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AMRI to Receive Second Milestone Payment from Licensing Agreement with Bristol-Myers Squibb
Business Wire, June 12, 2008
ALBANY, N.Y. -- AMRI (NASDAQ: AMRI) announced today it will receive a $4 million milestone payment from Bristol-Myers Squibb Company (NYSE: BMY) as a result of Bristol-Myers Squibb's submission of a Clinical Trial Application (CTA) to the Health Products and Food Branch (HPFB), Health Canada for approval to initiate Phase I studies on an AMRI compound exclusively licensed to Bristol-Myers Squibb. Upon approval of the CTA by Health Canada, Bristol-Myers Squibb may begin Phase I testing in Canada.
This compound is a biogenic amine reuptake inhibitor acting at multiple targets, which may represent a new class of therapeutic agent that could lead to an improved treatment for depression or other CNS disease indications. AMRI and Bristol-Myers Squibb are parties to an ongoing research collaboration to develop treatments for depression and diseases of the central nervous system (CNS). The two companies will continue to evaluate additional compounds under this collaboration.
"We are pleased to announce the achievement of a second milestone in our research collaboration with Bristol-Myers Squibb," said AMRI Chairman, President and CEO Thomas E. D'Ambra. "The advancement of our licensed compound to a Phase I trial is a significant first for AMRI, demonstrating the ability of AMRI's internal R&D efforts to generate valuable assets with commercial potential. We continue to believe that the biological mechanism underlying this approach has the potential to ultimately generate multiple clinical candidates."
"We also want to take this opportunity to acknowledge the substantial investment, support and leadership of Bristol-Myers Squibb, particularly the research team that has led the development of this series from an advanced preclinical stage to where we are today," D'Ambra continued. "From the beginning, Bristol-Myers Squibb's commitment to develop this technology has been outstanding. We look forward to further progress from our collaboration."
This is the second milestone for this first candidate to emerge from the collaboration; AMRI announced a payment of $1.5 million in June 2007, when this compound was nominated by Bristol-Myers Squibb for development. Under the collaborative agreement, AMRI is 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.
About AMRI
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 it 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) 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, 2007 as filed with the Securities and Exchange Commission on March 17, 2008 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.
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