SEPTEMBER 25, 2023

Biophytis and Skyepharma, a French pharmaceutical company specializing in the formulation, development and production of pharmaceutical products, announce the signature of a partnership agreement for the production of regulatory batches of Sarconeos (BIO101) for severe forms of Covid-19, with a view to the submission of marketing authorization applications.

Based on the active ingredient produced by SEQENS, Skyepharma will develop finished product batches meeting the GMP (Good Manufacturing Practice) standards required for market access filings. The key stages in the production of Sarconeos (BIO101) will be entrusted to leading, innovative French partners meeting the highest standards of pharmaceutical quality. Pharmaceutical development work at the industrial stage will complete the information required for early access authorizations, particularly in France and Brazil.

Stanislas Veillet, CEO of Biophytis, states: “Following on from the framework contract signed with SEQENS in July for the production of Sarconeos active ingredient (BIO101), this new partnership is a key step for Biophytis as it secures the production of finished product batches of its leading drug candidate, and thus continues our efforts to access our targeted markets.”

David Lescuyer, CEO of Skyepharma, added: “We are delighted to be working alongside Biophytis to develop the regulatory batches for Sarconeos (BIO101). We are also proud to have approvals from the world’s leading health agencies – the FDA in the United States, the EMA in Europe and ANVISA in Brazil – enabling us to ensure the marketing and commercial production of Sarconeos (BIO101) in these countries. For us, it’s a question of putting our expertise at the service of ambitious projects capable of solving major public health issues.”