AMRI will develop and initially provide cGMP manufacturing and analytical support for the registration of the new product candidates. Eagle will be responsible for advancing the product candidates through clinical trials and regulatory submissions.
AMRI will be reimbursed certain costs for formulation activities, process and analytical development and manufacture of regulatory submission batches. Following FDA approval, AMRI will supply the products to Eagle pursuant to a commercial supply agreement and receive payments based on Eagle's sales of the products. Eagle will be responsible for U.S. commercial distribution of all approved products, once approved by the FDA.
“As we commercialize our FDA approved products and bring additional products pending approval to market in 2016, this agreement will allow Eagle to expand our portfolio of injectable therapies in a focused and efficient manner by coupling our internal expertise in clinical, regulatory and commercial execution with AMRI’s unique depth of experience with aseptic formulation development, working with complex APIs and handling highly-specialized manufacturing requirements,” said Scott Tarriff, president and chief executive officer, Eagle Pharmaceuticals. With this agreement, we expect to more efficiently scale our development infrastructure and speed our market entry with new products, ultimately building long-term value for customers and shareholders alike.”