Gerresheimer signs agreement with drug development firm ISR for large-scale production of IcoOne nasal inhaler for ISR’s Phase 3 study of its dry powder COVID-19 vaccine; Gerresheimer has annual production capacity of more than 100 million inhalers

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WACKERSDORF, Germany , June 2, 2022 (press release) –

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, industrialization 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.

About ISR Immune System Regulation Holding AB (publ)
ISR is an innovation-driven drug development company in the field of immunotherapy.  The company’s business model is to convert promising preclinical immunological research into game changing vaccination products.  By stimulating the immune system in conjunction with, the administration of a target immunostimulatory immunolides and Immunorhelins molecule, the company aims to fight chronic infections such as HIV, HBV and cancer.  The company is headquartered in Stockholm. 

About Gerresheimer
Gerresheimer is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems. The company is an innovative solution provider from concept to delivery of the product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence and concentration on quality and customer focus. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 10,000 employees and generated annual revenues in 2021 of around EUR 1.5b. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.

ISR 
For further information, please contact:
Ola Winqvist
CEO, ISR Immune System Regulation Holding AB (publ)
E-mail: ola.winqvist@israb.se  
Tel: +46 (0)70 5427939

Gerresheimer
For further information please contact:
Marion Stolzenwald                    
Gerresheimer AG                    
Klaus-Bungert-Str. 4                    
40468 Düsseldorf                    
Tel.: 0211-6181246                    
E-mail: marion.stolzenwald@gerresheimer.com    

Karin Fischer
Gerresheimer Regensburg GmbH
Oskar-von-Miller-Str. 6
92442 Wackersdorf
Tel.: 09431-639 6140
E-mail: karin.fischer@gerresheimer.com

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