USA-based Eagle Pharmaceuticals (Nasdaq: EGRX) and Albany Molecular Research (Nasdaq: AMRI) have agreed to co-develop and manufacture several select and complex parenteral drug products for registration and subsequent commercialization in the USA, 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.
Scott Tarriff, chief executive of Eagle Pharmaceuticals, said: “As we commercialize our FDA [Food and Drug Administration] 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.”
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze