Biofrontera AG: Biofrontera transfers clinical research to the U.S.

Leverkusen (pta022/20.02.2024/14:15) - Biofrontera AG announces that Biofrontera AG and Biofrontera Inc. have agreed on an amendment to the existing license and supply agreement (LSA). This amendment provides that Biofrontera Inc. will take over the entire clinical development program, thus reducing the cost burden for Biofrontera AG.

The clinical study program, which includes the clinical studies for the market expansion of Ameluz® in the US, had already been defined in the original LSA between the two companies. Previously, Biofrontera AG had the responsibility and expenses to conduct this clinical trial program and received an agreed transfer price of 50% to 30%, depending on year sales level, of the U.S. sales price of Ameluz® as compensation.

The now agreed switch of responsibilities for the clinical program effective on or before June 1, 2024, will be temporarily offset by a decrease in revenues for Biofrontera AG. Over the next two years, Biofrontera AG will receive 25% of the U.S. sales price, with this share increasing again from 30% to 35% in the following years.

Through this agreement, Biofrontera Inc. is now able to manage its own clinical program, taking into account the needs of the U.S. market, while Biofrontera AG will not have to incur any further costs for clinical developments for the U.S. market. As a result, Biofrontera AG's available resources can now be focused on expanding its portfolio and growing the market in Europe and other countries.

"The strategic agreement allows both companies to focus more clearly on their core businesses. We can be much more flexible in our strategy to expand our market presence in Europe thanks to the newly defined cost structure. In addition, Biofrontera can continue to benefit significantly from the positive growth of the U.S. business. We are therefore very pleased about this new agreement with Biofrontera Inc., which now offers clear advantages for both companies," commented Pilar de la Huerta, Chief Financial Officer of Biofrontera AG.

(Ende)