(AOF) – Maat Pharma announces that its drug MaaT033 (capsule), currently developed as an adjuvant treatment to improve the overall survival of patients who have received a hematopoietic stem cell transplant, has obtained orphan drug status (ODD) issued by the Agency European Medicines (EMA). This status offers several advantages including commercial exclusivity, clinical protocol assistance, waivers or reductions in regulatory fees.
This is the first orphan drug designation granted to MaaT033 and the third to date for the Company, which has already been granted orphan drug status for MaaT013 in the United States and Europe.
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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 financing by venture capital for start-ups. These companies are therefore obliged to carry out redundancy plans. Added to this is a much more restrictive regulatory framework. First, in the United States, the measures linked to the Inflation Reduction Act (IRA) could have a strong impact on the margins of the participants. Indeed, from 2026, the federal Medicare program will be able to renegotiate the price of drugs marketed for nine years (chemicals) or 13 years (biologicals), with discounts that could range from 35 to 60% for biotechs. Similarly, 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.