ALBANY, N.Y., Feb. 21, 2017 /PRNewswire/ -- AMRI (NASDAQ: AMRI) today announced that it has entered into an agreement with the pharmaceutical group Ferrer and Accord Healthcare, Inc. ("Accord Healthcare") to jointly develop and manufacture an undisclosed complex parenteral drug product for registration and subsequent commercialization in the United States with the option to partner on additional drug products.
Under terms of the agreement, AMRI will work with Ferrer to develop and initially provide cGMP manufacturing and analytical support for the registration of the new product. Accord Healthcare will be responsible for advancing the product candidate through regulatory submission and commercialization.
William S. Marth, president and CEO, said, "As one of the fastest growing generic companies in the United States, AMRI is very impressed with Accord's performance and excited to be able to extend our deep scientific and product development expertise to help the company advance this product towards the market. Strategic partnerships, such as this agreement with Accord Healthcare, are just one example of how we can help biopharmaceutical companies enhance the value of their innovation and accelerate development and manufacturing, and at the same time we gain access to the benefits of the end market sales of the developed product when they become commercially available."
Gerald Price, president of Accord Healthcare US and Canada, said, "AMRI brings unique capabilities and experience to drug development and manufacturing. We look forward to working with AMRI and Ferrer to leverage the companies' complementary expertise and abilities to address the unique challenges involved in complex drug product development and manufacturing."
Ernest Domenech, COO of Ferrer HealthTech, said, "This agreement with Accord and AMRI provides an excellent opportunity to enter the US market with this product. We are convinced that Ferrer's expertise in the manufacturing of high quality generic drugs combined with the expertise of AMRI and Accord Healthcare will ensure the success of this project in the United States."
About AMRIAMRI 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 Services (DDS), Active Pharmaceutical Ingredients (API), Drug Product (DP), and Fine Chemicals. For more information about AMRI, please visit our website at www.amriglobal.com or follow us on Twitter (@amriglobal).
About Accord Healthcare, Inc. As part of the Intas Group, Accord Healthcare is a young and dynamic pharmaceutical company, involved in the development, manufacturing and distribution of pharmaceutical products to over 70 markets around the world. Accord Healthcare has very rapidly become one of the fastest growing generic pharmaceutical companies with a robust product portfolio in growth oriented therapies, such as Oncology, Immunosuppression, Cardiovascular and Central Nervous System and over 7000 market authorizations (as of December 2016) in various markets. Additional information is available on the company's website atwww.accordhealthcare.us.
About FerrerFounded in 1959, Ferrer is a privately-held Spanish pharmaceutical company, with full vertical integration from R&D to distribution. It is present in more than 95 countries, with 24 international affiliates. Ferrer is active in the pharmaceutical, health, fine chemicals and food sectors; key areas for contributing to people's health and quality of life. The main therapeutic areas covered by Ferrer's pharmaceutical production are dermatology, cardiovascular, CNS, cancer, gastrointestinal, analgesics, bone metabolism, anti-infectives, immunology, diagnostics, OTC and dermocosmetics. Visit www.ferrer.com.
Forward-looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "will," "may," "intends," "anticipate(s)," "plan," "enables," "potentially," "expects," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include, but are not limited to: statements regarding expected future performance of each of AMRI, Ferrer and Accord under the agreement; the parties' ability to work effectively together; statements regarding potential FDA approval; statements made by the CEOs of AMRI and Accord; successful compliance with FDA and other applicable governmental regulations; and the ability of the company's strategic collaborations to perform as expected. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond AMRI'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, Ferrer and Accord will successfully perform each of their respective obligations under the agreement; whether the FDA will ultimately approve the product candidate or candidates developed under the agreement; as well as those risks that are discussed in AMRI's Annual Report on Form 10-K for the fiscal year ended December 31, 2015 as filed with the U.S. Securities and Exchange Commission on March 30, 2016, its subsequent Quarterly Reports on Form 10-Q and its other 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.
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Under terms of the agreement, AMRI will work with Ferrer to develop and initially provide cGMP manufacturing and analytical support for the registration of the new product. Accord Healthcare will be responsible for advancing the product candidate through regulatory submission and commercialization.
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William S. Marth, president and CEO, said, "As one of the fastest growing generic companies in the United States, AMRI is very impressed with Accord's performance and excited to be able to extend our deep scientific and product development expertise to help the company advance this product towards the market. Strategic partnerships, such as this agreement with Accord Healthcare, are just one example of how we can help biopharmaceutical companies enhance the value of their innovation and accelerate development and manufacturing, and at the same time we gain access to the benefits of the end market sales of the developed product when they become commercially available."
Gerald Price, president of Accord Healthcare US and Canada, said, "AMRI brings unique capabilities and experience to drug development and manufacturing. We look forward to working with AMRI and Ferrer to leverage the companies' complementary expertise and abilities to address the unique challenges involved in complex drug product development and manufacturing."
Ernest Domenech, COO of Ferrer HealthTech, said, "This agreement with Accord and AMRI provides an excellent opportunity to enter the US market with this product. We are convinced that Ferrer's expertise in the manufacturing of high quality generic drugs combined with the expertise of AMRI and Accord Healthcare will ensure the success of this project in the United States."
About AMRIAMRI 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 Services (DDS), Active Pharmaceutical Ingredients (API), Drug Product (DP), and Fine Chemicals. For more information about AMRI, please visit our website at www.amriglobal.com or follow us on Twitter (@amriglobal).
About Accord Healthcare, Inc. As part of the Intas Group, Accord Healthcare is a young and dynamic pharmaceutical company, involved in the development, manufacturing and distribution of pharmaceutical products to over 70 markets around the world. Accord Healthcare has very rapidly become one of the fastest growing generic pharmaceutical companies with a robust product portfolio in growth oriented therapies, such as Oncology, Immunosuppression, Cardiovascular and Central Nervous System and over 7000 market authorizations (as of December 2016) in various markets. Additional information is available on the company's website atwww.accordhealthcare.us.
About FerrerFounded in 1959, Ferrer is a privately-held Spanish pharmaceutical company, with full vertical integration from R&D to distribution. It is present in more than 95 countries, with 24 international affiliates. Ferrer is active in the pharmaceutical, health, fine chemicals and food sectors; key areas for contributing to people's health and quality of life. The main therapeutic areas covered by Ferrer's pharmaceutical production are dermatology, cardiovascular, CNS, cancer, gastrointestinal, analgesics, bone metabolism, anti-infectives, immunology, diagnostics, OTC and dermocosmetics. Visit www.ferrer.com.
Forward-looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "will," "may," "intends," "anticipate(s)," "plan," "enables," "potentially," "expects," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include, but are not limited to: statements regarding expected future performance of each of AMRI, Ferrer and Accord under the agreement; the parties' ability to work effectively together; statements regarding potential FDA approval; statements made by the CEOs of AMRI and Accord; successful compliance with FDA and other applicable governmental regulations; and the ability of the company's strategic collaborations to perform as expected. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond AMRI'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, Ferrer and Accord will successfully perform each of their respective obligations under the agreement; whether the FDA will ultimately approve the product candidate or candidates developed under the agreement; as well as those risks that are discussed in AMRI's Annual Report on Form 10-K for the fiscal year ended December 31, 2015 as filed with the U.S. Securities and Exchange Commission on March 30, 2016, its subsequent Quarterly Reports on Form 10-Q and its other 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.
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