Biostock published August 27th an article about Iconovo that can be found in its entirety below

Together with ISR, Iconovo is developing an inhaled Covid-19 vaccine in ICOone and a nasal version in ICOone Nasal. ISR has now signed a MoU agreement with the CRO Bangladesh Clinical Trials for a clinical phase I study with the vaccine, as well as with UniMed UniHealth Pharmaceuticals for manufacturing and distribution in Bangladesh. However, these agreements are only declarations of intent, not binding agreements, but they are nevertheless good news for Iconovo as it means significant progress within the vaccine project.

Iconovo develops inhalation products that are licensed to other companies to accelerate development and quickly reach the inhalation market.

One of Iconovo’s partners is ISR Immune System Regulation, a Stockholm-based pharmaceutical and research company that, among other things, has a vaccine candidate against SARS-CoV-2 under development.

ISR has developed two dosage forms of the Covid-19 vaccine, one for inhalation through the mouth down to the lungs and one for intranasal application (in the nose). ISR will test which of the routes of administration provides the best immune response and protection against the virus. The company has selected Iconovo’s inhalers ICOone and ICOone Nasal for this purpose.

Broadened collaboration

In late March, Iconovo and ISR announced an agreement giving ISR global exclusive rights to use Iconovo’s ICOoneinhaler for vaccination against SARS-CoV-2. Since then, the collaboration has been broadened to include a nasal version with Iconovo’s new platform ICOone Nasal. There can be great value in having two formulations according to ISR because they can individually lead to market registration. Ola Winqvist, CEO of ISR, said in a press release that he saw the collaboration as a start of a long-term partnership with Iconovo to develop a series of vaccines.

Several benefits with inhaled vaccines

Inhaled/nasal vaccines have a number of advantages over vaccines given in injection form. One advantage is its ease of use – with Iconovo’s inhalers ICOone and ICOone Nasal, patients can administer the vaccine themselves without the aid of a healthcare professional. Vaccine powder formulations for inhalation translated to cheaper transport and storage without the need for cooling or freezing temperature, which can be of great benefit in developing countries. In addition, needle sticks and handling of syringes and other contagious waste are avoided.

MoU agreement for clinical study in Bangladesh

ISR and Iconovo are preparing for a phase I clinical study with the inhaled/nasal Covid-19 vaccine to evaluate the safety, dose, route of administration, immunogenicity, and efficacy of the inhalable/nasal vaccine.

ISR is now evaluating the possibility of conducting the study in Bangladesh as the company has entered into a memorandum of understanding (MoU) with the CRO Bangladesh Clinical Trials, and the two principal investigators Prof Dr ABM Abdullah and Prof Dr Ahmedul Kabir at Mugda Medical College Hospital in Dhaka. In a recent press release, ISR’s CEO Ola Winqvist mentioned how pleased he is to have made contact with these experts:

»We are very pleased to work with experts from Bangladesh to conduct a phase I clinical study with our vaccine formulations designed for optimal immune response at the entrance for the SARS-CoV-2 virus, respiratory tract.«

MoU with UniMed for manufacturing and distribution

In addition to conducting the study in Bangladesh, ISR is also exploring the possibility of producing the Covid-19 vaccine in the country. In early August, ISR announced that it had entered into a MoU agreement with UniMed UniHealth Pharmaceuticals, one of the largest pharmaceutical companies in Bangladesh. The purpose of the MoU is to agree on a long-term cooperation agreement in which Unimed can potentially obtain exclusive rights to manufacture and distribute the vaccine against SARS-CoV-2 in Bangladesh.

If the two parties enter into a licensing agreement, it would mean that ISR would receive compensation in the form of payments upon signing and upon market approval, as well as a double-digit royalty. However, the MoU agreement with UniMed is only a preliminary agreement and not legally binding. The company is currently in negotiations with various parties regarding the delivery of the Covid-19 vaccine.

Great need for vaccine in Bangladesh

In a press release, Ola Winqvist emphasised that Bangladesh has been hit hard by the pandemic and is in dire need of a vaccine against Covid-19 and subsequent mutations. The goal is a quick path to market approval to reach the large population of 160 million people with the inhaled/nasal vaccine.

ISR’s and Iconovo’s vaccine project is now proceeding at a high pace. According to ISR, UniMed has the resources needed to produce and distribute the Covid-19 vaccine effectively. UniMed can produce up to 100 million vaccine units per year and the goal is to be able to produce up to 300 million units or more annually within 5 years. In addition, the ISR’s CEO believes that Iconovo’s platforms ICOone and ICOone Nasal can accelerate the development further: 

»The platform of ICOone with its flexibility enables a rapid, affordable and effective development of a SARS-CoV-2 vaccine for the respiratory tract. The platform can make ISR’s vaccine available on the global market shortly after conducting clinical studies.«

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 July 16th an article about Iconovo that can be found in its entirety below

Earlier this year, two Swedish life science companies, Iconovo, which develops complete inhalation products, and ISR, which develops immunotherapies, came together to start working on an inhalable Covid-19 vaccine using Iconovo’s ICOone platform. Now, the two companies have announced another agreement, this time for developing a nasal application of the vaccine using Iconovo’s new version of ICOone, called ICOone Nasal. The new application will lead to a faster track through clinical studies and thus a quicker path to market for this much-needed therapy.

In March, BioStock reported the news that Lund-based Iconovo had signed an agreement with Stockholm-based immunotherapy company ISR Immune System Regulation for the development of an inhaled Covid-19 vaccine. Through that agreement ISR would develop a dry-powder formulation of the vaccine able to be administered with Iconovo’s the single-use inhaler ICOone, thus making it particularly user-friendly and more cost-effective since it does not require refrigeration and is cheaper to transport.

New agreement introduces ICOone Nasal

Now, the partners have signed a new agreement, this time for the development of dry powdered vaccine, which reaches the airways by inspiratory flow to the nasal cavity instead of inhalation to the lungs through the mouth using Iconovo’s new proprietary version of ICOone – ICOone Nasal.

ICOone Nasal works similarly to ICOone, in that it is a single-dose, user-friendly device with a design that leads to low manufacturing costs. Since the new device is driven by inspiratory flow rather than being sprayed into the nasal cavity, it leads to a more even and natural distribution over the nasal mucosa. This gives ICOone Nasal a unique position versus competitors such as Aptar Pharma’s Unidose (UDS) Systems, which relies on spray performance and is used by Eli Lilly for its FDA-approved nasal glucagon powder in treating hypoglycemia.

A faster path to market

Thanks to this new agreement, there are now two dosage forms of a dry-powder Covid-19 vaccine currently in development – an inhaled application and a nasal application. With both applications, the vaccine reaches the gateway for the virus directly, thus creating a local immune response instead of a systemic response. Furthermore, the addition of the nasal application will help accelerate development and generate a fast track through clinical studies and thus a quicker path to market.

ISR’s CEO Ola Winqvist further explained the benefits of having two dosage forms in a recent press release:

»We have chosen to develop two dosage forms to evaluate which route of administration provides the optimal immune response and the best protection against infection. Administration of vaccines via the respiratory tract is so far relatively new and knowledge is needed to determine the best route for activating the immune system. By broadening the collaboration with Iconovo AB, we are investing in knowledge and time to be able to clinically provide a simple vaccine as quickly as possible for countries where cold chains are not secured.«

Potential paradigm shift in vaccination

The new agreement gives ISR an exclusive global right to use ICOone Nasal for the treatment of Covid-19 and its variants with a technology based on spike proteins with an adjuvant. Moreover, ISR also has a future option to use its vaccination technology with ICOone Nasal in influenza, RS-virus and new strands of coronavirus vaccines based on the same technology.

The total value of the deal is 10.4 MSEK, which equals to an added 4.9 MSEK to the previously communicated contractual sums. Payments are expected to be divided into 9.1 MSEK over the coming six months and the remaining amount over the next 24 months. Upon signing of the order, an initial payment of 1.3 MSEK will be paid.

Iconovo’s CEO Johan Wäborg is also excited about this new opportunity:

»This order provides a great opportunity to evaluate the new platform ICOone Nasal in a clinical study for Covid-19. We give the project the highest priority to support ISR in their efforts to advance the project according to the aggressive timelines required during a pandemic. This project could be the start of a paradigm shift that opens the door to inhaled vaccines instead of injectable vaccines. A shift where Iconovo is well positioned to take the lead.«

Significant market potential

According to the WHO, an estimated 11.6 billion vaccine doses are needed for global vaccination to stop the spread of SARS-CoV-2, an estimate that is now being re-evaluated since data suggest that a third round of vaccination may be required for adequate protection from new variants. If successful, this new development track for a new Covid-19 vaccine using ICOone Nasal could have a profound impact, particularly in developing countries that have restricted access to refrigeration and where the vaccination programs have not advanced yet.

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 July 8th an article about Iconovo that can be found in its entirety below

All Covid-19 vaccines on the market are given in injection form by healthcare professionals and require transport and storage at low temperatures. Inhalation company Iconovo and immunotherapy company ISR want to change this by developing an inhaled Covid-19 vaccine that can be stored at room temperature and is easily administered by the patients themselves with Iconovo’s disposable inhaler ICOone. The inhaled vaccine reaches the affected area of the lungs directly, which is expected to create a protective effect against the virus.

Lund-based Iconovo develops inhalers with associated drug preparations that are mainly used to develop treatments for asthma and COPD, but also new types of inhaled drugs such as vaccines.

At the end of March, the company announced signing an agreement with ISR Immune System Regulation for the development of an inhaled Covid-19 vaccine. The agreement means that ISR has exclusive global rights touse Iconovo’s single-use inhaler ICOone for vaccination against SARS-CoV-2 using a technology based on thespike protein on the surface of the virus along with adjuvant (substances that enhance the immune response). The vaccine project has received a lot of attention, especially after a feature in TV 4 where Iconovo’s founder Orest Lastow and CEO Johan Wäborg talked about the benefits of the inhalable Covid-19 vaccine.

Iconovos single-dose inhaler ICOone

ISR develops the vaccine and Iconovo provides the inhaler

Stockholm-based ISR has developed the candidate Covid-19 vaccine ISR52, which will now be used in a powder formulation in Iconovo’s disposable inhaler ICOone. An inhaled preparation has several advantages: ease of use, not requiring the presence of healthcare professionals to administer the vaccine, cheaper transportation and storage without the requirement of refrigeration or freezing. In addition, the risk of transmission of blood-borne viruses through needles and syringes is avoided.

Another advantage is that the vaccine reaches the affected area of the lung tissue directly, which is expected to give a more adequate and local immune response in the lung in addition to the systemic immune reaction.

Iconovo and ISR believe that an inhaled vaccine will be of greatest use in developing countries with restricted access to refrigeration and where the vaccination programs have not advanced yet. In the TV 4 feature, Iconovo’s CEO said that he sees a future where inhalable vaccines can be distributed to large parts of the population so that millions of people can take the vaccine at the same time. 

Several Covid-19 vaccines already approved 

However, there are many other Covid-19 vaccines in development, and several have already received market approval. In the EU, the vaccines from Pfizer/BioNTechModernaAstraZeneca/University of Oxford and Janssen/Johnson & Johnson have been approved.

Both Pfizer’s and Moderna’s Covid-19 vaccines are based on a relatively new technology using mRNA (messenger RNA) encoding the spike protein on the surface of the SARS-CoV-2 virus. The body’s immune system identifies the spike protein as something foreign and begins to produce antibodies to the protein, creating protection against the virus.

AstraZeneca’s and Janssen’s/Johnson & Johnson’s Covid-19 vaccines send instructions for the formation of the spike protein via double-stranded DNA encoded into an adenovirus vector – a common and harmless coldvirus. These vaccines do not need to be stored as cold as those based on mRNA, which require storage atvery low temperatures (-20 degrees for Modern and -70 degrees for Pfizer).

 Iconovo’s/ISR’s vaccine is a subunit vaccine

There is also another type of vaccine technology called subunit vaccine, which means that the vaccinecontains certain harmless parts of the virus. The US company Novavax is developing the subunit vaccine NVX-CoV2373 containing the spike protein located on the surface of the SARS-CoV-2 virus that is synthetically produced and not taken directly from the virus.

In June, Novavax presented positive results from a phase III study showing that the company’s vaccine candidate has 90.4 per cent efficacy, and that it has a 100 per cent protection against severe and moderate Covid-19.

The Covid-19 vaccine developed by Iconovo and ISR is similar to Novavax’s vaccine technology, with the difference being that it is inhaled instead of injected.

Respiratory tract and lungs – the virus’s doorway into the body   

The nose, airways and lungs are the most common entryways to the body for SARS-CoV-2 and other respiratory viruses. Iconovo/ISR want to take advantage of this fact by generating protection against the virus already in the lungs with the inhalation vaccine.

However, Iconovo and ISR are not alone in researching the opportunity to develop an inhalable Covid-19 vaccine. The Chinese company CanSino Biologics also has an inhalable Covid-19 vaccine under development. CanSino Biologics believes that an inhaled variant may be more effective than in injection form, as the inhaled vaccine also activates antibodies and T-cells in the airways, according to Pharmaceutical Technology.

There are also a number of companies and researchers who want to develop nasal spray Covid-19 vaccines, such as AstraZeneca and the University of Helsinki and the University of Eastern Finland. Finnish researchers believe that a Covid-19 vaccine in this form can create immunity to the virus in the mucous membranes of the upper respiratory tract and nose, which can stop the virus at an early stage.

Great future potential for inhaled vaccines 

ISR has previously shown in mouse studies that the Covid-19 vaccine candidate gives good protection against the virus. ISR and Iconovo are now planning to start a clinical trial with the inhalable Covid-19 vaccine using ICOone during the second half of 2021. The goal is to take rapid steps in the development in order to reach the market as quickly as possible and take a strong position in the ongoing race for vaccine development.

The technology of Inhaled vaccines may also be applicable to other respiratory viruses. ISR has a future option to use its vaccine technology in ICOone to create vaccines against influenza, respiratory syncytial virus and new coronaviruses. According to Iconovo’s CEO Johan Wäborg, there is a huge market potential for inhalation vaccines, an area in which the company is a pioneer in according to a press release regarding the agreement with ISR: 

»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 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 July 6th an article about Iconovo that can be found in its entirety below

Last week Iconovo carried out a directed share issue of 75 MSEK at a subscription price of 70 SEK per share. A large part of the proceeds from the issue will be used to expand the project portfolio in the field of innovative inhalation products and to build up the Nordic sales of pharmaceuticals through the pharmaceutical division Iconovo Pharma. BioStock contacted Iconovo’s CEO Johan Wäborg to find out more about which doors are opened thanks to the directed share issue.

Iconovo develops ready-to-use inhalation products, i.e. inhalers and associated dry powder formulations that are used to develop both generic and innovative inhalation drugs through partnering and licensing agreements. The company currently has four inhalation platforms in its portfolio – ICOres, ICOcap, ICOone and ICOpre.

On Thursday evening last week Iconovo announced that they had completed a directed share issue of 75 MSEK before issue costs. According to Iconovo, the issue was carried out to enable continued high pace in the company’s development and initiatives connected to their long-term strategy consisting of three focus areas:

  • Own sales of generic inhalation products in the Nordics
  • Development of innovative inhalation products
  • Development of generic inhalation products.

Read more about Iconovo’s long-term strategy in the financial targets for 2026

New and existing owners subscribed to the issue

The directed share issue was carried out at a subscription price of 70 SEK, which was determined through an accelerated bookbuilding procedure. The issue was subscribed to by several new Swedish and international institutional investors, such as Alcur FonderFE Fonder and Humle Fonder, as well as several existing owners, for example Andra AP-fonden, Fjärde AP-fonden, Handelsbanken Fonder and Länsförsäkringar Fondförvaltning.

Investments in innovative inhalation drugs and own sales

Approximately 40 per cent of the issue proceeds are intended to be used to expand the project portfolio within innovative inhalation products. An equal share of the proceeds will be used to build and scale up the company’s own sales in the Nordic market via Iconovo Pharma.

Iconovo Pharma is the company’s pharmaceutical division in the Nordic region which was started in connection with Iconovo acquiring the rights from Amneal to sell generic Symbicort in the multi-dose inhaler ICOres on the Nordic market. This was the first building block in creating a portfolio of inhalation products for sale through its own organisation in the Nordic region.

The remaining share of the proceeds, approximately 20 per cent, will be used to increase the company’s project capacity and thereby reduce the risk in the portfolio and increase the likelihood of launch of additional products to the market. In addition, it will be used to strengthen the commercialisation efforts connected to Iconovo’s three strategic focus areas.

Johan Wäborg, CEO Iconovo

Iconovo’s CEO comments

BioStock spoke to Iconovo’s CEO Johan Wäborg to find out what the directed share issue means for the company.

 Iconovo’s finances are now strengthened by 75 MSEK before issue costs. Why did you choose to do this right now and why through a directed share issue?

– We see an opportunity to continue to maintain a strong drive and create even greater value for shareholders by both accelerating and increasing the number of projects.

– It was a very good time for us to raise capital. In May, we launched our long-term strategy with three strategic focus areas; Nordic Pharmaceutical Sales, Innovative Inhalation Products and Generic Inhalation Products. We want to invest a significant part of the capital in the great opportunities that we see in innovative inhalation products. In the last six months, we have signed three agreements in this area, and we see great opportunities to reach more customers.

– Funds that specialise in small companies with high growth potential, e.g. Alcur, FE Fonder and Humle, have participated in the directed share issue. The issue was also subscribed to by several of our existing owners – among others AP2, AP4, Länsförsäkringar and Handelsbanken showed their confidence in what Iconovo can achieve with this money.

What opportunities are now opening up for Iconovo through the strengthened financial position?

– The money we had before the issue is sufficient for our communicated generic projects and for the first innovative projects. With the proceeds from this issue, we want to increase capacity and commercialisation and build a portfolio of projects in the strategic area of innovative inhalation products. Capital is also needed to establish Iconovo Pharma and set up a small but efficient sales business for a number of generic products in the Nordic 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.

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