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

Iconovo AB (publ), som utvecklar kompletta inhalationsprodukter för en global marknad, och TOA Pharmaceutical Co., Ltd, som utvecklar generiska produkter för den japanska marknaden, meddelade idag att de har tecknat avtal om att utvärdera en inhalator från Iconovo för en generisk produktutveckling. Avtalet har ett värde på 202 000 euro som ska betalas under de kommande 12 månaderna.

"Vi är mycket glada över att fortsätta samarbetet mellan TOA och Iconovo som inleddes 2017. Slutmålet är att ingå ett licensavtal, att utveckla en inhalerbar generisk produkt till ett läkemedel med betydande försäljning på den japanska marknaden baserad på en inhalator från Iconovo," säger Johan Wäborg, VD för Iconovo.

Om TOA Pharmaceuticals

TOA Pharmaceuticals Co, Ltd baserade i Japan tillverkar och marknadsför läkemedel, kemikalier, sanitetsartiklar och medicintekniska produkter. Företaget har investerat i en produktionsanläggning som specialiserat sig på tillverkning och fyllning av inhalerbara läkemedel samt tillverkning av substanser som används inom inhalation. http://www.toayakuhin.co.jp/english/top.html

At the Annual General Meeting of 8 May 2020, it was resolved that Iconovo shall have a Nomination Committee consisting of four members representing the four largest shareholders as of 30 September each year.

The Nomination Committee for the 2022 Annual General Meetings consists of:

Mats Johansson, appointed by Mats Johansson and holding company, and Chairman of the Nomination Committee

Karin von Wachenfeldt, appointed by Lastow Consulting AB;

Stefan Berger, appointed by Eiffel Investment Group;

Sussi Kvart, appointed by Handelsbanken Fonder

Participates as co-opted;

Gunnar Gårdemyr, Chairman of the Board

The Nomination Committee’s overarching responsibility for the 2022 Annual General Meeting is to present suitable candidates for the positions of Board Chair, Board members and auditor(s) of the Company, and to propose their remuneration.

The Nomination Committee shall prepare proposals in the following matters to be submitted to the Annual General Meeting for decision:

proposal for Chair of the AGM,

proposal for the number of AGM-elected Board members and, where applicable, number of auditors,

proposal for remuneration to non-employed members of the Board and to non-employed members of the various committees of the Board,

proposal for remuneration to the auditors,

proposals for election of Board Chair, other members of the Board and, where applicable, auditors,

proposals for guidelines for appointing members to the Nomination Committee and for the Nomination Committee’s assignments,

proposal for remuneration to the members of the Nomination Committee.

 

Shareholders who wish to submit proposals to the Nomination Committee can contact the Nomination Committee by email at gunnar.gardemyr@gmail.com.

In order for the Nomination Committee to process received proposals with sufficient care, these should be received by the Nomination Committee by 1 March 2022.

Vid årsstämman den 8 maj 2020 beslutades att Iconovo ska ha en valberedning som ska bestå av fyra ledamöter representerande de fyra största aktieägarna per den siste september varje år.

Valberedningen inför årsstämman 2022 består av:

Mats Johansson, utsedd av Mats Johansson och bolag, och valberedningens ordförande

Karin von Wachenfeldt, utsedd av Lastow Consulting AB;

Stefan Berger, utsedd av Eiffel Investment Group;

Sussi Kvart, utsedd av Handelsbanken Fonder

Deltar som adjungerad;

Gunnar Gårdemyr, styrelsens ordförande

Valberedningens övergripande ansvar inför årsstämman 2022 är att presentera lämpliga kandidater för ordförande respektive styrelseledamöter och revisor(er) i Bolaget, samt att föreslå deras arvodering.

Valberedningen ska arbeta fram förslag i nedanstående frågor att föreläggas årsstämman för beslut:

förslag till ordförande vid stämman,

förslag till antalet bolagsstämmovalda styrelseledamöter samt, i förekommande fall, antalet revisorer,

förslag till arvode till icke anställda ledamöter i styrelsen samt till icke anställda ledamöter i styrelsens olika utskott,

förslag till arvode för revisorerna,

förslag till val av styrelsens ordförande och övriga styrelseledamöter samt, i förekommande fall, val av revisorer,

förslag till riktlinjer för att utse ledamöter i valberedningen och för valberedningens uppdrag,

förslag till arvode till valberedningens ledamöter.

 

Aktieägare som önskar lämna förslag till valberedningen kan vända sig till valberedningen per e-post på adress: gunnar.gardemyr@gmail.com.

För att valberedningen skall kunna behandla inkomna förslag med tillräcklig omsorg bör dessa vara valberedningen tillhanda senast den 1 mars 2022.

Iconovo AB (publ) meddelar att den kinesiska patentmyndigheten har informerat att de avser att godkänna (Notice of Allowance) ett patent avseende Iconovos inhalatorplattform ICOone.

Iconovo har sedan tidigare godkända patent på ICOone i Sverige, Europa (EPO), USA samt Indien. Patentet beskriver den endos-inhalator som används i Iconovos två innovativa kundprojekt med Oxytocin och Covid-19 vaccin.

ICOone är Iconovos plattform för administrering av vacciner och bio-molekyler på ett mycket enkelt och kostnadseffektivt sätt. Eftersom ICOone innehåller läkemedlet som ett torrt pulver, krävs ingen dyr och komplicerad kylförvaring. Med ICOone inhaleras läkemedlet och man undviker på detta sätt hantering av engångssprutor och begagnade kanyler som kan sprida blodsmitta.

”Det nya patentet stärker vårt internationella skydd för ICOone. Kina är en mycket viktig marknad för enkel och kostnadseffektiv vaccinering”, säger Dr. Orest Lastow, CTO på Iconovo.

Om ICOone® 
ICOone är en unik och patenterad torrpulverinhalator avsedd för engångsbruk. Den smarta konstruktionen ger en ultralåg tillverkningskostnad kombinerad med en enkel och diskret användning. Den är speciellt lämplig för korttidsbehandlingar och sällandoserings-behandlingar då den ger en oöverträffat låg behandlingskostnad och prispunkt för behandlingar med få doser. Den enkla konstruktionen gör också att patienter och behandlare kan lära sig hantera inhalatorn med minimal träning. ICOone kan leverera stora inhalationsdoser som är väl fuktskyddade, vilket är viktigt för många biomolekyler. 
 
 
https://iconovo.se/products/icoone/ 
 

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

**Number of agreements at the end of the period.

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

Mats Johansson, styrelseledamot och den enskilt störste ägaren i Iconovo AB (publ), har förvärvat 5 000 aktier för totalt 414 000 SEK.

Efter förvärvet uppgår Mats Johanssons innehav till 955 000 aktier som ägs både privat och via bolag, dessa motsvar 10,8% av aktierna i bolaget.
 

Iconovo AB (publ), that develops complete inhalation products for a global market today announces 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.

Iconovo AB (publ), som idag utvecklar kompletta inhalationsprodukter för en global marknad, meddelar att företagets kvalitetssystem (QMS) har uppgraderats för att uppfylla USA:s Quality System Regulation (QSR 21 CFR 820) för medicintekniska produkter. Företagets utvecklings- och dokumentationsprocess måste följa denna FDA-förordning för att möjliggöra registrering och marknadsföring av medicintekniska produkter i USA.

Uppgraderingen är ett avgörande steg för att få framtida amerikanskt marknadstillträde för alla Iconovo-kombinationsprodukter för läkemedel, inklusive ICOres, ICOpre, ICOone och ICOcap.

Sedan år 2020 uppfyller Iconovo QMS kraven i den internationella standarden ISO 13485: 2016 för medicintekniska produkter. Därmed uppfyller QMS även EU:s förordning MDR för medicintekniska produkter. Detta har gjort det möjligt för Iconovo att utveckla kombinationsprodukter för läkemedel som är redo för registrering på den europeiska marknaden.

”Iconovo har globala ambitioner för våra inhalationsplattformar och USA är den största läkemedelsmarknaden i världen. Att uppfylla även det amerikanska regelverket gynnar våra pågående projekt, och kommer att öppna upp ännu fler möjligheter i vårt kund- och affärsutvecklingsarbete”, säger Johan Wäborg, VD för Iconovo.