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Leverkusen, Germany (pta010/24.01.2024/11:20) - The international biopharmaceutical company Biofrontera AG (ISIN: DE0006046113) announces that the European Medicines Agency (EMA) has approved a variation to the marketing authorization of Ameluz® for an improved Ameluz® formulation. The U.S. Food and Drug Administration (FDA) had already granted its approval for the variation in September 2023.
The improved Ameluz® formulation does not contain propylene glycol, a component commonly found in semi-solid formulations. The removal of propylene glycol may have a positive impact on the safety profile of the Ameluz® gel eliminating potential risks, particularly regarding the formation of impurities and allergic reactions.
The new formulation will be implemented in Ameluz® production for the U.S. market from 2024 and it is expected that European production batches can also be manufactured with the new formulation in the second half of this year.
"The positive decisions from both authorities are a further milestone in optimizing our product and ensuring product safety. With a newly designed formulation of Ameluz®, Biofrontera can not only offer a superior product with reduced side effects, but this change is also a building block in a complex strategy to extend our market exclusivity," adds Pilar de la Huerta, Chief Financial Officer of Biofrontera AG.
emitter: Biofrontera AG
address: Hemmelrather Weg 201, 51377 Leverkusen
contact person: Investor Relations
phone: +49 (0) 214 87 63 20
ISIN(s): DE0006046113 (share)
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