- Acrux (ACR) has announced its subsidiary, Acrux DDS, has entered an exclusive sales, marketing and distribution agreement with TruPharma
- Subject to FDA approval, TruPharma will commercialise six unnamed products from Acrux's portfolio
- It will also management and sponsor each FDA application as well as the commercial manufacturing and distribution of each product
- The 10-year agreement will see Acrux and TruPharma share the gross profits generated from product sales
- Company shares have gone up a healthy 29.6 per cent and are trading for 17.5 cents each
Acrux (ACR) has announced its subsidiary, Acrux DDS, has entered a 10-year exclusive sales, marketing and distribution agreement with TruPharma in the U.S.
Essentially, TruPharma distributes high-quality prescription pharmaceutical products to the U.S. market. It partners with reliable developers and manufactures to bring niche and limited supply products to its customers.
Subject to approval by the U.S. Food and Drug Administration (FDA), TruPharma will be responsible for commercialising six of Acrux's existing products. It will also be responsible for the sponsorship and management of each FDA application, management of commercial manufacturing, marketing and the distribution of each product.
"We are excited to enter into this agreement with TruPharma and we look forward to developing a long-lasting relationship between the two companies," Acrux CEO and Managing Director Michael Kotsanis said.
These selected products are at various stages of development and have not been lodged with the FDA.
Acrux will continue to conduct the development, scientific and bio-equivalence activities to develop its generic products and seek FDA approval.
The company develops a range of topical products and has an expanding pipeline of products under development.
However, generic product development is usually less time-consuming, costly and complex than the new chemical entity development process. It generally doesn't require new preclinical and clinical studies.
Acrux has a portfolio pipeline of 14 products, two of which have received FDA approval. Out of the 14 products, 11 have not yet been disclosed and are still in the formulation and process development phases.
Acrux and TruPharma will share the gross profits generated from the product sales.
Company shares have gone up a healthy 29.6 per cent and are trading for 17.5 cents each at 11:33 am AEST.