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

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

Yesterday, Iconovo presented its business goals for 2021 and provided an update on the progress with the company’s four inhalation platforms and related agreements. It turned out that many milestones are within reach and that Iconovo is approaching final delivery in several of its customer projects. The company also has high ambitions when it comes to entering into new agreements and the goal is to sign two new customer agreements during 2020.

Iconovo develops complete inhalation products with associated drug preparations for the treatment of mainly asthma and COPD. The development mainly concerns generic products, but recently the door to innovative projects was opened when Iconovo entered an agreement with Monash University for the use of ICOone with oxytocin in a phase I study in 2021.

Yesterday, Iconovo presented its business goals for 2021, which show the company has high ambitions for the year, both in current customer projects but also in terms of reaching new agreements.

Raised ambitions for 2021

 Since its founding in 2013, Iconovo has developed a product portfolio that includes four inhalation platforms – ICOres, ICOcapICOone and ICOpre. The business model is based on entering into agreements with pharmaceutical and generic companies regarding these inhalation platforms in order to receive royalty income after market launch. Iconovo currently has licensing agreements with AmnealStevanatoIntasMonash University and BNC Korea. The goal for 2021 is to enter into at least two more customer agreements.

Iconovo managed to build strong momentum in 2020, and now they are raising their ambitions further, according to the company’s CEO Johan Wäborg: 

»Last year, we were able to achieve several important milestones and we are thus approaching final delivery in several projects. With two new license agreements, we were able to exceed our set goal and also show that our commercial approach works. We are now raising our ambitions for 2021.«

Final delivery to Amneal during Q1

Together with Amneal, Iconovo is developing a budesonide/formoterol ICOres product (generic version of AstraZeneca’s Symbicort). Iconovo’s plan is for final delivery of the development project to Amneal during Q1 so that the client can start a second pharmacokinetic pilot study during Q2 to demonstrate bioequivalence. The purpose of a bioequivalence study is to investigate whether two drugs, in this case Symbicort and Iconovo’s generic version of Symbiocort, have an equivalent clinical effect.

The results of the pharmacokinetic pilot study are expected to be presented in the second half of 2021. Iconovo’s long-term goal is to launch the generic product on the European market by 2023.

Great progress in ICOres project with Intas

In its business goals, Iconovo also provided an update for the ICOres project with Intas. The product to which the collaboration relates has not yet been announced, but what has been communicated previously is that the agreement applies to a specific generic product for the treatment of asthma and COPD that is being developed and adapted to the ICOres inhaler.

plans to complete the development work and carry out technology transfer to Intas in 2021. The product will then be ready for a first pharmacokinetic pilot study with the aim of demonstrating bioequivalence between the ICOres product and the unnamed original drug.

ICOcap

First royalty income on the horizon

With regard to ICOcap, Iconovo’s distribution partner Stevanato made several advances in 2020. For example, in May of last year, ICOcap received CE marking, meaning that it could start being sold to customers for use in clinical studies.

In addition, Stevanato submitted a Type III Drug Master File (DMF) to the FDA. According to yesterday’s press release, this is expected to lead to a first delivery agreement with an end customer and thus a first royalty income for Iconovo in 2021.

Launch in South Korea 2024

In 2020, Iconovo entered into a licensing agreement with BNC Korea for the development of two generic versions of Novartis’ Ultibro Breezhaler and Seebri Breezhaler in ICOcap, both approved for the treatment of COPD.

Yesterday, Iconovo announced that they expect to be able to final deliver the first product to BNC Korea by the end of 2021. The product will then be ready for a first pharmacokinetic pilot study to demonstrate bioequivalence.

Before Iconovo’s generic versions of Ultibro and Seebri can be launched, patents for the original products must expire on the markets in BNC Korea’s territory (Korea, Japan, China, Taiwan, Russia, CIS countries and Southeast Asia). South Korea is expected to be the first country with a patent expiration at the end of 2023. Thus, Iconovo plans to do a market launch in South Korea in 2024.

ICOpre – Iconovo’s largest investment to date 

ICOpre is the company’s latest addition to the family of inhalation products and also the company’s largest investment to date. The inhaler is a generic equivalent of GlaxoSmithKline’s Ellipta inhaler.

According to yesterday’s press release, the development of ICOpre is progressing according to Iconovo’s schedule. The development of the product is expected to be completed in 2021, and thereafter it will move to a phase where ICOpre will be optimised with different powder formulations. The idea is to develop five powder formulations in 2021 to match the five dry powder formulations in the Ellipta portfolio. In the subsequent phase, the formulations will be optimized with ICOpre.

Iconovo plans to present ICOpre to the public for the first time at Respiratory Drug Delivery, a virtual conference held on May 4-7.

High goal regarding new agreements

The marketing of ICOpre will be strengthened in 2021 to capture the interest of potential customers. Iconovo will also continue in discussions with customers who have already shown interest in the product. They also have ongoing discussions regarding the other inhalation platforms with current and new potential customers, both for generic and innovative applications.

To be well prepared for 2021, Iconovo has strengthened the commercial part of the organisation, e.g., through new recruitments. Thus, the company has chosen to raise the target for the number of customer agreements per year.  The goal is now to enter into two new customer agreements in 2021, according to CEO Johan Wäborg:

»We make major efforts in business development and work with increased capacity and focus. We aim to reach two new business agreements this year, which is a doubling of the previously communicated ambition for the number of new agreements per year«

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 January 18th an article about Iconovo that can be found in its entirety below

2020 was an eventful year for Iconovo, which included the company entering into agreements with BNC Korea, Amneal and Monash University. A CE marking and several positive patent notices were also obtained. Additionally, Iconovo made significant changes in its organisation to strengthen the company’s business development, including the appointment of Johan Wäborg as CEO, with Orest Lastow becoming CTO. BioStock contacted Johan Wäborg to hear his thoughts on 2020 and the company’s plans for 2021.

Iconovo develops inhalation products consisting of both inhaler devices and associated dry powder formulations. The complete inhalation products are out licensed to customers, thus, Iconovo offers a faster way to market with lower risk and at a lower cost.

The inhalation products are primarily intended for the treatment of asthma and chronic obstructive pulmonary disease (COPD), but there is also potential in other and new types of inhaled drugs, which is exemplified by Iconovo’s latest agreement with Monash University for inhaled oxytocin (more details below).

Achieved milestones and good sales in 2020

Since its founding in 2013, Iconovo have developed a broad product portfolio that includes four inhalation platforms – ICOres, ICOcap, ICOone ICOpre. In 2020, significant progress was made in the development and commercialisation of all platforms despite the Covid pandemic. A strong sales trend could also be noted in combination with several achieved milestones.

New CEO with international experience in business development

In early 2020, Iconovo announced that Dr. Orest Lastow, the inventor behind the company’s inhaler platforms, had decided to leave his role as CEO to instead act as Iconovo’s CTO. Taking over the role as CEO was Johan Wäborg, who most recently held a position as CEO of Actelion Pharmaceuticals in the Nordic and Baltic countries, where he was involved in the process when the company was acquired by Janssen Pharmaceuticals for USD 30 billion.

Since Wäborg’s appointment as CEO in April, Lastow, as CTO, has focused in particular on the development of Iconovo’s fourth inhalation platform, ICOpre, which is the company’s largest investment to date. At the same time, this marks a shift where the company is transitioning from a company in establishment phase, to a growth company with sustainable profitability.

Amneal – new development partner for ICOres

In May, Amneal Ireland Ltd was welcomed as the new partner for the development of Iconovo’s ICOres budesonide/formoterol product, a generic version of AstraZeneca’s Symbicort. The global market value of a combination product with budesonide/formoterol is estimated at approximately USD 2.5 billion per year according to Iconovo.

Amneal has extensive experience in bringing generic products to market, but also the necessary financial muscle to guarantee continued progress in development. Iconovo wants to reach the market as quickly as possible in order to offer a good product alternative to asthma and COPD patients, but also to obtain royalties on future sales

CE marking for ICOcap and DMF submitted to FDA

 At the end of May, Iconovo received a Class I certification for the capsule inhaler ICOcap, which means that the requirements for a Class I medical device are met. With this quality stamp on its back, ICOcap could start being sold to customers for use in clinical trials. This was an important step towards the ultimate goal – to launch ICOcap globally and start commercial sales.

ICOcap is sold through Stevanato, Iconovo’s manufacturing and distribution partner, which announced in December that a Type III Drug Master File (DMF) had been submitted to FDA. According to Wäborg, this was a big step forward in the American market, the world’s largest pharmaceutical market and a crucial market for success with ICOcap.

Extended patent portfolio

 In March 2020, the European Patent Organization (EPO) announced that they intend to grant two of Iconovo’s patents – one for ICOres and one for ICOone.

Iconovo already had two approved Swedish patents for ICOone and now they had also received a European patent for ICOone, which is a single-dose inhaler. The European patent for ICOone describes the technology used in Iconovo’s oxytocin project with Monash University, among other projects.

Agreement with Monash University for inhaled oxytocin in ICOone

Just before the turn of the year 2020/2021, Iconovo signed an agreement with Monash University for the development of inhaled oxytocin in ICOone. The agreement gives Monash University the exclusive right to use ICOone to administer oxytocin to the lungs to prevent postpartum haemorrhage (PPH), which is the most common cause of maternal mortality worldwide.

Today, oxytocin is only administered as an injection to prevent bleeding in the mother after childbirth. If Monash University and Iconovo succeed in developing an inhaled preparation of oxytocin in ICOone, it would mean great benefits such as cheaper and smoother transport and greater user-friendliness than a syringe. According to Iconovo, the main strength of the product will be its thermal stability allowing it to be distributed and stored without refrigeration temperature requirements.

Patent protection for ICOres in China and the USA

In April 2020, the EPO announced the intention to grant a third patent regarding ICOres, which is important as Europe is the largest market for the multi-dose inhaler.

During the summer, two more positive patent notices were received for ICOres in the USA and China. Iconovo previously had approved patents for ICOres in Sweden, Europe and Japan. The US patent in particular will be an important asset in Iconovo’s patent portfolio, according to CEO Johan Wäborg:

»With a granted patent in USA we can now intensify our global business development. This patent means that ICOres has broad international patent protection, which increases the value of our product portfolio.«

The Chinese market is also of high value given the increasing prevalence of respiratory diseases in China. Additionally, a patent granted in China is crucial for business development in the country.

Agreement with BNC Korea

 In July, Iconovo signed its fourth licensing agreement – a 20-year agreement with BNC Korea Co Ltd for ICOcap formulations – covering the development of generic versions of Novartis’s Ultibro Breezhaler and Seebri Breezhaler, both approved for the treatment of COPD. Iconovo’s CEO had this to say about the agreement:

»Iconovo is looking forward to work with BNC Korea to bring these two products to market in a very important territory with over 2.7 billion inhabitants. With BNC Korea we are confident that the products can be advanced to market in a fast and effective way.« 

The deal has a milestone value of EUR 550,000. In addition, future royalty payments from BNC Korea will be received based on the sales of the generic products once they have been launched.

According to Novartis’s financial report 2019, Ultibro and Seebri together generated 548 MUSD in sales during the financial year. Iconovo estimates that about 15 per cent of global sales derive from the territory where BNC Korea has exclusive rights.

Two new recruitments for increased customer focus

With the company’s growing project portfolio and with many projects in an active final phase, Iconovo chose in October to make two key recruitments for an increased focus on customer needs and project delivery. Nina Bladh, Ph.D, was appointed to Director Project Management and Måns Österberg Widerstrand was appointed to Director of Alliance Management.

Nina most recently held a position as Director CMC Regulatory Affairs for Camurus, while Måns previous position was Senior Scientific Advisor Allergy for Thermo Fischer.


The CEO comments on 2020 and Iconovo’s future plans

Johan Wäborg, CEO

BioStock contacted Iconovo’s CEO, Johan Wäborg, to hear his thoughts on the past year and the plans for 2021.

Johan Wäborg, 2020 was a successful year for Iconovo and it was also the year that you took over as CEO of Iconovo. How would you describe 2020 and your first months as CEO of the company?

– My first 9 months at Iconovo have been really good! Full speed ahead. When I came in as the new CEO in the middle of the Covid-19 pandemic’s first wave, I did not know at all how we would be affected. It was just a matter of rolling up my sleeves and getting into the business with high energy.

– Helpful and knowledgeable employees made my introductory period smooth. I feel confident and I have a management team that works very well together – it’s incredibly fun.

Iconovo has certainly achieved a great deal in 2020, despite the pandemic. What do you think is Iconovo’s biggest achievement in 2020? 

– I am proud of our employees who worked with good energy throughout 2020. It has led to progress in all functional areas, for example new customer agreements, new patents, progress in ICOpre development, deliveries in projects and more.

– I think our greatest achievement is that we managed to end the year according to our tough plan. It shows that this team can deliver even in tough times.

Iconovo has just signed an agreement with Monash University for the development of inhaled oxytocin in ICOone. How do you assess the potential in this project?

– Inhaled oxytocin is an exciting project as it is our first commercial project for ICOone and our first innovative inhalation project as our previous projects are generic projects.

– The deal has a milestone value of 900 000 Euro and will provide some royalty income, even if the low prices in resource-poor countries will affect the royalty income. However, it opens up a door to more innovative inhalation projects such as vaccines, migraines or emergency treatment of various conditions.

»We will also continue our commercial approach and aim to enter into new agreements during the year.«

Now that 2020 has passed, it is time to look ahead – what plans does Iconovo have for 2021?

 – This year we will be able to accelerate further and work with increased capacity, especially since we hired several new employees during 2020. We will soon make a Technology transfer to Amneal so that they can carry out a pilot PK study during the year. A clinical study will also be conducted for the project with Monash.

– The other projects have some remaining time left until studies can be initiated. However, the projects with Intas and BNC also have important deliveries during the year that are in the late phase of development. We will also continue our commercial approach and aim to enter into new agreements during the year.

 

Read the article at the Biostock webpage

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

In a final push before the Christmas break this week, the inhalation device company Iconovo announced the signing of a deal with Monash University to develop an inhaled oxytocin treatment against postpartum haemorrhage using Iconovo’s ICOone platform. The project is supported by a research agreement with Johnson & Johnson aimed at speeding up clinical development. BioStock takes a closer look at the ramifications of this new partnership.

Most maternal deaths occur during the first 24 hours after delivery, and one of the main causes is postpartum haemorrhage (excessive bleeding) (PPH) due to the lack of uterus contractions right after childbirth. The hormone oxytocin, often referred to as the love hormone thanks to its role played in establishing romantic relationships, is also a key player during childbirth as it causes the uterus to contract during labour.

Therefore, through the years, oxytocin became a treatment for PPH, and is, in fact, recommended by the WHO that women receive an injected dose of oxytocin during the third stage of labour to prevent PPH. While the treatment is considered effective, there is a strong demand for alternative forms of drug delivery, as the injections require skill levels and equipment that may not always be available. This is especially problematic in developing countries.

New PPH treatment platform in the pipeline

Researchers at Monash University’s Institute of Pharmaceutical Sciences (MIPS) in Melbourne, Australia, have been working on an alternative oxytocin formulation that does not require an injection. To speed things along, the MIPS recently entered into an R&D agreement with Janssen Pharmaceutica, part of Johnson & Johnson, to further advance the clinical development of inhaled oxytocin for the prevention of PPH in developing countries.

Iconovo contributes with ICOone system

This week, news broke that the project received a big boost as Monash University signed a development deal with Swedish inhalation device company Iconovo to use Iconovo’s proprietary ICOone platform to deliver an inhalable dry powder version of oxytocin through the lungs. The dry powder formulation would not require refrigeration and would enable ease of use by frontline health workers, birth attendants and mothers themselves.

Iconovo’s CEO Johan Wäborg displayed his excitement regarding the news in the latest press release:

»We are excited to be contributing with ICOone and our inhalation know-how to such an important medical innovation. There is a huge need to ease administration of oxytocin so that these unnecessary and tragic deaths can be reduced all over the globe. In this project, we all come together to make great things happen. For Iconovo, this project will broaden our experience to include innovative development and we look forward to many more such projects where we can use our inhalation experience. It sends a clear signal that these innovation-focused partners see ICOone as a promising inhaler for innovative applications«

A clinical phase I trial for the project is planned for 2021, and the agreement has a staged technology access fee of 900 000 EUR that will be triggered by milestones in the clinical trial stage. The first out of three milestones will be paid as an exercise fee to license the device subject to a positive outcome during phase I. In addition, Monash will pay Iconovo for commissioned development work through milestones that are yet to be defined. Royalties from sales over a 20-year period from launch will range from 5 – 10 per cent.

ICOone has versatility and strong IP protection

The ICOone platform, which consists of a single-dose disposable user-friendly dry powder inhaler, can be used with a wide range of formulations and can deliver treatments more quickly and safely to patients. The technology for the device has good IP protection. In fact, during the spring of this year, it had received an intention to grant from the EPO for ICOone.

Photo: Iconovo

Thanks to its versatility, PPH is not the only indication where the ICOone platform could make a difference; in fact, this is not the first collaboration for Iconovo regarding ICOone. In 2018, the company  signed an agreement with McMaster University in Canada for the joint development of a vaccine against tuberculosis (TB). The agreement relates to the development of a dry powder preparation of inhalable vaccine to be administered through Iconovo’s ICOone inhaler. The project was highlighted by BioStock earlier this year in recognition of World TB day.

Contributing to significant market potential

Overall, the Iconovo-Monash University agreement has the potential to address a critical unmet medical need among women. Iconovo estimates that roughly 15 – 20 per cent of the expected 115 million annual live births occurring in less developed parts of the world, like the rural parts of Africa or Asia, could benefit from an inhaled formulation. It could provide important advantages such as ease of use, cheaper transport and management of hazardous waste material like used syringes.

In the future, such potential could expand to other markets like USA and Europe where the need for a safer, non- invasive alternative to injections is not to be overlooked.

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

Since entering a collaboration with the Italian healthcare technology company Stevanato Group, Iconovo has taken significant steps towards commercialisation with its ICOcap inhaler platform. After receiving CE-marking for use in clinical trials earlier this year, most recently the device has been submitted to the FDA by Stevanato as Type III Drug Master File, a certification that would guarantee the device a stronger standing globally, especially on the US market.

Iconovo is a Swedish medical device company that develops not only generic inhalers but also dry powder formulations to be used with their inhalers for the treatment of respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD) through its four proprietary inhalation platforms – ICOresICOoneICOcap, and ICOpre. The company’s business strategy partly involves partnering with global healthcare distributors and receive royalty payments through their sales. This gives Iconovo the opportunity to insert itself into a growing global market, and the company has taken several steps to reach that goal.

A great partner in Stevanato

One of Iconovo’s first licensing deals came in 2018, when the company made an agreement with Italian healthcare technology company Stevanato Group for the manufacturing, international sales, and distribution of their ICOcap platform. ICOcap is a capsule-based dry powder inhaler designed to be robust but also easy to use and with the potential to handle different capsule sizes. The device itself has the same function and performance as Boehringer Ingelheim’s capsule-based dry powder inhaler HandiHaler and Novartis’s dry powder inhaler Breezhaler, both of which have been licensed by Stevanato. However, currently, the Breezhaler version is the only one available from Stevanato.

Since beginning the partnership with Stevanato, ICOcap has received a Class I Medical Device certification in conformity with the requirements of Directive 93/42/EEC. This CE marking means that European customers who produce dry powder formulations for treating asthma and/or COPD can now purchase ICOcap from Stevanato and use the device in clinical trials.

Large investments and more visibility in US market

Following the CE-marking announcement, Stevanato stated their intention to invest heavily in the ICOcap platform – part of an almost 400 million EUR investment in manufacturing and R&D programs for drug delivery systems. In the meantime, Stevanato also launched a new product site to increase the visibility of ICOcap underlining its position as an important product for the future, where Iconovo is featured as a service provider for customisations and formulation services. See the site here.

More good news came out of the Iconovo-Stevanato partnership recently when Stevanato announced that it had submitted a Type III Drug Master File (DMF) application to the FDA for ICOcap. This means that new ICOcap customers can now reference this DMF submission when developing their drug-device product for the US market, thus giving ICOcap even more market visibility on a global level.

Iconovo’s CEO, Johan Wäborg, was very pleased with the announcement and overall collaboration with Stevanato:

”Stevanato is doing a great job in getting the ICOcap inhaler globally ready for pharmaceutical companies to develop their products with ICOcap. Now they have managed to take major steps in two of the largest markets in the world. US, the largest pharma market in the world, is a crucial market to be in with ICOcap.”

One of two royalty agreements regarding ICOcap

The partnership with Stevanato is one of several that Iconovo has entered in the last two years and one of two agreements regarding ICOcap. The other partnership involving ICOcap was announced this summer when Iconovo signed a licensing agreement with BNC Korea – a deal that gives Iconovo access to a vast territory in Asia representing about 15 per cent of today’s global market for generic formulations of Novartis’ Seebri Breezhaler and Ultibro Breezehaler.  Read more about this agreement here.

However, the deal with Stevanato is expected to generate royalty payments to Iconovo starting in 2022 according to analysts. This would make it the first partnership to show that Iconovo has a business model that can generate more sustainable business opportunities as it moves from 100 per cent milestone income to longer-term royalty income.

Overall, considering the progress made through the ongoing relationship between the two companies and assessing the future potential, Stevanato will remain an important partner for Iconovo, and vice versa.

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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CEO Johan Wäborg – Iconovo company presentation and Q&A att the BioStock Life Science Summit 2020.

See the presentation

Biostock published November 4th an article about Iconovo that can be found in its entirety below

During Q2 and Q3, Iconovo took several steps to put more focus on business development, and the latest quarterly report shared by the Swedish inhalation company indicates that the moves have been paying off so far. Thanks to a strong sales performance along with several milestones achieved during Q3, analysts predict a significant upside in Iconovo’s share price.

Since the spring of this year, Iconovo has quickly transitioned from a company in establishment phase to a company more focused on growth, setting its sights on more sustainable profitability with a secure profit margin through growing royalty revenues.

A big step in that transition came during Q2, when Iconovo hired Johan Wäborg as new CEO. This move secured international strategic business development experience at the very top levels of management, which is essential for Iconovo’s future growth. Read more.

Best quarter for Iconovo in three years

Wäborg gave a presentation to investors at Erik Penser Bank’s Company Day, on September 24, giving a detailed overview of the company’s four inhalation platforms and overall business model. Thanks to Iconovo’s in-house inhalation expertise, which pertains to both inhalation devices and dry-powder formulations to match those devices, generic pharma companies could potentially save three to four years in product development time by partnering with Iconovo, who, in turn, would receive revenue in the form of milestone payments and royalties from the market sales.

Thanks to a strong sales performance equal to SEK 5.8 million in Q3 (a 66 per cent increase compared to the same period last year) Iconovo recently posted its best quarterly results in the last three years. Overall, the company’s Q3 report highlights the progress made so far this year and is a testament to its business model.

Business model pays off

During that period, Iconovo received milestone payments from its partnership with Amneal. The pharma company is developing a generic version of AstraZeneca’s Symbicort Turbuhaler (budesonide/formoterol) for treating asthma and chronic obstructive pulmonary disease (COPD) using Iconovo’s ICOres platform.

Furthermore, in July, Iconovo was able to announce a new licensing deal with BNC Korea. This is the fourth royalty agreement for the company, and this one relates to generic formulations of Novartis’ Seebri Breezhaler and Ultibro Breezehaler for Iconovo’s ICOcap platform. Read more details about the deal and why it is important for Iconovo here. In connection with signing, a technology access fee of EUR 150 000 was paid to Iconovo.

Good cash position

In Q3, Iconovo also invested significantly in expanding its team with highly qualified workers, including a formulation specialist, a mechanical design engineer, a personal responsible for commercial partnerships and customer relationships, and a senior project manager. Furthermore, Iconovo made investments in the adaptation of the quality system to meet the requirements of the US Food and Drug Administration (FDA), as well as lab upgrades. And the company is continuing to make investments in the development of their new ICOpre platform.

However, the company’s cash position, SEK 72 million in cash and cash equivalents at the end of September, shows a good balance between investments and invoicing. In fact, Iconovo estimates its cash balance to last just over three years given its current burn rate. By then, Iconovo is expecting to receive royalties, which will translate to positive cash flow and good profitability for the company.

Analysts forecast jump in share price

The good Q3 report was picked up by analysts from Danske Bank and Erik Penser Bank, both of which ran positive valuations for Iconovo and a significant upside in the company’s share price.

Both analyses expect Amneal’s ICOres-based product to commercially launch in Europe during the first part of 2023, which will result in Iconovo collecting its first royalty payments from this deal. Meanwhile, Penser expects royalty payments from the BNC Korea deal to come in 2025.

It is also worth noting that the Danske Bank analysis forecasts first royalty payments from Stevanato Group to come in 2022. The Italian healthcare service provider sells Iconovo’s ICOcap platform, which has been CE-marked for use in clinical trials.

Overall, analysts see a medium risk in Iconovo’s stock, and with Iconovo expecting the same high pace in delivery of milestones for the rest of the year, high invoices are expected for Q4 as well.

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