being user-friendly, not requiring refrigerated storage and being cheaper to transport. In addition, there are also clinical benefits of a dry powder vaccine; it reaches the affected area of the lung tissue directly, and it does not require needle jabs with the risk of transmission of blood-borne viruses.

Promising results in an animal model

Earlier this year, ISR completed a provocation study with SARS-CoV-2 in mice transgenic for the ACE2 receptor, and results showed that the mice that were administered two doses of the vaccine in the respiratory tract were fully protected against the virus. With this positive outcome behind it, the company moved on to the next phase of vaccine development, which is now under joint management with Iconovo, which has strong patent protection for ICOone in Europe and India and with several patent applications under consideration in China, the US and Japan.

»The potential for an innovation like this will be huge if it reaches the market. We believe that ICOone has the potential to replace injections of vaccines and other important molecules, thereby offering a smarter way to administer these pharmaceuticals. Iconovo is a global leader and wants to act as a driving force in this development« — Johan Wäborg, CEO of Iconovo.

Clinical study begins H2, 2021

ICOone

The agreement between the parties gives ISR an exclusive global right to use ICOone for vaccination against SARS-CoV-2, using a technology based on the virus’s spike proteins with adjuvant.

Iconovo’s commitment is to contractually develop an inhalation product with the goal of evaluating it in a clinical study starting in the second half of 2021. In the agreement, ISR has a future option to use its vaccination technology together with ICOone for the prevention of respiratory infections such as influenza, RS-virus, and new strands of Covid virus vaccines based on the same technology.

High market potential

The parties rely on World Bank data showing that there are currently 3.9 billion people in lower-middle-income and low-income countries that will have later access to vaccines. The data also creates a price benchmark against AstraZeneca’s and J&J’s vaccines, which cost USD 8 – 10 per vaccination. This thus provides a total market potential of USD 31-39 billion, depending on the vaccination rate of a stable inhaled vaccine in these countries. Yesterday’s press release also mentions a scenario in which the virus mutates, which would require annual vaccinations as is happening today for influenza. The market for annual flu vaccinations is estimated at least USD 5.5 billion per year.

»This is a very important step towards taking our inhaled covid-19 vaccine to the market quickly with a suitable single-use inhaler. We believe that the product will be of greatest use in developing countries with restricted access to refrigeration and where the vaccination programs have not advanced yet. We also hope that an inhaled vaccine will give a more adequate immune reaction in the lung which is patrolled by another type of anti-body« – Ola Winqvist, CEO of ISR

Milestone payments and royalties

The agreement includes stepwise payments of a 9 MSEK technology access fee, set up as five increasing milestone payments over the development to market authorisation. The first milestone of 0.2 MSEK was paid at the agreement signature. ISR will also pay Iconovo for the contract development of the inhalation product, which, in a first binding feasibility trial, amounts to 3.6 MSEK, followed by the production of clinical trial material at a preliminary value of 5.5 MSEK. Additionally, the agreement will give Iconovo low single-digit percentage royalties over a period of 14 years from market launch.

The agreement means that Iconovo now has two projects in its innovative inhalation project portfolio – one with ISRfor an inhalable Covid-19 vaccine and one with Monash University for inhalable oxytocin. BioStock will follow thedevelopment of both projects and potential future projects in the new strategic area of innovative inhalation products.

Read the article at the Biostock webpage

Biostock published March 16th an article about Iconovo that can be found in its entirety below

Last week, Iconovo announced that they have been granted their first patent in India for the inhaler ICOone. The patent opens up significant opportunities for innovative inhalation products, such as inhalable vaccines and biomolecules. Iconovo has already begun a development project with the biomolecule oxytocin with the aim of preventing major bleeding in women after childbirth.

Iconovo develops and outlicenses complete inhalation products with associated dry powder formulation based on the company’s four inhalation platforms – ICOcap, ICOres, ICOone and ICOpre. The company recently received a patent in India for ICOone, a user-friendly disposable inhaler with a low manufacturing cost.

 At the end of 2020, Iconovo entered into collaboration with Monash University in Australia for the development of inhaled ocytoxin in ICOone to prevent Postpartum Haemorrhage (PPH), i.e., severe blood loss after childbirth. PPH is globally the most common cause of maternal mortality with approximately 60,000 deaths annually. Read more about the collaboration with Monash University here. 

First granted patent in India for ICOone

Iconovo already has approved patents on ICOone in Europe and recently India was added to the list of countries with approved patents for the inhalation platform. Several patent applications are also pending in China, the US, and Japan.

The ICOone patent in India will be important in Iconovo’s cooperation with Monash University as India is one of the countries with major problems with PPH. India accounts for about 19 per cent of global maternal mortality, with PPH as the main cause.

Today, oxytocin is injected to avoid major bleeding in the mother following childbirth. However, it is far from all mothers who receive such an injection, especially in India and other developing countries. Injectable oxytocin requires refrigeration storage, which can be difficult to maintain in regions with limited infrastructure.

ICOone has broad potential

Iconovo also sees opportunities in India for other innovative inhalation products, such as dry powder vaccines instead of the temperature-sensitive liquid form:

»A patent in India is extremely important for us since it is a large potential market for which ICOone is particularly well suited. A cheap, simple and safe way to supply vaccines to a large population is of great interest to many of our potential customers, not the least in India« – Orest Lastow, CTO and founder, Iconovo 

The ICOone dry powder inhaler is intended for single use, which makes it particularly suitable for administering vaccines in a simple and cost-effective way. ICOone is also adapted for the administration of biomolecules as it can deliver large inhalation doses that are well protected against moisture, which is important for many biomolecules.

ICOone contains a dry powder and does not require cold storage, which can otherwise be problematic and expensive when transporting and storing, for example, vaccines in liquid form. Inhalable vaccine also eliminates the use of syringes and the hazardous waste that occurs from injections. Iconovo founder Orest Lastow talks more about this in an article in MEDTECH Outlook.

Iconovo’s CEO Johan Wäborg also highlights ICOone’s potential in a presentation from the latest edition of BioStock Live. Like Lastow, Wäborg sees great potential in inhaled vaccines, but also in emergency medicine where syringes are often used, for example, in allergic reactions, epilepsy, hypoglycemia and heart attacks.

New inhalation products

In the past, Iconovo has mainly focused on the development of generic products for the treatment of COPD and asthma, which is a significant market with over 590 million people affected worldwide. Now the company also has its sights set on innovative inhalation products, which the Monash project exemplifies.

Several other companies have previously successfully developed such inhalation products. One example is Mannkind, which has developed an inhalable insulin that was approved by the FDA in 2014. Furthermore, Relief Therapeutics has developed the vascular dilator aviptadil which is currently being evaluated in inhaled form for the treatment of severe Covid-19, but which has previously been used for the treatment of erectile dysfunction. Another example is Alexza Therapeutics, which has developed the inhalation drug loxapine for the treatment of schizophrenia and bipolar disorder.

These are just a few examples of companies that are an inspiration to Iconovo in their own development of innovative inhalation products and BioStock will continue to follow Iconovo’s advancement in the field.

Read the article at the Biostock webpage

Biostock published February 23th an article about Iconovo that can be found in its entirety below


Last week, Iconovo published its report for the fourth quarter and the result for the full year 2020. The company reported a higher turnover compared with the previous year, which is mainly due to the fact that Iconovo achieved several sub-goals within the customer projects. During the past year, Iconovo also initiated new projects with strong partners.

Iconovo develops complete inhalation products, i.e., both inhalers and associated dry powder formulations. The inhalation products are primarily intended as generics for the treatment of asthma and COPD, but the company also plans to develop innovative inhalation drugs such as inhaled oxytocin and vaccines.

The company has developed four product platforms – ICOres, ICOcap, ICOone and ICOpre – which are linked to five different royalty agreements. According to the year-end report and the previously communicated operational goals, one of the goals for Iconovo is to enter two more royalty agreements in 2021.

One of the better quarters in Iconovo’s history

In 2020, Iconovo kept up a good pace in project deliveries and this was also reflected in the turnover figures. During the fourth quarter, Iconovo had a turnover of SEK 7.7 million, which is the highest quarterly turnover in three years. The sales figures during the fourth quarter stemmed from, among other things, large project deliveries in the customer projects with Amneal and Intas.

For the full year in 2020, Iconovo had a 50 per cent increase in turnover: from SEK 11.7 million in 2019 to SEK 17.8 million in 2020. After having presented these positive figures, Iconovo was able to announce that the company’s CEO Johan Wäborg has bought shares in Iconovo for SEK 1.1 million at the price of SEK 55 per share.

Two new customer agreements

In 2020, Iconovo entered into two new customer agreements, one with BNC Korea and one with Monash University, both of which are expected to create great value for Iconovo. The licensing agreement with BNC Korea applies to the production and sale of generic versions of Novartis’ Ultibro and Seebri in ICOcap in an Asian territory with 2.7 billion inhabitants.

The agreement with Monash University, signed in December 2020, gives Monash a license to commercialise ICOone with inhalable oxytocin. This is a groundbreaking agreement for Iconovo for several reasons according to Johan Wäborg. 

Through the deal, Iconovo is entitled to royalties from BNC Korea’s net sales once the products launch. The royalties will be affected by the sub-licensing terms agreed with their distributors. Overall, these royalty payments, not milestone payments, will represent most of the value in the deal, and they will be a mid-single digit percentage of sales, depending on country and distribution setup.

The report highlights the sustainability aspect

The project with Monash is Iconovo’s first project in innovative inhaled drugs, i.e., a drug that is not a generic drug.

According to Wäborg, inhalable oxytocin has the potential to save thousands of lives. Every year, 75,000 women die from postpartum haemorrhage, mainly in rural areas in Asia and Africa. In regions that are economically stronger, oxytocin injections are given to prevent the bleeding. However, they require transport and storage in an unbroken cold chain. If Iconovo and Monash succeed in developing an inhalable oxytocin, the problem of cold storage will be solved, all while eliminating the risks of spreading infection and hazardous waste.

Furthermore, Wäborg believes that the project with Monash and Iconovo’s other activities has a strong connection to the UN’s sustainability goals. The company mainly focus on three global goals – Good Health and Well-beingDecent Work and Economic Growth, and Climate Action.

Orest Lastow sees potential in ICOone

Iconovo sees an increased interest in projects similar to the one with Monash, i.e., where substances are suitable for administration with the disposable inhaler ICOone. Iconovo’s idea is to use ICOone with inhalable vaccines, as Dr Orest Lastow, CTO and founder of Iconovo, recently communicated in MEDTECH Outlook.

Read Orest Lastows article 2021 – Search for vaccinations without cold storage in MEDTECH Outlook

ICOpre accounts for a large part of the development costs

According to the report, the company’s development costs amounted to SEK 4.85 million in 2020. A relatively large part of the costs stems from the development of ICOpre, Iconovo’s largest investment to date. In 2020, Iconovo reached the goal of developing a functional ICOpre inhaler with several injection-molded parts. Now the goal is to complete the development of ICOpre so that a structured sales process can take off.

We will see the finished version of ICOpre in May when Iconovo presents the inhaler at the Respiratory Drug Delivery congress. After that, Iconovo will develop five powder formulations for ICOpre, which are expected to be fully developed by the end of 2021. The plan is to use the powder formulations to develop generic versions of the products in GSK’Ellipta portfolio.

High expectations and increased commercial focus in 2021

After a very active fourth quarter, Iconovo is entering the new year with MSEK 8.9 in accounts receivable. At the end of 2020, Iconovo had SEK 61.7 million in cash and is thus well financed for 2021. According to CEO Johan Wäborg’s presentation in connection with the year-end report, much can be expected from Iconovo in 2021. The company is increasing the pace of business development and has set the high goal of entering into two new deals in 2021. To achieve this goal, Iconovo has strengthened the organisation with several key employees and now has 27 employees. The new recruitments will contribute to a broadening of skills, increased capacity in current projects and an increased attractiveness in the eyes of potential customers and projects.

2021 will also be a year in which Iconovo will deliver in several projects, which means that the customer can initiate studies. A bioequivalence study will be initiated in the project with Amneal during Q2, and the results are expected to be presented during Q3. In 2021, Iconovo will also initiate a phase I study in the oxytocin project with Monash University and complete the development work in the projects with BNC Korea and Intas so that they can begin studies in 2022.

Iconovo is now one year closer to the launch of the first products on the market. The goal is to launch the first product, a generic version of Symbicort in ICOres, on the European market by 2023.

 

Read the article at the Biostock webpage

 

Inhalationsbolaget Iconovo har idag publicerat bokslutskommunikén för 2020 som visar högre omsättningssiffror jämfört med året innan. Under 2020 lyckades bolaget teckna två nya kundavtal och målet är att ingå ytterligare två kundavtal under 2021. Se videon på BioStock.

 

 

Biostock published February 8th an article about Iconovo that can be found in its entirety below

Iconovo recently submitted the first two patent applications for ICOpre, the company’s latest inhalation platform and largest investment to date for the company. To optimise the development of ICOpre, Iconovo appointed Dr Kyrre Thalberg as Senior Advisor in formulation development. The activity around ICOpre comes as good sales results were presented for GSK’s Ellipta range of inhalation platforms, i.e. the inhalers that ICOpre is intended to mimic as a generic version.

Iconovo develops complete inhalations products with associated dry powder formulations. In 2019, Iconovo decided to make a significant investment in the development of a new inhalation platform, ICOpre, with the goal of entering both the US and European markets.

Also read Biggest investment in Iconovo’s history

Iconovo has now submitted the first two patent applications for ICOpre. Additionally, they have recruited the dry powder formulation expert Dr Kyrre Thalberg as Senior Advisor for the development of formulations, primarily for ICOpre.

ICOpre – pre-metered multi-dose inhaler for simple treatment

ICOpre. Click on the image to make it bigger.

ICOpre is a pre-metered multidose inhaler with 30 individually-sealed doses for a month’s supply, complete with a dose counter. Every dose comes from two compartments, which makes the inhaler suitable for combination therapies with up to three different drug substances.

Iconovo has earmarked SEK 20 million for the development of ICOpre, and, if the company sticks to its current schedule, the development process will be completed in 2020. Iconovo plans to present ICOpre to the public for the first time at the virtual conference Respiratory Drug Delivery, which runs between 4-7 May.

Iconovo can circumvent GSK’s patent for Ellipta

When the inhaler is fully developed, Iconovo will move to a phase where ICOpre will be optimized with different powder formulations. The plan is to develop five powder formulations to develop generic versions of the products in GlaxoSmithKline’s (GSK) Ellipta portfolio, for the treatment of COPD and asthma. Over the next 10 years, the inhalation market is expected to be dominated by these products.

The mechanism in ICOpre mimics the ease of use and the simple three-step handling in Ellipta: open, inhale, close. However, ICOpre has an improved design and other technical characteristics not pertaining to the Ellipta inhaler, which means that Iconovo can circumvent GSK’s patent for Ellipta. Thus, Iconovo is not limited by the Ellipta inhaler’s patent protection to 2030, which means that Iconovo can reach the market earlier than other competing generic alternatives. Iconovo’s goal is to find a partner who also wants to be the first, or one of the first, out with a generic Ellipta version on the market.

Good sales figures in 2020

On 3 February, GSK released its annual report for 2020, which shows that the Ellipta products generated a total of 2,755 million pounds in sales revenue in 2020. This corresponds to 20 per cent growth compared to the year before. A predominant part of sales comes from the US market. 

Sales of Ellipta products are not expected to decline, on the contrary – analysts forecast sales of USD 4.5 billion in 2023.

Attracts expertise in formulation development 

Last week, Iconovo announced that they have appointed Dr. Kyrre Thalberg as the company’s Senior Advisor in formulation development. Thalberg, whose vast experience will primarily be valuable in the development of formulations for ICOpre, is an internationally recognised expert in the development of dry powder formulations for inhalation products. He has worked for nearly 30 years with formulation development in leading roles at AstraZeneca.

»We are very pleased to be able to attract such international authority on formulation development. This will further strengthen the high scientific level of our work and help us to accelerate the development of our generic Relvar ICOpre« – Johan Wäborg, CEO of Iconovo. 

Thalberg’s focus will primarily be on developing a generic version of Relvar Ellipta from GSK. According to GSK’s annual report for 2020, sales of Relvar amounted to 1.1 billion pounds in 2020, which means that Relvar accounted for almost half of the sales revenue for the Ellipta portfolio.

84 granted patents and 25 patent applications

In addition to strengthening the organisation with key competencies, Iconovo has also filed the first two patent applications for ICOpre. Last week, Iconovo was also able to announce that the USPTO intends to approve a patent for ICOres, which will be the second approved patent for ICOres in the United States:

»This new patent demonstrates how unique and innovative ICOres is. With two granted patents in the USA, we now have a very strong position on the American market. Our broad international patent protection allows us to intensify our global business development effort« – Orest Lastow, CTO Iconovo.

The patents cover the technology used in several of Iconovo’s customer projects, such as the development of a generic version of AstraZeneca’s Symbicort together with Amneal. Iconovo has granted patents on ICOres in the USA, Sweden, Europe, Japan and China.

In total, the company now has 84 granted patents and 25 ongoing patent applications. Strong patent protection is an important part of Iconovo’s strategy and also an absolute requirement from potential customers.

Big plans for 2021

 In addition to the development of ICOpre, Iconovo has much to look forward to in 2021. The company will enter into a phase I study with ICOone together with Monash University in Australia for inhaled oxytocin against postpartum haemorrhage. Last week, Iconovo received the first work order from Monash University. Payments for these development works are in addition to the 900,000 EUR in technology asset compensation as well as milestone payments and royalty income that the agreement entitles to.

With the company’s new CEO Johan Wäborg at the helm, Iconovo spoiled the market with a long list of positive news in 2020. For example, several granted patents, a new development partner, CE-marking, new collaborative projects and agreements, major progress by partner Stevanato in the production of ICOcap, and more. BioStock will follow Iconovo with interest in 2021 and see if the company can maintain the positive momentum that defined 2020.

Also read Iconovo aims to reach ambitious goals in 2021