Significant successes for ICOres and ICOone

Significant events 1 January – 31 March

  • Iconovo is expanding its collaboration with the immunotherapy company Immune System Regulation AB (ISR), which is now accelerating the development of an inhalable COVID-19 vaccine. The expansion increases the contract value of the collaboration by nearly SEK 13.6 million. Iconovo is also entitled to low single-digit royalties on sales of the finished product.
  • Iconovo has announced that a pilot clinical pharmacokinetic study, conducted by Amneal Pharmaceuticals, has been completed. The study has provided valuable information that supports the continued development of ICOres budesonide/formoterol as a potential replacement product for Symbicort.

Significant events after the end of the first quarter

  • No significant events have occurred since the end of the quarter.
Key figures for the Group, in TSEK unless otherwise indicated  Jan-Mar 2022 Jan-Mar 2021* Jan-Dec 2021*
Net turnover 2,766 2,145 15,409
Operating profit/loss -9,462 -7,325 -26,513
Cash flow for the period -15,540 -8,521 33,348
Earnings per share (SEK) before and after full dilution -1.05 -0.91 -3.15
Cash and cash equivalents 79,497 53,168 95,037
Equity 127,882 85,651 137,034
Number of shares at period-end 8,847,500 7,776,000 8,847,500
No. of licensing agreements (royalty)** 6 6 6
No. of feasibility agreements** 2 0 2

*Refers to the figures of the parent company, as there were none for the Group at this time point.
**Number of agreements at the end of the period.

A WORD FROM THE CEO

Strong interest in working with Iconovo

The first quarter of the year saw progress in both the originator drugs area and in generics development, while work was continued to establish the Iconovo Pharma subsidiary ahead of the potential launch of our first own-label product in the Nordic region. This quarterly report is the first to be prepared in accordance with the International Financial Reporting Standards (IFRS), a natural transition in light of the company's increasing maturity.

Expanded collaboration with ISR on the development of ICOone

At the end of March, we expanded our collaboration with the immunotherapy company Immune System Regulation (ISR), which is now accelerating the development of an inhalable COVID-19 vaccine using two different variants of our unique ICOone inhaler – one for administration to the lungs and one for inhalation via the nose. The supplementary agreement increases the contract value of the collaboration by nearly SEK 13.6 million. Iconovo is also entitled to low single-digit royalties on sales of the finished product.

During the COVID-19 pandemic, it has become clear that vaccines need to be administered in more ways than by injection, and the benefits of delivering treatment via the nose and airways are obvious. The practical handling of vaccines in dry powder form is very simple; no refrigerated transport is required and the vaccine can be administered without injection. ICOone and ICOone Nasal open up completely new possibilities for simplified mass vaccination, especially in countries with limited access to qualified healthcare personnel and well-functioning logistics chains. Nasal inhalation has the advantage that the immune system is triggered by the first contact of the vaccine with the nasal mucosa and the lungs.

Completed pilot study of ICOres budesonide/formoterol

ICOres budesonide/formoterol is being developed under a licensing agreement with Amneal Pharmaceuticals as a generic version of Symbicort Turbuhaler, a well-established treatment for asthma and COPD with sales of approximately USD 2.7 billion. Amneal holds the global rights to ICOres budesonide/formoterol, but Iconovo has the option to market the product in the Nordic region following regulatory approval.

A previous clinical pharmacokinetic study showed that ICOres worked as intended when used in clinical practice. The aim of the second pilot study, which was completed in the first quarter of 2022, was to further compare the pharmacokinetic properties between ICOres budesonide/formoterol and Symbicort Turbuhaler. Two batches of ICOres budesonide/formoterol and one batch of Symbicort Turbuhaler were investigated in 30 healthy subjects.

The relative bioavailability results support further development of ICOres budesonide/formoterol, and provide valuable information to optimise the product for the next study. The development programme is progressing according to plan, with the aim of submitting an application for marketing authorisation in the EU in 2023. This would allow for a product launch in 2024.

In place in new premises

In March, we inaugurated our new premises in Ideon Science Park in Lund. The move meant not only that we now have all our functions under one roof, but also that we have access to even more purpose-built laboratories. We are now able to house the new employees we plan to recruit in the coming years, as the company continues its journey of growth.

A stable position for our continued value creation

Iconovo’s cash position at the end of the quarter was approximately SEK 80 million, providing a stable base for continued investment in product development, the establishment of new commercial cooperation agreements, and the building of our own marketing organisation in the Nordic region. We have already established eight commercial cooperation agreements, and the goal is to sign two to three new agreements per year. The basis for value creation is our proprietary and patent-protected inhalers, and I can say that there is great interest in collaborating with Iconovo from both originator and generic drug companies around the world. We are now moving forward to continue to support our existing partners and establish more revenue-generating collaborations.

Johan Wäborg
CEO

Iconovo AB (publ), som utvecklar kompletta inhalationsprodukter för en global marknad, har inlett ett strategiskt samarbete med Galenica AB – ett företag specialiserat på utveckling och tillverkning av läkemedel för kliniska studier. Samarbetet syftar främst till att underlätta produktionen av kliniskt prövningsmaterial för bolag som utvecklar nya läkemedel med hjälp av Iconovos innovativa engångsinhalator ICOone.

Innovativa inhalatorer är en förutsättning för att framtidens läkemedel mot sjukdomar i luftvägar och lungor ska komma till sin fulla rätt. Även andra typer av läkemedel och vacciner kan med fördel administreras via inhalatorer, inte minst biologiska läkemedel som annars måste ges som injektion, vilket i sin tur medför krav på sterilitet och ofta även kylförvaring. För att utveckla kompletta inhalationsprodukter krävs dock både en teknologisk plattform och formuleringsexpertis, något som de flesta forskande läkemedelsbolag saknar, men som Iconovo kan erbjuda. Det kan även vara en utmaning för läkemedelsföretag att ta fram det material som behövs för att kunna påbörja de första kliniska studierna. Iconovo investerar nu i en lösning, där utrustning placeras hos Galenica, för att standardisera processerna för tillverkning av kliniskt prövningsmaterial i GMP-miljö. Standardiserade processer och etablerade samarbetsformer kommer att korta tiden för tillverkning av kliniskt prövningsmaterial och underlätta tekniköverföring till kundens produktionsanläggning. Att båda företagen ligger i Malmö-Lund-området är en stor fördel då tekniköverföring kan effektiviseras avsevärt genom ett nära samarbete. Fokus kommer att ligga på kunder som utvecklar nya originalläkemedel och vill använda Iconovos innovativa engångsinhalator ICOone.

”Samarbetet med Galenica sker som ett led i vår satsning på att bredda användningen av ICOone bland internationella läkemedelsbolag som utvecklar nya originalläkemedel. Vi får nu ett ännu mer attraktivt och komplett kunderbjudande genom att kunna erbjuda företag en färdig produkt att ta in i tidiga kliniska prövningar”, säger Johan Wäborg, vd för Iconovo.

Genom ett tätt samarbete mellan Iconovo och Galenica blir samarbetet med Iconovos kunder mer sömlöst och slot-tider för tillverkning kan planeras med korta ledtider. Inom ramen för samarbetet kommer Galenica ansvara för att förberedelserna inför varje enskilt kundprojekt är så effektiva som möjligt, exempelvis genom att på förhand säkra tillgång till såväl kvalificerad utrustning som godkända råvaruleverantörer.

”Det är glädjande att vi genom samarbetet med Iconovo nu kan erbjuda fler kunder vår kompetens inom inhalation. Genom ett nära samarbete med Iconovo kan kunden snabbare och mer friktionsfritt få tillgång till en utveckling i världsklass inom inhalation vilket gynnar framtagning av nya behandlingar som därmed snabbare kan komma patienterna till gagn”, säger Ronnie Wallin, vd för Galenica.

Planen är att tillverkningsutrustningen ska vara implementerad och tas i drift i augusti 2022.

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.

Om Galenica AB
Galenica AB grundades 1999 och finns på Medeon Science Park i Malmö. Verksamheten omfattar utveckling och tillverkning av nya läkemedel både i egen regi och för kunders räkning. Ett omfattande arbete bedrivs inom tre olika verksamhetsgrenar – CRO, CMO och Pharma. Inom CRO sker analytisk och farmaceutisk utveckling i pre-klinisk och klinisk fas, såväl som tillverkning och kvalitetskontroll av prövningsläkemedel. Inom CMO sker småskalig kommersiell läkemedelsproduktion. I den tredje verksamhetsgrenen, Pharma, finns bolagets patenterade läkemedel Ovixan®, en receptförskriven kräm mot psoriasis och eksem. Ovixan® är marknadsledande i Norden och säljs även på ett flertal utomnordiska marknader. 2018 lanserades Oviderm®, en mjukgörande kräm som används för att behandla torr hud hos vuxna, ungdomar och barn. Sedan 2021 bedriver Galenica även licensförsäljning av läkemedlet Ameluz, som behandlar aktinisk keratos, i Norden.

Iconovo AB (publ), that develops complete inhalation products for a global market, has entered into a strategic collaboration with Galenica AB – a company specializing in the development and manufacture of pharmaceuticals for clinical studies. The main purpose of the collaboration is to facilitate the manufacturing of clinical trial material for companies developing new drugs for Iconovo's innovative single dose inhaler ICOone.

Innovative inhalers are necessary to bring out the full potential from future medicines for respiratory and lung diseases. Other types of medicines and vaccines can also be administered via inhalers, not least biological drugs that otherwise have to be given as an injection, which comes with requirements for sterility and often also cold storage. The development of complete inhalation products requires both a technology platform and formulation expertise, something that most research-based pharmaceutical companies lack, but which Iconovo can offer. Another challenge for pharmaceutical companies is the manufacturing of the material needed to start the first clinical studies. Iconovo is now investing in a solution, where equipment is placed at Galenica, to standardize the processes for the manufacture of clinical trial material in a GMP environment. Standardized processes and established forms of cooperation will shorten the time for the manufacture of clinical trial material and facilitate technology transfer to the customer's production facility.

Both companies are located in the Malmö-Lund region which is a great advantage as the technology transfer can be significantly streamlined through close cooperation. The focus of the collaboration will be on customers who develop novel pharmaceuticals and want to use Iconovo's innovative disposable inhaler ICOone.

"The collaboration with Galenica is part of our efforts to broaden the use of ICOone among international pharmaceutical companies developing novel medicines. We will have an even more attractive and complete customer offering by being able to provide our customers with a product ready to go into early clinical trials," says Johan Wäborg, CEO of Iconovo.

The process for Iconovo's customers becomes more seamless and slot times for manufacturing can be scheduled with short lead times due to the close collaboration between Iconovo and Galenica. Galenica will be responsible for the efficient preparation of each individual customer project, for example by ensuring prior qualification of equipment and approved raw material suppliers.

"I’m happy that we can offer more customers our expertise in inhalation by collaborating with Iconovo. Through this close cooperation with Iconovo, the customer can quickly and seamlessly access world-class development in inhalation, which benefits the development of novel treatments that can help patients sooner," says Ronnie Wallin, CEO of Galenica.

The plan is for the manufacturing equipment to be implemented and put into operation in August 2022.

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 Galenica AB
Galenica AB was founded in 1999 and is located at Medeon Science Park in Malmö. The business offers development and manufacturing of new pharmaceuticals both in-house and on behalf of customers. Extensive work is carried out in three different branches of activity – CRO, CMO and Pharma. Within CRO, analytical and pharmaceutical development takes place in pre-clinical and clinical phases, as well as manufacturing and quality control of investigational drugs. Small-scale commercial drug manufacturing takes place within CMO. The third branch of operations, Pharma, comprise of the company’s patented Ovixan®, a prescription cream for psoriasis and eczema. Ovixan® is the market leader in the Nordic region and is also sold in several non-Nordic markets. Oviderm® was launched in 2018, a moisturizing cream used to treat dry skin in adults, youth, and children. Galenica has also been conducting license sales of the drug Ameluz since 2021 which treats actinic keratosis in the Nordic region.

Iconovo AB expands its collaboration with immunotherapy company Immune System Regulation (ISR) that accelerates the development of an inhaled vaccine for covid-19. The contract value of the collaboration between ISR and Iconovo increases by 13.6 million SEK. Iconovo is also entitled to low, single-digit royalty on the sale of the finalized product.

The agreement is an expansion of the ongoing collaboration with ISR within Iconovo´s business area for novel pharmaceuticals and vaccines. Iconovo and ISR have been collaborating since April 2021 in developing an inhaled covid-19 vaccine for Iconovo´s innovative single use inhaler ICOone. There are two projects running in parallel: one project is a feasibility study and the other project is for the manufacture of clinical trial material. In July 2021, both projects were extended to cover covid-19 vaccine in a new version of ICOone adapted for nasal inhalation.

ISR is now accelerating the development of an inhaled vaccine and extends the phase 1 clinical trial that has been planned to a combined phase 1 and 2 trial. Four different dose formulations will be evaluated in the new study design and compared to placebo. Around 10 000 doses will be manufactured in total. The project for the manufacture of clinical trial material will be extended from 7.4 MSEK to 21 MSEK.

“The collaboration with ISR has already made great progress and it is gratifying to see the development agreement being further expanded. Once again, Iconovo shows that ICOone is an outstanding inhalation technology that is excellent for use in the administration of vaccines. The new study approach is more ambitious than previously planned and will include comparisons of four different dosage formulations and placebo. Iconovo is well equipped to meet the high quality requirements for clinical trials”, says Iconovo's CEO, Johan Wäborg.

There is a large and growing need to administer treatment via the nose and respiratory system. It has become clear that there is a need for more options to administer vaccines than only by injections during the covid-19 pandemic. Dry powder vaccines are convenient to handle; no refrigerated transport is required, and the vaccine is given without injection. ICOone and ICOone Nasal open up new possibilities for mass vaccination as well as for short-term treatment with pharmaceuticals that normally have to be injected. This is perhaps most important in countries with limited access to qualified healthcare staff and well-functioning distribution. Inhaled vaccines trigger the immune system at its first contact with the nasal and lung mucosa, which is an advantage compared to injected vaccines.

“We are now accelerating the clinical development program for our covid-19 vaccine aiming to give patients a more adequate immune response in the lungs. We are convinced that an inhalable covid-19 vaccine will be of great benefit, both in developing countries where access to refrigeration is limited and as a complement to existing vaccination programs globally”, says Ola Winqvist, CEO of ISR.

About ICOone Nasal

ICOone Nasal is a unique, proprietary nasal inhaler with a very low manufacturing cost. It is suitable for short-term treatments, vaccinations, and on-demand medication as it provides an unsurpassed low treatment cost with many medical and practical benefits. ICOone Nasal is driven by the user's inhalation providing an even and natural distribution of the drug or vaccine in the airways. The drug deposition can be controlled by the size of the particles, to stay in the nose, completely or partially, or transported further down into the airways.

About ISR AB

ISR is an innovation-driven drug development company in the field of immunotherapy. The company’s business concept is to convert preclinical immunological research into clinical trials in order to, with the assistance of a stimulated immune system, fight chronical infections such as HIV, HBV and cancer by developing the company’s pipeline of immunostimulatory immunolides and immunohelines and take advantage of the immune system by developing specifically designed vaccines. The company has its headquarters in Stockholm.

Significant progress in Iconovo’s three strategic business areas

Significant events 1 October – 31 December

  • Iconovo signed an agreement with TOA Pharmaceutical Co, Ltd for the evaluation of an Iconovo inhaler for generic product development. The agreement has a value of SEK 2 million, with potential further development.
  • Iconovo registered its subsidiary Iconovo Pharma AB with the Swedish Companies Registration Office. This is part of the communicated strategy to establish a proprietary pharmaceutical sales infrastructure in the Nordic market. Iconovo’s target is to reach sales revenues totalling
    SEK 200 million by 2026, of which approximately one-third is expected to be generated from Iconovo Pharma.
  • The China National Intellectual Property Administration intends to approve (Notice of Allowance) a patent for the ICOone inhalation platform. Iconovo already has approved patents for ICOone in Sweden, Europe (EPO), the USA and India. The patent describes the single-dose inhaler used in Iconovo’s two innovative customers products with Oxytocin and a COVID-19 vaccine.

Significant events 1 January – 30 September

  • In July, Iconovo carried out a directed share issue and raised SEK 75 million before issue expenses. The issue was 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.
  • The agreement with Amneal for a generic equivalent of Symbicort has been expanded during the year to include the key US and Chinese markets and the Nordic sales rights, more than doubling the potential for future annual royalty income.
  • In May, Iconovo communicated its 5-year business targets at its first Capital Market Day. By 2026, the Company expects to achieve sales of SEK 200 million, with an operating margin of 50%. The Company also announced its long-term strategy, with three strategic areas with the original core operation of generic inhalation product development now supplemented with the new areas of innovative inhalation product development and pharmaceutical sales in the Nordics.
  • In March, Iconovo signed an agreement with ISR (Immune System Regulation AB) for the development of an inhaled COVID-19 vaccine.
  • In July, Iconovo entered into an agreement with ISR 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.
  • In May, Iconovo entered into an agreement with Respiratorius for the development of an inhalation product for the treatment of COPD. The agreement includes a tiered fee for project work, with a total value of up to SEK 3 million.
  • The Board was strengthened at the AGM with the election of Ann Gidner. Gunnar Gårdemyr took over the chairmanship from Mats Johansson, who continues to serve on the Board as a member.
  • The quality system has been upgraded to meet the requirements for medical devices in the USA under the Quality System Regulation. The upgrade is a critical step in gaining access to the US market for Iconovo’s products together with pharmaceuticals.
  • During the year, the Company received notification that the United States Patent and Trademark Office intends to approve (Notice of Allowance) a patent for the ICOres inhalation platform. The Japan Patent Office also intends to approve (Intention to Grant) a patent for the 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. The Company also received notification that the United States Patent and Trademark Office intends to approve (Notice of Allowance) a patent for the ICOone inhalation platform. Iconovo already has approved patents for ICOone in Sweden, Europe (EPO) and India.

Significant events after the end of the fourth quarter

  • Subsequent to the end of the quarter, Iconovo announced the completion of a pilot clinical pharmacokinetic study conducted by Amneal Pharmaceuticals. The study has provided valuable information that supports the continued development of ICOres budesonide/formoterol as a potential replacement product for Symbicort.
Key figures in TSEK unless otherwise indicated  Oct-Dec 2021 Oct-Dec 2020 Jan-Dec 2021 Jan-Dec 2020
Net turnover 3,600 7,681 15,409 17,792
Operating profit/loss -8,706 -3,610 -26,513 -16,717
Cash flow for the period -12,060 -10,398 33,248 -27,467
Earnings per share (SEK) before and after full dilution -0.98 -0.58 -3.15 -2.20
Cash and cash equivalents 94,937 61,689 94,937 61,689
Equity 137,034 92,729 137,034 92,729
Number of shares at period-end 8,847,500 7,776,000 8,847,500 7,776,000
Number of royalty agreements** 6 5 6 5

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

A WORD FROM THE CEO

Our long-term strategy is already yielding good results

Last May, we launched a new long-term strategy for Iconovo based on three business areas – generic inhalation products, innovative inhalation products and Nordic pharmaceutical sales. This strategy is already starting to bear fruit, which is extremely gratifying. Among other things, we have achieved our goals for the development of the ICOpre® inhalation platform, which is based on entirely proprietary technology that does not infringe on the patent protection of GSK’s bestseller Ellipta®, but at the same time provides a user experience that is very similar to Ellipta®. By using ICOpre®, generic companies can start manufacturing, marketing and selling Ellipta-based drugs as soon as patent protection is lost for several of the compounds in best-selling Ellipta-based asthma and COPD products. ICOpre is now ready for the market and we will focus on increasing customer acquisition in this large segment going forward.

Four partner agreements last year
Another key element of our strategy is the goal of signing two to three partner agreements each year. During the year, we were able to sign four. In May, we signed an additional agreement with the generics company Amneal Pharmaceuticals, giving them the right to sell our ICOres-based generic version of Symbicort® also in the US and China, more than doubling the potential for our future annual royalty income to between SEK 110 and 220 million.

In the same month, we signed an agreement with biotech company Respiratorius to develop a dry powder formulation and an inhalation product based on Iconovo’s ICOone® inhaler for use in Phase I clinical trials for Respiratorius’ drug candidate RES030-085. The agreement also involves jointly investigating which of Iconovo’s inhalation platforms is best suited for the commercialisation of Respiratorius’ drug substance. The first part of the agreement is worth approximately SEK 3 million.

Together with the immunotherapy company Immune System Regulation (ISR), we contracted for the development of an inhaled COVID-19 vaccine in Iconovo’s ICOone inhaler and also a nasal version of ICOone. The agreement has a value of SEK 14 million, excluding royalties.

The fourth agreement was signed in November with TOA Pharmaceuticals of Japan for the development of an inhaler for a generic version of a drug with significant sales in the Japanese market.

Proof that our business model works
This is strong proof that our business model and strategy are working, and that our three different areas of activity complement and support each other in a logical and positive way. Based on our proprietary inhalation platforms, we are able to develop inhalation products with international pharmaceutical companies for both generic and innovative drugs that are then sold globally by our partners, but for which we have the option of retaining the rights for the Nordic market. The collaboration with Amneal Pharmaceuticals is an excellent example of this. As we have the rights to sell generic Symbicort in our ICOres® inhaler in the Nordic region, we have the opportunity to work a market with the potential to generate between SEK 80 to 100 million in annual turnover. Additional proof is that during the year we completed a successful share issue that raised SEK 75 million before issue costs, which at the end of the year gave us a strong cash position with SEK 95 million in cash and cash equivalents, compared to SEK 62 million at the end of 2020.

Now we are growing in numbers and strengthening our skills
There is a lot happening in the Company as we continue to deliver on our strategy and attract more and more customers. That is why we are strengthening our skills by recruiting new employees and establishing collaborations with external expertise for e.g. our commercial department, which brings together marketing, communication, business development and the development of established partnerships – all to take on more projects and become a more sales-oriented organisation.

I am also pleased to announce that we will be moving to new premises this spring. For some time now, we have been in a cramped space and even in different buildings. The move, about 500 metres to Ideon Science Park, will take place in March. It will be an incredible boost for us to gather the Company under one roof in facilities and labs that meet the standard we need for the development of inhalation products according to our long-term strategy.

All of this means that we can feel both proud and satisfied with the year that has passed, and approach 2022 with great confidence.

Johan Wäborg, CEO

Iconovo AB (publ), a company developing complete inhalation products for a global market, today announces that a clinical pilot pharmacokinetic study, comparing the pharmacokinetic profile of ICOres budesonide/formoterol and Symbicort® Turbuhaler®, has been successfully concluded. The study, which was carried out by Amneal Pharmaceuticals, has provided valuable data that supports continued development of ICOres budesonide/formoterol as a potential generic substitution of Symbicort® Turbuhaler® for the management of asthma and COPD.

ICOres is an innovative proprietary dry powder inhaler developed by Iconovo. ICOres budesonide/formoterol is being developed by Iconovo under a license agreement with Amneal Pharmaceuticals as a generic version of Symbicort Turbuhaler, a well-established treatment of asthma and COPD with sales of approx. USD 2.7 billion in 2020. Amneal has licensed the global rights to ICOres budesonide/formeterol, and Iconovo intends to market the product in the Nordics following a potential regulatory approval.

The clinical development of ICOres budesonide/formoterol contains a series of pilot pharmacokinetic studies. These studies are carried out sequentially, to optimize the product prior to a final registration study with statistical power to prove bioequivalence with Symbicort Turbuhaler.

In 2020, a first clinical pharmacokinetic study demonstrated that the ICOres dry powder inhaler functioned as intended when used in clinical practice. The objective of the second study, that has now been completed, was to further establish the in vivo and in vitro correlation of the pharmacokinetic properties of ICOres budesonide/formoterol compared to Symbicort Turbuhaler. Two batches of ICOres budesonide/formoterol and one batch of Symbicort Turbuhaler were investigated in a single-dose cross-over design in 30 healthy individuals.

The obtained relative bioavailability results support the continued development of ICOres budesonide/formoterol and provides valuable information that will be used to optimize the product for the next study. The development program is still on track to allow a filing for market approval in the EU during 2023, potentially allowing a product launch in 2024.

“We are pleased to have taken another important step forward in the development of ICOres budesonide/formoterol. Albeit the limited size of this pilot trial, the data gathered is very helpful in the process of optimizing the product. Iconovo is now looking forward to support Amneal in further progressing the development of ICOres budesonide/formoterol,” said Johan Wäborg, CEO Iconovo.

“The results from this pharmacokinetic study have given us valuable information on how to further optimize the product. Amneal is firmly committed to bringing this strategically important and complex generic product to the market as soon as possible. We look forward to completing development, collaborating closely with Iconovo, and ultimately making our product available for patients around the world,” said Gregory Sgammato, Head of Global Corporate Development at Amneal Pharmaceuticals, Inc.

Iconovo AB (publ), ett företag som utvecklar kompletta inhalationsprodukter för en global marknad, meddelar idag att en klinisk farmakokinetisk pilotstudie som jämför ICOres® budesonid/formoterol och Symbicort® Turbuhaler® har slutförts framgångsrikt. Studien, som genomfördes av Amneal Pharmaceuticals, har gett värdefull information som stöder fortsatt utveckling av ICOres budesonide/formoterol som en potentiell generisk ersättningsprodukt för Symbicort® Turbuhaler® vid behandling av astma och KOL.

ICOres är en innovativ egenutvecklad torrpulverinhalator utvecklad av Iconovo. ICOres budesonide/formoterol utvecklas av Iconovo enligt ett licensavtal tecknat med Amneal Pharmaceuticals som en generisk version av Symbicort Turbuhaler, en väletablerad behandling av astma och KOL med en försäljning på cirka USD 2,7 miljarder under 2020. Amneal har licensierat in de globala rättigheterna till ICOres budesonide/formeterol och Iconovo avser att marknadsföra produkten i Norden efter ett möjligt regulatoriskt godkännande.

Den kliniska utvecklingen av ICOres budesonide/formoterol består av ett antal farmakokinetiska pilotstudier. Pilotstudierna utförs sekventiellt för att optimera produkten före en slutlig registreringsstudie med statistisk styrka som avser att visa bioekvivalens med Symbicort Turbuhaler.

En första klinisk farmakokinetisk studie 2020 visade att ICOres torrpulverinhalator fungerade som avsett när den användes i klinisk praxis. Syftet med den andra studien som nu har slutförts, var att ytterligare fastställa in-vivo och in-vitro korrelationen mellan ICOres budesonide/formoterol och Symbicort Turbuhaler angående de farmakokinetiska egenskaperna. Två batcher av ICOres budesonide/formoterol och en batch av Symbicort Turbuhaler undersöktes i en singel-dos cross-over design i 30 friska individer.

Resultatet avseende den relativa biotillgängligheten stöder fortsatt utveckling av ICOres budesonide/formoterol och ger värdefull information för att optimera produkten inför nästa studie. Utvecklingsprogrammet fortgår enligt plan för att en ansökan om marknadsgodkännande i EU ska kunna lämnas in under 2023, vilket skulle möjliggöra en produktlansering 2024.

"Vi är glada över att ha tagit ytterligare ett viktigt steg framåt i utvecklingen av ICOres budesonide/formoterol. Även om denna pilotstudie har en begränsad storlek så ger den viktig information vilket blir till stor hjälp i den fortsatta produktoptimeringen. Iconovo ser fram emot att stödja Amneal i den fortsatta utvecklingen av ICOres budesonide/formoterol," säger Johan Wäborg, VD Iconovo.

"Resultaten från denna farmakokinetiska studie har gett oss värdefull information om hur vi ytterligare optimerar produkten. Amneal är fast beslutet att föra denna strategiskt viktiga och komplexa generiska produkt till marknad så snart som möjligt. Vi ser fram emot att slutföra utvecklingen genom nära samarbete med Iconovo och slutligen göra vår produkt tillgänglig för patienter runt om i världen," säger Gregory Sgammato, chef för Global Corporate Development på Amneal Pharmaceuticals, Inc.

Iconovo AB (publ), som utvecklar kompletta inhalationsprodukter för en global marknad, har registrerat dotterbolaget Iconovo Pharma AB hos Bolagsverket. Detta är ett led i den tidigare kommunicerade strategin att etablera en infrastruktur för läkemedelsförsäljning i egen regi på den nordiska marknaden. Iconovos målsättning är att år 2026 nå försäljningsintäkter om 200 MSEK varav cirka en tredjedel beräknas komma från Iconovo Pharma.

Försäljningen av läkemedel i Norden kommer att bedrivas i dotterbolaget Iconovo Pharma AB eftersom verksamheten skiljer sig från utvecklingen av inhalationsprodukter för den globala marknaden. Genom en separat och dedikerad struktur säkras det fokus som krävs i en effektiv och dynamisk försäljningsorganisation. Rekryteringen av en erfaren ledare för Iconovo Pharma kommer att påbörjas under 2022, och bolaget planerar att därefter successivt anställa den handfull specialiserade medarbetare som bedöms vara tillräcklig för att skapa en slagkraftig bearbetning av den nordiska marknaden.

Läkemedlen som ska ingå i Iconovo Pharmas portfölj förväntas till stor bestå av produkter som för närvarande utvecklas tillsammans med Iconovo AB:s nuvarande globala samarbetspartner. Iconovos globalt etablerade partnernätverk öppnar dessutom möjligheter till effektiv inlicensiering av andra värdeskapande produkter.

Bolaget har genom ett avtal med sin globala partner Amneal redan säkrat de nordiska rättigheterna för en generisk version av astma- och KOL-läkemedlet Symbicort®. Produkten utvecklas i Iconovos inhalator ICOres, vars unika feedbackfunktioner kan innebära betydande fördelar för patienten. Den nordiska marknaden för generiskt Symbicort uppskattas till cirka 900 MSEK.

”Vår ambition är att etablera ett nordiskt läkemedelsbolag med en produktportfölj bestående av utvalda egenutvecklade inhalationsprodukter, där vi redan säkrat rättigheterna till generisk Symbicort i vår unika egenutvecklade inhalator ICOres. Därutöver öppnar vi även upp för licensiering av andra läkemedel med hög kommersiell potential,” säger Johan Wäborg, vd för Iconovo.

Om Iconovo Pharma AB

Iconovo Pharma AB ska bedriva läkemedelsförsäljning i Norden baserat på de produkter som Iconovo AB utvecklar åt globala läkemedelsföretag samt andra läkemedel med hög kommersiell potential. Rättigheterna att sälja den egenutvecklade generiska versionen av Symbicort® i ICOres på de nordiska marknaderna har förvärvats från Iconovos partner Amneal. Detta är den första byggstenen i en portfölj av inhalationsprodukter för egen försäljning i Norden.

Iconovo AB (publ), that develops complete inhalation products for a global market, has registered the subsidiary Iconovo Pharma AB with the Swedish Companies Registration Office. This is part of the previously communicated strategy to establish an infrastructure for in-house pharmaceutical sales in the Nordic market. Iconovo's goal is to reach sales revenues of SEK 200 million by 2026, of which approximately one third is estimated to come from Iconovo Pharma.

The sales of pharmaceuticals in the Nordic region will be conducted in the subsidiary Iconovo Pharma AB as the business differs from the development of inhalation products for the global market. A separate and dedicated structure ensures the necessary focus needed in an efficient and dynamic sales organization. The recruitment of an experienced leader for Iconovo Pharma will begin in 2022, and the company plans to gradually hire the handful of specialized employees needed to promote effectively in the Nordic market.

Iconovo Pharma's product portfolio is expected to consist largely of products that are currently being developed together with Iconovo AB's current global partners. Iconovo's current global partner network will open up opportunities for effective in-licensing of additional value-creating products.

Iconovo has already secured the Nordic rights for a generic version of the asthma and COPD drug Symbicort® through an agreement with its global partner Amneal. The product is developed in Iconovo's inhaler ICOres with unique feedback features that brings significant benefits to the patient. The Nordic market for generic Symbicort is estimated to approximately SEK 900 million.

"Our ambition is to establish a Nordic pharmaceutical company with a product portfolio consisting of selected inhalation products developed by Iconovo, where we have already secured the rights to generic Symbicort in our unique proprietary inhaler ICOres. In addition, we open up for licensing of other medicines with high commercial potential," says Johan Wäborg, CEO of Iconovo.

About Iconovo Pharma AB
Iconovo Pharma AB will sell pharmaceutical products in the Nordic region based on products that Iconovo AB develops for global pharmaceutical companies as well as other medicines with high commercial potential. The rights to sell the proprietary generic version of Symbicort® in ICOres in the Nordic markets have been licensed from Iconovo's partner Amneal. This is the first building block in a portfolio of inhalation products to be sold in the Nordic region.

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://www.iconovo.se/products/icoone/