(AOF) – Biophytis SA, a biotechnology company at the clinical stage and Skyepharma, (French pharmaceutical company specializing in the formulation, development and production of pharmaceutical products) have signed a partnership relating to the production of regulatory batches of Sarconeos (BIO101) for severe forms of Covid-19, with a view to requests for marketing authorizations.
From the active ingredient produced by Seqens, Skyepharma will develop batches of finished products meeting GMP (Good Manufacturing Practices) standards, necessary for the submission of market access files.
Thus, the key stages of the production of Sarconeos (BIO101) will be entrusted to leading French partners, innovative and meeting the highest pharmaceutical quality standards.
Pharmaceutical development work at the industrial stage will complement the information required for early access authorizations, particularly in France and Brazil.
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Biotechs put to the test
These companies are suffering from a much less favorable economic cycle, which is reflected in particular by a drop in venture capital financing of start-ups. These companies are therefore obliged to carry out layoff plans. Added to this is a much more restrictive regulatory framework. First, in the United States, measures linked to the Inflation Reduction Act (IRA) could have a strong impact on the margins of stakeholders. Indeed, from 2026, the federal Medicare program will be able to renegotiate the price of drugs marketed for nine years (chemical) or 13 years (biological), with discounts that could range from 35 to 60% for biotechs. Likewise, in Europe, with the new drug regulations presented in Brussels in April, the duration of patent protection will be reduced if the innovative treatment is not marketed in all member countries within two years.