WOODCLIFF LAKE, N.J. & ALBANY, N.Y.--(BUSINESS WIRE)--Eagle Pharmaceuticals (“Eagle” or the “Company”) (NASDAQ:EGRX) and AMRI (NASDAQ: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, 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.
About Eagle Pharmaceuticals Inc.
Eagle is a specialty pharmaceutical company focused on developing and commercializing injectable products that address the shortcomings, as identified by physicians, pharmacists and other stakeholders, of existing commercially successful injectable products. Eagle’s strategy is to utilize the FDA’s 505(b)(2) regulatory pathway. Additional information is available on the company’s website at www.eagleus.com.
Albany Molecular Research Inc. (AMRI) is a global contract research and manufacturing organization that has been working with the Life Sciences industry to improve patient outcomes and the quality of life for more than two decades. With locations in North America, Europe and Asia, our key business segments include Discovery and Development Solutions (DDS), Active Pharmaceutical Ingredients (API), and Drug Product Manufacturing (DPM). Our DDS segment provides comprehensive services from hit identification to IND, including expertise with diverse chemistry, library design and synthesis, in vitro biology and pharmacology, drug metabolism and pharmacokinetics, as well as natural products. API supports the chemical development and cGMP manufacture of complex API, including potent, controlled substances, biologics, peptides, steroids, hormones, cytotoxic compounds and sterile API. DPM supports development through commercial scale production of complex liquid-filled and lyophilized parenterals, sterile suspensions and ophthalmic formulations. For more information about AMRI, please visit our website at www.amriglobal.com or follow us on Twitter (@amriglobal).
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended and other securities laws that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Words such as “will,” “may,” “intends,” “anticipate(s),” “plan,” “enables,” “potentially,” “expects,” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to: statements regarding expected future performance of each of AMRI and Eagle under the agreement; the parties’ ability to work effectively together; statements regarding FDA approval; statements made by the CEOs of AMRI and Eagle; successful compliance with FDA and other applicable governmental regulations; the ability of the company's strategic investments and acquisitions to perform as expected, as well as those and other factors that are discussed in Eagle's Annual Report on Form 10-K for the fiscal year ended September 30, 2014, and its other filings with the U.S. Securities and Exchange Commission, as well as those risks discussed in AMRI's Annual Report on Form 10-K for the fiscal year ended December 31, 2014 as filed with the U.S. Securities and Exchange Commission on March 16, 2015, and its other filings with the U.S. Securities and Exchange Commission. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond Eagle’s control, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. Such risks include, but are not limited to: whether AMRI and Eagle will successfully perform each of their respective obligations under the agreement; Eagle's ability to terminate the agreement on short notice; whether the FDA will ultimately approve the product candidates developed under the agreement; and other risks described in Eagle’s filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.