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Replies to post #198351 on Biotech Values
Bickema
12/17/15 2:33 PM
#198353 RE: DewDiligence #198351
DewDiligence
01/11/16 10:14 AM
#198940 RE: DewDiligence #198351
Eagle Pharmaceuticals and AMRI today 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… 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.