The drug development company ISR has signed an agreement with Gerresheimer for large-scale production of the IcoOne nasal inhaler, for its phase III study of its dry powder Covid-19 vaccine
Gerresheimer is an established company with global capacity for the manufacture of medical plastics systems and medical plastic devices.
“We have signed a very important agreement to be able to produce large enough quantities of our game-changing inhaler, to cover the needs of our late-stage development studies and our pivotal phase III program. This agreement also opens the door for further collaborations with Gerresheimer, to produce sufficient quantities of our inhaler to secure our commercial supply chain and the global launch of our exciting dry powder SARS-CoV-2 vaccine,” comments Ola Winqvist, CEO of ISR.
“We are happy and delighted to support ISR with our high expertise in the development, industrialisation and manufacturing of drug delivery devices. With our annual production of more than 100 million inhalers we are the ideal partner for ISR,” says Manfred Baumann, Global Executive Vice President Sales & Marketing, Administration & TCC, Gerresheimer Medical Systems.
ISR is now entering a new phase and securing the long-term partners needed to produce its vaccine for phase III and the market. Iconovo is now starting part two of the previously signed cooperation agreement. The trial investigators recently submitted clinical documentation to the BMRC (Ethics) to start the phase I/II vaccination study and the ISR clinical team staff has established good working relationships with all involved for this phase I/II trial in Dhaka. For the phase III trial, Gerresheimer are now running the design for manufacturing, mold marking and manufacturing the nasal inhaler.