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

Iconovo kommer under kvartalet att delta på följande events och där presentera bolaget.

Aktiespararna – Aktiedagen Lund

Presentation Iconovo Onsdag 27 januari kl. 10.15-10.45

Datum: 27 och 28 januari 2021
Tid: 08.00-21.00
Plats: Digital, livestreaming via webb

Anmälningar via Hemsida/website: https://www.aktiespararna.se/aktiviteter/aktiedagen-lund-digitalt
Vi streamar live och on demand via Aktiespararnas YouTube-kanal samt via aktiespararna.se

Swiss Nordic Bio

Datum: 10 och 11 februari 2021
Tid: 09.00-18.00
Plats: Digital, livestreaming via webb

https://www.swissnordicbio.com/

Stockholm Corporate Finance 13:e Life Science-seminarium 

Stockholm Corporate Finance bjuder in investerare, analytiker och finansmedia till det trettonde årliga Life Science-seminariumet i samarbete med Financial Hearings. Moderator under dagarna är Charlotte Stjerngren, partner Cord Communications.

Datum: 23 och 24 mars 2021
Tid: 07.30-12.15
Plats: Digital, livestreaming via webb

Klicka på nedanstående länk för att anmäla dig till seminariumet.
Anmälning via: https://www.lyyti.fi/reg/scf-life-science-seminarium-2021

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.

Attachments, PDF iconovo-signs-agreement-for-development-of-inhaled-oxytocin-in-icoone-for-maternal-health

Iconovo announce that the capsule-based dry powder inhaler ICOcap® has been submitted to U.S. Food and Drug Administration (FDA) by partner Stevanato Group as Type III Drug Master File. New customers to ICOcap® can now reference this DMF submission when developing their drug-device product for the US market. This FDA submission follows a receival of CE-mark in European Union for clinical trials with ICOcap®.

”Stevanato is doing a great job in getting the ICOcap® inhaler globally ready for pharmaceutical companies to develop their products with ICOcap®. Now they have managed to take major steps in two of the largest markets in the world. US, the largest pharma market in the world, is a crucial market to be in with ICOcap®”, says Johan Wäborg, CEO for Iconovo.

About ICOcap

ICOcap is a patented capsule-based dry powder inhaler with a one-piece-design and improved handling features making it easy-to-use. It is currently designed with a low flow resistance but can be customized to a flow resistance of choice. ICOcap™ is available from Stevanato for quick product launch and competitively priced off-the-shelf supply.

Good progress in customer projects

Key figures in TSEK unless otherwise indicated  Jul-Sep 2020 Jul-Sep 2019 Jan-Sep 2020 Jan-Jun 2019 Jan-Dec 2019
Net turnover 5,754 3,474 10,111 11,737 11,737
Operating profit/loss -2,304 -2,036 -13,104 -4,567 -11,774
Cash flow for the period -3,640 -4,908 -17,069 -12,299 36,106
Earnings per share (SEK) before full dilution -0.25 -0.26 -1.62 -0.57 -1.68
Cash and cash equivalents 72,087 40,751 72,087 40,751 89,156
Equity 97,245 60,123 97,245 60,125 108,794
Number of shares at period-end 7,776,000 6,776,000 7,776,000 6,776,000 7,776,000
Number of royalty agreements** 4 3 4 3 3

Significant events 1 July – 30 September

  • Iconovo has signed a regional know-how licensing agreement with BNC Korea Co Ltd. The agreement gives exclusive rights to manufacture, market, sell and distribute two capsule formulations together with ICOcap in the territory. The deal has a milestone value of TEUR 550 and additional future royalties of a medium single-digit percentage of sales.
  • The United States Patent and Trademark Office issued an intention to approve (Notice of Allowance) a patent for the ICOres inhalation platform.

Significant events 1 January – 30 June

  • Amneal joined as a new partner in the development of Iconovo’s project with generic Symbicort. Amneal is taking over all obligations under the current agreement from CBC. The project will proceed according to plan.
  • The ICOcap capsule inhaler has become CE-marked for use in clinical trials and can be purchased directly from Stevanato, which is the manufacturing and distribution partner.
  • Iconovo only anticipates a limited impact from COVID-19 currently and in the future. The company has the required goods in stock, and sales are not physical. The greatest potential impact would be some delay in development in the event that company employees fall ill.
  • Gunnar Gårdemyr was elected to the Board at the Annual General Meeting. Gunnar has a degree in economics from Lund University and over 35 years of experience in the pharmaceutical and biotech industry. Previous positions include CEO of Targovax AS, SVP Commercial development/M&A at Nycomed, Global marketing director at Ferring.
  • Orest Lastow took the role of company Chief Technology Officer (CTO), and Johan Wäborg was hired as the new CEO of Iconovo in April. Orest Lastow, one of the co-founders, is one of the largest shareholders together with the company’s Chairman of the Board. Orest previously combined the position of CEO and CTO. He will now devote all of his time to the role of company CTO. Orest is the inventor behind Iconovo’s three inhaler platforms and will now focus on the development of the new ICOpre platform.
  • On 11 March 2020, an Extraordinary General Meeting was held which decided on an incentive programme and the issue of 200,000 warrants to the future CEO. Subsequently, there was subscription of 200,000 warrants for a total of SEK 1,224,000.
  • The Chinese Patent Office issued an Intention to Grant notification regarding a patent for the ICOres inhalation platform. The European Patent Office, EPO, issued an Intention to Grant notification for the third European patent for the ICOres inhalation platform (which is already covered by three approved Swedish patents, two European patents, and one Japanese patent). The patents describe the technology used in Iconovo’s many customer projects, including generic Symbicort.
  • The European Patent Office, EPO, issued an Intention to Grant notification for the first European patent for the ICOone inhalation platform (which is already covered by two approved Swedish patents). The patent describes the technology used in Iconovo’s vaccine project.

Significant events after the end of the third quarter

  • Iconovo recruited a Director Project Management and a Director Alliance Management. These roles will focus on customer needs and enable the delivery of high-quality customer projects in a planned, efficient manner.

A word from the CEO

Strongest quarter in three years
During the third quarter, significant progress was made in the projects, and several milestones were achieved and could be invoiced to Amneal and Intas. Sales for the quarter amount to SEK 5.8 million, making it the strongest quarter in three years.

Generic Symbicort
The Amneal project with a generic version of Symbicort in ICOres is now in its final phase and work with the final milestones will take place in the next quarter. The final technical delivery will then take place at the beginning of next year and the customer will begin pharmacokinetic studies. The purpose of the studies is to verify that our product gives the patient the same uptake of drug as the original product.

With the technical delivery completed at the beginning of next year and an assumption that the studies will be positive, we can assume that launch in European countries should be possible from early to mid-2023. This timepoint will also mark the start of royalty income for Iconovo from this product.

Important new agreement
In early July, we were able to announce a new customer agreement with BNC Korea. In connection with signing, a technology access fee of EUR 150 000 was paid. The agreement relates to the development of generic formulations of Seebri and Ultibro, which will be used in our ICOcap inhaler.

It is an important agreement for several reasons. Having active customers and business in Asia will help us establish more projects in this part of the world. The contracted territory currently has about 2.7 billion inhabitants, and they are increasing sharply in both number and purchasing power. In the near future, this part of the world may drastically increase its need and consumption of inhalation drugs. The territory currently accounts for approximately 15% of global Seebri and Ultibro sales, which means that the remaining 85% is left as an opportunity for a new contract.

The agreement also serves as verification that a model with early in-house development of certain interesting formulations makes our projects even more commercially viable. Since this leads to a more finished product, it will also be easier for the customer to enter into an agreement.

Other progress during Q3
Our ICOres project with Intas also made good progress in Q3, with subsequent invoicing of milestones. The Intas project will enter a new phase at the beginning of next year, when a period of technical delivery begins. We expect the entire project to be fully delivered by the end of 2022.

COVID-19
COVID-19 has had minimal impact on Iconovo and the work with our projects is progressing according to plan. In business development, it is also possible to maintain a high level of activity through virtual meetings. We look forward to and are planning to reconnect with our customers via physical meetings as soon as possible.

Investments for increased capacity and customer focus
We have recently made many investments that will help us expand our capacity, put further focus on project implementation, and make us even better in attracting new customers.

During the period July-October, we appointed four new highly qualified people: a formulation specialist, a mechanical design engineer, a personal responsible for commercial partnerships and customer relationships, and a senior project manager.

We are also building efficiency and capacity through several investments, including adaptation of the quality system to meet the requirements of the US Food and Drug Administration (FDA), acquisition of modern HPLC equipment, and setup of two new formulation labs. The new labs will lead to higher capacity and efficiency. At the same time, several patents, design protection and trademarks have also been registered. Last, but not least, we are making investments in the development of the new ICOpre platform according to plan.

I consider the investments we are now making, absolutely necessary in order to help the company grow, keep up our pace, and increase our commercial success.

Our investments affect our cash flow, but at the same time are balanced by good invoicing. We are currently well capitalised and had SEK 72 million in cash and cash equivalents at the end of September. At our current burn rate, our capital is estimated to last just over 3 years. This takes us into a period when we are expected to receive royalties, which will provide good profitability in the company.

Optimistic about next quarter
We are now keeping the same high pace in our delivery of current milestones for the rest of the year. We therefore expect to be able to invoice to the same extent in Q4 as we were in Q3.

Johan Wäborg, CEO


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.

Iconovo announces two new recruitments to increase focus on customers’ needs and to deliver their projects in an effective and high-quality manner. With a growing project portfolio and many projects in a very active late phase, Iconovo has made appointments to two new positions that will contribute to an increased capacity for delivering new as well as existing projects.

Iconovo has accordingly appointed the following two new Directors.

Nina Bladh, PhD; has been appointed to Director Project Management. Nina has 25 years of experience in the development of pharmaceutical products. Her previous position was Director CMC Regulatory Affairs at Camurus, Lund, where she has gained considerable experience in taking pharmaceutical combination products to registration and launch. Prior to Camurus, Nina worked 16 years at AstraZenca including project management positions and work with inhalation products. She obtained her PhD in Physical Organic Chemistry at the University of Lund in 1995. Nina will primarily be responsible for leading customer and internal development projects.

Måns Österberg Widerstrand has been appointed to Director Alliance Management. Måns has a broad experience from the pharmaceutical industry. He started his career as a pharmaceutical scientist, later to lead manufacturing and R&D departments while the latest 11 years has been spent in advisory and customer relation roles with KOLs and B2B customers, such as Key Account Manager at Thermo Fisher and Head of Global Generics Sales at Polypeptide. Most recently, Måns held a position as Senior Scientific Advisor Allergy at Thermo Fischer. Måns will be responsible for the alliance management of current customers, follow our projects to market, while developing the business relationship with the customer. He brings a general strengthening of the commercial abilities of Iconovo.

”With joy I can today announce that we have appointed two persons in two newly created key positions. Nina and Måns brings a lot of experience that is directly applicable and complementary to the competence we have in Iconovo today. This is an important investment at a time when we move our existing projects towards final delivery. With these new positions we can intensify our commercial efforts and goal-oriented continue to secure new contracts with customers”, says Johan Wäborg, CEO at Iconovo.

Breakthrough in Asia with a fourth royalty agreement

Key figures in TSEK unless otherwise indicated  Apr-Jun 2020 Apr-Jun 2019 Jan-Jun 2020 Jan-Jun 2019 Jan-Dec 2019
Net turnover 2,425 3,028 4,357 8,263 11,737
Operating profit/loss -5,819 -2,800 -10,800 -2,532 -11,774
Cash flow for the period -9,697 -4,584 -13,429 -7,391 36,106
Earnings per share (SEK) before full dilution -0.82 -0.38 -1.37 -0.31 -1.68
Cash and cash equivalents 75,727 45,659 75,727 45,659 89,156
Equity 99,220 61,893 99,220 61,893 108,794
Number of shares at period-end 7,776,000 6,776,000 7,776,000 6,776,000 7,776,000
Number of royalty agreements** 3 3 3 3 3

**Number of agreements at the end of the period. One further royalty agreement was signed after the end of the period.

Significant events 1 April – 30 June

  • Amneal joined as a new partner in the development of Iconovo’s project with generic Symbicort. Amneal is taking over all obligations under the current agreement from CBC. The project will proceed according to plan.
  • The ICOcap capsule inhaler has become CE-marked for use in clinical trials and can be purchased directly from Stevanato, which is the manufacturing and distribution partner.
  • The Chinese Patent Office issued an Intention to Grant notification regarding a patent for the inhalation platform ICOres. The European Patent Office, EPO, issued an Intention to Grant notification for the third European patent for the ICOres inhalation platform (which is already covered by three approved Swedish patents and two European patents). The patents describe the technology used in Iconovo’s many customer projects, including generic Symbicort.
  • Iconovo only anticipates a limited impact from COVID-19 currently and in the future. The company has the required goods in stock, and sales are not physical. The greatest impact expected to occur is some delay in development in the event that company employees fall ill.
  • Gunnar Gårdemyr was elected to the Board at the Annual General Meeting. Gunnar has a degree in economics from Lund University and over 35 years of experience in the pharmaceutical and biotech industry. Previous positions include CEO of Targovax AS, SVP Commercial development/M&A at Nycomed, Global marketing director at Ferring.

Read more

 

Iconovo has been recognized as a leading solution provider of drug delivery devices by Medtech Outlook when the magazine listed 10 companies that are at the forefront of providing drug delivery device solutions and impacting the industry. Iconovo is profiled in the MedTech Outlook special edition of Drug Delivery Devices.

www.drug-delivery-device.medicaltechoutlook.com/vendor/iconovo-an-experienced-partner-for-the-development-of-inhalation-products-cid-866-mid-96.html

Orest Lastow, CTO and Founder of Iconovo was interviewed by the magazine to describe why Iconovo is a leading provider of inhalation products to the pharmaceutical industry.

“Iconovo represents inhalation experience that is only matched by a handful of companies in the world. I’m really happy that the Iconovo team gets global recognition for these efforts.” says Johan Wäborg, CEO of Iconovo.