Current report No. 26/2022 – Conclusion of the agreement on joint development and commercialization of an inhalation drug containing fluticasone and salmeterol in the US

Current report No. 26/2022

Date prepared: 29/11/2022

Abbreviated name of the issuer: CELON PHARMA S.A.

Topic     Conclusion of the agreement on joint development and commercialization of an inhalation drug containing fluticasone and salmeterol in the US

Legal basis: Article 17 section 1 of the Market Abuse Regulation (MAR) – inside information.

Content of the report:

The Management Board of Celon Pharma S.A. (“Issuer”) hereby announces that on November 29, 2022, it concluded an agreement with Zydus Worldwide DMCC (“Partner”) on joint development of an inhalation drug containing a combination of fluticasone propionate and salmeterol (“Agreement”). The Agreement concerns joint development of a generic product in relation to Advair, i.e. a product of GlaxoSmithKline plc, and providing the Partner with exclusive rights to the commercialization of this product in the US.

Under the Agreement, the Issuer will receive milestone payments for the implementation of particular stages related to the development, registration and commercialization of the drug in question. Moreover, the Agreement provides for profit sharing payments with regard to supplies and sale of the product in the US.

The Agreement term is 7 years, starting from the day of introducing the product to the market, with an option to extend the Agreement term by further 2-year periods.

The Issuer advises that the drug containing a combination of fluticasone and salmeterol is used in the treatment of bronchial asthma and chronic obstructive pulmonary disease (COPD) in adult patients and in children over the age of four.

Zydus Worldwide DMCC is a company which is the subsidiary of Zydus Lifesciences Ltd., a global pharmaceutical company. It is an innovative pharmaceutical group that develops, manufactures and commercializes a wide range of healthcare products.