Commercial-stage tropical pharmaceutical developer Acrux Limited (ASX:ACR) has entered into an exclusive development and commercialisation agreement with Amring Pharmaceuticals Inc. in the United States.
Managing Director, Michael Kotsanis, said the product under development generated sales in the United States in excess of $400 million in the 12 months to the end March 2020 based on IQVIA data.
Under the terms of the agreement, Acrux will continue to conduct the development, scientific and bioequivalence activities necessary to develop the generic product and Amring will seek regulatory approval with the US Food and Drug Administration (FDA). Subject to approval by the FDA, Amring will commercialise the product in the United States.
Acrux and Amring will share the development costs and the profits generated from the sales of the generic product.
This is a significant opportunity for both Acrux and Amring and we look forward to developing a long-lasting relationship with Amring,” Mr Kotsanis said.
“This is an important step forward in the development of a complex and exciting product. The development of a generic of this product will benefit patients and provide a platform for continued long term growth.”