Melbourne-based topical pharmaceuticals specialist Acrux Limited (ASX:ACR) has entered into an exclusive sales, marketing and distribution agreement with TruPharma, LLC in the United States
Subject to approval by the US Food and Drug Administration (FDA) TruPharma will be responsible for the commercialisation of six existing products from the Acrux pipeline, including the sponsorship and management of each FDA application, management of commercial manufacturing, marketing and distribution of each product.
Acrux CEO and Managing Director, Michael Kotsanis, said the selected products are at various stages of development and have not been lodged with the FDA.
Under the terms of the Agreement, Acrux will continue to conduct the development, scientific and bioequivalence activities necessary to develop the generic products and seek regulatory approval with the FDA.
Acrux and TruPharma will share the gross profits generated from the sales of the generic products.
The Agreement for each product will have a 10-year term from launch, unless otherwise agreed.
We are excited to enter into this agreement with TruPharma and we look forward to developing a long-lasting relationship between the two companies,” Mr Kotsanis said.
“The agreement marks a significant step forward in achieving Acrux’s transition into the generics market.”
Acrux has successfully developed and commercialised through licensees a number of topically applied pharmaceutical products in the US and Europe.
The company is developing of a range of generic products for the US market by leveraging its on-site laboratories, GMP manufacturing suite, clinical and commercial experience to bring affordable products to market.