Nanoform signs GMP agreement and achieves near-term business target

Published: 17-Nov-2021
Regulatory

Nanoform, an innovative nanoparticle medicine enabling company, announces it has signed an agreement to manufacture GMP (Good Manufacturing Practice) nanoformed material for a European headquartered international company. This follows the Letter of Intent (LOI), signed between the parties in June 2021, to nanoform and develop, manufacture, and commercialise an improved version of a current blockbuster drug

In Q3 Nanoform signed 6 new customer non-GMP projects, taking the total for the first nine months of 2021 to 14 signed customer non-GMP projects (10 in 2020, 2 in 2019). Nanoform has now achieved its near-term business target of “At least 12 new non-GMP customer projects and at least one new GMP customer project in 2021”. The company has therefore achieved all near-term business targets for 2021.

The value of the GMP and non-GMP projects are according to Nanoforms guided business model, €0.5m to €10m per GMP project and €0.05m to €0.5m per non-GMP project. The announced GMP agreement is for early clinical development and therefore in the lower end of the company GMP guidance range. The final contractual terms for commercialisation will be negotiated as the project progresses.

Professor Edward Hæggström, CEO of Nanoform, commented: “Following our clinical results earlier this year, Nanoform now enters its next growth phase; manufacture of nanoformed clinical grade APIs (Active Pharmaceutical Ingredients) for our customers and partners. Our manufacturing expansion is on track and in the coming years we’ll have additional GMP lines in place, catering to our customers’ growing needs for nanoformed APIs.”

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