Current report No. 12/2021 – Agreement to terminate cooperation with the company’s current partner in development, manufacturing and commercialisation of an inhalation drug in the US

Current reports March 2, 2021

Legal basis: Article 17 section 1 of the Market Abuse Regulation (MAR) – confidential information. Time: 6:06 PM

Content of the report:

In relation to the information provided in the Prospectus of Celon Pharma S.A. (the “Company”) approved by the Polish Financial Supervision Authority on August 29, 2016 and to the information provided in the Company's annual reports regarding the agreement with Lupin Atlantis Holdings S.A. (“Lupin”) on cooperation in the development, manufacturing and commercialisation of an inhalation drug containing a combination of salmeterol and fluticasone for the markets of the USA and Australia, Canada, Mexico and South Africa, concluded on February 4, 2015 (License and Development Agreement, the “Agreement”), the Management Board of the Company hereby informs that on March 2, 2021 it signed an agreement to terminate the collaboration with the Company in question.

The Agreement provided for Lupin to take all steps to obtain approval by the US Food and Drug Administration (“FDA”) of the application (the “Abbreviated New Drug Application”) for the licensed product in the US and to conduct the entire registration process and to communicate with the FDA as well as to be responsible for completing all post-registration requirements in the licensed territory. As part of the Agreement, the Company also had concluded a Supply Agreement with Lupin under which the Company was required to supply Lupin with a pharmaceutical product approved for marketing in the US by the FDA as well as in Australia, Canada, Mexico and South Africa.

The termination of the above-mentioned agreements does not entail any claims against the Company and also enables Celon Pharma S.A. to start searching for new partners for cooperation on the above-mentioned markets.