Iconovo CEO Dr. Orest Lastow took part in an FDA workshop on the evaluation of new methods for characterizing and demonstrating equivalence of OINDP. The workshop was a part of the new GDUFA II initiative and the objective was to discuss how science and technology can be used to reduce the time and effort to register a generic IONDP in the US. It was a fantastic opportunity to discuss this important topic with senior FDA officials and industry representatives.

Iconovo, a Swedish inhalation development company has signed a second major product development and licensing agreement with Intas Pharmaceuticals Ltd.

Iconovo AB has signed a 2.8 million (EUR) royalty-backed product development and licensing agreement with Intas Pharmaceuticals Ltd. The agreement includes an adaptation of Iconovo’s proprietary reservoir inhaler ICOres and the development of a dry powder formulation for treatment of asthma and COPD. The agreement includes a royalty fee when the product reaches the market.

 

“This second agreement is an important milestone for Iconovo. Once again, we validate our business model and capabilities as well as a recognition of our inhalers and our formulation development. We are thrilled to partner with Intas Pharmaceuticals in this development project.” says Dr. Orest Lastow, CEO of Iconovo.

 

Iconovo is developing proprietary dry powder inhaler devices for licensing to pharmaceutical companies. Approx. 500 million people are suffering from respiratory diseases worldwide and the market value reaches 40 billion USD. The fully injection molded and ready to use device range includes; ICOres, a reservoir inhaler, ICOcap, a capsule inhaler and ICOone, a unit-dose inhaler. Iconovo also offers a complete dry powder formulation development. The primary market is generic companies globally planning to enter the inhalation business but lacking access to devices. The devices are primary intended for asthma and COPD but also for vaccines and biomolecules. Iconovo is based at Medicon Village in Lund.

 

About Intas Pharmaceuticals Ltd.

Intas is among the top-10 Indian pharmaceutical companies and the largest privately held pharmaceutical company in India, with annual turnover in excess of US$ 1 billion, of which 60% comes from international operations. The group has an extensive geographic footprint with presence in 70 countries worldwide and more than 80% of export revenue coming from US, UK and EU.

 

In addition to generics formulation, R&D is focused on value added products such as complex formulations, biosimilar, and improved generics using novel drug delivery systems (NDDS). Intas is delighted to strike this deal with ICONOVO and entering, this way, in the challenging respiratory field with this first development and licensing agreement.

 

Contact:

Dr. Orest Lastow, CEO
Phone +46 76-5422220
Orest.Lastow@iconovo.se
www.iconovo.se

Dr. Orest Lastow

ICOres, a reservoir inhaler

Iconovo has had a fantastic year. In May, we raised 2.5 million EUR to invest in our formulation development capability. As a consequence we have moved to new specialized labs and doubled our work force. We now have an in-house capability to develop complete dry powder inhalation products including device, formulation and all the analytical testing it takes. Adding to that we now have equipment and experience to develop both carrier-based and micronized spheronized formulations.

There is a tremendous interest in our devices and our product development service. In just a few years we have become the partner of choice for the development of dry powder inhalation products. We are currently in active negotiations with several potential customers. Next year we expect to have ongoing development projects in all our device platforms ICOres, ICOcap and ICOone.

 

The Team

Iconovo has grown significantly over the last year. Fredrik Gunnarsson is our new analytical chemist. Vesna Åkerberg has joined us and is our director of pharmaceutical development. Mårten Appelgren is our new director of business development. Since the operation has grown, we have recruited Mette Gross as our new CFO. To further strengthen our team we have also recruited Henrik Svedberg, who is a very experienced mechanical engineer and Eva Persson who has over 25 years of formulation experience from AstraZeneca.

 

Formulation Development

Iconovo has made major investments in formulation development equipment, glove box and humidity-controlled labs. The labs are now fully equipped to develop carrier based and micronized spheronized formulations and we can work in a scale up to 1 kg. We have also invested in two climate chambers to enable ICH stability studies. Our analytical lab is equipped with several NGI and HPLC-systems for performance testing of dry powder inhalers.

 

Inhaled Vaccine

Iconovo has now completed a two-year project, which was funded by Vinnova (Sweden’s Innovation Agency). The project aimed to industrialize ICOone, which is Iconovo’s disposable unit dose inhaler. The inhaler has been optimized for ultra-low-cost manufacturing. And we have made it suitable for administration of vaccines. Over the last months we have had many discussions with major pharma companies and also with WHO about possible inhaled vaccine projects.

 

DDL

Iconovo is proud to sponsor DDL this year again. We see DDL as the most important meeting for inhaled drug delivery in Europe and we are looking forward to participate this week. We will have our exhibition booth at the same place as always. Please come visit us at booth 300, just to the left after entering the exhibition hall. Welcome!

Iconovo is proud to sponsor DDL this year again. We see DDL as the most important meeting for inhaled drug delivery in Europe and we are looking forward to participate this week. We will have our exhibition booth at the same place as always. Please come visit us at booth 300, just to the left after entering the exhibition hall. Welcome!

The Swedish Patent and Registration Office, PRV, has granted Iconovo’s first ICOone patent. This is a key milestone showing that Iconovo’s inhalers are novel and inventive. More patent applications regarding ICOres, ICOcap and ICOone will soon enter the PCT phase.

We welcome our two new associates; Maggie Adméus and Henrik Svedberg. Maggie as an Executive Assistant and Henrik as a Mechanical Engineer.

Mårten Appelgren has joined Iconovo as Director Business Development. Mårten has over 25 years experience from the inhalation industry. Mårten has previously been with Teva, Boehringer Ingelheim, Schering-Plough, Novartis and GSK.

We are very glad to announce that Vesna Åkerberg has joined Iconovo as Director of Pharmaceutical Development. Vesna will head the new dry powder formulation development lab. Vesna has over 10 years of formulation experience from AstraZeneca.

Iconovo has moved into new labs and offices at Medicon Village. We have now doubled our space and have several specialized labs and equipment for dry powder formulation development and analytical work. We have also invested in climate cabinets to be able to perform stability studies.

Iconovo has raised 2.3 million EUR to expand the in-house development capacity. We will now be able to offer a comprehensive product development including device, formulation and analytical testing.