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Since entering a collaboration with the Italian healthcare technology company Stevanato Group, Iconovo has taken significant steps towards commercialisation with its ICOcap inhaler platform. After receiving CE-marking for use in clinical trials earlier this year, most recently the device has been submitted to the FDA by Stevanato as Type III Drug Master File, a certification that would guarantee the device a stronger standing globally, especially on the US market.

Iconovo is a Swedish medical device company that develops not only generic inhalers but also dry powder formulations to be used with their inhalers for the treatment of respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD) through its four proprietary inhalation platforms – ICOresICOoneICOcap, and ICOpre. The company’s business strategy partly involves partnering with global healthcare distributors and receive royalty payments through their sales. This gives Iconovo the opportunity to insert itself into a growing global market, and the company has taken several steps to reach that goal.

A great partner in Stevanato

One of Iconovo’s first licensing deals came in 2018, when the company made an agreement with Italian healthcare technology company Stevanato Group for the manufacturing, international sales, and distribution of their ICOcap platform. ICOcap is a capsule-based dry powder inhaler designed to be robust but also easy to use and with the potential to handle different capsule sizes. The device itself has the same function and performance as Boehringer Ingelheim’s capsule-based dry powder inhaler HandiHaler and Novartis’s dry powder inhaler Breezhaler, both of which have been licensed by Stevanato. However, currently, the Breezhaler version is the only one available from Stevanato.

Since beginning the partnership with Stevanato, ICOcap has received a Class I Medical Device certification in conformity with the requirements of Directive 93/42/EEC. This CE marking means that European customers who produce dry powder formulations for treating asthma and/or COPD can now purchase ICOcap from Stevanato and use the device in clinical trials.

Large investments and more visibility in US market

Following the CE-marking announcement, Stevanato stated their intention to invest heavily in the ICOcap platform – part of an almost 400 million EUR investment in manufacturing and R&D programs for drug delivery systems. In the meantime, Stevanato also launched a new product site to increase the visibility of ICOcap underlining its position as an important product for the future, where Iconovo is featured as a service provider for customisations and formulation services. See the site here.

More good news came out of the Iconovo-Stevanato partnership recently when Stevanato announced that it had submitted a Type III Drug Master File (DMF) application to the FDA for ICOcap. This means that new ICOcap customers can now reference this DMF submission when developing their drug-device product for the US market, thus giving ICOcap even more market visibility on a global level.

Iconovo’s CEO, Johan Wäborg, was very pleased with the announcement and overall collaboration with Stevanato:

”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.”

One of two royalty agreements regarding ICOcap

The partnership with Stevanato is one of several that Iconovo has entered in the last two years and one of two agreements regarding ICOcap. The other partnership involving ICOcap was announced this summer when Iconovo signed a licensing agreement with BNC Korea – a deal that gives Iconovo access to a vast territory in Asia representing about 15 per cent of today’s global market for generic formulations of Novartis’ Seebri Breezhaler and Ultibro Breezehaler.  Read more about this agreement here.

However, the deal with Stevanato is expected to generate royalty payments to Iconovo starting in 2022 according to analysts. This would make it the first partnership to show that Iconovo has a business model that can generate more sustainable business opportunities as it moves from 100 per cent milestone income to longer-term royalty income.

Overall, considering the progress made through the ongoing relationship between the two companies and assessing the future potential, Stevanato will remain an important partner for Iconovo, and vice versa.

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.

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