Eagle Pharmaceuticals and AMRI have announced that they have entered into an agreement to jointly develop and manufacture several select and complex parenteral drug products for registration and subsequent commercialization in the United States, which will significantly expand Eagle’s portfolio of existing products and product candidates targeting therapeutic areas including oncology, critical care and orphan diseases.
Under terms of the agreement, 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 U.S. Food and Drug Administration (“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 Active Pharmaceutical Ingredients (API) and handling highly-specialized manufacturing requirements. 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,” stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.
“We are very pleased to partner with Eagle as they look to expand their portfolio of innovative products that address unmet needs. We are very impressed with what Eagle is preparing to bring to market and look forward to playing a key role in the advancement of their product portfolio,” said Bill Marth, AMRI’s President and CEO.