ALBANY, N.Y.--(BUSINESS WIRE)--AMRI (NASDAQ: AMRI) announced today that it has entered into a development and long term exclusive commercial supply agreement with Parnell Manufacturing Pty Ltd (Parnell), an Australian company specializing in the research, development and manufacture of veterinary products.
Under the agreement, AMRI will provide process development, manufacturing and supply of active pharmaceutical ingredients (APIs) to support Parnell’s submission of a New Animal Drug Application (NADA) with the United States Food and Drug Administration (FDA) and commercial launch of its veterinary product onto the US market pending regulatory approval. The development and manufacture of this API will take place at AMRI’s facilities in Albany, NY. The product is currently sold commercially in several countries outside of the US including Australia, New Zealand, Singapore, Hong Kong and Dubai.
“We are pleased to support Parnell in its introduction of this important veterinary product to the US market,” said AMRI Chairman, President and CEO Thomas E. D’Ambra, Ph.D. “Our new relationship with Parnell illustrates again AMRI’s ability to provide integrated support covering development and manufacturing to US FDA standards. We look forward to working with Parnell to expeditiously achieve regulatory approval, a successful project launch and great success in the US market.”
“Parnell sought expressions of interest for the development and long term supply of this API from several companies and we are pleased that AMRI was ultimately successful in their tender. This product is an extremely important project for Parnell and the FDA compliant development is paramount to the successful launch,” said Parnell CEO Robert Joseph.
Founded in 1991, Albany Molecular Research, Inc. provides scientific services, products and technologies focused on improving the quality of life. AMRI works on drug discovery and development projects and conducts manufacturing of active ingredients and pharmaceutical intermediates for many of the world’s leading healthcare companies. As an additional value added service to its customers, the company is also investing in R&D in order to expand its contract services and to identify novel early stage drug candidates with the goal to outlicense to a strategic partner. With locations in the U.S., Europe, and Asia, AMRI provides customers with a wide range of services, technologies and cost models.
AMRI Forward-Looking Statement
Statements in this press release that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These statements may be identified by forward-looking words such as “may,” “could,” “should,” “would,” “will,” “intend,” “expect,” “anticipate,” “believe” and “continue” or similar words. Readers should not place undue reliance on our forward-looking statements. The company’s actual results may differ materially from such forward-looking statements as a result of numerous factors, some of which the company may not be able to predict and may not be within the company’s control. Factors that could cause such differences include, but are not limited to (a) FDA approval of the NADA with respect to this product, and (b) Parnell’s continued utilization of the company’s services at levels stated in the contract, as well as those factors discussed in the company’s Annual Report on Form 10-K for the year ended December 31, 2010 as filed with the Securities and Exchange Commission on March 16, 2011 and the company’s other SEC filings. The company does not undertake any duty to and does not intend to update any forward-looking statements contained in this press release after the date of this press release.