Iconovo AB (publ), that develops complete inhalation products for a global market, and TOA Pharmaceutical Co., Ltd, which develops generic products for the Japanese market announced today that they have signed a feasibility agreement to use an inhaler from Iconovo for a generic product development. The feasibility agreement has a value of EUR 202.000 to be paid over the coming 12 months.

“We are very happy to continue the collaboration between TOA and Iconovo that was started in 2017. The end goal is to enter a license agreement to develop an inhaled generic product to a pharmaceutical product with significant sales in the Japanese market based on an inhaler from Iconovo,” said Johan Wäborg, CEO of Iconovo.

About TOA Pharmaceuticals

TOA Pharmaceuticals Co., Ltd. based in Japan manufactures and markets pharmaceuticals, chemicals, sanitary ware and medical devices. The company has invested in a production facility specializing in the manufacture and filling of inhalable drugs as well as manufacture of substances used in inhalers. http://www.toayakuhin.co.jp/english/top.html

The Chinese Patent Office has announced the intention to grant a patent (Notice of Allowance) regarding Iconovo’s inhalation device ICOone.

Iconovo has previously granted ICOone patents in Sweden, Europe (EPO), USA and India. The new patent covers a unit dose inhaler used in Iconovo’s two innovative customer projects with Oxytocin and Covid-19 vaccine.

ICOone® is Iconovo’s platform for simple and cost-efficient delivery of vaccines and biomolecules to the lung. Since ICOone® delivers a dry powder, there is no need for expensive and complicated cold storage. Inhaling the drug eliminates the use of disposable syringes and no hazardous waste with blood contaminated syringes is generated.

”This patent strengthens our international patent protection of ICOone. China is a very important market for simple and cost-effective vaccination”, says CTO Dr. Orest Lastow.

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.

https://iconovo.se/products/icoone/ 

New nasal inhaler has great potential in treatment of COVID-19

Key figures in TSEK unless otherwise indicated  Jul-Sep 2021 Jul-Sep 2020 Jan-Sep 2021 Jan-Sep 2020 Jan-Dec 2020
Net turnover 6,169 5,754 11,809 10,111 17,792
Operating profit/loss -3,895 -2,304 -17,807 -13,104 -16,717
Cash flow for the period 60,741 -3,640 45,308 -17,069 -27,467
Earnings per share (SEK) before and after full dilution -0.43 -0.25 -2.15 -1.62 -2.20
Cash and cash equivalents 106,997 72,087 106,997 72,087 61,689
Equity 145,667 97,245 145,667 97,245 92,729
Number of shares at period-end 8,847,500 7,776,000 8,847,500 7,776,000 7,776,000
Number of royalty agreements** 6 4 6 4 5

Significant events 1 July – 30 September

  • In July, Iconovo carried out a directed share issue and raised SEK 75 million before issue expenses. The issue has been subscribed by a number of Swedish and international institutional investors, including Alcur Fonder, FE Fonder and Humle Fonder, as well as a number of existing shareholders, including Andra AP-fonden, Fjärde AP-fonden, Handelsbanken Fonder and Länsförsäkringar Fonder. The proceeds of the issue will primarily be used for acceleration and value creation activities and investments linked to the Company’s long-term strategy.
  • In July, Iconovo entered into an agreement with ISR (Immune System Regulation AB) for additional work on the ongoing inhaled COVID-19 vaccine project for the development of a nasal version of Iconovo’s ICOone inhaler. The additional work could provide up to SEK 4.9 million on top of the previous agreement. In addition, there is the possibility of future royalties.
  • The Japan Patent Office issued an Intention to Grant notification regarding a patent for the ICOres inhalation platform. Iconovo already has approved patents for ICOres in Japan, Sweden, Europe (EPO) and the USA. The patent describes the technology used in Iconovo’s many customer projects, including generic Symbicort.
  • Iconovo’s Quality Management System (QMS) has been upgraded to comply with the US Quality System Regulation for medical devices. The upgrade is a critical step in gaining access to the US market for Iconovo’s pharmaceutical products.

Significant events after the end of the third quarter
No significant events have occurred since the end of the quarter.

A word from the CEO – More innovative deals through increased focus on business development

New nasal development for ICOone
Iconovo’s inhalation expertise and vast experience in the development of inhalation products for the lungs has been used to develop a new version of ICOone for nasal use. With this product, the Company entered into a further agreement with ISR in July on the use of a new version of ICOone adapted for nasal delivery of powder. Starting with this agreement, a parallel track will be opened up in the development of a powder vaccine against COVID-19. Nasal delivery enables faster progression through the study programme, which is one of the key components of the project. There will be an enormous need for vaccination for a long time to come, especially in developing countries, where liquid-based vaccines requiring cold storage are not a sustainable solution. It is very gratifying to see our partner ISR moving forward and making the plans concrete. In recent months, they have inter alia released a press release to announce that they have entered into an agreement with Northway Biotech for large-scale production of the spike protein to be used. An agreement has also been entered into with a clinical investigator in Bangladesh to start a phase 1 study.

The ISR agreement for ICOone Nasal has enabled us to kick-start our nasal version of ICOone. ICOone Nasal will be a unique inhaler based on the same innovative concept as ICOone. We can now offer the world’s first inhalation-driven, single-use inhaler for nasal powder with high performance, with a production cost that is very difficult to beat. ICOone Nasal is developed according to the same technical principles as its sibling ICOone. The technical solution is patent protected.
There is a very high demand for nasal powder delivery among several companies, all of which are looking for a smart, cost-effective solution.

In Q4, we will initiate a major marketing initiative to find suitable innovative customer projects for ICOone Nasal.

ICOpre progressing as planned
The goal for 2021 is to be able to present an ICOpre inhaler with all parts in injection-moulded plastic. Proprietary generic formulations of Relvar®, Anoro®, Trelegy®, Incruse® and Arnuity® will be tested. Once the goal is reached, we will intensify dialogues with potential customers.

Increasing our commercial efforts
A strong cash position enables additional efforts and drive behind each of our three strategies. The capital raising of SEK 75 million completed in July now enables us, among other things, to invest more heavily in business development. We aim to build a strong and well differentiated portfolio of both Generic and Innovative inhalation drugs, and have the ambition to enter into one to three new deals per year.

We are building for success by now starting recruitment and strengthening the organisation with two additional key positions, a Director Business Development and a Communications & Marketing Manager.

We recently launched a major continuous marketing effort that will target our identified customer groups using modern technology in various campaigns.

It will be an exciting and intense end to the year, with continued focus on delivering success for existing projects and securing new agreements.

Johan Wäborg, CEO

 

 

Iconovo will participate at Bio-Europe Digital, an online event that will be held 25-28 October. Here we will present ICOone – our disposable single-dose dry powder inhaler for short-term treatments.

We hope to see you at Bio-Europe Digital, please make sure to book a meeting with us to discuss innovative inhalation solutions.

Book a meeting with us at Bio-Europe Digital >>

BBC, and a line of other media channels, has acknowledged Iconovo and its groundbreaking work with immunotherapy company ISR for the development of inhaled and nasal Covid-19 vaccines. Iconovo will develop the dry-powder formulation of the vaccine for ISR, which will be distributed with Iconovo’s single-use inhaler ICOone.

An inhaled Covid-19 vaccine will have several benefits, such as not requiring medical competence to administer, nor a cooling chain. Read more through the following links:

BBC article
https://www.bbc.com/news/health-57553602

Läkemedelsvärlden article
https://www.lakemedelsvarlden.se/vilka-covid-19-vaccin-kommer-vi-ha-i-framtiden/

Swedish TV4 news feature
https://www.tv4.se/artikel/6Kl39r6VPM2RsPuZcKDMRn/haer-aer-nya-vacciniden-pulver

Iconovo will participate at the CPhI event in Milan Italy, 9-11 November 2021. Here thousands of pharma suppliers and buyers unite, connect and do business. If you don’t have the possibility to travel to Milan, you can also experience the event online between 25 October to 19 November.

We hope to see you in Milan, please make sure to book a personal meeting with us to discuss innovative inhalation.

Book a meeting with us at CPhI:


Roger Lassing

Mail: roger.lassing@iconovo.se


Måns Österberg Widerstrand

Mail: mans.osterberg@iconovo.se

Iconovo has developed a new and innovative dry powder inhaler platform – ICOpre – aimed for a global market. ICOpre is a pre-metered dry powder inhaler for simple, once-daily treatment, containing 30 individually sealed doses.

Hear dr Orest Lastow, founder and CTO at Iconovo, tell the story about the development process and business opportunities ICOpre enables.

Biostock published September 24th an article about Iconovo that can be found in its entirety below

One of Iconovo’s goals is to launch future inhalation products in the US, the world’s largest pharmaceutical market. The company has several products in the pipeline directed towards this ambition, including the generic versions of GSK’s Ellipta portfolio in ICOpre and AstraZeneca’s Symbicort in ICOres. There are also significant opportunities in the US for the development projects in the business area that Iconovo calls innovative inhalation products. On Monday, the news came that the company’s quality system (QMS) meets the requirements set by the FDA’s Quality System Regulation, which is a prerequisite for launching inhalation products on the US market.

Iconovo develops complete inhalation products, i.e. inhalers and associated drug preparation. The company’s product portfolio includes four inhalation platforms – ICOres, ICOcap, ICOone and ICOpre – that are licensed to customers for the development and sale of generic and innovative inhalation products.

Upcoming launches on the growing US market

Iconovo has several ongoing customer projects with planned launches in the coming years and with some of the products it aims for the valuable US market. Total sales of inhalation products in the US are expected to grow over the next few years, partly due to an increased prevalence of respiratory diseases, an increasing geriatric population, and favourable reimbursement models.

Generic Relvar in ICOpre with significant sales potential

Iconovo plans to launch a generic version of GlaxoSmithKline’s Relvar Ellipta in ICOpre in the US after the patent for the pharmaceutical substance expires in 2025.

ICOpre, Iconovo’s latest major investment, is a pre-filled inhaler with 30 doses that are individually sealed. The company’s plan is to develop five dry powder formulations for ICOpre in order to offer generic versions of GSK’s Ellipta portfolio for the treatment of COPD and asthma. The Ellipta portfolio consists of five products that had total sales of 3.5 billion USD in 2020. The sales are expected to increase to 4.9 billion USD by 2025, and the products are likely to dominate the inhalation market over the next 10 years. Iconovo has opened up the possibility to take advantage of this market space through the development of ICOpre.

According to Iconovo, a market share of 10-15 per cent volume at a 25 per cent discounted price would give a sales potential of 100-150 million USD for Relvar Ellipta alone. The big launch awaits in 2030 when Iconovo plans to launch a generic Trelegy Ellipta.

US included in the extended license agreement with Amneal

Within the same time frame as Relvar, there are also plans to launch a generic Symbicort in ICOres in collaboration with the US pharmaceutical company Amneal. The original agreement with Amneal covered sales in Europe, but also Canada, Australia, Russia and some smaller emerging markets. In May, the contract was extended to the US and China, thus covering about 90 per cent of the total global Symbicort market, of which about a third is US sales.

Iconovo believes that the agreement with Amneal can generate future annual royalty revenues of 110–220 million SEK. The project is in the final phase, and Amneal has begun the set-up of commercial manufacturing.

Potential in the US in new business area

Iconovo now has three collaborations in a relatively new business area that they have chosen to call innovative inhalation products. The strategic area was initiated at the end of 2020 in connection with the signing of a license agreement with Monash University for the development of inhaled oxytocin in ICOone in maternal health. Since then, Iconovo has also entered into a license agreement with ISR Immune System Regulation for the development of inhaled Covid-19 vaccine in ICOone, as well as a development agreement with Swedish Respiratorius for the development of a new drug for COPD and asthma.

The Monash University and ISR projects initially target developing countries where there is a great need for such products, but the US may also become relevant in the future. According to Roger Lassing, Iconovo’s Vice President Business Development, the market for innovative products is large in the US due to higher prices and faster acceptance of innovative products compared to other countries.

Progress in quality work

In order to launch in the US, Iconovo must comply with the requirements of FDA regulations for medical devices. As part of this, Iconovo announced on Monday that the company’s quality system has been upgraded to meet the requirements of the Quality System Regulation (QSR 21 CFR 82), which will benefit the company’s development projects and ambitions to reach the US market according to CEO Johan Wäborg:

»Iconovo have global ambitions for our inhalation platforms and US is the biggest pharma market in the world. Compliance with the US regulations is a key component to advance existing projects and will unlock even more opportunity in our partnering and business development process.«

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.

Iconovo AB (publ), that develops complete inhalation products for a global market today annonces that the company´s Quality Management System (QMS) has been upgraded to meet the US Quality System Regulation (QSR 21 CFR 820) for medical devices. The company´s development and documentation process must comply with this FDA regulation to enable registration and marketing of medical device products in the US.

This achievement is a crucial step to obtain future US market access for all Iconovo drug device combination products including ICOres, ICOpre, ICOone and ICOcap.

In 2020, Iconovo’s QMS became compliant with the international ISO 13485:2016 standard for medical devices. Thus, the QMS also complies with the EU Medical Device Regulation. This has enabled Iconovo to develop drug device combination products that will be ready for registration on the European market.

“Iconovo have global ambitions for our inhalation platforms and US is the biggest pharma market in the world. Compliance with the US regulations is a key component to advance existing projects and will unlock even more opportunity in our partnering and business development process,” said Johan Wäborg, CEO for Iconovo.

Pareto Securities´12th Annual Healthcare Conference

CEO Johan Wäborg presents Iconovo.