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.

 

 

Dr. Orest Lastow, CTO and Founder

After an unprecedented year in the covid-19 pandemic, the challenges with vaccines requiring cold storage, from refrigeration to ultra-cold storage has become public knowledge. Dr Orest Lastow, founder and CTO of Iconovo AB (publ) that develops complete inhalation products, shares his thinking about a better vaccine solution in MEDTECH Outlook – to inhale a stable dry powder formulation using a single-use inhaler like ICOone from Iconovo.

To read more:
https://www.medicaltechoutlook.com/vp/iconovo/2021_-_search_for_vaccinations_without_cold_storage__/

ICOone has already been selected by Monash University for its suitability as a single-use inhaler of oxytocin replacing injectable oxytocin in resource-constrained countries.


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

United States Patent and Trademark Office has announced the intention to grant a patent (Notice of Allowance) regarding Iconovo’s inhalation device, ICOres.

Iconovo has previously granted ICOres patents in USA, Sweden, Europe (EPO), Japan and China. The new patent covers the technology used in many of Iconovo’s projects like generic Symbicort©.

“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”, says CTO Dr. Orest Lastow.

Contacts


Johan Wäborg, CEO
+46 707 78 51 71
johan.waborg@iconovo.se

Iconovo AB (publ) has appointed dr. Kyrre Thalberg to be Senior Advisor in formulation development.

Dr. Thalberg is an internationally renowned expert in development of dry powder formulations for inhalation. Over close to 30 years, he held many leading roles in formulation development at AstraZeneca. He has more than 50 academic publications, several patents and has supervised 5 Ph.D. students. He will take an active role in the development of formulations for Iconovo’s new inhalation device ICOpre®. It will mainly be a generic version of Relvar© Ellipta©.

“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”, says Johan Wäborg, CEO of Iconovo.

About ICOpre®

ICOpre® is a pre-metered multi-dose inhaler for simple once-daily treatment. It works well with all types of inhalation powders. It has an easy three-step operation; open-inhale-close, like the well-known Ellipta® inhaler from GSK. With 30 aluminum-sealed doses, it provides one month of treatment. Each dose comes from two different cavities that are inhaled simultaneously, making ICOpre suitable for mono, duo and triple products. ICOpre has a precise dose-counter that shows the number of doses remaining. ICOpre is being developed based on a unique principle that will be protected by a number of patents.

https://iconovo.se/products/icopre/

Iconovo AB (publ) has filed two ICOpre® patent applications.

ICOpre® is Iconovo’s new inhalation platform and builds on novel proprietary technology and unique technical solutions. For an innovative company like Iconovo it is paramount to protect its inventions and intellectual property. These two patents are the first step in building a strong patent portfolio around ICOpre. Iconovo has already 84 granted patents and 25 applications covering the other inhalation platforms.

”I am very pleased that ICOpre has reached this very important milestone. A strong protection of our intellectual property has always been Iconovo’s strategy and an absolute requirement from our customers. This is a major step forward in the development of our generic Relvar® ICOpre®”, says CTO Dr. Orest Lastow.

About ICOpre®

ICOpre® is a pre-metered multi-dose inhaler for simple once-daily treatment. It works well with all types of inhalation powders. It has an easy three-step operation; open-inhale-close, like the well-known Ellipta® inhaler from GSK. With 30 aluminum-sealed doses, it provides one month of treatment. Each dose comes from two different cavities that are inhaled simultaneously, making ICOpre suitable for mono, duo and triple products. ICOpre has a precise dose-counter that shows the number of doses remaining. ICOpre is being developed based on a unique principle that will be protected by a number of patents.
https://iconovo.se/products/icopre/

 

Contacts


Johan Wäborg, CEO
+46 707 78 51 71
johan.waborg@iconovo.se

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.

 

Read the article at the Biostock webpage

Lund, December 21, 2020. Iconovo AB (publ) today announced that the company has signed a development agreement with Monash University for the development of inhaled oxytocin in ICOone®. The agreement verifies the suitability of ICOone for use with innovative pharmaceuticals. Monash University’s Institute of Pharmaceutical Sciences (MIPS) is leading the development project supported by a research agreement with Janssen Pharmaceutica N.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, and ongoing support from long term partner GSK.

The agreement gives Monash an exclusive global right to use ICOone with oxytocin to prevent postpartum haemorrhage in women giving birth. The agreement has a staged technology access fee of €900,000 that will be triggered by milestones in the clinical trial stage of the project where the first out of three milestones will be paid as an exercise fee to license the device subject to a positive Phase 1 trial that is planned for 2021. 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 be in the 5 – 10 % range, as previously communicated for similar agreements.

“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,”

said Johan Wäborg, CEO of Iconovo.

“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. We are very pleased that we now have commercial royalty bearing agreements for all Iconovo’s three platforms,” continued Johan Wäborg.

Currently, injectable oxytocin is used to prevent postpartum hemorrhage (PPH) after childbirth. It is recommended by the WHO that women should receive an injected dose of oxytocin during the third stage of labor to prevent PPH. An inhaled formulation can provide important advantages such as ease of use, cheaper transport and storage without cold chain and no handling of used needles and syringes. It is particularly important in parts of the world where infrastructure is less developed, like in rural parts of Africa or Asia. To remove the need for a cold-chain and the management of hazardous waste will be a great cost reduction and potentially help eliminate disease spreading by infected needles. Iconovo estimates that there are 115 million live births in the region of interest, whereof 65 million are in rural areas with the greatest need. Iconovo believes that the product will be used in 15 – 20 % of live births in rural areas. In the future there is a possibility that also other markets like USA and Europe will open for inhaled oxytocin as a safer, non-invasivealternative to injections.

“This is an exciting opportunity to expand this collaboration between industry and academia to develop an important healthcare innovation that aims to address a critical unmet medical need,” said Monash University’s Professor Michelle McIntosh, who has pioneered the inhaled delivery of oxytocin. “There is a massive ripple effect when a mother dies – it’s a very significant burden for these families and communities, and we are committed to bringing gold-standard care to all mothers.”

ICOone is a single-dose inhaler designed for ultra-low manufacturing cost and easy operation. In these areas, ICOone is particularly suitable since it can deliver one dose at a low price-point and with a mode of operation that requires a minimum of training. Therefore, ICOone supports the potential of delivering an inhaled oxytocin product at an affordable price point comparable to other uterotonic options available in low- and middle-income countries.

About PPH

PPH, a condition of excessive blood loss after birth, is the leading cause of maternal mortality globally, resulting in an estimated 60,000 deaths per year, overwhelmingly in resource-limited countries. Most deaths resulting from PPH could be avoided if access to suitable medical innovation were available. It is effectively managed in developed countries using the gold standard therapy, oxytocin, a manufactured form of a natural hormone. Accessibility to quality oxytocin in resource-poor countries is, however, limited as current products are only available in an injectable form requiring supply and storage under refrigerated conditions and trained personnel to administer the product safely.

About ICOone®

ICOone is a unique, patented dry powder inhaler for single use. The smart design generates an ultra-low manufacturing cost combined with simple and discreet use. It is particularly suitable for short-term treatment and as-needed use as it provides an unsurpassed low treatment cost and price point for treatments with a low number of doses. The simple design also enables patients and caregivers to learn how to handle the inhalers with minimal training. ICOone can deliver large inhalation doses that are well protected against moisture, an important factor for many biomolecules.

About Monash University’s Institute of Pharmaceutical Sciences (MIPS)
MIPS has formed an alliance with a number of industry partners, including Janssen Pharmaceutica N.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, and GSK, as well as philanthropic organisations such as the McCall MacBain Foundation, to develop a novel, temperature-stable formulation of oxytocin. The 2020 QS World University Rankings by Subject ranked Monash University number two in the world for Pharmacy and Pharmacology. The University has also retained a long-held position as Australia’s and the Asia-Pacific’s number one University for Pharmacy and Pharmacology, and since the subject rankings were introduced in 2011 has consistently ranked in the most elite group of Pharmacy and Pharmacology programs worldwide with an average top ten ranking.

For further information, please visit https://www.monash.edu/pharm/research

Contacts

Johan Wäborg, CEO
+46 707 78 51 71
johan.waborg@iconovo.se

About Iconovo

Iconovo was founded in 2013 by people with long experience in inhalation development. The company develops inhalers and associated drug preparations that are used to treat asthma and COPD. However, Iconovo also has the competence to develop products for new types of inhaled drugs such as vaccines.

By working with Iconovo, pharmaceutical companies and generic companies can access a complete pharmaceutical product, thereby eliminating the complex and costly early stages of the development phase. Iconovo licenses its patented products to customers and offers a faster way to the inhalation market with lower risk and at a lower cost.

More information about the company can be found at www.iconovo.se.

Iconovo is based in Lund and its share (ticker ICO) is listed on Nasdaq First North Growth Market, Stockholm since April 6, 2018. The Company’s Certified Adviser is Erik Penser Bank AB, Box 7405, SE-103 91 Stockholm, phone +46 8 463 80 00, email: certifiedadviser@penser.se.

This information is information that Iconovo is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2020-12-21 07:30 CET.

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