Phase I Testing to Commence on Second Compound Developed from AMRI, Bristol-Myers Squibb Collaboration
AMRI to Receive $4.0 Million Milestone Payment from Licensing Agreement
Albany, NY (May 26, 2009) - AMRI (NASDAQ: AMRI) announced today that Bristol-Myers Squibb Company (NYSE: BMY) has submitted a Clinical Trial Application (CTA) to the Medical Products Agency (MPA) in Sweden for approval to initiate Phase I studies on an AMRI compound exclusively licensed to Bristol-Myers Squibb. Upon approval of the CTA by the MPA, Bristol-Myers Squibb may begin Phase I testing in Sweden.
AMRI will receive a $4 million milestone payment from Bristol-Myers Squibb as a result of the submission of this CTA per the collaborative agreement between the two companies. This is the second AMRI compound from this collaboration to be selected by Bristol-Myers Squibb for Phase I testing. Bristol-Myers Squibb initiated a Phase I study on a separate AMRI compound in Canada in 2008.
"We are pleased to announce the advancement of a second AMRI compound toward a Phase I trial by Bristol-Myers Squibb," said AMRI Chairman, President and CEO Thomas E. D'Ambra. "We continue to remain excited about the future prospects for this technology. This development illustrates the ability of AMRI's internal R&D programs to generate valuable assets with commercial potential, creating longer term significant value for AMRI and its stakeholders."
"We again want to acknowledge and thank Bristol-Myers Squibb for their investment, support and leadership in this collaboration, and in particular, the research team responsible for progressing this series from advanced preclinical stage to this most recent development," D'Ambra continued. "We look forward to further progress from our collaboration."
This is the fourth milestone payment in the on-going research collaboration to develop improved treatments for depression and diseases of the central nervous system (CNS) bringing the total milestone and licensing fees earned to date to $17.5 million. The two companies will continue to evaluate additional compounds.
Under the collaborative agreement, AMRI is potentially eligible to receive up to $66 million per compound in development and regulatory milestone payments for the first two compounds, and additional payments of up to $22 million per compound on subsequent compounds. In addition, AMRI will receive royalties on worldwide sales of commercialized compounds.
Founded in 1991, AMRI 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," "potentially," "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) the company's performance under the collaboration with Bristol-Myers Squibb; (b) Bristol-Myers Squibb's continuous utilization of the company's services at levels set forth in the contract; (c) Bristol-Myers Squibb's continued pursuit of programs under which the company provides services; (d) delay or denial of marketing approvals from the FDA resulting from, among other things, adverse FDA decisions or interpretations of data that differ from Bristol-Myers Squibb's interpretations and that may require additional clinical trials or potential changes in the cost, scope and duration of clinical trials; and (e) the outcome of clinical work that will be required to commercialize compounds, as well as those factors discussed in the company's Annual Report on Form 10_K for the year ended December 31, 2008 as filed with the Securities and Exchange Commission on March 13, 2009 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.